ML20066C504
| ML20066C504 | |
| Person / Time | |
|---|---|
| Site: | South Texas  |
| Issue date: | 09/24/1990 |
| From: | Bliley T HOUSE OF REP., ENERGY & COMMERCE |
| To: | Carr K NRC COMMISSION (OCM) |
| References | |
| FRN-55FR35648, RULE-PR-26 55FR35648-00032, 55FR35648-32, NUDOCS 9101100201 | |
| Download: ML20066C504 (132) | |
Text
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- -w.o JQn. .t CLO A, #8 C'f08 The Honorable Kenneth M. Carr Chairman Nuclear Regulatory Commission Washington, D.C. 20055
Dear Mr. Chairman:
In December 1989, the Committee on Energy and Commerce commenced an investigation into the case of a Bay City, Texas woman who had been fired from a clerical position at a nuclear power plant on the basis of a drug test result that she alleged to be incorrect. The investigation revealed that she had in fact been the victim of a faulty drug test, the direct consequence of incompetent handling by her employer, Houston Lighting and Power Co. (HL&P), and the employer's confirmation laboratory, Accu-Chem Laboratories of Richardson, Texas. Because the facts here lend themselves to a case study of the potentially devastating consequences wrought by human error and incompetence in the handling of urine dr*.:: tests generally, the committee is releasing a Staff Repor; .'. a: oing an detail its investigation. A copy is enciesed t'or your information. Although the drug test in question here was administered prior to the effective date of the Nuclear Regulatory Commission's fitness for duty regulations, our investigation nonetheless indicates that several aspects of the Commission's regulations provide cause for serious concern. It appears that in many respects the Commission's drug testing guidelines have sacrificed fairness, accuracy, and confidentiality for test subjects in favor of cost-cutting measures and other questionable procedures sought by the nuclear industry. -In addition, the Commission quite obviously ignored the facts and recommendatir.,ns of s study prepared at the Commission's own request by Battelle Humar. Affairs Research Centers in connection with the fitness for duty rulemaking. The major problems with the Commission's program are identified at the end of the Staff Report. 9101100201 900924 PDR PR 26 55FR35648 PDR [Q
( The Honorablo Kenneth M. Carr September 34, 1990 4 9 Page 3 We strongly urge you to examine the Report carefully and to give serious consideration to the concerns raised about the Commission's fitness for duty program. The Report demonstrates that the NRC's current regulations are inappropriate in several particulars and that they run counter to the weight of scientific evidence and consensus in the field of forensic urine drug testing. Furthermore, while we applaud the Commission's recent issuance of a proposed amendment to its regulations that would clarify the unacceptability of taking action against an individual based solely on an unconfirmed positive screening test result, we are concerned by the separate views critical of that proposed amendment published by you and Commissioner Remick. We hope the enclosed Report will cause you to give more careful consideration to this issue. The Commission is requested to provide the Committee with a formal response to the concerns raised in the Report by no later than Monday, October 15, 1990. If you have any questions regarding this matter, please feel free to contact staff member Alan J. Roth at 225-3147. Thank you for your cooperation. Sincerely, f L
'l JOEN D. El LLL ' / THO S J. BLILEY Chairman Ran ing Republican Me ber Energy and Commerce Committee Sub ommittee on Overs ght and Investigations Enclosure cc The Honorable Kenneth C. Rogers The Honorable James R. Curtiss The Honorable Torrest Remick j
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JC w00 . . . p a c t. TO: The Honorable John D. Dingell Chairman The Honorable Thomas J. Bliley Ranking Republican Member Subcommittee on Oversight and Investigations FROM: CommitteeStaffd)V( RE: The Need for Drug Testing Standards: A Case Study in the Consequences of Incompetence STAFF REPORT _ Introduction In December 1989, tne Committee was requested to investigate the case of a Bay City, Texas woman who had been fired from a clerical position et a nuclear power plant on the basis of a drug test result that she alleged to be incorrect. Mrs. Judy Proffit, age 35, was hired by Houston Lighting and Power Company (HL&P) on July 3, 1989 to work at the company's South Texas Project (STP) Electric Generating Station in Bay City. Pursuant to HL&P's " fitness for duty" program, she had provided a urine test. specimen on June 28, 1989 for a pre-employment urine drug i Her employment was terminated by HL&P on August 3, 1989 on the ground that her specimen had tested positive for methamphet-i amines. She denied the charge and, through an intermediary ~, sought l the Committee's assistance. Thr staff believed that investigation of this particular case was warranted becaose the documentation provided by HL&P to Mrs. Proffit purporting to support her drug test result raised serious questio'is of 'airness and accuracy. The facts here thus lent themselves te a ":ase study" of the potentially devastating consequences wrought by human error and incompetence in the handling of urine drug tests. l l l
, Staff Report l September 12, 1990 i Page 2 l j 1 1 Based upon its investigation, the staff believed that Mrs. 4 Proffit had in fact been the victim of a faulty drug test, which i resulted from analytical errors and poor procedures on the part of j Accu-Chem Laboratories (Accu-Chem) of Richardson, Texas, the laboratory that purportedly performed a confirmation test on Mrs. ! Proffit's specimen. Following discussion with EL&P of the results of the staff's investigation, HL&P informed the staff that it i planned to send the remaining portion of Mrs. Proffit's urine specimen, which had been kept in frozen storage by the company i since her original test, to a laboratory certified by the 4 Department of Health and Human Services (DHHS) for retesting. In a j letter dated July 19, 1990, EL&P informed the staff that the retest , wa: negative for methamphetamine. Accordingly, HL&P stated, it planned to treat the inconsistent test results as " indeterminate," to so inform Mrs. Prof fit, and to discuss with her the ! possibilities for reemployment at STP. I 3 Mrs. Proffit suffered economic losses as a result of her firing, as well as the emotional