SOURCES SOUGHT
B -- Standardization Program to Improve the Clinical Measurement of Glycohemoglobin & C-peptide
- Notice Date
- 4/8/2010
- Notice Type
- Sources Sought
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2010-N-12096
- Archive Date
- 5/8/2010
- Point of Contact
- Richard Jenkins, Phone: 7704882604, Richard Jenkins, Phone: 7704882604
- E-Mail Address
-
rjenkins@cdc.gov, rjenkins@cdc.gov
(rjenkins@cdc.gov, rjenkins@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction. "This is a Non-Research and Development (NonR & D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential NonR & D requirement." The proposed NAICS code for this requirement is 541380, Size Standard is $10.0 Mil. Background. The Centers for Disease Control and Prevention (CDC) has been and is actively represented on the National Glycohemoglobin Standardization Program (NGSP) Steering Committee, which has a critical role in the operation of the program. Of major interest to CDC is the established primary reference method, the availability of QC and reference materials, and comparative performance data analysis. CDC, Center for Environmental Health, Division of Laboratory Sciences has been funded and charged with the task to improve diagnostic care for diabetes. Specific goals include providing improved measurement of GHB testing through long term standardization of current and emerging test methods, developing a definitive reference method for HbA1c, and developing methods and interventions for improved care of type 1 and type 2 diabetes. Diabetes mellitus is a chronic disorder characterized by insulin deficiency, hyperglycemia, and high risk for development of complications of the eyes, kidneys, peripheral nerves, heart and blood vessels. The disease is highly prevalent, affecting as many as 16 million people in the U.S. Trends show that minority and elderly populations are disproportionately affected by diabetes. It is estimated that approximately 1 in every 7 health care dollars spent in the U.S. goes to diabetes care - mostly for treatment of the chronic complications. In the U.S., diabetes is the most common cause of blindness in young adults, kidney failure, and non-traumatic limb amputation. The landmark nine-year Diabetes Control and Complications Trial (DCCT), completed in 1993, showed conclusively that the risk for development and progression of the chronic complications in patients with type 1 (insulin dependent) diabetes mellitus is directly related to blood glucose control as assessed by serial glycohemoglobin (GHB or hemoglobin A1c (HbA1c)) determinations. GHB was determined to be a reliable index of average blood glucose during the previous 2-3 months that could be used routinely to monitor glycemic control in diabetic individuals. Based on the DCCT results, the American Diabetes Association (ADA) developed a series of specific diabetes treatment goals using GHB as an index of mean blood glucose. However, the fact that GHB assay methods had not been well standardized among laboratories prevented optimal use of the test. Subsequent studies showed the advantages and feasibility of standardizing GHB assays, and a candidate reference method for GHB was proposed. Because of the positive impact standardization of GHB determinations would have on the care of diabetic patients, the American Association for Clinical Chemistry (AACC) Standards Committee established a GHB Standardization Subcommittee in April 1993 - with active representation by the Centers for Disease Control and Prevention (CDC). The goal of the subcommittee was to develop a plan for GHB standardization that would ultimately allow individual clinical laboratories to relate their GHB assay results to those of large-scale studies such as the DCCT, where relationships of GHB values to mean blood glucose and to risks for developing chronic diabetic complications have been established. Purpose and Objective. The purpose of this project is to establish and operate a standardization program for glycohemoglobin (GHB) testing so that clinical laboratory results are comparable to those values reported in the Diabetes Control and Complications Trial (DCCT). The contractor will be required to: (1) establish and maintain the DCCT primary reference method; (2) establish a network of reference laboratories, all of which maintain reference methods or precise methods traceable to the reference method; (3) monitor Network Laboratories monthly to meet monitoring criteria; (4) interact with manufacturers of GHB methods through the Network, providing assistance in standardizing their methods and then providing comparison data for certification of traceability to the DCCT; (5) provide assessment of effectiveness of the program through evaluation of independent Proficiency Testing data from College of American Pathologists (CAP); (6) provide data and reference materials to assist CDC in the development of definitive reference method; (7) establish and maintain a C-peptide standardization program for select laboratories following guidelines provided. Project Requirement. The contractor shall, as an independent organization, and not as an agent of the Government, furnish all labor, materials, facilities, and equipment necessary to establish and maintain a GHB standardization program following the American Association of Clinical Chemistry (AACC) Standards Committee's protocol. The program shall establish and monitor a voluntary network of reference laboratories for GHB testing, which, in turn, interact with manufacturers of GHB methods to (1) assist in standardizing their methods; and (2) provide comparison data for certification of traceability to DCCT primary reference method. Two elements are key in the design of the program: (1) an Administrative Center to coordinate certification processes, analyze certification and monitoring data, and issue certificates of traceability; and (2) a Central Primary Reference Laboratory that analyzes GHB by high performance liquid chromatography (HPLC) using Bio-Rex 70 resin, sets the initial calibration based on the "set-point" used in the DCCT, and administers a monitoring program for all certified laboratories. (Voluntary primary reference laboratories, which serve as back-up laboratories for the central laboratory, and secondary reference laboratories, which maintain methods traceable to the central laboratory, assist manufacturers in standardizing their methods, and provide comparison data for certification.) Note that a "steering committee" was established to provide expert direction and review for the NGSP and is expected to continue in this capacity. Period of Performance. The period of performance shall be a Base year of 12-month and One (1) 12 month option year. Capability statement /Information sought. Please explain, in detail, your experience, knowledge and ability to provide the following: Your opinion about the difficulty and or feasibility of the potential requirement or proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts. Your staff expertise, including your availability, experience, and formal and other training. Your current in house capability and capacity to perform the work. Your completed projects of similar nature. Your corporate experience and management capability. Provide any examples of prior completed Government contracts, reference, and other related information. Provide a rough order of magnitude (estimate cost) of the effort or time that may be required for completion of the work. The Government will not return capability statements received. Information Submission Instructions: Please include a cover page with the following business information: a) DUNS: b) Organization name and address c) Do you have a Government approved accounting system? If so, please identify the agency that approved the system. d) Business size and type of business, (e. g., small business, 8(a), woman owned, veteran owned, etc.) pursuant to the applicable NAICS code 541380, size standards which is $10.0 M. e) Point of Contact, phone, fax and email address of individuals who can verify the demonstrated capabilities identified in the response. Page Limitation : Capability Statements shall be limited to 6 single-spaced pages including cover page. Pages shall be formatted as follows: MS Word, 8 ½ x 11, 12 pitch, Times New Roman font with one (1) inch margins. Response Due Date : Submit capability statements and questions, via email to Richard Jenkins, Contract Specialist at rjenkins@cdc.gov with reference to (2010-N-12096) in the subject line. Responses must be submitted not later than 10:00 am, Eastern Standard Time (EST) by April 23, 2010. Capability statements will NOT be accepted after the due date. The Government will not return capability statements received. "Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2010-N-12096/listing.html)
- Place of Performance
- Address: 3919 North Peachtree Road, Chamblee, Georgia, 30341, United States
- Zip Code: 30341
- Zip Code: 30341
- Record
- SN02117187-W 20100410/100408235720-5d17262fc19f4e36a4e0f9559f5ba189 (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 |