TMI-09-086, Submittal of Concerning Unsatisfactory Laboratory Performance Tests
| ML092120650 | |
| Person / Time | |
|---|---|
| Site: | Crane, Limerick  |
| Issue date: | 07/30/2009 |
| From: | Cowan B Exelon Generation Co, Exelon Nuclear |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| TMI-09-086 | |
| Download: ML092120650 (18) | |
Text
Exelon Nuclear 200 Exelon Way Kennett Square, PA 19348 TMI-09-086 July 30, 2009 www.exeloncorp.com Nuclear 10 CFR 26.719(c)
U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001 Limerick Generating Station, Units 1 and 2 Facility Operating License Nos. NPF-39 and NPF-85 NBC Docket NoS 50-352 and 50-353 Three Mile Island Nuclear Station, Unit 1 Facility Operating License No. DPR-50 NBC Docket No 50-289
SUBJECT:
10 CFR 26.719(c) Report Unsatisfactory Laboratory Performance Tests Pursuant to 10 CFR 26.719(c), "Drug and alcohol testing errors," Exelon Generation Company, LLC (Exelon), is submitting information for Limerick Generating Station (LGS), Units 1 and 2, and Three Mile Island Nuclear Station (TMI), Unit 1, concerning unsatisfactory laboratory performance tests of "blind-specimen" samples tested at a Department of Health and Human Services (HHS) certified laboratory. The HHS-certified laboratory is under contract with Exelon to perform drug testing as required by 10 CFR 26 in support of implementation of the Exelon Fitness-for-Duty (FFD) Program at the LGS and TMI facilities.
10CFR26.719(c) stipulates in part that licensees shall notify the NRC within 30 days of completing an investigation of any testing errors or unsatisfactory performance discovered in performance testing at either a licensee testing facility or an HHS-certified laboratory, in the testing of quality control or actual specimens.
Attachments 1, 2, and 3 to this letter provide information and details concerning unsatisfactory HHS-certified laboratory performance tests conducted for LGS and TMI by an HHS-certified laboratory and the associated corrective actions. Enclosures 1 and 2 to this letter contain reports from the HHS-certified laboratory that conducted the analysis of the "blind specimen" samples.
There are no regulatory commitments contained within this letter.
u.s. Nuclear Regulatory Commission Docket Nos. 50-352 and 50-353 Docket No. 50-289 10CFR26.719(c) Report July 30,2009 Page 2 If you have any questions or require additional information, please contact Richard Gropp at 610-765-5557.
Respectfully, Yf/4
~£'vldrJ Pamela B. Co an Director, Licensing & Regulatory Affairs Exelon Generation Company, LLC : Summary of Unsatisfactory Laboratory Performance Test - Sample Specimen No. 19818776 : Summary of Unsatisfactory Laboratory Performance Test - Sample Specimen No. 19800225 : Summary of Unsatisfactory Laboratory Performance Test - Sample Specimen No. 19800824 :
Medtox Laboratories' Letter dated June 23, 2009 - Sample Specimen Nos.
19818776 and 19800225 :
Medtox Laboratories' Letter dated July 15, 2009 - Sample Specimen No.
19800824 cc:
Regional Administrator - NRC Region I NRC Senior Resident Inspector - Limerick NRC Senior Resident Inspector - TMI NRC Project Manager NRR - Limerick and TMI w/ attachments/enclosures
ATTACHMENT 1 Limerick Generating Station, Units 1 and 2 Docket Nos. 50-352 and 50-353 10 CFR 26.719(c) Report Summary of Unsatisfactory Laboratory Performance Test Sample Specimen No. 19818776 SlJmmaryof Unsatisfactory Laboratory pedormance Test Sample No 19818776 Introduction 10CFR26.168, uBlind performance testing," stipulates that each licensee shall submit blind performance test samples to the HHS-certified laboratory and shall use only blind performance test samples that have been certified by the supplier.
