Current through Register Vol. 54, No.43, October 26, 2024
Section 240.605 - QA requirements for testing using secondary devices(a)CRMs for secondary testers.(1)Calibration. Each Department-listed CRM must have a current calibration. To have a current calibration, the CRM shall be calibrated in a Department-approved calibration facility within 1 year from the date of the previous calibration and when alterations or repairs are made to the CRM. A current calibration certificate shall be retained for each monitor.(2)Check source counting. For a CRM with a check source, check source counting shall be documented and completed with that check source prior to each test.(3)Routine instrument checks. Before and after each measurement, the CRM shall be checked according to the manufacturer's instructions. For each check, all of the following shall be verified:(i) The correct input parameters and the unit's clock or timer are set properly.(ii) The pump's flow rates are within the range of the manufacturer's specifications.(4)Data collection log.(i) CRM data shall be tracked on a form that contains all of the following:(A) The CRM serial number.(B) The exposure dates and times.(D) The address of the building tested.(E) The test location in the building.(F) The name of the tester who placed the CRM.(G) The name of the tester who retrieved the CRM.(H) The calibration, repair and Department listing dates.(ii) For a CRM without a check source, the data collection log must also contain all of the following intercomparison measurement information:(A) The intercomparison device serial number.(B) The RPE value or RPD value.(C) The intercomparison measurement result.(5)Intercomparison measurements. An intercomparison measurement shall be performed for each CRM without a check source. (i) Intercomparison measurements shall be made at least every tenth test with another Department-listed passive device that is analyzed by a Department-certified laboratory or with another CRM with a hard copy printout. The intercomparison measurements shall be distributed systematically throughout the entire population of test locations. Original printouts or Department-certified laboratory results, or both, shall be kept for each intercomparison. Each intercomparison measurement must be performed with the devices side by side for the measurement for at least 48 hours.(ii) When performing intercomparison measurements, the RPD shall be used to track performance. The RPD value shall be tracked using control charts from "Protocols for Radon and Radon Decay Product Measurements in Homes," EPA 402-R-92-003, May 1993, Appendix B, Exhibits B-2 and B-3.(iii) If the RPD value exceeds the control limit, the CRM may not be used for radon measurements until the problem is identified and corrected. If the RPD value exceeds the warning level, the criteria in the "Protocols for Radon and Radon Decay Product Measurements in Homes," EPA 402-R-92-003, May 1993, Appendix B, Exhibit B-5, shall be followed.(iv) In addition to the control charts, intercomparison measurements shall be documented on the CRM data collection log.(b)CWLM for secondary testers.(1)Calibration. Each Department-listed CWLM must have a current calibration. To have a current calibration, the CWLM shall be calibrated in a Department-approved calibration facility within 1 year from the date of the previous calibration and when alterations or repairs are made to the CWLM. A current calibration certificate shall be retained for each monitor.(2)Data collection log.(i) CWLM data shall be tracked on a form that contains all of the following:(A) The CWLM serial number.(B) The exposure dates and times.(D) The address of the building tested.(E) The test location in the building.(F) The name of the tester who placed the CWLM.(G) The name of the tester who retrieved the CWLM.(H) The calibration, repair and Department listing dates.(ii) For CWLMs without a check source, the data collection log must also contain all of the following intercomparison measurement information:(A) The intercomparison device serial number.(C) The intercomparison measurement result.(3)Intercomparison measurements. An intercomparison measurement shall be performed for all CWLM monitors without a check source. (i) A CWLM without check source capability shall have an informal intercomparison measurement made with another CWLM with a hard copy printout at least every tenth test. This printout shall be retained for each intercomparison. The intercomparison measurements shall be distributed systematically throughout the entire population of test locations. Each intercomparison measurement must be performed with the devices side by side for the measurement for at least 48 hours.