Inactive

This is a Small Business 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 availabil... This is a Small Business 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 requirement. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the NAICS code 621511 for the potential acquisition. Responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Additionally, organizations submitting information must have an active registration in the System for Award Management (SAM). The Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS) seeks to contract with a CLIA - certified laboratory to obtain laboratory to to obtain laboratory measurements on biological specimens for the following sample types: Refrigerated biologic samples for a standard biochemistry profile, consisting of 25 analytes: albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, blood urea nitrogen (BUN), creatine phosphokinase (CPK), creatinine, gamma glutamyl transferase (GGT), glucose, iron, lactate dehydrogenase (LDH), magnesium, phosphorus, potassium, sodium, chloride, total bilirubin, total calcium, total cholesterol, total protein, triglycerides, uric acid, globulin (calculated), and osmolality (calculated) on participants ages 12 years and older; Frozen biologic samples for iron status, consisting of two (2) analytes: iron and unsaturated iron binding capacity (UIBC) on participants ages 12 years and older; and high-sensitivity C-reactive protein (hs-CRP) on participants ages 1 year and older. The contractor shall provide all labor, equipment, supplies, services, permits, and licenses necessary to perform these measurements, develop the manual and perform tasks included in the Statement of Work (SOW). The attached draft SOW contains additional details about the work. Anticipated period of performance is approximately 56 months. Capability statement /information sought. Respondents believing that they possess the expertise and experience to meet the government's needs described in the SOW are invited to submit technical and management capabilities addressing those requirements. These may include but are not limited to: (a) staff expertise, including staff availability, experience, and formal and other training and (b) examples of prior completed Government contracts, references, and other related information. Below are the minimum qualifications that a laboratory will have to meet to be considered as capable of successfully performing this work. Capability submittals must document the following qualifications: 1. Operation of a CLIA certified laboratory 2. Ability to keep quality control information relevant to this project for at least three (3) years after the conclusion of the contract. 3. Ability to keep a laboratory log containing a record of the status of all vials upon arrival, date of receipt, deviations from protocol or good laboratory practice, and an account of all vials. In addition, a record of all handling, storage, and manipulation of samples, which might affect the quantitative results reported (e.g., freezing, thawing of sera, spilled, contaminated). Must demonstrate an existing CLIA-compliant processes for tracking receipt and processing of NHANES samples from receipt in the lab, to output of the analysis product in accordance with the Statement of Work. 4. Maintainence of a quality assurance system by which random or systematic errors may be detected and monitored. 5. Operation of a secure storage facility (-70 degrees C for sera) for storing any residual (excess) sera greater or equal to 0.2 mL remaining in vials after analysis for at least one (1) year. The government will pay for shipment of returned residual samples. 6. Enrollment in a proficiency-testing program through independent laboratories such as the College of American Pathologists (CAP) or a comparable program, and report the results of the proficiency testing to the COR in the quarterly reports. 7. Documentation verifying performance specifications comparable to those established by the manufacturer for the following four (4) performance characteristics for a standard biochemistry profile, iron status biomarkers, and hs-CRP: • accuracy; • precision; • reportable range of test results; and • manufacturer's reference intervals (normal values) for each of the 28 analytes listed in the requirement. 8. Implementation of Westgard quality control rules for a standard biochemistry profile, iron status biomarkers, and hs-CRP. 9. Implementation of guidelines for the prevention of HIV transmission in health-care settings. 10. Ability to perform analytical methods that are practical and reliable. Practicality of methods will be based on speed, cost, technical skill required, dependability and safety, and must be included in the proposal 11. Indicate acceptable alternative methods or analytical test systems (backup instrumentation) and recommended storage conditions including optimal and maximum storage time for sample retention. Additionally, a respondent must include the following in its capability statement: - Organization name - Address - DUNS number - Business size and Classification (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code of 621511 with a size standard of $35.0 M. - Point(s) of contact - Emails for contacts - Telephone numbers for contacts Response Due Date. Submit information regarding the above to Eric D. Sullivan, Contracting Officer via email at LRV4@cdc.gov and Reference: CDC-2021-46540-SBSS-EDS. Responses are due no later than 3:00 PM Eastern Time on December 4, 2020. Responses must be submitted via email addressed to LRV4@cdc.gov. Any information received by the government will not be returned. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response to this notice. 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).