On June 30, 2009, Exelon Generation Company, LLC (Exelon) completed an investigation concerning a potential testing discrepancy with a "blind specimen" sample submitted by Limerick Generating Station (LGS), Units 1 and 2, to the Department of Health and Human Services (HHS) certified laboratory used by LGS. The HHS-certified laboratory is under contract with Exelon to perform drug testing as required by 10 CFR 26 in support of implementation of the Exelon Fitness-for-Duty (FFD) Program at the LGS facility.
As a result of the potential testing discrepancy identified with the "blind specimen," LGS FFD personnel initiated a follow-up investigation. The details of this investigation are summarized below.
Summary A "blind-specimen" sample (i.e., #19818776) that was considered as "dilute," was submitted from the LGS facility to Medtox Laboratories, Exelon's HHS-certified laboratory for testing. 10CFR26.168(g) specifies several parameters for blind performance test samples. A "dilute" sample must be certified by the supplier and the test sample must contain a creatinine concentration that is equal to or greater than 5 mg/dL but less than 20 mg/dL, and the specific gravity must be greater than 1.0010 but less than 1.0030.
The "blind-specimen" was purchased from Professional Toxicology Services (PTS), an HHS-certified laboratory. The Certificate of Analysis (COA) from PTS verified the specimen to be "dilute" with a specific gravity target value of 1.0011 - 1.0029, which is within the range specified by 10CFR26.168(g). An analysis of the "blind-specimen" was performed at the LGS onsite FFD testing facility and the results showed low creatinine level (i.e., "dilute"). The sample specimen was submitted to Medtox Laboratories for processing and analysis. The results from Medtox Laboratories indicated an "invalid" test because of a specific gravity of 1.0009, rather than "dilute."
10CFR26.167(f), "Errors in testing," specifies that licensees shall ensure that the HHS-certified laboratory investigates any testing errors or unsatisfactory performance discovered in blind performance testing in the testing of actual specimens, or through the processing of reviews, as well as any other errors or matters that could adversely reflect on the testing process. Therefore, the Director of PTS (i.e., the supplier of the certified sample) was subsequently contacted and the following explanation was provided.
Page 1 of 3 Summary of Unsatisfactory Laboratory performance Test Sample No 19818776 The relatively new requirements of 10CFR26.168(g)(5) specify that "dilute" blind performance test samples must contain a creatinine concentration that is equal to or greater than 5 mg/dL but less than 20 mg/dL, and the specific gravity must be greater than 1.0010 but less than 1.0030. The Director explained that sometimes it is difficult to obtain a specific gravity within the required range between 1.0010 and 1.0030. This is a very narrow range taking into account the four decimal places. In this case, the specific gravity of the "blind-specimen" was measured by Medtox Laboratories to be 1.0009 (i.e.,
0.0002 below the certified lower limit of 1.0011), even though the COA indicated the specific gravity of the "blind-specimen" sample was within the acceptable range. The Director further indicated that PTS would take efforts to develop samples with a specific gravity value closer to 1.0020 for the lower end of the range.
The Director of Forensic Toxicology for Medtox Laboratories was contacted and the response is noted in a letter dated June 23,2009 (Enclosure 1), which was received by electronic mail. The letter provides the rationale for Medtox Laboratories reporting the result of "blind-specimen" Sample #19818776 as "invalid" rather than "dilute." Even though the specimen is actually "dilute," the result fell outside of the lower end of the required range (i.e., greater than 1.0010 for specific gravity). Therefore, it placed the test result in a different reporting requirement. Specifically, 10CFR26.161 (f), "Results indicating an invalid specimen," subpart (1) indicates that the laboratory shall report a specimen as invalid when:
"...Inconsistent creatinine concentration and specific gravity results are obtained (i.e., the creatinine concentration is less than 2 mg/dL on both the initial and confirmatory creatinine tests and the specific gravity is greater than 1.0010 but less than 1.0200 on the initial and/or confirmatory specific gravity test, the specific gravity is less than or equal to 1.0010 on both the initial and confirmatory specific gravity tests and the creatinine concentration is equal to or greater than 2 mg/dL on either or both the initial or confirmatory creatinine tests)...."
