SOLICITATION NOTICE
R -- National Health and Nutrition Examination Survey (NHANES) Imaging Validation Study
- Notice Date
- 6/21/2016
- 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 Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-DE-2016-162-KEW
- Archive Date
- 7/16/2016
- Point of Contact
- Kyle Wisor, , Kevin Alvarez,
- E-Mail Address
-
Kyle.Wisor@nih.gov, kevin.alvarez@nih.gov
(Kyle.Wisor@nih.gov, kevin.alvarez@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION (INCLUDING BRAND-NAME). The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) on behalf of The National Institute of Dental and Craniofacial Reseach (NIDCR) intends to negotiate and award a Purchase Order without providing for full and open competition (Including brand-name) to Manchester University for the National Health and Nutrition Examination Survey (NHANES) Imaging Validation Study. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541990, All Other Professional, Scientific and Technical Services, with a Size Standard $15M. REGULATORY AUTHORITY The resultant Purchase Order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-88 effective 15 June 2016. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($150,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. FAR Subpart 6.302-1-Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1), provides the authority to sole source. DESCRIPTION OF REQUIREMENT Background The National Institutes of Health (NIH) is the nation's leading medical research agency, and the primary Federal agency conducting and supporting medical discoveries that improve people's health and save lives. The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to "seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability". Through nurturing fundamental research and the development of researchers and public health professionals, the NIDCR aims to promote health, to prevent diseases and conditions, and to develop new diagnostics and therapeutics. Knowledge acquisition through science and effective and efficient knowledge transfer are the means used to contribute to improved quality of health. The Office of Science Policy and Analysis, located in the Office of the Director, develops and coordinates science policy and program planning and evaluation for the Institute. Purpose and Objectives The purpose of this project is to conduct a study to assess opportunities to maximize the data yield from the digital images currently acquired as part of the National Health and Nutrition Examination Survey (NHANES) fluorosis program. By conducting oral examinations on a group of children, then following up with the NHANES fluorosis imaging protocol on these same subjects, it will be possible to 1) characterize the clinical characteristics of the children regarding orthodontic conditions, anterior gingivitis, anterior dental caries, and tooth shade; and 2) determine whether the digital images of the same children enable a valid characterization of the same clinical conditions. Period of Performance (Expected) Base Year: July 15th, 2016 - July 14th, 2017 Option Period 1: July 15th, 2017 - December 15th, 2017 Performance Location Contractor Location Project Description Contractor Tasks/Deliverables: The proposed project comprises the following procedures: 1.Recruitment and arranging access to a group of approximately 400 children age 11 and 12 years old, approximately equally divided between male and female. 2.After obtaining parental consent, performing a visual oral screening of these subjects and selecting 200-300 suitable participants based on the presence of six natural, fully erupted, unrestored maxillary anterior teeth. 3.Obtaining parental consent for this subgroup, enabling further oral examination and digital imaging as follows: a.Using dental personnel trained in epidemiologic methods, and calibrated against a standard examiner for caries examination, and in compliance with all US infection control standards, performing clinical oral examinations on each child, to include: i.gathering tooth surface-level information on anterior dental caries using visual ICDAS protocols; ii.ascertaining tooth color using a standardized shade guide; iii.recording information on the gingival condition of the maxillary anterior region using the modified gingival index as described by Lobene (1986). b.Using dental personnel specializing in orthodontics, record occlusal characteristics and orthodontic treatment need for each subject, including: i.identifying maxillary midline diastema; ii.identifying the presence or absence of crossbite; iii.identifying and measuring open bite; iv.measuring the extent of over jet and over bite; v.measuring incisal alignment (displacement or rotation) to calculate the anterior irregularity index as defined in NHANES III; and vi.recording the Index of Orthodontic Treatment Need (IOTN) including the Dental Health Component (DHC) and the Aesthetic Component (AC). c.All data gathered during the clinical section of the study is to be stored securely on study laptops and copied to a secure online location, and then made available to NIDCR science staff in a secure manner that conforms to HIPAA regulations. 4.Using imaging equipment, image capture software, and capture protocols identical to those currently in use in the National Health and Nutrition Examination Survey (NHANES) fluorosis examination, obtain for each subject six high-resolution, color-calibrated images of the anterior 6 maxillary teeth from three angles (straight-ahead, left 45 degrees, and right 45 degrees): three images in polarized white light, and three in ultraviolet light at 468nm. Images must be simultaneously stored locally and stored securely online, and then made available to NIDCR science staff in a secure manner that conforms to HIPAA regulations. 5.A study manager must coordinate the activities described in this section; must be on-site for the study period, and must report periodically to designated NIDCR staff. Contractor Furnished Equipment The contractor shall use two (2) digital imaging cameras of the type currently used for the NHANES fluorosis examination (University of Manchester (UM) proprietary equipment); laptop computers running NHANES clinical examination and image capture software (MU proprietary software). Deliverables a)Plan and perform the study described in Section 4 by September 30, 2016. b)Provide online access to clinical data (section 3) and captured images (section 4) by December 31, 2016. Contractor Requirements Personnel with specific skills and training in the following areas are required: a)A dental doctorate degree (DDS or equivalent) and 2 years of experience in clinical dentistry. b)An orthodontic specialist c)A PhD in oral epidemiology or equivalent experience. Dental Personnel shall have: a)Expertise in techniques of clinical dental research, with documentation of comparable research projects completed. b)Expertise in imaging of dental fluorosis and other oral conditions. Meetings Occasional phone conferences and one (1) in person conference at the NIH Bethesda Campus mid-September for a period of 14 days. Travel Travel expenses will be covered by the contractor. Personnel Consideration Resumes for project planner, leader, and all staff must be submitted. The resumes should address the capabilities described herein. Security Considerations 1. Applicable security requirements The contractor agrees to abide by all pertinent security recommendations from OMB, HHS, NIH, and NIDCR. 2.A Baseline Security Requirements 2.A.1.Safeguarding Information and Information Systems. The Contractor (and/or any subcontractor) is responsible for the following: a)On behalf of HHS/NIH/NIDCR, protecting federal information and information systems in order to ensure: Confidentiality, which means preserving authorized restrictions on access and disclosure, including means for protecting personal privacy and proprietary information; Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and Availability, which means ensuring timely and reliable access to and use of information. b)Providing security of any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location per clause 52.239-1 of the Federal Acquisition Regulation (FAR) (https://www.acquisition.gov/sites/default/files/current/far/html/52_233_240.html). c)The Contractor is prohibited from subcontracting to companies to conduct HHS business in which foreign governments that support international terrorism have a "significant interest" per 10 U.S.C. § 2327 (https://www.gpo.gov/fdsys/pkg/USCODE-2011-title10/html/USCODE-2011-title10-subtitleA-partIV-chap137-sec2327.htm). 2.A.2. Contract Documentation. The Contractor shall contact the Contracting Officer and/or COR for any NIH/NIDCR templates, policies, forms and other documents necessary to comply with the requirements of this section. All contract deliverables shall be compliant with Section 508. 2.A.3. Contractor Agreement. The Contractor (and/or any subcontractor), performing under this contract, shall not release, publish, or disclose non-public federal information to unauthorized individuals. The confidentiality, integrity, and availability of such information shall be protected by the Contractor in accordance with the governing laws and regulations listed as follows: a)18 U.S.C. 641 (Criminal Code: Public Money, Property or Records) (https://www.gpo.gov/fdsys/granule/USCODE-2011-title18/USCODE-2011-title18-partI-chap31-sec641/content-detail.html) b)18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information) (https://www.gpo.gov/fdsys/pkg/USCODE-2014-title18/pdf/USCODE-2014-title18-partI-chap93-sec1905.pdf) c)Public Law 96-511 (Paperwork Reduction Act) (http://ciog6.army.mil/Portals/1/Policy/Paper Reduction 1980.pdf) 2.C Incident Response a)Per FAR 52.239-1, if new or unanticipated threats or hazards are discovered by either the Government or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party. b)The Contractor (and/or any subcontractor) shall report all suspected and confirmed information security and privacy incidents to the NIH IRT (irt-r@mail.nih.gov), COR, Contract Officer, NIDCR Privacy Coordinator, and other stakeholders, including incidents involving personally identifiable information (PII), in electronic or physical form, within 1 hour of discovery. The types of information required in a cyber-incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. c)The Contractor (and/or any subcontractor) shall provide full access and cooperation for all activities determined by the Government to be required to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. Incident response activities determined to be required by the Government may include, but are not limited to, the following: inspections, investigations, forensic reviews, and data analysis and processing. 2.F Contract Initiation and Close Out 2.F.1 Contractor Responsibilities Upon Physical Completion of the Contract. The Contractor certify that all HHS information has been properly sanitized and purged securely, in accordance with NIST SP 800-88, Guidelines for Media Sanitization, and NIH policies, from Contractor-owned (and/or any subcontractor) systems, including backup systems, used during contract performance. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION Justification Rationale: Only one source is available: The determination by the Government to make a single-sole source is based upon the market research conducted as prescribed in FAR Part 10- specifically the results of the Sources Sought Notice NHLBI-CSB-DE-2016-150-KEW posted 5/25/16 that The University of Manchester is the sole contractor able to provide the required dental imaging services. The Univeristy of Manchester uses imaging equipment and protocols identical to those currently in used in NHANES. It is important to use the same equipment for consistency in the analyzed data. UM is the only contractor that has access to this equipment as they are the developers of it. Its characteristics include the ability to gather high-resolution, color-calibrated images of the maxillary anterior teeth simultaneously in polarized white light and in ultraviolet light at 468nm, from three angles (front, left, and right); and to securely store and index the images. Equipment, protocols, and associated software are all proprietary, and are not available on the market from any source. The SDUM scientific staff presents a combination of oral imaging expertise, operation and maintenance of the approved NHANES imaging equipment and software, experience in the development of image analysis algorithms, and application of these to epidemiological settings. This combination of expertise is critical to the successful completion of the proposed project, and is unique to this contractor. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by July 1st, 2016 9:00 AM EST and must reference number NHLBI-CSB-DE-2016-162-KEW. Responses may be submitted electronically to Kyle Wisor, Kyle.Wisor@NIH.GOV, or by U.S. mail to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch,6701 Rockledge Drive, Suite 6150B, Bethesda, MD 20892-7902, Attention: Kyle Wisor. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."
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