SOLICITATION NOTICE
Q -- Allele Level Typing by SNA-Sequencing Based Methods
- Notice Date
- 7/28/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMLC, 1681 Nelson St, FT Detrick, Maryland, 21702-9203
- ZIP Code
- 21702-9203
- Solicitation Number
- N62645-08-R-0019
- Response Due
- 8/13/2008
- Archive Date
- 8/28/2008
- Point of Contact
- Tameka N Davis,, Phone: 301-619-1677, Burzie C Baker III,, Phone: 301-619-0707
- E-Mail Address
-
tameka.davis@med.navy.mil, burzie.baker@med.navy.mil
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12.6, Streamlined Procedures for Commercial Items, as supplemented with additional information included in this notice. Also, this acquisition is being conducted under FAR 13.5, Test Program Procedures for commercial items. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is N62645-08-R-0019 The solicitation is issued as a request for proposal (RFP). Provisions and clauses in effect through Federal Acquisition Circular 05-24 are incorporated. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses: www.acqnet.gov/far and www.acq.osd.mil/dpap/dfars/index.htm. The NAICS code is 621511, with a small business size of $12.5 million. This is a Full and Open Competition requirement; all qualified vendors are encouraged to submit a proposal. The Naval Medical Logistics Command request responses from qualified sources capable of HLA-A, B, C, and DRB1 allele level typing by DNA-Sequencing-based method with the following Statement of Work: Statement of Work: This contract is being offered to perform allele level testing on a large number (11,000) of volunteer donors at the time of initial recruitment as potential marrow donor volunteers for the C. W. Bill Young / DoD Marrow Donor Program and National Marrow Donor Program (NMDP). This award will result in a significant increase in the number of completely resolved allele typed donors on the DoD and NMDP donor files. The HLA types of these volunteers will be entered into the DoD and NMDP donor files as it is for all newly registered donors. These allele typed donors are likely to become available for transplantation for searching patients more rapidly than those donors typed at the current standard intermediate level typing. In addition to becoming more rapidly available, the Navy and NMDP will be able to determine what fraction of newly recruited volunteers add new HLA allele types and HLA allele level haplotypes (combination of HLA-A, HLA-B, HLA-C, and HLA-DRB1) to the donor files The ability to more rapidly find donors; the ability to better determine the percentage of newly entering donors have novel HLA alleles and haplotypes; the ability to better determine the likelihood that each searching patient will be able to find a match; and the ability to improve the methods used for donor searches are each important for both individual patients and our ability to develop plans for future needs of the program to respond to needs of patients and potential casualties. •The donors HLA typed through this contract shall be fully characterized at the allele level for each DNA base in the part of the HLA gene responsible for the biologic function of the molecule defined here as exons 2 and 3 for HLA-A, HLA-B and HLA-C, and exon 2 for HLA DRB1. • For this contract, there shall be no ambiguity of HLA typing in the specific exons based on the complete list of HLA allele definitions for HLA-A,-B,-C, and -DRB1 as of the definition of January 2008 (WHO Nomenclature Committee for Factors of the HLA System, January 2008). •To assure that all DNA bases that make up the HLA gene for exon 2 and 3 for HLA class I and exon 2 for HLA Class II are characterized, the typing shall be performed by individual base DNA sequencing (for example, Sanger sequencing). Other DNA typing methods may not always assure the positive typing of every nucleic acid position. Incomplete typing creates the likelihood that some new alleles will be missed, the precise allele typing data would be incomplete, and the requirements of this contract would not be accomplished. •Buccal swabs from all 11,000 donors will be sent in a single shipment to the contract recipient by Federal Express. Each sample will be identified by a unique bar code provided by the Navy. There will be no personal identifiers on any sample. •All testing and data submission and data acceptance for marrow donor transplant searching and data analysis to the Navy and to the National Marrow Donor Program shall be complete in 30 days for 95% (10,450 of the samples) and the remaining 5% (550 samples) shall be complete by a total of 60 days from original receipt of the samples for testing. •Individual DNA base data shall be reported electronically in a format specified by the Navy. Data is to be reported as consensus sequence using only IUPAC nucleic acid symbols (a,c,g,t) in either upper or lower case. The format is FASTA/Pearson and there can be any number of sequence lines, of any length to represent the nucleotide sequence. Complete primer sequences shall be registered with the NMDP and the primer name shall identify the locus and exon the primer amplifies. The primer shall be given a score of “8” in the probe scores section to indicate successful amplification. •Submitted data will be the property of the Navy. The contractor may use the data for public scientific reporting of new alleles, and will work with the Navy to be sure the same data is not reported twice. The Navy may perform additional analysis and report genetic data. Where appropriate, data analysis can be performed in a way including the contractor, Navy investigators, and investigators participating in the NMDP and NMDP programs. •Quality control samples will be included for quality control purposes as part of the original shipment consistent with existing NMDP and Navy quality control programs and error rates will be no greater than accepted by NMDP for contract laboratories. The Navy will randomly select approximately 100 samples sent to the contractor and will repeat the DNA sequence. If there