Exelon's Medical Review Officer (MRO) was contacted on June 24, 2009, and was requested to review the data associated with results of the testing of "blind-specimen" sample. The MRO reported on June 25, 2009, and concurred with the information provided by the Director of Forensic Toxicology, Medtox Laboratories, in its letter dated June 23, 2009. FFD personnel completed the investigation concerning this potential testing discrepancy with a "blind specimen" sample on June 30, 2009, as previously indicated.
Therefore, as required by 10CFR26.719(c) this report is being submitted to the NRC within 30 days of completing the investigation of the unsatisfactory laboratory performance test of a "blind-specimen" sample by the HHS-certified laboratory.
In addition, while performing benchmarking for this particular incident with other licensees within Region I, Exelon determined that other licensees are experiencing similar problems in that the specific gravity of some "blind-specimen" samples have Page 2 of 3 Summary of Unsatisfactory Laboratory performance Test Sample No 19818776 been reported slightly less than 1.0010. However, the samples were supplied from a different HHS-certified laboratory. Several licensees within Region I did report that they used PTS as their "blind-specimen" provider; however, they found no issues with any of the "dilute" specimens.
Exelon has entered this identified discrepancy into the Corrective Action Program (CAP) under Issue Report (IR) 935460. Other similar issues involving HHS-certified laboratory testing discrepancies have been entered into CAP under IRs 917486, 927241, and 935459.
Exelon previously reported similar testing discrepancies with "dilute" blind-specimens for LGS in a letter dated June 23, 2009.
10CFR26.168(e)(5) stipulates the following:
"To challenge the HHS-certified laboratory's ability to determine specimen validity, the licensee or other entity shall submit blind samples each quarter that are appropriately adulterated, diluted, or substituted, in the amount of 20 percent of the specimens submitted that quarter or at least three samples per quarter (one each that is adulterated, diluted, or substituted), whichever is greater.
These samples must be formulated at the concentrations established in paragraphs (g)(4) through (g)(6) of this section."
Exelon plans to suspend HHS-certified laboratory testing of "dilute" blind-specimens for its LGS, Three Mile Island, Peach Bottom, and Oyster Creek facilities, as necessary, until the testing discrepancy issues can be satisfactorily resolved. The recent problems being experienced with testing of "dilute" blind-specimens are expected to be a topic of discussion at a Nuclear Energy Institute (NEI) conference.
Page 3 of 3
ATTACHMENT 2 Three Mile Island Nuclear Station, Unit 1 Docket Nos. 50-289 10 CFR 26.719(c) Report Summary of Unsatisfactory Laboratory Performance Test Sample Specimen No. 19800225 Summary of Unsatisfactory Laboratory performance Test Sample No 19800225 Introduction 10CFR26.168, "Blind performance testing," stipulates that each licensee shall submit blind performance test samples to the HHS-certified laboratory and shall use only blind performance test samples that have been certified by the supplier.
On June 30, 2009, Exelon Generation Company, LLC (Exelon) completed an investigation concerning a potential testing discrepancy with a "blind specimen" sample submitted by Three Mile Island (TMI), Unit 1, to the Department of Health and Human Services (HHS) certified laboratory used by TM!. The HHS-certified laboratory is under contract with Exelon to perform drug testing as required by 10 CFR 26 in support of implementation of the Exelon Fitness-for-Duty (FFD) Program at the TMI facility.
As a result of the potential testing discrepancy identified with the "blind specimen," TMI FFD personnel initiated a follow-up investigation. The details of this investigation are summarized below.
Summary A "blind-specimen" sample (Le., #19800225) that was considered as "dilute," was submitted from the TMI facility to Medtox Laboratories, Exelon's HHS-certified laboratory for testing. 10CFR26.168(g) specifies several parameters for blind performance test samples. A "dilute" sample must be certified by the supplier and the test sample must contain a creatinine concentration that is equal to or greater than 5 mg/dL but less than 20 mg/dL, and the specific gravity must be greater than 1.0010 but less than 1.0030.
The "blind-specimen" was purchased from Professional Toxicology Services (PTS), an HHS-certified laboratory. The Certificate of Analysis (COA) from PTS verified the specimen to be "dilute" with a specific gravity target value of 1.0011 - 1.0029, which is within the range specified by 10CFR26.168(g). An analysis of the "blind-specimen" was performed at the TMI onsite FFD testing facility and the results showed low creatinine level (Le., "dilute"). The sample specimen was submitted to Medtox Laboratories for processing and analysis. The results from Medtox Laboratories indicated an "invalid" test because of a specific gravity of 1.0009, rather than "dilute."