(ii) Each intercomparison shall be documented on the data collection log.(iii) When performing intercomparison measurements, the RPD shall be used to track performance. The RPD value shall be tracked using control charts from "Protocols for Radon and Radon Decay product measurements in Homes," EPA 402-R-92-003, May 1993, Appendix B, Exhibits B-2 and B-3.(iv) If the RPD value exceeds the control limit, the CWLM may not be used for radon measurements until the problem is identified and corrected. If the RPD value exceeds the warning level, the criteria in the "Protocols for Radon and Radon Decay Product Measurements in Homes," EPA 402-R-92-003, May 1993, Appendix B, Exhibit B-5, shall be followed.(c)Electret ion chambers for secondary testers.(1)Data collection log. Electret data shall be tracked on a form that contains all of the following: (i) The electret serial number.(ii) The initial voltage reading.(iii) The final voltage reading.(iv) The exposure dates and times.(vi) The serial number of duplicate electret.(viii) The address of the building tested.(ix) The test location in the building.(x) The name of the tester who placed the electret.(xi) The name of the tester who retrieved the electret.(2)Known exposure measurements (spikes).(i) Spikes shall be conducted at a rate of 3 for each 100 test devices deployed, with a minimum of 3 spikes for each certification year when tests were conducted in the certification year, and with a maximum of 6 spikes each month.(ii) Spikes shall be submitted to a Department-certified laboratory labeled as QA. The RV of the spiked device may not be revealed to the laboratory prior to analysis.(iii) Spikes shall be monitored using a means control chart. The means control chart must be established as follows: (A) Using an RPE value of plus and minus 10%, which corresponds to the 1 sigma level.(B) A warning level of the RPE of plus and minus 20%, which corresponds to the 2 sigma warning level.(C) Control limits of the RPE of plus and minus 30%, which correspond to the 3 sigma control level.(iv) Each RPE value shall be plotted on the means control chart within 1 week of return of the device from the chamber. If the RPE value is outside the 3 sigma control level, all measurements shall cease until the problem is evaluated and corrected. All evaluations shall be documented.(v) In addition to the means control chart, all spikes shall be documented on a form that contains all of the following:(A) The radon chamber name.(B) The electret serial numbers.(C) The RV from radon chamber.(D) The measured spike value or values.(E) The individual RPE results.(F) The certification year beginning date and end date.(3)Duplicate measurements.(i) Duplicates shall be made in at least 10% of the total number of test devices deployed each month, or 50 each month, whichever is smaller.(ii) The RPD shall be calculated for all duplicate results with an average of greater than or equal to 2.0 pCi/L. Two control charts shall be constructed to monitor duplicate precision: (A) One for duplicates when the average is greater than or equal to 4.0 pCi/L.(B) One for duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L.(iii) Each RPD value shall be plotted on the control chart within 1 week of performing the duplicate measurement.(iv) The RPD shall be tracked using control charts from "Protocols for Radon and Radon Decay Product Measurements in Homes," EPA 402-R-92-003, May 1993, Appendix B, Exhibits B-2 and B-3.(v) For duplicates when the average is greater than or equal to 4.0 pCi/L, all of the following apply: (A) The control level shall be set at an RPD of 14%.(B) The warning level shall be set at an RPD of 28%.(C) The control limit shall be set at an RPD of 36%.(vi) For duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L, all of the following apply:(A) The control level shall be set at an RPD of 25%.(B) The warning level shall be set at an RPD of 50%.(C) The control limit shall be set at an RPD of 67%.(vii) If the plotted RPD result falls outside of the control limit, the measurements shall cease until the problem is identified and corrected.(viii) If the plotted RPD result falls outside of the warning level, "Protocols for Radon and Radon Decay Product Measurements in Homes," EPA 402-R-92-003, May 1993, Appendix B, Exhibit B-5, shall be used to determine the action to be taken.(ix) Documentation of duplicates must include all of the following:(A) The device serial numbers.(C) Each duplicate measurement result.(d)LS, AC and ATs for secondary testers.