STANDARD OPERATING PROCEDURES
AND
QUALITY ASSURANCE PLAN
AIR CHEK, INC.
MEASUREMENTS OF INDOOR AMBIENT RADON CONCENTRATIONS
USING
ACTIVATED CHARCOAL ADSORBER DETECTORS
December 15, 1998
CONTENTS
3.0 Description of Operations
Air Chek, Inc. is a privately held corporation which manufactures and analyzes activated charcoal radon measurement samplers used for measuring radon concentrations in indoor air. Headquarters and the analysis laboratory operate out of a 8000 square foot facility located on three acres in Henderson County, North Carolina. The property, buildings, patents, inventory, supplies, vehicles, and all fixtures are wholly owned by Air Chek, Inc. and/or its stockholders. The company employs a full-time staff of management and customer service personnel, a Quality Assurance (QA) Officer, and manufacturing and warehouse personnel. The company also maintains a toll-free phone, 800-AIR-CHEK, for customer assistance during regular business hours.
Air Chek routinely manufactures and analyzes hundreds to thousands of samplers daily. In-house operations include the printing of sampler materials, the screening/cleaning/drying of charcoal, and the total fabrication and filling of the test samplers. The sampler manufacturing system is totally computer controlled and includes sampler manufacturing, automatic filling equipment, and form-fill-and-seal packaging machinery. Computer controlled equipment automatically assembles, fills, weighs, prints, and records parameters on each sampler. Sampler contents are held to a tolerance of +/- 0.4 of a gram.
Samplers are shipped from the laboratory individually or sold in batches containing sequential serial numbers. A database is maintained listing the name and address of the purchaser indexed by serial number. Each detector is accompanied by extensive and detailed instructions for choosing a location and performing the measurement, and for labeling, sealing and returning the detector. In addition, a pre-addressed first-class return mailer is incorporated as part of the test device.
Our computer controlled automated laboratory is staffed by quality assurance personnel and data entry specialists. When samplers arrive, either from the US postal service or a courier service, they are first inspected for damage and then separated according to condition, model, and type.
All samplers determined to be in acceptable condition are passed on to the analysis system operator where they are placed on a computer controlled balance/data input station. After the barcode is scanned and the relevant data is entered into the controlling computer terminal, the sample is placed in one of sixteen computer selected gamma detectors. From this point the sample is not touched again by human hands. Instead, the sample analysis is completely handled by the computer program and the automated sampler handling system.
After the “normal” samplers have been analyzed, all samplers that were pulled during the initial inspection (and marked according to condition) are entered into the analysis computer. If the sampler’s contents (charcoal) are intact, the sample is fed into the automated analysis system. Any data collected and measured is stored along with information indicating the abnormal condition of the sample.3.1On-site Visits
The facilities are available for inspection by clients, potential clients, the news media, and appropriate governmental agents. However, it is requested that visitors make an appointment at least 24 hours in advance of a desired visit.
3.2 Distribution
Air Chek markets passive charcoal radon samplers to individuals, to EPA listed Radon Measurement Service Providers, and to distributors, providing samplers and analysis services only. Air Chek operates a toll-free hotline to answer questions from clients or distributors.
3.3 Primary Measurement Method
The Air Chek radon test devices use activated charcoal as an adsorption medium that collects gas atoms (including radon) in a highly concentrated fashion. The adsorption characteristics of a specific batch of charcoal in conjunction with a particular package configuration that includes a method of containing the charcoal, restricting the access to the charcoal (type of diffusion barrier) and a method of sealing the container allows the capture of a concentrated sample of ambient air for easy return to a remote analysis site. Once delivered to a site having properly calibrated analysis equipment, the sample can be measured for its radon content. Once a calibration factor has been established (see 9.0) and sampler exposure conditions are properly met (see 7.1) a radon-in-air test result can be calculated that closely matches the actual radon levels of the exposure site.
3.4 Field Sampler Deployment
Included with each device are detailed instructions (per US EPA protocols) which lead the user through choice of a proper location for the measurement, correct performance of the measurement, and proper sealing procedures for returning the sampler to the Air Chek laboratory.
3.5 Transmittal of Results
Sampler test results are sent to the end user and/or property owner and to some state radon departments by telephone, facsimile, internet e-mail, US mail, or any combination of the above. Test results are offered in many different combinations and formats, based on the customer’s needs and/or according to the dozens of different state regulations. All results are submitted to the receiving party within one day of receipt of the test kit’s return to the laboratory.
4.0 Organization and Responsibilities
The organization of Air Chek, Inc. is shown below. The founder and President is B. V. Alvarez. He oversees all aspects of the business and supervises the day to day operations. Shawn G. Price assists in daily management including the monitoring of compliance with various procurements and proficiency programs. Overseeing customer service and the order department is Nancy F. Mullen (since 1986). Quality assurance activities, laboratory operation, and computer system maintenance are supervised by M. G. DeVaynes (since 1987). He operates under the direction of the Laboratory Director, Dr. J. L. Alvarez, Ph.d.(since 1985). Peter Finegan (since 1993) is the controller under the supervision of Judy Alvarez, Office Manager.
5.0 Quality Assurance Objectives for Measurement Data in Terms of Precision and Accuracy
The objective for the precision of the measurements of indoor ambient radon concentrations measured with Air Chek samplers at or above 4 pCi/L is an average ten percent relative difference between duplicates. (This is the warning level, necessitating an investigation into the cause of the discrepancy between duplicates.) The precision levels achieved are determined following the procedures described in sections 9.0 and calculated following the procedures described in section 12.0.
The objective for accuracy of the measurements of indoor ambient radon concentrations measured with Air Chek samplers is ten percent at concentrations of 4 pCi/L or greater. This value is the average percent accuracy, or the ratio of the measured to the known (chamber) value. The accuracy achieved is determined following the procedures described in section 9.0 and calculated following the procedures described in section 12.0.
6.0 The Measurement Method
Air Chek measures radon by analyzing charcoal adsorption samplers using high-geometry sodium iodide well counters. The charcoal adsorption method used is described by EPA Indoor Radon and Radon Decay Product Measurement Protocols, EPA 520-1/89-009, issued by the Office of Radiation Programs. The charcoal container is a packet incorporating a tubular diffusion barrier in series with a restrictive filter covering the inlet. For a 96-hour exposure, the typical moisture gain of a sampler ranges from two to five percent of the total charcoal weight. The Air Chek analysis procedures involve removing the charcoal from the packet prior to placing it in the counter, ensuring consistent geometry. The analysis system is extensively shielded, providing very low background count rates and allowing relatively short counting times (a minimum of 300 seconds). The results of the calculations of radon concentrations are computer generated using information provided by the client as to exposure time, count rates as recorded by the computer, and calibration curves for moisture uptake of up to 20 percent of total charcoal weight.
6.1 Sampler Deployment
The instructions included with each device explain choosing a location and how to correctly deploy the device (see Attachment A).6.3 Recordkeeping Procedures
6.3.1 Information provided by client
Clients must provide the date and time of the beginning and end of the measurement period, the average temperature of the test location, the location (floor) tested, and they must note whether or not closed house conditions were maintained. Additionally, in the case of individual users, their name and address is recorded directly on the sampler packet. (see Attachment A).
6.3.2 Information entered at laboratory
Air Chek employs a computer menu-driven data input system indexed on the serial number of the sampler. The information provided by the client (deployment times and dates, average temperature, and the test location) is entered by a data entry specialist into the database.
The above information is subsequently re-entered by another data entry specialist at a separate work station. The two entries are automatically compared by the computer. Any samplers with differing entries are flagged by the computer and a list of these entries is printed. A supervisor investigates the discrepancies and authorizes any changes.
Net counts per minute are converted to the average pCi/L during the collection period using decay correction factors and calibration curves. All calculations are performed by the computer, and the information is automatically entered into the file.
All sampler data are stored on hard disk periodically during the day and printed to hard copy at the end of each analysis cycle. A daily analysis master sheet is generated and kept in an active file for 90 days and then transferred to archive storage. Computer printouts are maintained in archive storage for up to one year, and all computer (hard disk) records are kept indefinitely.