distress and humiliation that one ! would naturally expect to accompany a termination under these cir-cumstances. The staff believes that these injuries were the direct consequence of HL&P's and Accu-Chem's incompetent handling of her drug test. Errors and poor test procedures were not detected by ' i HL&P in this case primarily because HL&P had neither a medical review officer (MRO) nor other qualified expert to review drug test results reported by Accu-Chem. The staff is not aware of whether other specific employees and applicants for employment at STP were similarly victims of this incompetence, but evidence obtained by the Committee suggests that Mrs. Proffit's was in all likelihood not an isolated case. In addition, it appears that HL&P's ignorance concerning proper forensic drug testing methodology and interpretation led the company to issue inappropriate warnings to employees to cease using certain medications prescribed by their personal physicians.- i Summary of Conclusions and Recommendations This case study has important implications for public policy with respect to drug testing laboratory standat4s and the manner in which test results are handled. At present, to the extent such 1 standards exist at all, they are limited to testing performed in the' federal workplace, in the transportation industry (as of January 2, 1990),~ and in the nuclear-power industry (as of January 3, 1990). .The standards applicable even to each of these three employment sectors differ from one another,-and those applicable to i testing in the nuclear industry-provide materially less protection for test subjects than the standards covering federal and transpor-tation workplaces. Mrs. Proffit's case helps to demonstrate the urgent need for a single set of stringent standards applicable to all drug testing
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Staff Report September 12, 1990 Page 3 programs -- standards covering both what goes on behind the laboratory's doors and the manner in which reported results are in-terpreted, evaluated, and used. Such standards would be provided by the enactment of H.R. 33, legislation you have introduced to establish a federal certification program for drug testing labs. Specifically, drug testing programs should, at a minimum, provide the following protections: Use of laboratories certified by DHHS or a qualified designee pursuant to a single set of strong quality and proficiency standards. I Compliance by such laboratories with uniform federally mandated standards and procedures appropriate to the performance of forensic urine drug testing, including confirmation of all initial positive results by gas chromatography / mass spectrometry (GC/MS). Adequate personnel. training and continuing educetion for laboratory Standardized methods and procedures for the performance and interpretation of GC/MS confirmation tests. Uniform cut-off levelsl for both screening and confirmation tests set (and, as appropriate, revised) by a regulatory process that is based on appropriate examination by experts of the available scientific and technical evidence. Maintenance by certified laboratories of adequate back-up documentation to support fully the results of every positive test, with prompt reporting _of results. Verification of drug test results by a qualified MRO. A well-designed blind performance testing program to 1 The ability of any assay to detect low levels of drugs has an inherent limit. The concentration of drug in the urine sample-below which the assay can no longer be considered reliable is . .
. sometimes called the
" detection limit" and is expressed as a concentration of the analyte in the specimen. The ' cutoff' point is the concentration 11mic that will actually be used to assay samples. It is a value serving as an adminis-trative break or negative. point for labeling a urine result positive Hawks, " Analytical Methodology" in Urine Testing for Drugs of Abuse, NIDA Research Monograph 73, at p. 36 (1986).
1 1
Staff Report September la, 1990 Page 4 l assess the true proficiency of a laboratory, as well as ! other methods of quality control. I Maximum practicable confidentiality for the identity of test subjects, regardless of the results of their tests. Split specimens that readily provide the possibility of a reliable retest when a positive result is challenged, and a right on the part of the test subject to obtain an appropriate retest in such cases. i _Investication
)
Cn December 7,1989, Dr. Arthur J. McBay, a forensic toxicolo- l gist, wrote to Chairman Dingell on Mrs. Proffit's behalf to request that the Committee investigate her case. This request followed Dr. McBay's discussion about the matter with a member of the Committee staff at a consensus conference on drug testing standards sponsored by the National Institute on Drug Abuse (NIDA) from November 28 to December 1, 1989. Dr. McBay provided the Committee with a copy of the test report se r. by HL&P to Mrs. Proffit on August 24, 1989, together with th' attachments to that report. In his request letter, Dr. McBay expressed his opinion that "the submitted documentation did not confirm the identification of methamphetamine, amphetamine, or any other drug in the urine specimen and is inadequate, lacking documentation of controls, standards, procedures, etc." He also indicated that he had been unable to find Accu-Chem listed among the forensic urine drug testing laboratories certified by NIDA or accredited by the College of American Pathologists (CAP). A review of the material by the Committee staff indicated several causes for concern about Mrs. Proffit's test results. The Committee therefore undertook to obtain from HL&P and Accu-Chem additional information and documentation relevant to this caso and to BL&P's drug testing program. In letters to Don D. Jordan, HL&P's Chairman and Chief Executive Officer, and to Dr. John Laseter, Accu-Chem's Laboratory Director, both dated December 8, 1989, the Committee requested the company and the laboratory respectively to provide documents pertaining to this case and to answer certain questions potentially relevant to the matter. In a letter dated December 28, 1989, Accu-Chem responded with complete answers to the questions posed and partial production of the documents requested. In a letter dated December 29, 1989, HL&P responded to the Committee's requests with partial answers to the questions posed and production of the documents requested.
Staff Report Septembor la, 1990 Page 5 In a letter dated January 12, 1990, following a telephone con-versation with Committee staff regarding the Committee's request, Accu-Chem supplemented its prior production with a copy of the relevant portion of its Standard Operating Procedures (SOP) manual for (GC/MS) confirmation of amphetaminev and methamphetamines. Following review and analysis of the materials supplied by HL&P and Accu-Chem, as well as additional telephone communications with Dr. Laseter, the Committee staff sought and requested opinions with regard to Accu-Chem's report of a methamphetamine positive in this case from several well-known and highly regarded independent experts in the fields of toxicology, pharmacology, and forenric urine drug testing. These experts were Dr. Stuart C. Bogeri, Director of Toxicology and Therapeutic Drug Monitoring at A crican Medical Laboratories, Inc., a DHHS-certified lab in Fairfax, Virginia; Dr. Kurt M. Dubowski, Distinguished Professor of Medicine and Director of Forensic Science Laborateries at the University of Oklahoma College of Medicine, Oklahoma City Campus; Dr. Rodger L. Foltz, Director of Forensic Toxicology at Northwest Toxicology, Inc. and Associate Director of the Center for Human Toxicology at the University of Utah, both in Salt Lake City; and Dr. S. Michael Owens, Associate Professor, Department of Pharmacology and Toxicology at the University of Arkansas for Medical Gelences in Little Rock. These experts were provided with copies of all materials obtained by the Committee relevant to Accu-Chem's purported GC/MS confirrnatjonofthemethamphetaminepositiveonMrs.Proffit's specimen. The independent experts were not informed of the 2 These materials included a copy of a sample table showing a list of the controls, standards, and specimens analyzed by Accu-Chem in the same batch as Mrs. Proffit's specimen, the chromatograms and mass spectra printouts for the controls and specimens in that batch provided to the Committee by Accu-Chem, Accu-Chem's " drug confirmation worksheet" for Mrs. Proffit's specimen dated July 13, 1989, and the SOP excerpt supplied by Accu-Chem to the Committee with its January 12, 1990 letter. Accu-Chem's SOP calls for working positive standards set at 300 i ng/ml, 500 ng/ml, and 1000 ng/ml to be run with each batch of urine specimens. The documentation submitted by Accu-Chem to the Committee (and provided, in turn, to the experts) suggested that a 1000 ng/ml standard was run with the batch containing Mrs. Proffit's specimen. However, the 1000 ng/ml data was not fully l included with Accu-Chem's production of documents to the Committee. i The staff made a specific request for this data on June 8, 1990. l In a conversation with the staff on June 18, Dr. Laseter stated that the 1000 ng/ml standard "did not work on that QC (quality control] run," but that Accu-Chem went ahead and ran the batch (Footnote continued) l
Staff Report September la, 1990 1 Page 6 1 identities of the test subject, the employer, the confirmation laboratory, or the on-site contract laboratory used by HL&P for screening tests. The SDP documents were redacted to remove Accu-Chem's name. None of the other documents provided to the independent experts identified the relevant parties in any manner. On May 30, 1990, the Committee again contacted HL&P to request that the company supplen=nt and complete its responses of December 29, 1989 and provide additional information regarding the responsi-bilities and qualifications of Dr. B. J. Blankenship, M.D., the STP medical director. HL&P responded to these requests on June 8, 1990. Also on May 30, 1990, the Committee wrote to Dr. Laseter of Accu-Chem, enclosing a copy of two of the four experts' opinions with regard to this case (the other two having not yet been received) and inviting Dr. Laseter to respond to the comments contained therein. On June 5, 1990, Dr. Laseter wrote to the Committee, declining the invitation to respond. On June 8, 1990, the Committee staff telefaxed to Dr. Laseter a copy of the other two experts' opinions and again invited a response. In addition, Dr. Laseter was requested to respond to certain factual questions that had originally been posed to him by the Committee staff in a telephone conversation on June 6, 1990. On June 12, 1990, Dr. Laseter replied that the information request-ed "has already been supplied in our respense dated December 28, 1989." The staff believed this reply to se non-responsive and contacted Dr. Laseter by telephone on June 18 to obtain the information. The Committee staff had several meetings and telephone discus-sions with representatives of HL&P during the period from June 19 to July 19, 1990 to discuss its findings and to offer HL&P an opportunity to respond or comment. In addition, on June 26, the Col.m.ittee received from Dr. Laseter a letter dated June 21, 1990 in response to the comments of the Commi+'ee's independent experts. This letter was provided in turn to tne experts (again with the identities of Accu-Chem and Laseter blanked out). The experts were asked to comment if Laseter's letter contained any information that warranted further attention or caused them to change their opinions. None of the experts altered their original conclusions and several pointed out deficiencies and contradictions in Dr. Laseter's purported answers and explanations. 2(continued) without it. :n a letter to the Committee dated June 21, 1990, Dr. Laseter confirmed "the lack of an appropriate 1000 ng/ml positive standard to use with sample 6805," which was Mrs. Proffit's specimen.
Staff Report September 11, 1990 i Page 7 HL&P also wrote to the staff on July 10, 1990, commenting on i the evidence and indicating that the company had decided to have a ! remaining portion of Mrs. Proffit's specimen, which had been frozen since July 1989, retested by a DHHS-certified lab using DHHS guidelines. { On July 19, 1990, HL&P informed the staff by letter . l that this retest was negative for methamphetamine.
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racts of the Case l Under HL&P's Titness for Duty Policy for STP in effect in June 1989, the "(p)ossession, use, distribution, sale, influencing others toward use, or being under the influence of illegal drugs at any times [ sic) (was) cause for denial of access to STP" for all ~- HL6P Nuclear Group employees. (Emphasis in original). The term
" illegal drugs" was defined by the policy to mean " drugs, or the synthetic or generic equivalents of drugs, which are illegal under federal, state or local laws including, but not limited to marijuana, heroin, hashish, cocaine, hallucinogens, eepress, ants and stimulants not prescribed for current personal medical treatment by an accredited physician and any other drug or drug-like substance, the sale, use or possession of which is unlawful."
Under the policy, such employees were " subject at any time te being screened, including psychological testing, breathalyzer, functional testing, polygraph, urine testing or other physical or psychological tests as requested" to determine fitness for duty. The policy provided that "(alny person seeking access to STP will be required to submit to any required search or screenin co .! tion to being granted initial or continued access."g as a (Emphases in original). Pursuant to this policy, Mrs. Proffit, an applicant for employment at STP, reported on June 28, 1989 to the STP Fitness for Duty Center for a pre-employment drug and alcohol test. She completed a consent and authorization form that, among other things, permitted her to disclose any over-the-counter or prescrip-tion medication that she was taking, together with the name of the physician who wrote any disclosed prescription. Mrs. Proffit clearly disclosed on the form that she was taking Advil and phentermine. She also filled in the name of the physician who had prescribed the phentermine. Phentermine is typically prescribed as a diet medication. According to the Physicians' Desk Reference, it is "a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines.'- l The STP Fitness for Duty Center contained an on-site laboratory at which an EL&P contractor performed screening tests for alcohol and nine other substances: propoxyphene, methaqualone, amphet-amines, opiates, barbiturates, cocaine metabolites, phencyclidine, cannabinoids, and benzodiazepines. Mrs. Proffit provided a urine l
Staff Report Scptember 12, 1990 Page 8 specimen to a laboratory assistant there and completed the chain of custody forms accompanying her specimen. According to documents provided by HL&P to Mrs. Proffit and the Committee, Mrs. Proffit's specimen tested negative for all substances except amphetamines. An initial screen and a repeat screen, however, were both positive for amphetamines. These screens were performed using an enzyme immunoassay test (EMIT) manufactured by Syva Company. According to information provided to the Committee by a Syva marketing representative, Syva manufactures four EMIT products for amphetamine screening, two of which have recommended cut-off levels of 300 ng/ml and the other two of which have recommended cut-off levels of 1000 ng/ml. The manufacturer advises that laboratories use the recommended cut-off level for each test because that is the level at which the particular test's performance is claimed to be optimal. EL&P's on-site contract laboratory used the 300 ng/ml EMIT kit for amphetamine screening. In response to a question from the Committee, HL&P indicated that it had previously approved the use of the 300 ng/ml cut-off on the recommendation of a prior on-site laboratory contractor and thet the prior contractor's recommenda-tion was "apparently based on the availability of a reliable Syva-Emit calibrator kit set at that level." Documents and information provided by HL&P to Mrs. Proffit and the Committee indicate that the instrument used to perform the screening tests on Mrs. Proffit's specimen was calibrated on June 29 at 9:54 a.m. using six samples of known amphetamine concentration -- two negative (containing no amphetamine), two containing .3 ug/ml (or 300 ng/ml), and two containing 2.0 ug/ml (or 2000 ng/ml). Based on this calibration, according to the test report provided to Mrs. Proffit, the lab technician established a cutoff rate of 533.6. HL&P documents indicate that at 10:02 a.m. on June 29, the lab technician ran an EMIT test for amphetamines on a batch of urine specimens that included Mrs. Proffit's, using the previously established cutoff rate of 533.6. A test report form states that Mrs. Proftit's specimen "show[ed) positive for amphetamines with a rate of 565.6 which is above the cut-off rate of 533.6." According l to the test report form, a repeat EMIT test was run on Mrs. l Proffit's specimen at 10:39 a.m. on the same day. The form states i that this test " confirmed the initial positive finding with a rate of 562.4." Based on these findings, A:c.-Chem was asked to perform i a GC/MS confirmation test for amphetamar.es on Mrs. Proffit's I specimen. On July 3, prior to EL&P's receipt of her final drug test results, secretary. Mrs. Proffit was formally hired by the company as a l l
Staff Report September 12, 1990 Page 9 On July 17, Accu-Chem telefaxed an undated laboratory report concerning its GC/MS confirmation of Mrs. Proffit's specimen to the STP Fitness for Duty Center. Another copy of the undated report was received by mail on July 1). According to the undated report, Mrs. Proffit's cpecimen was received at Accu-Chem on June 29, 1989 and assigned a sample identification number. This number variously appears on #'4 u-Chem documents as 6805, 26805, and 507026805. The report and n., manying documentation obtained by the Committee indicate th t .a/s. Proffit's sample was analyzed by GC/MS on July 13 at approximately 3:12 a.m. for the presence of amphetamines and methamphetamines. According to the report, the " assay detection limits" of this confirmation test were 300 ng/ml for both drugs.3 The specimen was reported as negative for amphetamines, but positive for methamphetamines. An internal Accu-Chem worksheet indicates that the concentra-tion of methamphetamine in Mrs. Proffit's specimen was determined by Accu-Chem to be 621 ng/ml. Accu-Chem provided no backup material with respect to this calculation, and it is impossible to determine from the Accu-Chem documentation how that calculation was made. No quantitation of the results was provided by Accu-Chem to HL&P or the STP on-site contract laboratory. HL&P told the Committee that it instructed Accu-Chem simply "to report test results as positive or negative" and that quantitative results were retained by Accu-Chem. According to typewritten notes of Diana L. Brown, Acting Supervisor of the Fitness for Duty Center, Accu-Chem was requested on July 18 to perform a " repeat test" on Mrs. Proffit's specimen. Ms. Brown'snotesindicatethagshe"receivedconfirmationon(the] repeat test" on July 28, 1989. 3 HL&P denied that it established the 300 ng/ml cut-off level for GC/MS confirmation of amphetamines and methamphetamines; Accu-Chem told the Committee that it had been instructed by the on-site laboratory to use 300 ng/ml as the cut-off for these substances. 1 4 An HL&P memorandum prepared on December 28, 1989 in connection with the Committee's inquiry states:
" Subsequent conversation with Dr. John Laseter of Accu-Chem and Diana Brown has revealed there was a misunderstanding between the two individuals with regard to a retest on the GC/MS of the (Mrs.
