SOLICITATION NOTICE
R -- FDA Compliance Measurement Method - Radiation Protection
- Notice Date
- 9/9/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-1135444
- Archive Date
- 10/1/2014
- Point of Contact
- ZetherineGore, Phone: (301) 827-5093
- E-Mail Address
-
zetherine.gore@fda.hhs.gov
(zetherine.gore@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Request for Quotation No. 1135444 This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12 Commercial Items acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-76. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code, 541690 is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. This is a full and open competition. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. The Food and Drug Administration (FDA) intends to award a purchase order for Scientific and Technical Consulting Services. This solicitation is issued as Request for Quote (RFQ) No. 1135444. Project Title/Description: FDA Compliance Measurement Method - Radiation Protection This project shall provide the information needed to update radiation protection criteria for more practical compliance measurements of external x-ray emissions. Work performed on this project shall perform a series of Monte Carlo calculations to establish the effective dose from hypothetical x-ray exposures and to correlate the results to practical measurements of the same exposures. This will enable a quantitative analysis of the effectiveness of the various standards in minimizing cancer risk. The project shall focus on a number of x-ray energy spectra spanning the range of expected emissions. For each spectrum a number of beam geometries shall be considered, and the effective dose shall be calculated using the PC-based Monte Carlo program for calculating patient doses in medical x-ray examinations (PCXMC). Several locations of incidence on the body shall be selected so as to maximize the effective dose to the most vulnerable areas of the body. The procedure shall be repeated for three Adult body sizes: small, medium, and large. The incident exposure and ambient dose equivalent shall also be calculated for comparison. Thus, for each exposure condition, there shall be a ratio of effective dose to exposure and a ratio of effective dose to ambient dose equivalent. This project shall perform a dosimetric analysis of external x-ray emissions from electronic products and evaluate the FDA exposure limit and compliance measurement method for radiation protection. The standard covers external radiation emissions from baggage inspection units, industrial and analytical cabinet x-ray units, cathode ray tubes and other electronic products. 1.0 Statement of Work The purpose of this project is to perform a series of Monte Carlo calculations to establish the effective dose from hypothetical x-ray exposures and to correlate the results to practical measurements of the same exposures. This shall enable a quantitative analysis of the effectiveness of the various standards in minimizing cancer risk. The project shall focus on a number of x-ray energy spectra spanning the range of expected emissions. For each spectrum a number of beam geometries shall be considered and the effective dose shall be calculated using the PCXMC computer code. Several locations of incidence on the body shall be selected to maximize the effective dose to the most vulnerable areas of the body. The procedure shall be repeated for three adult body sizes: small, medium and large. The incident exposure and ambient dose equivalent shall also be calculated for comparison. Thus, for each exposure condition, there shall be a ratio of effective dose to exposure and a ratio of effective dose to ambient dose equivalent. In most situations, real measurements of exposure or ambient dose equivalent will not correspond to the above calculations of the same quantity. This is due to detector response characteristics and partial irradiation of the detector. The second component of this project shall examine the beam geometry response to appropriately calibrated detectors having several different cross-sectional areas. Thus, for each situation, a relationship between effective dose and expected measurement results may be found. This work expands on and completes previous unfinished work using the latest recommendations of the International Commission on Radiation Protection (ICRP) for dosimemetric analysis of external x-ray emissions from electron products. The work includes the following: 1) Examine potential effective doses from radiation emitting electronic products using Monte Carlo calculations and the most recent ICRP organ weighting factors. Perform the calculations for a range of representative exposure geometries, x-ray beam energy spectra, and exposure conditions encountered by security workers performing x-ray baggage inspections, a most significant affected population. 2) Re-examine FDA's regulatory emission limit vis-à-vis the Monte Carlo results. Examine the suitability of exposure measurements using different sizes of detectors for each beam geometry. Estimate maximum instrument readings that would assure appropriate annual limitation on effective dose for each detector size. 3) Perform measurements using at least two radiation protection instruments to demonstrate proof of concept for different detector response characteristics and partial irradiation of the detector uncertainty for actual measurements. 4) Document the results, prepare and submit a paper suitable for publication in a peer-reviewed journal and present results at a conference. 