(1)Data collection log. Detector data shall be tracked on a form that contains all of the following:(i) The device serial number.(ii) The serial number of duplicate devices.(iii) The serial number of spiked devices.(iv) The exposure dates and times.(vi) The RPE value or RPD value.(vii) The address of the building tested.(viii) The test location in the building.(ix) The name of the tester who placed the device.(x) The name of the tester who retrieved the device.(xi) The name of the laboratory to which device was sent.(2)Known exposure measurements (spikes).(i) Spikes shall be conducted at a rate of 3 for each 100 test devices deployed, with a minimum of 3 spikes for each certification year when tests were conducted in the certification year, and with a maximum of 6 spikes each month.(ii) Spikes shall be submitted to a Department-certified laboratory labeled as QA. The RV of the spiked device may not be revealed to the laboratory prior to analysis.(iii) Spikes shall be monitored using a means control chart. The means control chart must be established as follows: (A) Using an RPE value of plus and minus 10%, which corresponds to the 1 sigma level.(B) A warning level of the RPE of plus and minus 20%, which corresponds to the 2 sigma warning level.(C) Control limits of the RPE of plus and minus 30%, which correspond to the 3 sigma control level.(iv) Each RPE value shall be plotted on the means control chart within 1 week of receiving the result from the laboratory. If the RPE value is outside the 3 sigma control level, all measurements shall cease until the problem is evaluated and corrected. All evaluations shall be documented.(v) In addition to the means control chart, all spikes shall be documented on a form that contains all of the following:(A) The radon chamber name.(B) The device serial numbers.(C) The RV from radon chamber.(D) The measured spike value or values.(E) The individual RPE results.(F) The certification year beginning date and end date.(3)Duplicate measurements.(i) Duplicates shall be made in at least 10% of the total number of test devices deployed each month, or 50 each month, whichever is smaller.(ii) The RPD shall be calculated for all duplicate results with an average of greater than or equal to 2.0 pCi/L. Two control charts shall be constructed to monitor duplicate precision: (A) One for duplicates when the average is greater than or equal to 4.0 pCi/L.(B) One for duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L.(iii) Each RPD value shall be plotted on the control chart within 1 week of performing the duplicate measurement.(iv) The RPD shall be tracked using control charts from "Protocols for Radon and Radon Decay Product Measurements in Homes," EPA 402-R-92-003, May 1993, Appendix B, Exhibits B-2 and B-3.(v) For duplicates when the average is greater than or equal to 4.0 pCi/L, all of the following apply: (A) The control level shall be set at an RPD of 14%.(B) The warning level shall be set at an RPD of 28%.(C) The control limit shall be set at an RPD of 36%.(vi) For duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L, all of the following apply:(A) The control level shall be set at an RPD of 25%.(B) The warning level shall be set at an RPD of 50%.(C) The control limit shall be set at an RPD of 67%.(vii) If the plotted RPD result falls outside of the control limit, the measurements shall cease until the problem is identified and corrected.(viii) If the plotted RPD result falls outside of the warning level, "Protocols for Radon and Radon Decay Product Measurements in Homes," EPA 402-R-92-003, May 1993, Appendix B, shall be used to determine the action to be taken.(ix) Documentation of duplicates must include all of the following:(A) The device serial numbers.(C) Each duplicate measurement result.(4)Field blanks.(i) Field blank results shall be monitored and recorded. Field blanks shall be performed at a rate of 5% of the devices that are deployed each month, or 25 each month, whichever is smaller, or a minimum of 1 per certification year, unless tests are not performed. These devices shall be set aside, kept in a low-radon environment and labeled as QA when submitted to the laboratory.(ii) If a field blank has a concentration greater than the lowest level of detection (LLD) as established by the laboratory, all of the following shall occur: (A) The occurrence shall be documented and reported to the laboratory.(B) The cause shall be investigated in conjunction with the laboratory and documented.(iii) Documentation of field blanks must include all of the following: (A) The device serial numbers.(B) The date submitted to laboratory.(C) The measurement results.(D) The laboratory's reported LLD.