Proffit) specimen. Dr. Laseter referenced a reanalysis when talking to D. Brown. He was referring to a review of testing protocol and test data and determining the original and only GC/MS test was valid. D. Brown misinterpreted reanal to mean a rerun of the GC/MS on the specimen." ysis l (Footnote continued) l l 1
Staff Report September aa, 1990 Page 10 '**' delayBrown's notes contacting Mrs. also indiente that she elected on July ?? to Proffit, with regard to the GC/MS results until Brown's Division Manager, Bob Smith, returned to work and could attend a meeting with Mrs. Proffit. According to Brown's notes, Smith returned to Oli< on August 1 and was notified of the test results at 9:00 a.m. Brown also contacted the on-site contract laboratory for an explanation of why the test results had been so long delayed. Smith discuss theand Brown test results. met with Mrs. Proffit at 11:00 a.m. that day to Brown apparently suggested that Mrs. Proffit inform them of an y medications she might have taken -- her own or someone else's - that might have caused the positive test result. According to Brown's notes, Mrs. Proffit " assured me that she doesn't take other peoples [ sic) prescriptions." Brown gave Mrs. Proffit two days to think about what medications she might have taken and promised to " work with her," but indicated that site access would have to be denied if Mrs. Proffit could not " clear the file." According to Brown's notes, Mrs. Proffit stated that she understood and her medicine cabinet, was going to list for them all of the medications in including those of other family members. At 1:00 p.m. that day, Brown had a conversation with Accu-Chem's laboratory director, Dr. John Laseter, summarized in her notes as follows: I talked with Dr. Laseter. He told me that it had taken longer to get the resulte because of the 4th of July holiday, that people vore off, and that they had some machine failures which caused them to get behind. He went on to explain that on (Mrs. Proffit's) test it showed a positive Phentermine, a peak for amphetamine but was not high enough to call a positive and then peaked on methamphetamine which they did call a positive. He also explained that the phentermine and methamphetamine was two different spikes for two different substances. He said that they had done a thin layer chromatography to ensure the test rescalts and that he was confident inthereadings. report on his findings I requested a written 4(continued) Thus, it appears that Brown proceeded on the assumption that a second GC/MS test was run on Mrs. Proffit's specimen and had been found positive, when in fact no such second test was done. 5 The Committee requested Dr. Laseter to provide it with copies of "all documents and materials in Accu-Chem's possession, custody (Footnote continued)
! I i
Staff Report September 12, 1990 l Page 11 1 According to Brown's notes, Mrs. Proffit returned to the Fitness for Duty Center on the following morning, August 2, with a list of the drugs she found in her medicine cabinet. This list included 10 over-the-counter drugs, 5 vitamins and minerals, and 16 prescription medications. Among the prescription medications en the list were phentermine, one of the druge originally disclosed by Mrs. Proffit on her consent form, and Fastin, the brand name used by Beecham Laboratories for its phentermine capsule. Brown's notes indicate that upon further questioning, Mrs. Proffit reiterated that she had never taken a.myone else's medication. They told Mrs. Proffit they would get back to her "as soon as we found out anything." Mrs. Proffit's list of drugs was then telefaxed to Dr. Laseter. Brown's notes next describe a 1:00 p.m. conversation with < Laseter: Dr. Laseter called, said he had reviewed all of the medications, reviewed his paperwork again, and had repeated the test again. He saw no medications that would give a reading of methamphetamine or combinations that he could say would give this reading result.g The repeated test still gave the same At 3:00 p.m. that afternoon, according to Brown's notes, Smith and Brown met with Mrs. Proffit's division manager and department manager to explain the situation to them and advise them of the action required on a positive test result under HL&P's fitness for duty program. The division manager was asked to speak to Mrs. Proffit about any other medication she might have taken of which she might have been reluctant to inform the Fitness for Duty staff. Brown's notes indicate that at 8:00 a.m. on the following morning, August 3, the division manager informed Brown that Mrs. Proffit was on her way to the Fitness for Duty Center and that the 5(continued) or control, relating or referring to this individual's drug test, test results, and urine specimen." Dr. Laseter provided the Committee with documents responsive to the request and stated, "To our knowledge, the Committee has in its possession or is included [ sic) in this document all Specimen Number 61728." materials related to (Mrs. Proffit's) Apart from the statement in Ms. Brown's notes, no evidence was provided to the Committed to indicate that Accu-Chem performed a thin layer chromatography on Mrs. Proffit's specimen. In addition, neither Accu-Chem nor EL&P provided the Committee with any " written report" to EL&P from Dr. Laseter with l respect to this test subject other than Accu-Chem's undated report of its July 13, 1989 GC/MS and documentation purporting to support l that report. 6 As noted above, such a repeat test was never in fact performed. I
Staff Report September 12, 1990 Page 12 only other medication Mrs. Proffit recalled taking but not disclosing was Parapectolin. Ms. Brown's notes state that Mrs. Proffit was informed upon her arrival that "Parapectolin was not what we needed." After Mrs. Proffit indicated that there were no other medications she could have taken, Ms. Brown informed Mrs. Proffit that she would have to be denied site access. Her incediate supervisor was then contacted to escort Mrs. Proffit off the STP site, and Mrs. Proffit's employment was terminated. Later on August 3, Mr. John W. Odom, HL&P's Department Manager for Human Resources-Nuclear, informed Mrs. Proffit's division manager by letter of the termination resulting from the positive drug test and directed him to initiate a safety work review "to identify past and present work activities and the possible quality impact on workmanship in (Hrs. Proffit's) direct responsibility." This review was apparently conducted and completed on that same day - by Mrs. Proffit's immediate supervisor, who described the " quality impact" of the positive drug finding as "NONE." Prior to her leaving the STP site on August 3, Mrs. Proffit had addressed a written request to Mr. Odom for her test results. On August 9, Mrs. Proffit wrote to Mr. Odom again, requesting all of her test results and further requesting that the remainder of her urine specimen be preserved or returned to her. Odom wrote to Mrs. Proffit on August 24, enclosing the test report form regarding her specimen with several attachments purporting to support the positive test resuit. The only documents supporting the GC/MS confirmation, however, were a copy of Accu-Chem's undated labora-tory report and a single page shoying the gas chromatogram and mass spectra printout for sample 6805 on August 23, the day before Odom responded to Mrs. Proffit's requests for her test results, HL&P's fitness t'or duty staf f received from Accu-Chem a report of a confirmed positive for methamphetamines on a urine specimen that had tean provided by another employee, according to a memorandum w:.tten on December 18, 1989 by a fitness for duty supervisor following initiation of thc Committee's investigation. That employee had indicated on her consent form that she was taking a prescribed drug known as Didrex. Like the phentermine taken by Mrs. Proffit, Didrex is typically prescribed as a diet medication. The memorandum described HL&P's response to this second employee's test results as follows: In view of the fact this was the second con-firmed positive for Methamphetamine in 8 weeks, and 7 Tne on-site contract laboratory split the urine specimen it l obtained from Mrs. Proffit into two parts, retaining one portion and sending the other to Accu-Chem. Both Accu-Chem and HL&P (through its contractor) apparently placed their respective portions in long-term frozen storage.