2.0 Background 21 CFR 1020.40 is a FDA performance standard for cabinet x-ray systems which limits exposures from x ray emissions from electronic products. There is also a mandatory standard for radiation emissions from medical x-ray housings other than the primary beam. The FDA radiation protection standards are based on measurements of exposure at a specified distance from the external surface of the unit averaged over a specified detection area, and states that radiation emitted from the cabinet x-ray system shall not exceed an exposure of 0.5 milliroentgen in one hour at any point five centimeters outside the external surface. The quantity "exposure" is a measurement of the ionization in air due to the incident radiation and is related to the energy imparted to a volume of air. The European Union promulgates similar standards based on the "ambient dose equivalent," a quantity defined by the ICRP that is intended to approximate the average dose to the tissues of a human body. The ICRP also defines "effective dose." The effective dose is a compilation of the actual doses to the most vulnerable human organs and tissues from a specific exposure condition. Each organ dose is weighted by a factor depending on the cancer induction potential for that specific organ. Effective dose is meant to be an indicator proportional to the risk of fatal cancer to the human body. For the case of protection level exposures, the cancer risk is the dominating factor for setting allowable exposure limits. Because of the complexity of radiation interactions and scattering within the human body, the effective dose cannot be measured directly. In most situations, real measurements of exposure or ambient dose equivalent will not correspond to the above calculations of the same quantity. This is due to detector response characteristics and partial irradiation of the detector. The FDA requirement for limiting external x-ray emissions was influenced largely by a study of exposures to radiation from television receivers in the late 1950's and was based on mid-20th century radiobiology. Verifying compliance with the FDA regulation has been challenging because of the lack of appropriate measuring instrumentation, specifically integrating detectors meeting the size and sensitivity requirements while retaining a suitable energy response. For these reasons there is a need to update the radiation protection criteria and to investigate the possibility of more practical compliance measurements. 3.0 Objective The objective of this project is to obtain a Contractor to perform a dosimetric analysis of external x-ray emissions from electronic products and evaluate the FDA exposure limit and compliance measurement method for radiation protection. The results of this project are intended to provide the information needed to calculate effective dose for Field Compliance Testing of Cabinet X-ray Equipment standard on radiation safety for ionizing radiation. During the second component of this project, the Contractor shall examine the response to each beam geometry of appropriately calibrated detectors having several different cross-sectional areas. Thus, for each situation, a relationship between effective dose and expected measurement results may be found. 4.0 Scope of Work The Contractor work shall be required to perform the following: 1) Examine potential effective doses from radiation emitting electronic products using Monte Carlo calculations and the most recent ICRP organ weighting factors. Perform the calculations for a range of representative exposure geometries, x-ray beam energy spectra, and exposure conditions encountered by security workers performing x-ray baggage inspections, a most significant affected population. 2) Re-examine FDA's regulatory emission limit vis-à-vis the Monte Carlo results. Examine the suitability of exposure measurements using different sizes of detectors for each beam geometry. Estimate maximum instrument readings that would assure appropriate annual limitation on effective dose for each detector size. 3) Examine the response to each beam geometry of appropriately calibrated detectors having several different cross-sectional areas. Thus, for each situation, a relationship between effective dose and expected measurement results may be found. 4) Perform measurements using at least two radiation protection instruments to demonstrate for proof of concept for different detector response characteristics and partial irradiation of the detector uncertainty for actual measurements. 5) Document the results and prepare a paper suitable for publication in a peer-reviewed journal, and present paper at Health Physics Society or Council on Ionizing Radiation Measurements and Standards Conference. List of Acronyms used in this Contract: CDRH: Center for Devices and Radiological Health FDA: Food and Drug Administration IRML: Ionizing Radiation Measurements Laboratory ISO: International Standards Organization NVLAP: National Voluntary Laboratory Accreditation Program OSEL: Office of Science and Engineering Laboratories PCXMC: PC-based Monte Carlo program for calculating patient doses in medical x-ray examinations ICRP: International Commission on Radiation Protection 5.0 Location, Work Schedule and Travel FDA White Oak Facility is located at: 10903 New Hampshire Avenue W062-4103 Silver Spring, Maryland 20993-0002 Contractor will not be compensated for travel to the job site. 6.0 Period of Performance It is anticipated that the purchase order award will begin in September, and that the period of performance will be for a base period of one (1) year and an option period of one (1) year. 7.0 Task Deliverables and Milestones Deliverables The contractor shall provide monthly status report that provides information about the current status and anticipated completion date for each deliverable at a minimum. Reports must also include unanticipated problems with completion of a deliverable. IRML reserves the right to change