10CFR26.167(f), "Errors in testing, " specifies that licensees shall ensure that the HHS-certified laboratory investigates any testing errors or unsatisfactory performance discovered in blind performance testing in the testing of actual specimens, or through the processing of reviews, as well as any other errors or matters that could adversely reflect on the testing process. Therefore, the Director of PTS (Le., the supplier of the certified sample) was subsequently contacted and the following explanation was provided.
Page 1 of 3 Summary of l Jnsatjsfactory Laboratory performance Test Sample No 19800225 The relatively new requirements of 10CFR26.168(g)(5) specify that "dilute" blind performance test samples must contain a creatinine concentration that is equal to or greater than 5 mg/dL but less than 20 mg/dL, and the specific gravity must be greater than 1.0010 but less than 1.0030. The Director explained that sometimes it is difficult to obtain a specific gravity within the required range between 1.0010 and 1.0030. This is a very narrow range taking into account the four decimal places. In this case, the specific gravity of the "blind-specimen" was measured by Medtox Laboratories to be 1.0009 (Le.,
0.0002 below the certified lower limit of 1.0011), even though the COA indicated the specific gravity of the "blind-specimen" sample was within the acceptable range. The Director further indicated that PTS would take efforts to develop samples with a specific gravity value closer to 1.0020 for the lower end of the range.
The Director of Forensic Toxicology for Medtox Laboratories was contacted and the response is noted in a letter dated June 23,2009 (Enclosure 1), which was received by electronic mail. The letter provides the rationale for Medtox Laboratories reporting the result of "blind-specimen" Sample #19800225 as "invalid" rather than "dilute." Even though the specimen is actually "dilute," the result fell outside of the lower end of the required range (Le., greater than 1.0010 for specific gravity). Therefore, it placed the test result in a different reporting requirement. Specifically, 10CFR26.161 (f), UResults indicating an invalid specimen," subpart (1) indicates that the laboratory shall report a specimen as invalid when:
U...Inconsistent creatinine concentration and specific gravity results are obtained (i.e., the creatinine concentration is less than 2 mg/dL on both the initial and confirmatory creatinine tests and the specific gravity is greater than 1.0010 but less than 1.0200 on the initial and/or confirmatory specific gravity test, the specific gravity is less than or equal to 1.0010 on both the initial and confirmatory specific gravity tests and the creatinine concentration is equal to or greater than 2 mg/dL on either or both the initial or confirmatory creatinine tests)...."
Exelon's Medical Review Officer (MRO) was contacted on June 24, 2009, and was requested to review the data associated with results of the testing of "blind-specimen" sample. The MRO reported on June 25, 2009, and concurred with the information provided by the Director of Forensic Toxicology, Medtox Laboratories, as subsequently documented in its letter dated June 23, 2009. FFD personnel completed the investigation concerning this potential testing discrepancy with a "blind specimen" sample on June 30, 2009, as previously indicated.
Therefore, as required by 10CFR26.719(c) this report is being submitted to the NRC within 30 days of completing the investigation of the unsatisfactory laboratory performance test of a "blind-specimen" sample by the HHS-certified laboratory.
In addition, while performing benchmarking for this particular incident with other licensees within Region I, Exelon determined that other licensees are experiencing similar problems in that the specific gravity of some "blind-specimen" samples have Page 2 of 3 SlJmmaryof Unsatisfactory Laboratory performance Test Sample No 19800225 been reported slightly less than 1.0010. However, the samples were supplied from a different HHS-certified laboratory. Several licensees within Region I did report that they used PTS as their "blind-specimen" provider; however, they found no issues with any of the "dilute" specimens.
Exelon has entered this identified discrepancy into the Corrective Action Program (CAP) under Issue Report (I R) 935459. Other similar issues involving HHS-certified laboratory testing discrepancies have been entered into CAP under IRs 917486, 927241, and 935460.