i Staff Report 50ptember 12, 1990 Page 13 that again there was no listed medication known to tect positive for Methamphetamine the Human Re-sources Department became concerne,d that there may have been a problem with prescribed diet medication being used by site employees. A particular concern was the factprescriptions medication that both individuals had filled At the their diet same pharmacy. The Human Resources Department thereupon undertook to determine whether necessary. such a problem existed and whether corrective action was began with an According interviewtoofthe theDecember second em 18 memorandum, this inquiry author of the memorandum, Cindy McClary,ployee by Mr. another Odom fitness forand the duty supervisor. This interview was conducted much like the ones involving Mrs. Proffit following receipt of her test recults. second employee, like Mrs. Proffit, denied use of any medicationTnis other result. than Didrex and could not explain the confirmed positive test terminated. However, unlike Mrs. Proffit, this second employee was not Instead, her site access was suspended with pay, pending a determination of whether her use of Didrex would cause a confirmed positive for methamphetamines. contact her physician and her pharmacist She was also advised to to enlist their assistance in this determination. On August 25, one day following Odom's transmittal to Mrs. Proffit of her test results, the Human Resources Department distributed a flyer to all site employees requesting that anyone
" currently taking or using prescription medications for diet control, weight control or similar reasons please contact the Fitness ly."
for Duty Center or the Security Force Supervisor immediate-Employees were assured, "No punitive action will occur as a result of your cooperation." According to McClary's memorandum, a survey collection of urine samples was then undertaken "around-the-clock" in "an effort to determine if there was a common test result on a particular drug, a , particular pharmacy." lot number of a drug or prescriptions filled at any one ] Twenty-seven such samples were collected from 4:20 p.m. on Friday, August 25, 1989 to 5:00 p.m. on Sunday, August 27, 1989. These were taken from individuals who disclosed taking seven different drugs, including phentermine, Fastin, and Didrex, on prescriptions filled at six different pharmacies. McClary's memorandum states that none of chese samples confirmed positive for mechamphetamines but that through the efforts of the second employee's physician and pharmacist, Upjohn Co., which manufactures Didrex, released internal test data indi-cating that Didrex does have a potontial to test positive for methamphetamine. In fact, an August 29, 1989 letter from Upjohn to the that physician stated that studies conducted by Upjohn have shown "following single-dose oral administration of 75 mg tritium-
l Staff Repvrt September la, 1990 Page 14 labelled benzphetamine hydrochloride (Didrex) to normal human male volunteers, . .
. 5.51% was excreted in the urine as amphetamine and 1.84t as metamphetamine [ sic)."
McClary's memorandum indicates that she telefaxed this Upjohn information August to Dr. Laseter at Accu-Chem on August 30, 1989. On 31, Dr. Laseter wrote to the Fitness for Duty Center that upon a review of the Upjohn data, "one would conclude that normal therapeutic doses of Didrex would result in readily detectable levels of amphetamine and methamphetamine (>300 ng/ml) in the urine during a routine drug-of-abuse screen." Based on this opinion from Dr. Laseter, HL&P reinstated the second employee's site access and informed for her testherresult. that the Upjohn data provided an adequate explanation Following this incident, Mr. Odom issued a memorandum to all STP site employees, dated September 8, 1989, which thanked employ-ees for the cooperation provided during the previous month's inves-tigation of prescription diet medications. Odom then stated, "It has been determined that due to a molecular breakdown during the manufacturing process and possibly an individual's metabolization, certain diet medicatiogs may result in a confirmed positive test for methamphetamines." follows: Odom went on to cou ion employees as Anyone currently using a prescription medica-tion for diet / appetite control should contact their physician or pharmacist to determine if a pre-scribed diet medication will result in a breakdown for methamphetamines. If there is a possibility of a positive for methamphetamines, please consult your physician to discuss alternative methods of weight control. A confirmed positive test result for methamphetamines may result in denial of site access. Ms. McClary's December 18, 1989 memorandum states that Mrs. Proffit "was aware of this activity," apparently a reference to HLEP's efforts to determine whether prescription diet medications might be causing methamphetamine positives. McClary's memorandum indicates that Mrs. Proffit learned of the internal inquiry when 8 While the Odom memorandum referred to data having been provided by "some manufacturers of prescription diet medications," no evidence was supplied to the Committee indicating that any manufac-turer other than Upjohn had been contacted or had supplied such data. Moreover, HL&P provided no documents supporting Odom's assertion that a methamphetamine positive could result from "a molecular breakdown during the manufacturing process."
Staff Report September la, 1990 Page 15 the pharmacist in question referred her to the second employee. McClary also stated that Mrs. Proffit and her husband made
" subsequent and numerous telephone calls" to the Fitness for Duty Center -- in an effort, it seems obvious, to reverse the decision in Mrs. Proffit's case. McClary's memorandum states they were
" told repeatedly that any data or information provided by the manufacturer of Phentermine that would support a determination of a positive for Methamphetamine when us;s.; Phentermine would be adequate to account for the positive test result." However, in a final comment evidently critical of the approach taken by Mrs.
Proffit and her husband, McClary stated, "To date, their efforts have been targeted at invalidating the Site Laboratory and the Confirmation Laboratory positive test results." that,In response to a question posed by the Committee, HL&P conceded prior to January 3, 1990, the STP fitness for duty program had no RRO to analyze the results of positive drug tests. On January 3, 1990, pursuant to Nuclear Regulatory Commission (NRC) regulations found at 10 CFR Part 26, Dr. B. J. Blankenship, M.D., who was the STP Medical Director, became the STP's MRO. Prior to that date, according to HL&P, Dr. Blankenship's only involvement in the testing. for ritness for duty program was to refer samples to the laboratory The significance of this fact is that no physician or other qualified health professional reviewed either Mrs. Proffit's test results in Jely-August 1989 or the test results of any other STP employee 1990. testing positive for amphetamines prior to January 3, This situation allegedly came as a surprise to Dr. Laseter, who told the Committee staff in a telephone conversation that he had always assumed Dr. Blankenship was reviewing Accu-Chem's positive test reports because Dr. Blankenship's name appeared on all drug test requisitions from HL&P. For example, the requisition form for Mrs. generated Proffit's account GC/MS contained information the left-hand in the upper following corner: computgr-- HL&P/STP DR. BLANKENSHIP SM 521, MATAGORDA CNTY WADSWORTH, TX 77483 TELEPHONE 512-972-8444 ACCOUNT NUMBER 60179-9 Despite the appearance of Dr. Blankenship's name on all 9 The form also contained Mrs. Proffit's name, age, sex, social security number, and urine specimen number (61728), together with the date and time of specimen collection, and, in a chain of custody section, che June 28, 1989 signatures of Mrs. Proffit, the - laboratory who receivedassistant who collected it following collection. the sample, and the supervisor l t
Staff Report September 12, 1990 Page 16 requisitions, Dr. Laseter said, he had never before spoken to or otherwise communicated directly with Dr. Blankenship. Dr. Laseter claimed that in a conversation with Dr. Blankenship following initiation of the Committee's inquiry, he learned for the first time that Dr. Blankenship had never reviewed any of his test reports. Analysis After their efforts to deal directly with HL&P failed, Mrs. Proffit and her husband contacted the Committee through Dr. McBay to seek assistance in vindicating their claim that she had been the victim of a faulty urine drug test. The Committee's investigation followed. In reviewing the material originally provided to the Committee by Dr. McBay, the staff took particular note of Mrs. Proffit's disclosure of phentermine use on her consent form. This fact was considered significant because positive results in EMIT screens for amphetamines are not uncommon among test subjects who have taken legal diet medications such as phentermine pursuant to a prescription. The positive result was of particular interest in Mrs. Proffit's case because the cut-off levels used by HL&P for amphetamines and methamphetamines were extremely low in comparison to the levels prescribed by DHHS in its federal workplace drug testing guidelines. As noted above, HL&P followed the guidance of a prior on-site laboratory contractor by opting for use in its on-site contract laboratory of an EMIT kit with a 300 ng/ml cut-off for its amphetamine screening tests; Accu-Chem, the confirmation laboratory, similarly used a 300 ng/ml cut-off for its GC/MS tests on amphetamines and methamphetamines. By contrast, the DHHS guidelines set the cut-off level for amphetamine screening tests at 1000 ng/ml and the cut-off level for amphetamine and methamphetamine GC/MS confirmations at 500 ng/ml. While the DHHS guidelines have been criticized by some as setting excessively high cut-off levels for some drugs and drug metabolites, the levels set by DHHS for amphetamines and metham-phetamines have generally been considered appropriate. The reasons for using such high levels were well-summarized in a study prepared for the NRC in September 1988 by the Batelle Human Affairs Research Centers at p. 5-21: The fundamental problem with setting lower immunoassay cut-off levels for amphetamines (than the 1000 ng/mi set by DHHS) is that several over-the-counter cold remedies and diet aids contain amphetamines. Cut-off levels lower than 1000 ng/ml may result in true positive results in
5
$2aff Report September 82, 8990 Page 17 as many as 25% to 30% of samples tested due to legitimate use of over-the-counter medications. . .
. . [A)vailable RIA [ radio-immuneassay) and EIA
[ enzyme immunoassay) tests cross-react with several other drugs. . . . [T)he following drugs have been found to cross-react with one or both of the imuJnoassays : benrephetamine, chlorphentamine, diethylpropion, ephedrine, fenfluramine, metham-phetamine, methylphenidate, phenmetrazine, phentermine, phenylpropanolamine, and propylhexe-drine. Several over-the-counter cold and diet medications contain ephedrine and phenylpro-panolquamine. Benzephetamine, fenflutamine, mephentermine, and phenmetrazine are contained in prescription medications. Gas chromatography / mass spectrometry assays can reliably detect Jew levels of amphetamines and reduce cross-reaction problems. The HHS 1988 guidelines set the confirmatory cut-off level at 500 ng/ml. Lower cut-off levels would very likely lead to the detection of drugs resulting from legitimate use. : Emphasis added; notes omitted). Reflecting this view, the recently released report of the NIDA consensus 1989, notes conference at p. 26: on drtg testing standards, held in the fall of Over time, the cut-off concentrations of various analytical methods have been reduced as the methods have been improved and refined. The levels should not be regarded ts immutable, and as existing methods are improved and new techniques become available, threshold levels should be redefined, but always with the conservative approach that the risk of a false positive result must be eliminated. There are sufficient data for some of the present drugs (covered by.the HHS guidelines), and the analytical methods used to detect them, to support reducing the cut-off concentrations, perhaps for the metabolites of THC (marijuana) and cocaine. In contrast, although present cut-off values for ~~ amphetamine (s) are apparently high, there are insufficient date to support a sionificant reduction for this croup of drugs. (Emphasis added). l The working group at the consensus conference charged with l L examining the DHHS cut-off levels accordingly recommended that, i with respect to amphetamines (and, implicitly, methamphetamines), l i
"a study should be undertaken to critically evaluate present data !
