SOLICITATION NOTICE
R -- RECOVERY – Quality Management System (QMS) for the Cancer Genome Atlas (TCGA) Program
- Notice Date
- 5/25/2010
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions-Treatment and Support Branch, Bldg 244, Room 112, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- N02-CO-07030-36
- Point of Contact
- Stanley Allen Knight, Phone: 301-228-4222, Robin M. Irving, Phone: (301) 228-4220
- E-Mail Address
-
knights@mail.nih.gov, irvingr@mail.nih.gov
(knights@mail.nih.gov, irvingr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS ACQUISITION IS BEING ADVERTISED UNDER FULL AND OPEN COMPETITION. The National Cancer Institute (NCI), National Institutes of Health (NIH), is seeking a qualified contractor to establish a Quality Management System (QMS) across the funded activities of The Cancer Genome Atlas (TCGA) program, with the goal of identifying non-conforming data in a timely fashion to ensure data released to the public is of the highest quality possible. TCGA is a comprehensive, collaborative effort led by the National Institutes of Health (NIH) to map the genomic changes that occur in major types and subtypes of cancer. Researchers throughout the nation are using various genome analysis technologies, including high through-put DNA sequencing, to carry out this effort. A pilot project initiated in 2006, focused on three tumor types (brain, ovarian, and lung), established the scientific infrastructure and demonstrated the "proof of concept" needed to mount a large-scale cancer genome mapping project. Based on the success of the pilot, TCGA announced in September 2009 that it will map the genomes of at least 20 additional cancers over the next five years. To facilitate expansion of the program, TCGA will focus on quality as a best management practice, and is seeking a qualified Contractor to define and implement a QMS. These services will include, but are not limited to the following: The Contractor shall establish TCGA-Quality Management (QM) policies, processes and procedures in line with the program organization goals, implement the QMS, and train the staff within the Biospecimen Core Resources (BCR) and the Data Coordinating Center (DCC). In addition, the Contractor shall provide a means to identify, track and report non-conforming data, establish and implement internal audit policies, processes, and methods to verify compliance with the QMS, and provide regular and detailed reports of the status of data quality at all stages in the TCGA workflow. Key to the program will be the establishment of a process and system to ensure data completeness and quality. The Contractor shall establish a QMS congruent with the guidelines described by the Clinical and Laboratory Standards Institute (CLSI) document HS1-A2, "A Quality Management System Model for Healthcare; Approved Guideline - Second Edition" (http://www.clsi.org/source/orders/index.cfm?section=Online_Store&task=3&CATEGORY=QM&PRODUCT_TYPE=SALES&SKU=HS01A2E). CLSI document HS1-A2 proposes Quality Management guidelines for organizations in the medical disciplines and these guidelines are based on a common set of 12 quality elements established by ISO 9001, typically referred to as Quality System Essentials (QSE). It is the intent of the TCGA Program Office to employ a minimal QMS based on 9 of the 12 QSEs. The Contractor shall define the quality policies, processes and procedures around these nine (9) QSEs as they relate to the TCGA program. The QSEs are (1) Documents and Records, (2) Organization, (3) Equipment, (4) Purchasing and Inventory, (5) Process Controls, (6) Information Management, (7) Occurrence Management, (8) Assessments, and (9) Customer Service. To overcome the late stage identification of non-conforming data, the Contractor shall provide a QMS that has the ability to implement a variety of workflow throughput measures and data quality checks across the BCR biospecimen repository, the clinical meta-data repository, and the data coordinating center. To support the regular data quality checks, the Contractor shall implement a QMS that, at a minimum, will provide the means to identify, manage, and track both throughput of samples and available data (including non-conforming data). Ideally, the QMS information management system (IMS) shall also support automated functions to reach into the various TCGA data repositories, perform a pre-defined list of data quality checks, capture the tests that passed and failed, and generate a summary report. Request for Proposal (RFP) N02-CO-07030-36 will be available on or about June 10, 2010, and receipt for proposals will be due on or about 2:00 p.m., Eastern Prevailing Time on July 12, 2010. The RFP will only be available electronically. The RFP may be accessed through the NCI Office of Acquisitions homepage by using the following internet address - http://rcb.cancer.gov/rcb-internet/index.jsp; once at the site, click on Current Requests for Proposals. Under the Section entitled The Cancer Genome Atlas (TCGA) Project, click on solicitation number N02-CO-07030-36 entitled "RECOVERY - Quality Management System (QMS) for The Cancer Genome Atlas (TCGA) Program." Interested parties are expected to review this notice at your firm's own risk. All information required for submission of a proposal will be contained in the electronic RFP package. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE RFP AND ANY AMENDMENTS. FAILURE TO DO SO WILL BE AT YOUR FIRM'S OWN RISK. It is the offeror's responsibility to monitor the above website for the release of this RFP and amendments, if any. This solicitation is anticipated to result in approximately one (1) award to the offeror capable of performing all aspects of the Statement of Work. The contract shall be a cost-reimbursement (completion type) contract and shall be awarded for an eighteen (18) month period of performance with three (3) one year option periods and one (1) six month option period to extend up to a five year period of performance. It is anticipated that the eighteen (18) month base period shall be funded utilizing American Recovery and Reinvestment Act (ARRA) funding. The option periods, if exercised shall be supported by appropriated funds. All responsible and qualified sources may submit a proposal which shall be considered by the Government. This advertisement does not commit the Government to award a contract. No collect calls will be accepted. The North American Industry Classification System (NAICS) code for this project is 541990, with a size standard of $7 million. Point of contact: Stanley A. Knight, Contracting Officer, Treatment and Support Branch, P.O. Box B, 244 Miller Drive, Room 104, Fort Detrick, Frederick, Maryland 21702-1202. If courier service is used, the address above is the same except delete P.O. Box B, 244 Miller Drive, Room 105 and replace with Building 244, Room 105. The Contracting Officer can be reached at knights@mail.nih.gov; telephone 301-228-4222 or facsimile 301-228-4240. Collect calls will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF2/N02-CO-07030-36 /listing.html)
- Place of Performance
- Address: Contractor Facility, United States
- Record
- SN02159464-W 20100527/100525235036-3c1cd86a29a0e86da52135c72b4577cb (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |