SOLICITATION NOTICE
B -- Set-up & Maintain a Secure File Repository of Radiographic Images, & Associated Relevant Medical Information, Relating to Occupational Respiratory Diseases, Particularly Those Associated with Pneumoconioses
- Notice Date
- 7/11/2011
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 621111
— Offices of Physicians (except Mental Health Specialists)
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Acquisition and Assistance Field Branch (Morgantown), 1095 Willowdale Road, Morgantown, West Virginia, 26505
- ZIP Code
- 26505
- Solicitation Number
- 000HCCHD-2011-99919
- Archive Date
- 8/26/2011
- Point of Contact
- Rebecca S Mullenax, Phone: 304-285-5880, Kimberly P Groves, Phone: 304-285-5885
- E-Mail Address
-
rmullenax@cdc.gov, kgroves@cdc.gov
(rmullenax@cdc.gov, kgroves@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- COMBINED SYNOPSIS/SOLICITTAION: The Centers for Disease Control and Prevention, National Institute of Occupational Safety and Health (NIOSH), Division of Respiratory Disease Studies (DRDS), Surveillance Branch, Morgantown, WV has a requirement to set up and maintain a secure file repository of radiographic images, and associated relevant medical information, relating to occupational respiratory diseases, particularly those associated with pneumoconioses. The CDC intends to award a single Firm-Fixed-Price Purchase Order in accordance with FAR Part 13. No government-wide notes apply. All vendors must be registered in the Central Contractor Registry (CCR) prior to an award of a Federal contract. The website is: www.ccr.gov. All responsible responsive sources may submit an offer which shall be considered by the agency. This is a combined synopsis/solicitation for professional services prepared in accordance with the format in Federal Acquisition Requirements (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation will not be issued. The solicitation number for this requirement is 000HCCHD-2011-99919 and is hereby issued as a Request for Quote (RFQ) using FAR Subpart 13.1 Simplified Acquisition Procedures. The Centers for Disease Control and Prevention, NIOSH, Morgantown, WV intends to award a firm-fixed-price contract for the following requirement, please either fill in the dollar amounts or provide a separate excel spreadsheet containing the same information: CLIN 0001: Total Price: File Respository - Radiographic Images - 1 job $__________________ STATEMENT OF WORK To set up and maintain a secure file repository of radiographic images, and associated relevant medical information, relating to occupational respiratory diseases, particularly those associated with pneumoconioses. I. Background Statement of Work Project Identification & Purpose: To set up and maintain a secure file repository of radiographic images, and associated relevant medical information, relating to occupational respiratory diseases, particularly those associated with pneumoconioses. The repository is intended to store digitally-acquired x-ray and computerized tomography (CT) chest images, and associated relevant medical information, taken for a variety of reasons, including medical screening, surveillance, epidemiology, clinical practice, or research studies. The repository will be employed for various applications, including the development of new national or international reference image standards, the development of education, training, and testing materials, the establishment of quality assurance collections, and for research into improved methods of disease identification and classification. Background and Need: NIOSH is the federal agency responsible for conducting research and making recommendations for the prevention of work-related injury and illness. Part of that activity relates to the interstitial lung diseases, including pneumoconioses, as well as other occupational pulmonary diseases typically identified by examination of radiographic images (e.g., pleural abnormalities). The technology used for decades to image the lungs of workers for the early detection of these work-related diseases has been conventional film-screen chest radiographic imaging. Trained readers assess the chest radiographs for the presence and severity of lung parenchymal opacities and pleural changes, using a classification system developed by the International Labor Office (ILO). The ILO classification system was designed to systematically record the changes seen on standard film-screen chest radiographs as a result of dust inhalation, and requires the reader to compare any abnormalities observed on a worker's radiograph to a set of standard radiographs exemplifying dust diseases, currently provided as hard copy films by the ILO. In order to assure that trained readers are available, NIOSH maintains a "B Reader Program," which trains physicians to perform ILO classifications. B Readers are physicians who have passed an examination administered by NIOSH to document their competence in using the ILO classification system. NIOSH, through its B Reader program and research and monitoring activities using radiographic assessments, continues to have an extensive impact on national and international practices in workforce medical screening, research, hazard evaluations, clinical practice, compensation, and standard setting in occupational disease. Increasingly, medical imaging and patient information systems are utilizing digital approaches to data acquisition, transmission, storage, display, and interpretation. Over the next decade, conventional radiography, including chest radiography, will be completely replaced by digital radiography systems in the United States. Because of this, NIOSH is in the process of adopting and facilitating the application of digital chest imaging systems in the recognition of occupational lung disorders within its own research and monitoring programs, as well as recommending and advising on the use of digital technologies in the identification and assessment of occupational lung disease both nationally and internationally. The transition to digital radiography has led to the need to update and modify certain aspects of the radiographic screening program within NIOSH, and has similar implications for our national and international partners. A comprehensive digital image repository would provide essential material for critical activities relating to the digital transition within NIOSH and beyond, including B Reader training and testing, and the development of new digital standard reference images. In the longer term, such a repository could also provide the basis for implementing quality assurance programs in both internal and external reading exercises. Such quality assurance is critically needed, since without it, control of variability among readers is difficult. The introduction of digital radiography makes quality assurance considerably simpler than it was for film-based radiography. Moreover, since the advent of digital imaging provides the opportunity to research and explore new concepts and methodologies that take advantage of computer technology, the repository will provide the material for research studies in this area. These include digital processing to enhance the appearance of abnormalities as well as computer-assisted recognition of abnormalities. Concept of Operations and Unique Characteristics of the repository: 1. Concept of Operations • NIOSH will advertize the repository to stakeholders, and, when useful and appropriate, solicit the submission of images from partners. • Whether a stakeholder independently offers images to NIOSH or NIOSH solicits images, discussions will be held by NIOSH to finalize details on the transfer. • When negotiations are complete, NIOSH will inform the repository manager of the transfer that is to take place. • The repository manager or designated staff will provide instructions on his/her website or contact the NIOSH stakeholder/partner directly to work through the transfer details for the image and associated relevant medical information, including verifying that the images are of required technical quality, stored in files of appropriate format, and fit established radiographic (DICOM) criteria, and that the medical information and consent forms have been completed and submitted. See appendix A for the requested medical information and appendix B for the consent form. • The repository manager or designated staff will provide the stakeholder/partner with a mechanism for transfer of images and associated relevant medical information, either via the internet using a secure pathway or using removable media. • The repository manager or designated staff will verify that the files, as described by the provider, arrive into the repository in a format as described and are as agreed. • If the submitted files contain protected health information (PHI), the repository manager or designated staff will assure all materials are anonymized prior to placing in the repository, using established criteria. • Each image file will be linked with the associated relevant medical information by a unique identifier and the linkage maintained in the database. • NIOSH should have continuous access to all data in the repository and be able to download any image file or set of files as required, including the linked medical information. • NIOSH will own the repository. Access to any materials in the repository will not be given to any third parties without authorization by NIOSH. All copies of files aside from any personal identifying information will be returned to NIOSH at the end of the contract, if no extension is granted. • The repository files should have physically separate duplicate systems and periodic back-up so that no image will be lost due to natural or human causes. Programs: The programs impacted by this procurement include 1) the NIOSH Coal Workers X-ray Surveillance Program (CWXSP), 2) the NIOSH B Reader training and certification program, 3) other NIOSH research or service programs that require the use of chest imaging (such as the NIOSH Health Hazard Evaluation Program), 4) any mandated or discretionary federal or non-federal programs requiring ILO classification of chest images, as in radiographic surveillance programs, 5) private and publicly-funded lung disease research activities. NIOSH Programmatic Goals Relevant to the Procurement: 1. To provide the tools needed by NIOSH B Readers participating in the NIOSH CWXSP to use digital imaging for classification of chest images according to the ILO classification system. 2. To enable NIOSH research and surveillance programs to accept standard digital radiographic chest images and to assure the integrity, accuracy, confidentiality, and ongoing utility of these chest images for NIOSH programs. 