Air Chek maintains a list of clients and zip codes cross-referenced to sampler serial numbers.
6.4 Shipment of Samplers to Laboratory
The Air Chek samplers are of a unitary design incorporating a first-class mailer packet. Clients are instructed to mail the samplers as soon as the test is over and the samplers are properly sealed (see Attachment A).
7.0 Sample Custody
7.1 Field Sampling Operations
Since Air Chek conducts all analysis on samplers that have been delivered to the laboratory, the accuracy and thoroughness of clients when completing information is critical. Provisions are made on each sample for entering the name, address, and other pertinent sample information. Air Chek provides detailed instructions, and uses a clock and calendar bar illustration on the sampler label to help clients easily provide the necessary information (see Attachment A).
7.2 Laboratory Operations
The receiving technician sorts samplers once they are in the analysis room. The quality assurance officer, M. G. DeVaynes, is responsible for monitoring the work of the receiving technician(s).
Express shipments are sorted to receive analysis first, followed by samples shipped via US Mail or via other standard shipping methods. Samplers are sorted by type as they are inspected for signs of damage or misuse. All samplers showing signs of damage or mishandling are separated by the receiving technician. A supervisor next initials and prints on the sampler packet, with permanent ink, a code letter(s) indicating the condition of the sampler.
The samplers in their sorting trays are moved to the automated analysis system where the information from the sampler package is entered into the computer database. This information includes the beginning and ending date and time of the measurement, the weight of the charcoal before and after deployment (both are automatically determined by the computer), the average temperature at the test location during the measurement, and any notes about the sampler’s condition. After the initial data entry the sample is placed into the automated analysis system. From this point the sample is never touched again and the sample is counted and then removed by the automated system. The sample data is re-entered (from the empty sampler packet) into the database by another data entry technician at a different workstation. The information from the two entries is automatically compared by the computer and any discrepancies are automatically flagged. Any adjustments of non-matching data must be approved by the quality assurance officer or another supervisor before final results are sent to the client.
Since Air Chek provides samplers in bulk to distributors, the name of the individual client is often different from the name of the purchaser. After automatic computer calculation of the result, the serial number of the sampler is automatically compared with the file of purchasers and the identity of both the original purchaser and the individual client are cross-referenced in the file. Air Chek will provide results to either or both the original purchaser and the individual client, as specified in the purchase agreement.
Reports are printed only after the second data entry has confirmed that the client-supplied information on the sampler was entered correctly. The reports include the name, address, serial number of the sampler(s), location of the test, and the pCi/L result. If there were any problems associated with the sampler, such as a late return to the laboratory, a special notice is appended to the report. Reports are automatically generated by the computer at the end of each analysis cycle.
Daily analysis summary reports containing a list showing each of the samplers analyzed and any problems with a sampler noted individually are signed by each person who has had any part in entering data and/or handling of samples.
These initialed summaries are then checked and signed by the quality assurance or other authorized supervisor with the statement:
“I hereby certify that all of the above listed test samples were received by Air Chek, Inc. on MM/DD/YYYY. These test samples have been inspected and were found to be free of defects and/or misuse unless otherwise noted in the “NOTE” column.”
A final daily step involves a review, of the number and types of reports generated and any errors that may have occurred, by the quality assurance officer.
8.0 Analytical Procedures
Air Chek samplers are analyzed using sodium iodide well-type counters. The detection system is configured to yield very high efficiencies and very low background counts. The efficiency and energy calibration (shift in peaks of interest) of the detectors are automatically determined by the computer, before each shift, using a known standard. Any discrepancies are automatically flagged and the system will halt. The quality assurance officer is responsible for checking the results of the measurements using the known standard, and making any necessary corrections to the system.