Exelon previously reported similar testing discrepancies with "dilute" blind-specimens for Limerick Generating Station facility in a letter dated June 23, 2009.
10CFR26.168(e)(5) stipulates the following:
"To challenge the HHS-certified laboratory's ability to determine specimen validity, the licensee or other entity shall submit blind samples each quarter that are appropriately adulterated, diluted, or substituted, in the amount of 20 percent of the specimens submitted that quarter or at least three samples per quarter (one each that is adulterated, diluted, or substituted), whichever is greater.
These samples must be formulated at the concentrations established in paragraphs (g)(4) through (g)(6) of this section."
Exelon plans to suspend HHS-certified laboratory testing of "dilute" blind-specimens for its LGS, Three Mile Island, Peach Bottom, and Oyster Creek facilities, as necessary, until the testing discrepancy issues can be satisfactorily resolved. The recent problems being experienced with testing of "dilute" blind-specimens are expected to be a topic of discussion at a Nuclear Energy Institute (NEI) conference.
Page 3 of 3
ATIACHMENT3 Three Mile Island Nuclear Station, Unit 1 Docket Nos. 50-289 10 CFR 26.719(c) Report Summary of Unsatisfactory Laboratory Performance Test Sample Specimen No. 19800824 SIJmmaryof Unsatisfactory Laboratory performance Test Sample No 19800824 Introductjon 10CFR26.168, "Blind performance testing," stipulates that each licensee shall submit blind performance test samples to the HHS-certified laboratory and shall use only blind performance test samples that have been certified by the supplier.
On July 16, 2009, Exelon Generation Company, LLC (Exelon) completed an investigation concerning a potential testing discrepancy with a "blind specimen" sample submitted by Three Mile Island (TMI), Unit 1, to the Department of Health and Human Services (HHS) certified laboratory used by TMI. The HHS-certified laboratory is under contract with Exelon to perform drug testing as required by 10 CFR 26 in support of implementation of the Exelon Fitness-for-Duty (FFD) Program at the TMI facility.
As a result of the potential testing discrepancy identified with the "blind specimen," TMI FFD personnel initiated a follow-up investigation. The details of this investigation are summarized below.
Summary A "blind-specimen" sample (Le., #19800824) that was considered as "dilute," was submitted from the TMI facility to Medtox Laboratories, Exelon's HHS-certified laboratory for testing. 10CFR26.168(g) specifies several parameters for blind performance test samples. A "dilute" sample must be certified by the supplier and the test sample must contain a creatinine concentration that is equal to or greater than 5 mg/dL but less than 20 mg/dL, and the specific gravity must be greater than 1.0010 but less than 1.0030.
The "blind-specimen" was purchased from Professional Toxicology Services (PTS), an HHS-certified laboratory. The Certificate of Analysis (COA) from PTS verified the specimen to be "dilute" with a specific gravity target value of 1.0011 - 1.0029, which is within the range specified by 10CFR26.168(g). An analysis of the "blind-specimen" was performed at the TMI onsite FFD testing facility and the results showed low creatinine level (Le., "dilute"). The sample specimen was submitted to Medtox Laboratories for processing and analysis. The results from Medtox Laboratories indicated an "invalid" test because of a specific gravity of 1.0010, rather than "dilute."
10CFR26.167(f), "Errors in testing," specifies that licensees shall ensure that the HHS-certified laboratory investigates any testing errors or unsatisfactory performance discovered in blind performance testing in the testing of actual specimens, or through the processing of reviews, as well as any other errors or matters that could adversely reflect on the testing process. Therefore, the Director of PTS (Le., the supplier of the certified sample) was subsequently contacted and the following explanation was provided.