3. To transition to the use of digital media all aspects of NIOSH training and competency testing programs for physicians who interpret chest radiographs for respiratory system changes due to occupational exposures (NIOSH B Reader Program). Scope of Work: 1. Under this procurement, the contractor shall provide the following goods and services: a. The contractor shall set up and maintain a data repository that accepts images and associated relevant medical information from third party providers, evaluates the data in terms of technical specifications and consistency with their description, stores them securely, and enables NIOSH to have continuous access to them, as follows. i. The contractor shall provide the electronic means for providers to securely download digital image files and associated relevant medical information via the internet or via removable media, including, but not restricted to, chest radiographic and CT images. ii. The contractor shall evaluate and compare the image files as received with the number expected, their description (e.g., chest radiographic images), their technical specifications, and the file format. iii. The contractor shall confirm that the image files are linked to the corresponding medical information and that consent forms were submitted with the image files from the corresponding patient, worker, or their legal representative. (See appendix A) iv. The contractor shall notify the providers of any discrepancies or problems in terms of supplied information, image quality, and image and file format, or related issue, and attempt to resolve the problem, providing limited guidance and instruction as needed. v. The contractor shall check the received image and medical information to determine whether they contain protected health information (PHI) and as necessary remove any PHI as well as adding a unique identifier. vi. The contractor shall notify NIOSH of the unique identifiers assigned, matched to the identifiers supplied by the provider. vii. The contractor shall inform NIOSH by email of file transfers, providing a short report concerning the factors listed in iv, as well as providing a file or spreadsheet showing the assigned identifiers and a list of image and medical information files, with confirmation of anonymization and evidence of consent. viii. The contractor shall securely store the files containing the images and linked medical information on appropriate media such that inadvertent loss is prevented and will protect the files from unauthorized access (i.e., anyone except the contractor and NIOSH). ix. The contractor shall provide continuous access to the files by NIOSH and no other party, and provide a means for NIOSH to download any image file or set of files as required. x. The contractor shall return to NIOSH the entire image database at the end of the contract, if no extension is granted. Education/Experience Qualifications: The contractor must have documented training, experience, and reputation relevant to the specified task. Documented performance in providing similar service will be viewed favorably. Period of Performance/Delivery Schedule: From date of award, time to repository set-up will be 6 months. During the next 18 months up to 500 digital images will be processed, with further 500 in the last of the three years. Period of Performance/Training: Not applicable Deliverables by contractor, except as indicated: Deliverable Due Date NIOSH Contact/ Format Required 1. Provide a functioning repository for digital images and associated relevant medical information. Up to 6 months after the contract is awarded, at the time to be agreed upon by the Project Officer and Contractor Project Officer 2. Receive and process up to 500 images and associated relevant medical information from NIOSH stakeholder/partner providers. After repository setup, during next 18 months. Project Officer 3. Receive and process up to 500 images and associated relevant medical information from NIOSH stakeholder/partner providers. During the next 12 month period. Project Officer Contractor Location Contractor may be based anywhere in the US. Estimated Cost and Project Funding: The contract will be paid in increments, including 25% at set up, 25% 6 months after the contract is awarded, and 25% for each set of up to 500 image files per year. The goods and services specified in this contract will be delivered over a period between FY12 and FY14. Technical Evaluation Criteria/Relative Weighting of a Cost/Price Proposal Evaluation criteria: This contract will not be awarded solely on the basis of cost among the vendors who meet the technical requirements. The following criteria will be considered: 1. Responsiveness in meeting or exceeding the stated specifications (Weight: 70% points) 2. The proposal documents appropriate expertise and experience, particularly as evidenced by successful and timely development, design, and completion of similar tasks to those specified in this contract (Weight: 30% points) Appendix A NIOSH Image Repository Submission Form 1. Type of Examination: Check all that apply: □ Digital chest radiograph □ Chest CT □ Chest HRCT 2. Diagnosis Check all that apply: a. Basis of diagnosis: □ Clinical history/ medical records □ Lung imaging □ Lung biopsy/ pathology b. Diseases: □ Coal Workers' Pneumoconiosis (CWP) □ Silicosis □ Asbestosis □ Asbestos-related Pleural Disease □ Malignant Pleural Mesothelioma □ Rheumatoid Pneumoconiosis □ Sarcoidosis □ Histoplasmosis □ Other Pneumoconiosis: _____________________________________________________ □ Other Interstitial Lung Disease: _______________________________________________ c. Other disorders associated with radiographic findings: □ Lung cancer □ Bronchiectasis □ Emphysema □ Cor Pulmonale □ Congestive Heart failure □ Tuberculosis □ Other: ¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬___________________________________________________________________ 3. Cigarette smoking: Total years______ Average # of cigarettes per day _____ 4. Occupational history, □ check here if unknown: a. Did the subject work? In an underground coal mine? □ Yes □ No Years_____ (if yes) At a surface coal mine? □ Yes □ No Years_____ (if yes) In any other type of mine? □ Yes □ No Years_____ (if yes) If yes, specify: ________________________________________________________ In construction? □ Yes □ No Years_____ (if yes) With asbestos? □ Yes □ No Years_____ (if yes) In any other dusty job? □ Yes □ No Years_____ (if yes) If yes, specify: ________________________________________________________ b. Current and past occupations (List up to three jobs; combine all similar jobs in an industry) Industry ___________________ Job ____________________ Tenure _______ Years Industry ___________________ Job ____________________ Tenure _______ Years Industry ___________________ Job ____________________ Tenure _______ Years FOR NIOSH OR CONTRACTOR USE ONLY De-identification of the image was performed? □ Yes □ No Consent to release image was signed (see attached)? □ Yes □ No Appendix B RELEASE FORM OF CHEST RADIOGRAPHIC IMAGE TO WHOM IT MAY CONCERN: I hereby grant full permission to the Department of Health and Human Services, Public Health Service, and Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, to use, reproduce, publish, distribute, and exhibit the radiographic image of my chest, after my name and other personal identifying information have been removed from the image, for research, training and education purposes. Without limitation as to time, I hereby waive all rights for compensation in connection with the use of my radiographic image so long as the United States Government uses the material only for the purposes of research, training and education. If person is under the age of 18, a parent or guardian must sign this consent form. _________________________________ Print name here _________________________________ __________________________________________________ Signature Signature of legal representative, if applicable _________________________________ Address _________________________________ Date The following clauses and provisions are incorporated by reference and are to remain in full force in any resultant purchase order. Full text clauses are located in Attachment 1: FAR 52.212-1, Instructions to Offerors-Commercial Items, and any addenda to the provision as listed in this notice; FAR 52.212-3, Offeror Representations and Certifications-Commercial Items- (Offeror must complete the representation and certifications and submit with offer. An offeror shall complete only paragraph (j) of this provision if the offeror has completed the annual representations and certificates electronically at http://orca.bpn.gov, see attachment 2. 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; FAR 52.204-6, Data Universal Numbering System (DUNS) Number FAR 52.204-7, Central Contractor Registration; FAR 52.204-9, Personal Identity Verification of Contractor Personnel (Sep 2007); FAR 52.309-2, Prohibition on Contracting with Inverted Corporations FAR 52.219-6, Notice of Total Small Business Set-aside; FAR 52.219-28, Post-award Small Business Program Representation (Apr 2009) FAR 52.222-3, Convict Labor; FAR 52.222-21, Prohibition of Segregated Facilities; FAR 52.222-26, Equal Opportunity; FAR 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans; FAR 52.222-36, Affirmative Action for Workers with Disabilities; FAR 52.222-37, Employment Reports on Disabled Veterans and Veterans of the Vietnam Era and Other Eligible Veterans; FAR 52.222-50, Combating Trafficking in Persons FAR 52.225-13, Restrictions on Certain Foreign Purchases FAR 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration; FAR 52.233-1, Disputes; FAR 52.233-3, Protest After Award; FAR 52.233-4, Applicable Law for Breach of Contract Claim; FAR 52.237-2, Protection of Government Buildings, Equipment, and Vegetation; FAR 52.247-4, F.O.B. Destination; FAR 52.246-4, Inspection of Services- Fixed Price FAR 52.252-1, Solicitation Provisions Incorporated by Reference http://farsite.hill.af.mil FAR 52.252-2, Clauses incorporated by Reference (http://farsite.hill.af.mil ); HHSAR 352.270-6, Publications and Publicity; HHSAR 352.270-13, Tobacco Free Facilities To view the provisions and clauses in full text, visit the web site: http://farsite.hill.af.mil. A Firm-Fixed Price purchase order will be issued in writing to the successful offeror. To be eligible to receive an award resulting from this solicitation, contractor must be registered in the Central Contractor Registration. To register you may call 1-888-227-2423 or apply via the Internet at http://www.ccr.gov. The quote format is at the discretion of the offeror. Include FAR 52.212-3, Offer Representation and Certification with Offer or indicate it is available at the ORCA website. No telephonic quotes will be processed. All responses must be received no later than 4:30 P.M., Eastern Standard Time on July 26,2011. Please send all questions and quotes to Rebecca Mullenax at RMULLENAX@CDC.GOV.
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