Upon receipt at the laboratory, exposed samplers are inspected for damage and missing information, and then sorted by type. The test samples that pass this first inspection are next individually placed into a mechanism which automatically reads the test serial number and the sample’s weight. At this station the deployment dates and times and the temperature during deployment at the test site are entered into a database by one of our data entry specialists. Every item entered is subsequently re-entered by a different data entry specialist in another room at a different entry station and an automatic computer comparison is made on each individual item entered.
Each sampler is individually removed from the auto-reading scale mechanism and then placed into our computer-controlled totally-automated counting system. The computer controls the automatic selection of the next available counting unit. Each sample is gamma counted by a heavily shielded extra-large sodium-iodide well detector. There are 16 detectors in our main analysis system. As each sample finishes being counted the system automatically removes the sample.
Computer-maintained calibration factors dependent upon length of deployment, test site temperature, and moisture gain, as well as daily background values, the natural background counts in the charcoal, the radon adsorbsion/moisture adsorbsion efficiency tables of the charcoal used, sample type tables, and decay factors are used by the computer to generate results in pCi/L. Individual test reports are automatically generated and each is printed with the end user’s address. Reports are mailed to individual clients the next business day after the detector’s arrival at the laboratory. Results for professionals (inspection companies, etc.) are automatically faxed or e-mailed as soon as the analysis is completed. Our registered professionals also have full-time toll-free access to their test information and can receive automated computer-generated voice response to their inquiries, as well as additional faxed reports.
The background of the system is automatically checked, before each shift and after every six sets of samples. The computer will automatically correct for any slight changes that may occur throughout the shift. If there is any occurrence of background results exceeding prescribed limits then the system will shut down. The quality assurance officer is responsible for making any necessary corrections to the system.
These daily system and background checks are conducted in the following steps:
The analysis system remains in a continuous operating mode to avoid problems that are inherent with electronic equipment when it is turned on and off repeatedly. Therefore, the need to let the system warm up and stabilize prior to making a measurement is eliminated.
A known and matched standard is placed in each detector.
Three-hundred-second counts are made and the results are automatically compared to the values obtained during previous standardization procedures. Any detector indicating more than a 3.5 percent change is automatically counted again. If the change persists, the system stops and a warning is posted to contact the quality assurance officer. The quality assurance officer is responsible for making any necessary corrections to the system.
Three-hundred-second background counts are made with empty detectors, and the results compared to the values obtained during the previous standardization procedures. Any detector indicating more than a ten percent change is counted again. If the change persists, the system stops and a warning is posted to contact the quality assurance officer. The quality assurance officer is responsible for making any necessary corrections to the system.
The analysis system incorporates a computer controlled electronic balance. At the beginning of each shift and during each automatic background check (after each set of six samples) the data entry specialist is directed by the computer to place a calibration standard on the balance pan. Also, a test of the zero/tare feature of the balance is automatically made each time a sample is removed from the balance. Any discrepancies will cause the system to halt. The quality assurance officer is responsible for checking the results of these measurements and making any necessary corrections.
9.0 Calibration Procedures and Frequency
Air Chek contracts with commercial radon chambers and maintains an in-house chamber to conduct batch calibrations. Each batch calibration includes at least 64 samplers. At least 8 of each are exposed for periods of two days through seven days at specified humidity and temperature. A minimum of three different (low, medium and high) humidities are specified for each production type. The results from these batch exposures are used to generate calibration tables for each batch of charcoal used in the samplers. These calibrations are performed whenever the activated charcoal type used in the samplers changes, and/or at least every twelve months.
10.0 Data Reduction, Validation, and Reporting
10.1 Data reduction
The result reported to the clients is calculated using the following equation.
(((cpm - bkg) * exp(.00756 * DCY)) / GRAMS / kFACTOR ) * TC
where
CPM = Gross counts per minute - System background counts per minute
bkg = Carbon background counts per minute
DCY = Time elapsed in hours since the end of the test until the time of
the analysis
GRAMS = Carbon weight in grams
kFACTOR* = Standard counts per minute per gram of pCi/L
TC = Temperature correction factor
*The kFactor is determined using a automatic computer look-up table which is indexed by the length of the test in hours, type of sampler, batch of charcoal, and the percent gain in moisture. Each batch of charcoal has its own table of kFACTORs, derived during the chamber calibrations conducted for each new batch. All kFACTORs are determined at 70 degrees F.
