§ 240.604. QA requirements for testing using primary devices.
(a) CRMs for primary 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.
(2) Background measurements. Background measurements shall be performed and documented after every 1,000 hours of operation of scintillation cell-type CRM. These background measurements shall be checked by purging the unit with clean, aged air or nitrogen in accordance with the manufacturer’s instructions. For all CRMs, the background shall be monitored in accordance with the manufacturer’s instructions.
(3) 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.
(4) 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.
(5) 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.
(C) The test result.
(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 devices’ serial numbers.
(B) The RPD value.
(C) The intercomparison measurements results.
(6) 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) For 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 ‘‘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) CWLMs for primary 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.
(2) Background measurements. CWLM background measurements shall be performed and documented at least every 168 hours of operation and when the unit is calibrated.
(3) Routine instrument checks. Routine instrument checks for each CWLM shall be documented and performed before and after each test by using an Am-241 or similar energy check source. Pumps and flow meters shall be checked in accordance with the manufacturer’s instructions and documented. The pump and flow meter check shall be performed with a dry-gas meter or other flow measurement device of traceable accuracy.
(4) 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.
(C) The test result.
(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 devices’ serial numbers.
(B) The RPE value or RPD value.
(C) The intercomparison measurement results.
(5) Intercomparison measurements. An intercomparison measurement shall be performed for each CWLM monitor without a check source.
(i) A CWLM without check source capability must 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) For 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 ‘‘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 primary testers.
(1) Calibration. Each Department-listed electret reader must have a current calibration. To have a current calibration, the electret reader 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 electret reader. Each electret reader shall be calibrated simultaneously with its corresponding reference electret’s recertification.
(2) Data collection log. Electret custody 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.
(v) The test result.
(vi) The serial number of duplicate electret.
(vii) The RPD value.
(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.
(3) 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 analyzed in the same manner as all other testing.
(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 corresponds 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.
(G) The exposure dates.
(4) 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.
(B) The exposure dates.
(C) Each duplicate measurement result.
(D) The RPD results.
(5) Voltmeter routine instrument checks.
(i) Proper operation of the surface voltmeter shall be monitored following the manufacturer’s procedures for analyzing the reference electrets and zeroing the voltmeter.
(ii) A voltage reading of a reference electret difference of more than 2 volts from the reference electret specified value shall be considered a wrong reading. The second reference electret in the set shall be read to determine whether the wrong reading is in the first reference electret or in the reader. Corrective action shall be taken in consultation with the manufacturer.
(iii) When zeroing the reader, if the voltmeter displays more than (±) 3 volts, corrective action shall be taken in consultation with the manufacturer.
(iv) Voltmeter checks shall be conducted at least once each week while the voltmeter is in use and shall be documented. Documentation of routine instrument checks must include all of the following:
(A) The reader serial number.
(B) The date of analysis.
(C) Zero value.
(D) The reference electret values.
(E) Corrective actions performed.
Cross References This section cited in 25 Pa. Code § 240.102 (relating to prerequisites for radon testing certification); and 25 Pa. Code § 240.122 (relating to prerequisites for radon laboratory certification).
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