Page 1 of 3 Summary of Unsatisfactory Laboratory performance Test Sample No 19800824 The relatively new requirements of 10CFR26.168(g)(5) specify that "dilute" blind performance test samples must contain a creatinine concentration that is equal to or greater than 5 mg/dL but less than 20 mg/dL, and the specific gravity must be greater than 1.0010 but less than 1.0030. The Director explained that sometimes it is difficult to obtain a specific gravity within the required range between 1.0010 and 1.0030. This is a very narrow range taking into account the four decimal places. In this case, the specific gravity of the "blind-specimen" was measured by Medtox Laboratories to be 1.0010, even though the COA indicated the specific gravity of the "blind-specimen" sample was within the acceptable range. The lower limit for specific gravity as discussed above must be greater than 1.0010. The Director further indicated that PTS would take efforts to develop samples with a specific gravity value closer to 1.0020 for the lower end of the range.
The Director of Forensic Toxicology for Medtox Laboratories was contacted and the response is noted in a letter dated July 23, 2009 (Enclosure 2), which was received by electronic mail. The letter provides the rationale for Medtox Laboratories reporting the result of "blind-specimen" Sample #19800224 as "invalid" rather than "dilute." Even though the specimen is actually "dilute," the result fell outside of the lower end of the range (Le., the result must be greater that 1.0010 for specific gravity). Therefore, it placed the test result in a different reporting requirement. Specifically, 10CFR26.161 (f),
UResults indicating an invalid specimen," subpart (1) indicates that the laboratory shall report a specimen as invalid when:
U...Inconsistent creatinine concentration and specific gravity results are obtained (i.e., the creatinine concentration is less than 2 mg/dL on both the initial and confirmatory creatinine tests and the specific gravity is greater than 1.0010 but less than 1.0200 on the initial and/or confirmatory specific gravity test, the specific gravity is less than or equal to 1.0010 on both the initial and confirmatory specific gravity tests and the creatinine concentration is equal to or greater than 2 mg/dL on either or both the initial or confirmatory creatinine tests)...."
Exelon's Medical Review Officer (MRO) was contacted on July 16, 2009, and was requested to review the data associated with results of the testing of "blind-specimen" sample. The MRO reported on July 16, 2009, and concurred with the information provided by the Director of Forensic Toxicology, Medtox Laboratories, as subsequently documented in its letter dated July 15, 2009. FFD personnel completed the investigation concerning this potential testing discrepancy with a "blind specimen" sample on July 16, 2009, as previously indicated.
Therefore, as required by 10CFR26.719(c) this report is being submitted to the NRC within 30 days of completing the investigation of the unsatisfactory laboratory performance test of a "blind-specimen" sample by the HHS-certified laboratory.
In addition, while performing benchmarking for this particular incident with other licensees within Region I, Exelon determined that other licensees are experiencing Page 2 of 3 Summary of Unsatisfactory Laboratory performance Test Sample No 19800824 similar problems in that the specific gravity of some "blind-specimen" samples have been reported slightly less than 1.0010. However, the samples were supplied from a different HHS-certified laboratory. Several licensees within Region I did report that they used PTS as their "blind-specimen" provider; however, they found no issues with any of the "dilute" specimens.
Exelon has entered this identified discrepancy into the Corrective Action Program (CAP) under Issue Report (IR) 942433. Other similar issues involving HHS-certified laboratory testing discrepancies have been entered into CAP under IRs 917486, 927241, 935459, and 935460 Exelon previously reported similar testing discrepancies with "dilute" blind-specimens for Limerick Generating Station facility in a letter dated June 23, 2009.
10CFR26.168(e)(5) stipulates the following:
UTo challenge the HHS-certified laboratory's ability to determine specimen validity, the licensee or other entity shall submit blind samples each quarter that are appropriately adulterated, diluted, or substituted, in the amount of 20 percent of the specimens submitted that quarter or at least three samples per quarter (one each that is adulterated, diluted, or substituted), whichever is greater.
These samples must be formulated at the concentrations established in paragraphs (g)(4) through (g)(6) of this section."
Exelon plans to suspend HHS-certified laboratory testing of "dilute" blind-specimens for its LGS, Three Mile Island, Peach Bottom, and Oyster Creek facilities, as necessary, until the testing discrepancy issues can be satisfactorily resolved. The recent problems being experienced with testing of "dilute" blind-specimens are expected to be a topic of discussion at a Nuclear Energy Institute (NEI) conference.