The percent gain in moisture is the ratio of the start to the end weight of the charcoal, multiplied by 100.
(No results are reported to clients who conduct tests in environments with temperatures greater than 90 degrees F or less than 30 degrees F.)
10.2 Data validation and reporting
Air Chek procedures involve 100 percent rekeying (by different data entry persons) and automatic computer comparison of the client-provided information including the start and stop dates and times and test site temperature. At the rekeying station the sampler serial number is checked against the bar-code number read by the lab computer. Discrepancies between entries for the same sampler are automatically flagged and printed out by the computer for investigation by a supervisor prior to the report being issued. The QA officer checks and signs off on any changes due to recalculations. The client name, address and pCi/L concentration generated by the computer are printed onto standardized information/answer reports. This allows no opportunity for transcription errors. The QA officer is responsible for reviewing the daily analysis summary sheets to ensure that the proper number and type of reports were issued.
A notice is appended to a client’s report if there have been any unusual circumstances, such as late-arriving samplers or samplers returned improperly sealed. These circumstances are completely described in section 15.0.
10.3 Automated Monthly Reports
Air Chek has established an automatic reporting program that compiles specific reports to several entities. The programs are set to run at specific frequencies and contain detailed information for each client. The QA officer is responsible for ensuring that the reports are completed and delivered as well as ensuring the data is appropriate and complete. The reports are available in both printed and electronic media. The electronic reports are either distributed via e-mail or diskette.
10.4 Report logs
Each analysis system has its own report log, in which are recorded any unusual circumstances, maintenance, changes in background, efficiency, and the results of the daily checks. In addition, Air Chek maintains a QA report log, in which are kept copies of results from calibration facilities, copies of the control reports, and any other pertinent information. The maintenance of these report logs is the responsibility of the QA officer or his designee.
11.0 Internal Quality Control Checks
11.1 Quality control checks of charcoal and sampler packaging used in production
Air Chek contracts with commercial radon chambers and maintains an in-house chamber to conduct batch calibrations. Each calibration run includes at least 64 samplers. At least 8 of each type of sampler are exposed for periods of two days through seven days at specified humidity and temperature. The results from these exposures are used to compare each new batch of charcoal to a specification table. Any new batch that does not fall within the table parameters is returned to the supplier.
Air Chek QA procedures for manufacture of the samplers require that the dry weight of charcoal in each sampler be within +/- 0.4 grams of the nominal sampler weight, or that sampler is automatically rejected by the computer controlling the automated filling machinery. The computer records the dry sample weight and prints onto each sampler packet the sequential serial number, a barcode representing that number, and the weight in grams to one-tenth of a gram. Additional checks include
a check for proper closure of the inner seals, the placement of the packet
sealant strip, and properly applied packet side seals;
a check that the serial numbers are in proper sequence and are legible; and
verification that the instructions are enclosed.
For every 100 samplers constructed, at least one sampler is pulled and used for
QA sampling.
11.2 Replicate measurements
Air Chek processes well over 50 duplicates each month. These duplicates are placed by separate Air Chek professional inspectors. Duplicate samplers are returned to the laboratory through the normal system, are not specially labeled, and are analyzed routinely. The QA officer maintains a list of the serial numbers of duplicate samplers reported each month and tracks the results. Reports of the average relative percent difference between duplicates are maintained, as described in section 16.0.
An additional system is in place regarding duplicate measurements. Although not directly involved with our sampler analysis system, we do process over 50 samplers each month that have been exposed in the field adjacent to and concurrent with a continuous monitor measurement. These measurements are made as part of a quality control procedure established for our blind CRM lease program. Reports and tables are maintained by the QA officer on each of the CRMs and the companion duplicate measurements.
11.3 Controlled exposures
Air Chek participates in Bowser-Morner’s monthly sample spiking program. The results from these samplers are used as a secondary check to monitor the calibration curves and the overall accuracy of the system.