the reporting frequency to Daily, weekly, bi-weekly. The contractor must provide a final documented version of all work in line with existing protocols and procedures that meet NVLAP accreditation requirement and follow International Commission on Radiation Protection (ICRP) recommendations and guidance on radiation protection. The contractor shall provide daily, weekly, bi-weekly or monthly status reports. Due Dates Status Reporting: Bi-weekly, Monthly, and upon completion of each projects - To Be Determined Meetings with Management As needed Invoices: 1st of each Month after contractor work has been performed, reviewed and approved according to acceptance criteria Suggested Implementation and deliverables The project may proceed as follows: 1. The number and type of spectra shall be agreed upon at the start of the project. For example, beams of 30 kV, 50 kV, 100 kV and 150 kV with moderate filtration may be chosen. 2. The number of beam sizes shall also be agreed upon. The code allows for rectangular beam cross sections obtainable from medical diagnostic collimators. For example square beams with a cross section of 1 cm2, 10 cm2, 100 cm2, 225 cm2 and a fan beam of 1 cm by 30 cm may be chosen. 3. Six general areas of incidence on the body are suggested based on ICRP tissue weighting factors: gonads, breasts, colon, lung, stomach and thyroid/esophagus. For each area the radiation field MC runs with low numbers of photons shall be performed in order to find the location of maximum effective dose. This may occur with multiple organs in the path of the field. At the selected location a more extensive MC analysis shall be performed. 4. Ratios of effective dose to entrance exposure and effective dose to ambient dose equivalent shall be calculated for each spectrum, field size and body location. For the examples above this shall result in 4x5x6 = 120 ratios for the exposure and 120 ratios for the ambient dose equivalent. 5. Several agreed-upon detector geometries shall be considered. For example detectors having active volumes with cross-sections of 1 cm2, 10 cm2, 100 cm2 and 225 cm2. For each detector size and beam size the detector under-response due to partial irradiation shall be calculated. The 240 ratios of step 4 above shall be modified accordingly, resulting in 960 ratios. 6. The results shall be analyzed for worst-case scenarios and most useful method of presentation. The aim is to produce a set of tables and/or graphics to aid operational health physicists and regulators in assessing potential risks from practical measurements. Conversely the effectiveness of measurement standards in limiting cancer risk can be evaluated. A limited set of measurements shall be performed using at least two radiation protection instruments to demonstrate for proof of concept for different detector response characteristics and partial irradiation of the detector uncertainty for actual measurements Suggested Schedule and Major Milestone The contractor shall submit a schedule and major milestone outline that must be reviewed and performance under the contract begins. Schedule and Major Milestones Month # (Relative to start of contract) Examine potential effective doses from radiation emitting electronic products using Monte Carlo calculations and the most recent ICRP organ weighting factors. Perform the calculations for a range of representative exposure geometries, x-ray beam energy spectra, and exposure conditions encountered by security workers performing x-ray baggage inspections, a most significant affected population. (60 Hours) Months 1-3 Re-examine FDA's regulatory emission limit vis-à-vis the Monte Carlo results. Examine the suitability of exposure measurements using different sizes of detectors for each beam geometry. Estimate maximum instrument readings that would assure appropriate annual limitation on effective dose for each detector size. (68 hours) Months 4-6 Provide expert design and oversight for measurements using at least two radiation protection instruments to demonstrate for proof of concept for different detector response characteristics and partial irradiation of the detector uncertainty for actual measurements. (30 hours)Months 7-9 Document the results. (50 hours) Months 10-12 Prepare a paper suitable for publication in a peer-reviewed journal; Address comments or concerns from peer-review process; Possibly present paper at Health Physics Society or Council on Ionizing Radiation Measurements and Standards Conference. (64 hours) Option Period - Months 13-24 8.0 Contractor Conformance with Applicable Laws, Regulations, Policies and Standards The Contractor shall have a senior level working knowledge and experience working with the requirements that are stated in the NVLAP which conforms to all requirements of NIST Handbook 150 "Technical Guide for Ionizing Radiation Measurements" as it applies to a secondary diagnostic x-ray calibration standards laboratory. The NIST handbook can be found at http://www.nist.gov/nvlap/upload/nist-handbook-150.pdf. 9.0 Security and Privacy Performance of work may require the contractor personnel to have access to and use of data and information which may be considered proprietary to a government agency or Government contractor, or which may be of such nature that its dissemination or use would be adverse to the interest of FDA or others. FDA, thereof, owns all proprietary information and all copies. The contractor agrees that contractor personnel shall not divulge or release data or information developed or obtained in connection with the performance of the resulting contract, unless made public by FDA, except to authorized FDA personnel or upon written approval of Project Officer. Except as may otherwise be permitted by a data owner, the contractor personnel agrees not to use, disclose or reproduce proprietary data, other than as required in performance of the contract; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the contractor without such limitation. FDA owns all proprietary information and all copies shall be returned to FDA upon completion of the work for which it was obtained or developed. 