is a discrepancy, the discrepancy will be verified. The error rate shall be less than 1.5% of the samples tested by the Navy containing any error on any locus by the contractor. •Data reporting requirements for typing result and underlying data shall be reported to the NMDP and Navy consistent with existing NMDP data reporting requirements (modified if necessary to be consistent with this data). Data is to be reported as consensus sequence using only IUPAC nucleic acid symbols (a,c,g,t) in either upper or lower case. The format is FASTA/Pearson and there can be any number of sequence lines, of any length to represent the nucleotide sequence. Complete primer sequences shall be registered with the NMDP and the primer name shall identify the locus and exon the primer amplifies. The primer shall be given a score of “8” in the probe scores section to indicate successful amplification and will be used for patients searching for matched donors and for data analysis to determine likelihood of patients finding allele matched donors and likelihood of each donor to express a unique HLA allele or unique haplotype at the HLA allele level. •Additional data may be required by the Navy for underlying intermediate results, for example electropherograms, and shall be available electronically so that unusual typing results could be analyzed. An electropherogram is a specific graphic representation of DNA sequence data and is automatically provided by the sequencing equipment. This can be readily sent in a computer file. For some of the data, there may be a result that needs further explanation and we will need to look at the original data to understand how the contractor obtained the answer. •The potential contract recipient shall have an existing contractual relationship with the National Marrow Donor Program to submit HLA testing data for inclusion of HLA data for inclusion as volunteer donors on the NMDP registry and for quality control of HLA typing data. •The potential contractor shall routinely submit 2,000 or more HLA typing results per month to the NMDP with a typing accuracy acceptable as an NMDP contract typing laboratory. NMDP has routine quality requirements by testing imbedded quality control samples, for initial donor typing that has no more than 1.5% error rate. •The potential contractor shall demonstrate the capability to HLA type large numbers of samples at the fully resolved level for allele testing for HLA-A,-B, -C and DRB1 using individual base DNA sequencing (for example Sanger sequencing). •The laboratory shall have current American Society for Histocompatibility and Immunogenetics inspection approval as required by NMDP standards for HLA data submission by NMDP contract laboratories and associated CLIA / CLIP approval for HLA testing required by this contract at time of award. •It is expected that a small percentage of the buccal swabs will not contain adequate amount of test sample. For these, the Navy will attempt to provide additional samples which contain adequate amounts of DNA, but the Navy may substitute a sample from another volunteer if additional sample from the original donor is not available. The data submission deadline will reflect the date the test laboratory receives the new buccal swab ( 95% of samples complete by 30 days and 100% complete at 60 days post receipt of sample). •There is also the potential for DNA amplification failure because of an unexpected HLA allele, particularly if the new allele is located in the primer site. For these, it may be necessary to use unique DNA primers to accomplish amplification and subsequent HLA sequencing. The laboratory shall complete typing for those samples with unexpected HLA alleles. There will be no additional charge to the Government for additional laboratory testing for samples with unusual types or amplification failure that require additional laboratory testing or additional sample and repeat or replacement testing. The estimated period of performance is 30 September 2008-30 November 2008. DELIVERY AND ACCEPTANCE: Results shall be sent electronically to the email address specified in the award EVALUATION FACTORS FOR AWARD: Offerors shall provide in sufficient detail a technical proposal that shall meet or exceed each of the requirements of the Statement of Work The Government intends to award a contract resulting from this solicitation to the responsible offeror whose offer is the Best Value, price and other factors considered. The technical and past performance factors below, combined are significantly more important than price, and are listed in descending order of importance. Technical Factors A-D will be evaluated individually on a pass/fail basis. If an offeror’s technical proposal is judged to have failed any one of the Factors A-D the firm’s offer will receive no further consideration for award. If an offeror’s technical proposal is judged to have passed all Factors A –D (Minimum Technical Qualifications), then the offeror will subsequently be evaluated on Technical enhancing factor E, Past Performance and Price. However, price may become a critical factor in the event that two or more offerors are determined to be essentially equal following the evaluation of technical and past performance factors. Evaluation of price will be based on the offeror’s total price. Minimum Technical Qualifications. To be qualified for this award, offers must have the following: (A)Current American Society for Histocompatibility and Immunogenetics inspection approval (B)Existing contractual relationship with the National Marrow Donor Program as a large volume HLA testing laboratory to submit HLA testing data for inclusion of HLA data for inclusion as volunteer donors on the NMDP registry and for quality control of HLA typing data. (C)Average monthly data submission, for at least one year, of 2,000 or more HLA typing results per month to the NMDP with an error rate of less than 1.5%.This includes laboratory certification by ASHI and CLIA / CLIP certification (D) ASHI Certified Personnel If an offer meets all