11.4 Determining background exposures
11.4.1 Determining empty detector backgrounds
At least once a month, and any time there is a system shutdown because specifications were exceeded, the QA officer institutes an overnight system background count sequence. This involves 100 or more 300 second count periods for each of the 16 empty detectors in each system. From these sessions the mean of the totals (for each separate detector) is taken and applied to the control tables being used by the computer during subsequent analysis sessions.
11.4.2 Determining the charcoal’s natural background
With each new batch of charcoal received for manufacture, and prior to use in operations, at least 32 samplers which have not been exposed to radon are analyzed for background levels. The results are reviewed by the QA officer, who ensures that the background levels are internally consistent and within specification. If necessary, new background values using the mean of the 32 results are generated and used for that batch of charcoal, as authorized by the laboratory director.
11.5 Cross-checking with a known standard
Each of the sodium-iodide well detectors in the Air Chek laboratory has an individual radium 226 source assigned to it. These sources are strategically placed into their assigned detectors each day prior to the start of lab operations. A three hundred second count is taken for each detector and compared to the known value. Deviations of 5 percent or more automatically halt the system, requiring the QA officer to conduct the appropriate checks and any necessary adjustments. All adjustments are automatically recorded by the controlling computer.
11.6 Quality Control Records
Air Chek documents its quality control measures using four types of Quality Control Reports (QCR). The first type of QCR records the system (empty detector) background maintained for each detector. Changes in the values used for background(s) and any recounts are automatically recorded by the computer.
The second type of QCR records the standard count rate maintained for each detector. Changes in the values for detector efficiency indicate a likely problem with the affected unit, and any required corrections made by the QA officer are automatically recorded by the computer.
The third type of QCR is for duplicates. The warning level, requiring an investigation into the disagreement between duplicates, is an average value greater than ten percent. The values on this QCR are recorded by the QA officer, who is responsible for notifying the laboratory director if the warning level is exceeded.
The fourth type of QCR is for spikes, using the results from the in-house exposures described in section 11.3.2. The warning level is an average percent accuracy greater than 10 percent for exposures greater than 4 pCi/L or 5 percent for exposures greater than 20 pCi/L. The QA officer is responsible for maintaining this report, and for notifying the laboratory director if the warning level is exceeded.
12.0 Quality Assurance Audits
The QA officer conducts daily audits of the laboratory operations and quality control procedures implementation, and quality assurance records are automatically updated on a daily basis. In addition, the QA officer conducts extensive audits after any significant change in procedure or method, or if there are problems with quality control samples.
13.0 Preventive Maintenance
Air Chek’s completely automated laboratory has been programmed to notify the QA officer when any component needs attention. Additionally, electronic sensors that monitor all mechanical aspects of the system will signal the computer to halt the system if any piece of equipment malfunctions. Our computer controlled approach toward preventative maintenance on all aspects of the laboratory’s operation assures the continuous and accurate performance of each piece of equipment in the system.
SOP requires the QA officer to perform a daily review of all systems to ensure their proper operation prior to starting any analysis procedure. This includes a visual and auditory survey of each piece of equipment. If deficiencies are identified by the QA officer the appropriate repairs or adjustments will be made and documented in the laboratory report log.
14.0 Procedures to Assess Data Precision, Accuracy, and Lower Limit of Detection
14.1 Assessment of precision
Precision is assessed as the average relative percent difference between duplicates for measurements in indoor ambient radon concentrations greater than 4 pCi/L. The “spiked” samples average is recorded on the QCR for duplicates.
14.2 Assessment of accuracy
Accuracy is assessed as the percent accuracy, or the measured value divided by the known value. The percent accuracy reported by the independent calibration facility will be noted in the QA report log and on the QCR.