10.0 The Estimated Level of Effort: (all rates proposed shall be burdened labor rates with indirect costs included). This estimate is provided for informational purposes only and is not intended to be a directive or restrictive. Base Year (208 hours) -Review previous work and procure updated MC code (20 hrs.) -Perform Monte Carlo calculations (40 hrs.) -Compile and evaluate results (68 hrs.) -Meetings with @ FDA White Oak with Lab staff (30 hrs.) -Design Limited Measurement setup for (50 hrs.) -Comparison to Calculated (option) Option year 1 (64 hours) -Prepare a paper suitable for publication in a peer-reviewed journal -Address comments or concerns from peer-review process -Possibly present paper at Health Physics Society or Council on Ionizing Radiation Measurements and Standards Conference Pricing shall include: Supplies (Base and option year 1) -PCXMC Monte Carlo Computer Program 11.0 Criteria for Evaluation of Contract A. BEST VALUE CRITERIA - BASIS FOR AWARD The Offeror should demonstrate the statement of work is understood and offer a logical approach to its achievement. Award will be made to the offeror who is deemed most responsive, whose proposal conforms to all requirements, and is judged to represent the best value. To conduct a best value assessment, FDA will evaluate the offerors proposal submission based on Technical Elements, Price, and Relevant Past Experience as described below. As this is a best-value selection, the government may make tradeoffs in the factors below to arrive at a best value decision. The Government may award a purchase order on the basis of initial offers received, without discussions. Therefore, each initial offer should contain the Offeror's best terms from a cost and technical standpoint. B. EVALUATION CRITERIA The evaluation will be based on the completeness, thoroughness and demonstrated capabilities of the prospective Offeror in relation to the needs of the Statement of Work as set forth in the RFQ. Each proposal must document the feasibility of successful implementation of the requirements of the RFQ. Offerors must submit information sufficient to evaluate their proposals based on the criteria listed below. TECHNICAL EVALUATION The contractor who performs work for this contract shall be a senior level expert. The Contractor shall have a senior level working knowledge and experience with ICRP reports as related to this project. Offerors are required to submit a resume for the person who is proposed to perform the work under the resulting contract so that level of expertise can be verified as adequate to meet project requirements. A senior level of expertise shall be defined based on the following criteria: Offerors shall provide information on all of the following criteria demonstrating senior level expertise: 1) Lead Assessor for NVLAP accredited ISO 17025 x-ray diagnostic/radiation protection laboratory; 2) Long-time contributor working to the development of performance test standards for diagnostic and radiation protection x-ray; 3) Lead role in primary standards laboratory or accredited secondary ISO 17025 x-ray diagnostic/radiation protection laboratory; 4) Senior level expertise with the application and use of latest recommendations of the ICRP reports as related to this project; 5) Senior level expertise with the application and use of Monte Carlo code that will be used for this project RELEVANT PAST PERFORMANCE FDA will evaluate the offeror's relevant past performance in the conduct of similar tasks and their relevance to this acquisition. PRICE FDA will evaluate the offeror's submission/proposal on their ability to provide support at a reasonable and realistic price (to include any discounts offered). Proposed pricing should be for the entire period of performance and detail the number of labor hours proposed and the price per hour. Labor hours should be fully loaded. Pricing should also include a fixed price for the supplies needed for performance on this contract. 12. PAYMENT SCHEDULE The contractor shall invoice no more than once a month for hours worked. 13. SAM Vendors must be registered in the System for Award Management (SAM) prior to the award of a purchase order. You may register by going to https://www.sam.gov/. You will need your Dun & Bradstreet number and banking information. 14. QUESTIONS DEADLINE: All questions are to be submitted via email to Zetherine.Gore@fda.hhs.gov no later than 2:00 P.M. on September 11, 2014 12:00 p.m. Eastern time. 15. OFFERS DUE: Proposals must be delivered no later than 12:00 p.m. Eastern time on September 16th, 2014. Offerors shall submit resume/curriculum vitae. Proposal submissions are restricted to a limit of ten (10) pages, excluding resume/curriculum vitae. Proposal must be submitted electronically via e-mail to zetherine.gore@fda.hhs.gov 16. PROVISIONS AND CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.217-9, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. No telephone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-1135444/listing.html)
- Place of Performance
- Address: Food and Drug Administration, White Oak Facility, 10903 New Hampshire Avenue, W062-4103, Silver Spring, Maryland, 20993-0002, United States
- Zip Code: 20993-0002
- Zip Code: 20993-0002
- Record
- SN03503622-W 20140911/140910001441-ce692cbd90125c426c45423b098e641a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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