Page 3 of 3
ENCLOSURE 1 Limerick Generating Station, Units 1 and 2 Docket Nos. 50-352 and 50-353 and Three Mile Island Nuclear Station, Unit 1 Docket Nos. 50-289 Medtox Laboratories' Letter dated June 23, 2009 Sample Specimen Nos. 19818776 and 19800225 Page 1 of 1 June 23, 2009 Ms. Dolores Adams Nuclear Security, FFD Lead Analyst Exelon Corporation By email: Dolores.adams@exeloncorp.com
Dear Ms. Adams:
This is in response to your inquiry regarding specimen numbers 19818776 and 19800225, Laboratory Accession Numbers H9929233 and H9930172, respectively. These specimens were receIved at MEDTOX Laboratories, Inc. on 06/16/2009 and were processed for routine testing.
Specific gravity testing was performed on two different aliquots of these specimens based on creatinine results < 20 mg/dl. All specific gravity results were < 1.0010, with reported values of 1.0009 for both specimens. AU associated quality control results were within the acceptable range, verifying the validity of the measurements. The combination of the creatinine and specific gravity results place the specimens into the "Invalid" reporting category rather than "Dilute". I have reviewed all relevant analytical data for these specimens and believe that the results reported were accurate.
In addition. we received permission from Dr. Pohlman, the Exelon MAO, to repeat the specific gravity testing as a part of our internal investigation of the discrepancy between the reported results and the expected results. The specimens were retrieved from storage, realiquotted and tested for specific gravity on two different 4-decima! place refractometers. Results for both specimens were 1.0009 on both refractometers, repeating the original results. The instrument calibration was current and was verified by analysis of quality control material. There is no apparent bias in any of the measurements. We believe that the results reported to you are accurate, and based on the creatinine and specific results, the specimens fall into the "Invalid" reporting category.
As we have discussed previOUSly, blind specimens targeted close to a decision point may risk falling into a different reporting category due to analytical variability within an acceptable range. To ensure that results fan into a specific category, blind specimens for validity testing should be ideally be targeted near mid-range.
Specimens targeted too close to thresholds could accurately be reported in either category.
Please let me know if you have additional questions in this regard.
Sincerely, Jennifer A. Collins, Ph.D.
Director of Forensic Toxicology MEDTOX Laboratories, Inc.
ENCLOSURE 2 Three Mile Island Nuclear Station, Unit 1 and 2 Docket Nos. 50-289 Medtox Laboratories' Letter dated JUly 15,2009 Sample Specimen No. 19800824 Page 1 of 1 July 15, 2009 Ms. Dolores Adams Nuclear Security, FFD Lead Analyst Exelon Corporation ByemaU: Dolores.adams@exeloncorp.com
Dear Ms. Adams:
This is in response to your inquiry regarding specimen number 19800824, laboratory Accession Number N0070784. This specimen was received at MEDTOX Laboratories, Inc. on 06/30/2009 and was processed for routine testing. Specific gravity testing was performed on two different aliquots of these specimens based on creatinine results < 20 mg/dl. Specific gravity results were confirmed at 1.0010. All associated quality control results were within the acceptable range, verifying the validity of the measurements. The combination of the creatinine and specific gravity results places the specimen into the "Invalid" reporting category rather than "Dilute". I have reviewed all relevant analytical data for this specimen and believe that the results reported on 07/02/2009 were accurate and the specimen was appropriately identified as "Invalid".
In addition, we received a request from Dr. Pohlman, the Exelon MRO, to repeat the creatinine and specific gravity testing as a part of the investigation of the discrepancy between the reported results and the expected results. The retesting confirmed the creatinine at 15.3 mg/dl and the specific gravity at 1.0009, consistent with the original results reported. The retest results have been reported to Dr. Pohlman.
As we have discussed previously, blind specimens targeted close to a decision point may risk falling into a different reporting category due to analytical variability within an acceptable range. To ensure that results faU into a specific category, blind specimens for validity testing should be ideally be targeted near mid-range.
Specimens targeted too close to thresholds could accurately be reported in either category.
Please let me know if you have additional questions in this regard, Sincerely, Jennifer A Collins, Ph.D.
Director of Forensic Toxico!ogy MEDTOX Laboratories, Inc.