14.3 Assessment of the lower limit of detection
The lower limit of detection used by Air Chek is that described by the EPA (EPA 1982 Standard Operating Procedures for Internal Quality Control, IQC-I and IQC-II, QORP-002/82/2, issued by the EPA Office of Radiation Programs) and by the NRC (NRC Regulatory Guide 8.30). This lower limit of detection (LLD) is described as the smallest amount of sample activity that will “yield a net count sufficiently large as to imply its presence” (EPA 1982). Air Chek follows EPA and NRC precedent and uses a 95 percent confidence level, accepting the chance of detecting activity when it is present 95 percent of the time but missing it 5 percent of the time. The LLD is dependent on the variability of the system background, and is therefore derived using the results of the blank samplers. It is calculated as 4.65 times the standard deviation of the system background (with blank samplers). In general, the LLD for Air Chek samplers is between 0.2 and 0.5 pCi/L.
15.0 Corrective Action
Several different types of corrective action are part of Air Chek procedures.
15.1 Corrective action due to degradation of precision or accuracy
The QA officer is responsible for noting degradation in quality control results, as evidenced by the QCRs. If the warning level is exceeded on any QCR, the QA officer will investigate the cause immediately and all processes involved will be placed on hold until the situation has been corrected.
15.2 Procedures for samplers returned to the laboratory late
Air Chek will not provide results for samplers returned to the laboratory more than 288 hours (12 days) after the end of the deployment period. Clients returning such samplers will receive a notice informing them that their test was invalid due to excessive decay time.
If the samplers are returned to the laboratory more than 192 hours but less than 288 hours after the end of deployment, Air Chek will calculate a result, but will send the result with a notice indicating long decay time and indicating that the result is only an estimate.
If the exposure period was more than 7 days, clients are advised to return the sampler to the laboratory. In some cases, if the moisture adsorbed has not exceeded the acceptable limits, the sampler can still be analyzed and the result will be reported to the client as being representative of the last 3 to 5 days of the test.
15.3 Procedures for samplers received with insufficient information
Unfortunately, approximately two percent of the samplers are returned to the laboratory without complete information. If the client provided the start and stop dates, but not time(s), Air Chek assumes that the missing time(s) are 12:00 noon. The client will receive a report with an estimated pCi/L value, accompanied by a notice that the times were missing and the included result is only an estimate. If the client did not provide the dates, they will receive only an estimated result and they are advised to retest. There is in place a procedure whereby the client can request in writing that the result be calculated based on times and dates additionally supplied to the laboratory. There will be an additional processing fee applied.
15.4 Procedures for samplers received containing excessive moisture
When samplers arrive that have increased in weight by more than 20 percent, the client receives a notice stating that the samplers were exposed to excessive moisture or exposed too long in a very damp environment, and the result is only an estimate.
15.5 Procedures for samplers received that were exposed in extreme temperatures
Samplers received at the laboratory that are labeled by the client as having been exposed to temperatures outside the acceptable limits are analyzed, but the client receives a notice that the sampler was exposed to extreme temperatures, and no result is provided.
15.6 Procedures for samplers received that were improperly sealed
Samplers received at the laboratory that were improperly sealed by the client are analyzed, but no result is provided and the client receives a notice that the sampler was invalidated.
16.0 Quality Assurance Reports to Management
The QA officer is responsible for maintaining all computer and manually generated QCR records. These reports are readily available to the laboratory director and the president.
16.1 Daily reports
The QA officer is responsible for maintaining computerized and manual reports on the following topics: daily backgrounds including any significant changes, results of the blank samplers analyzed, any alterations of procedures, any adjustments to standard values (efficiencies), the results of radon accuracy assessment conducted through the private radon calibration facilities, results of any calibrations conducted on any instruments (scales, continuous monitors), adjustments of calibration curves, and any changes in procedures, any maintenance of laboratory equipment, and the evaluation of outlying results.
The automatic computer system saves all files containing daily backgrounds and the known standard’s cross-checks. Also recorded are any results outside the warning level and any action taken.
16.3 Annual Reports
Audits conducted by the laboratory director and/or president on all QA procedures will examine the following topics: laboratory procedures and QA records, identification of any QA problems and their recommended solutions, the cumulative results of accuracy assessment conducted through the private chambers, any changes in methods or procedures, maintenance of laboratory equipment, and results of any calibration conducted on any laboratory maintenance instruments.
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