of the minimum qualifications listed in the paragraph above entitled, "Minimum Technical Qualifications" the offeror will be ranked against all other offerors. Factor E identified below will be the evaluation factor used to evaluate all offers passing all Minimal Technical Evaluation Factors A-D. Technical Factor to be used in a Contract Award Decision: (E) Ability to HLA type large numbers of with quality systems as defined by ASHI’s standard operating procedures with an error rate below 1.5% using individual base sequencing methods (for example Sanger sequencing) and the demonstrated ability to resolve the HLA allele assignment for all bases in exon 2 and exon 3 for HLA-A, HLA-B and HLA-C and for all bases for exon 2 for HLA-DRB1 with no HLA assignment ambiguity within 30 days for 95% of the data once samples are received and within 60 days from receipt of the samples for the remaining 5%. Experience and quantity of personnel, facilities, suppliers, analytic capability, reporting systems and high volume methods may be assessed when evaluating this factor. Past Performance Evaluation Factors (i) Provide dates of contracts, both NMDP and non NMDP or commercial, for the same work of similar size and complexity performed in the past three year period as follows: Name, address, and telephone number of the contracting organization; contract number and dollar value; date of contract and period of performance; and brief description of contract. For Government contracts, identify the name and telephone number of the procuring and administrative Contracting Officer(s). (ii) Quality: State for each contract cited above, the total error rate Price Evaluation Factors (i)Completeness. The offeror has submitted a total price, completed all required representations and certifications, and acknowledgement of any amendments. (ii) Reasonableness. The Government's determination that the proposed price is fair and reasonable based on price analysis. (iii) Realism. The offeror's prices shall be examined to identify unusually low pricing and potential misunderstanding of the requirements The offeror’s initial proposal shall contain the offeror’s best terms from a price and technical standpoint. The Government intends to evaluate offers and award a contract without discussions, but reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government reserves the right to award to other than the lowest offeror if the Government determines that a price premium is warranted due to technical merit. The Government reserves the right to award to other than the highest rated offeror. The Government reserves the right to make no award as a result of this solicitation. INSTRUCTIONS TO OFFERORS: Offerors shall provide sufficient technical documentation (including but not limited to: product literature, specifications) to allow for thorough evaluation of proposal. Additionally, the vendor shall fully explain their ability to meet the requirements above. Proposals shall be no more than ten pages with 12 point, Times new Roman font. Margins shall be no less than one inch on all sides Shipping shall be FOB Destination. Proposal shall specify the Total Price. Adequate competition is anticipated for this acquisition. The government anticipates award of a Firm Fixed Price contract. Offerors shall submit firm-fixed pricing for all above requirements. Include commercial price lists and if applicable, any Federal Supply Schedule (FSS) numbers and pricing. Include any applicable discounts to the Government. Other Administrative Instructions: Central Contractor Registration (CCR). Offerors shall be registered in the CCR database to be considered for award. Registration is free and can be completed on-line at http://www.ccr.gov; provide DUNS number; Cage Code and TIN. FAR Provisions & Clauses: FAR 52.212-1, Instructions to Offerors---Commercial Items FAR 52.212-3 Offeror Representations and Certifications-Commercial Items; FAR 52.212-4, Contract Terms and Conditions---Commercial Items; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items. In compliance with said clause, the following FAR clauses apply: 52.219-8, Utilization of Small Business Concerns; 52.222-3, Convict Labor; 52.222-26, Equal Opportunity; 52.222-35, Affirmative Action for Special Disabled and Vietnam Era Veterans; 52.222-36, Affirmative Action for Handicapped Workers with disabilities; FAR 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct 2003) (31 U.S.C. 3332). Offerors are reminded to include a completed copy of 52.212-3 with RFP response. All clauses shall be incorporated by reference in the order. DFARS 252.212-7000, Offeror Representations and Certification-Commercial Items; DFARS 252.212-7001, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders---Commercial Items, In compliance with said clause, following additional DFARS clauses apply: 252.225-7001, Buy American Act and Balance of Payment Program; 252.225-7012, Preference for Certain Domestic Commodities, 252.225-7021, Trade Agreements; 252.227-7015, Technical Data—Commercial Items; 252.232-7003, Electronic Submission of Payment Requests; 252.243-7002, Requests for Equitable Adjustment; 252.247-7024, Notification of Transportation of Supplies by Sea. DFARS 252.225-7000, Buy American Act-Balance of Payments Program Certificate. Proposals are due by 3:00om Eastern Time on 13 August 2008. Proposals shall be submitted by email only as a MS Word or Adobe PDF attachment to: tameka.davis@med.navy.mil. Any questions shall be addressed to tameka.davis@med.navy.mil by email only NLT 08 August 2008 No phone calls accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=74e30a192201eb62ead9e396d924351f&tab=core&_cview=1)
- Place of Performance
- Address: Naval Medical Logistics Command, 1681 Nelson St, Fort Detrick, MD, Rockville, Maryland, 20852, United States
- Zip Code: 20852
- Zip Code: 20852
- Record
- SN01625042-W 20080730/080728223922-2ee5fe7ba7d563a89413f04a6684113c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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