for the purpose of recommending lower cut-off levels for both l l l
Staff Report i September la, 1990 Page 18 screening and confirmation." Pending that evaluation, however, the group recommended leaving current DHHS cut-off levels intact. Given these considerations, it should not have been surprising that Mrs. screening the EMIT Proffit's urine test. specimen might have tested positive on , l Such a positive result does not in and of itself indicate any error on the part of the laboratory conducting the screening test since the immunoassay is designed to be highly sensitive, thus minimizing the possibilities for false negatives.10 However, such a resu3t should not be considered a basis on which to take action with respect to a test subject. Rather, this initial result must be confirmed by a second and distinctly different analytical technique. i l As noted by Dr. Richard L. Hawks of NIDA in an article in HIDA Research Monograph 73, Urine Testing for Drugs of Abuse at p. 35, "GC/MS is generally consTdered to be the most conclusive method of i confirming the presence of a drug in urine." However, Dr. Hawks ' further points out at pp. 34-35 that, "[i]n spite of the remarkable potential capabilities of GC/MS, it should not be assumed that the i results of all drug confirmations performed using GC/MS are conclusive.... The reliability of a GC/MS assay is also dependent on the skill and experience of the operator, as well as on the method used for extraction of the drug (s) from the urine and for preparation of the extract for injection into the GC/MS." Apart from the possibility of error in the performance of the GC/MS test, the possibility often exists that, as noted above, a positive amphetamine or methamphetamine result might be explainable by the legal use of a drug. Thus, the Medical Review Officer Manual published by DERS in connection with its mandatory guide-lines for federel workplace drug testing, as well as the Medical Review Officer Guide published by DOT in connection with its regulatiens on testing in the transportation industry, both advise that "a tested individual producing a confirmed positive amphetamine / methamphetamine should be carefully queried about his/her prescribed medications," including stimulant drugs used in treating obesity. This advice is provided in the context of guidelines establishing a screening cut-off for amphetamines at 1000 ng/ml and a confirmation cut-off for amphetamines and methamphetamines at 500 ng/ml. As suggested by the Battelle study such a review using lower cut-offs. procedure would be even more critical for a program , 10 In addition to reviewing the facts and documentation associated with Accu-Chem's confirmation test, see infra, the Committee staff conducted a similar review with respect to the ! screening tests performed by the on-site contract laboratory. The staff found no errors of omission or commission material to this l case on the part of the on-site contract laboratory, i i l^ __ _ _ _
- - - - - ~ ^ ^ ~ ^ ^ ^ ~ ~
V 1 1 d 1 i O EXHIBIT A ). LETTER TROM DR. McBAY ) ll l I 3:
-y,-- , .c ,.y,f....r*%,.+,-#, ,,m,- ,,.y,w,-.,,, ,,-r-e..,,,.,.,,,.w,,,-L.,..
ARTHUR J. McBAY 102 KINGS MOUhTA1N CT. CHAPEL HILL. N.C. 27514 Chairman John D. Dingell Committee on Energy and Commerce U.S. House of Representatives 2125 Rayburn HOB Washington, DC 20515 Ret Drug Testing- South Texas Project Electric Generating Station
Dear Chairman Dingell:
meeting Theiscase enclose! discussed 6. with Counsel Alan Roth at the Consensus My client has told me that he would be pleased to have the case investigated by you and the Committee. Copies of all of are Ior ey opinions the documents enclosed. which I received and were the basis A urine specimen was obtained from the employee on June 28, 1989 together with a signed sheet indicating that the employee was taking a prescribed drug, Phentermine (Attachment !!). On site tests which appear on page 3 indicated that the specimen was tested by a " preliminary urine EHIT-Cocaine Screen". I believe they meant kHIT-Asphetamine screen. On attachment V, the "lov calibrator" produced rates of "469" and "533" and speclaen "16728" was " positive" with rates of "519" and "565" respectively. On page 4 the "Lov amphetamines calibrators" are 0.3 ug/a1 which equals 300 ng/al, yet lamediately below it states " cutoff rate of 533.6 wasrates." calibrator established by taking the average of two 50 ng/ml immunoassays. Phantermine cross reacts with some amphetamine Page 4 indicates that the specimen was submitted to an off-site laboratory for_ gas chromatography / mass spectrometry (GC/MS) for confirmatory analysis. Attachment computer generated readout of a GC/MS. The VI top B appears to be a graph " TIC of Data t 5612A20A.D 6805" is a total ion chromatogram which is not labelled,- dated, or- identified as f rom specimen "61728". There are a number of unidentified responses on this chromatogram. The data below the chromatogram indicates that attempts were made only to identify amphetamine, internal standard. methamphetamine. and cyclizine (ISTD), the w- - y w - -
-yy - e +1 -,siw-e -repr-- w-+- -"*v-e ** *K
Staff Report September-la, 1990 Page 19 Givenduring program the absence of any the period KRO involvement in HL&P's drug testing relevant to Mrs. Proffit's case, coupled with Mrs. Proffit's disclosure of phentermine use, a 300 ng/ml C cut-off, and a positive methamphetamine finding, the Committee staff believed that a thorough review of Mrs. Proffit's GC/MS results was warranted. Accordingly, as noted above; the stsff provided the necessary materials to four outside exp rts in an effort to obtain such a review. that,The four experts consulted by the Committee uniformly concluded based on the documents they examined, there was no scientific basis onforwhich positive to conclude that Mrs. Proffit's specimen was methamphetamines. All of the experts cited similar with the procedures employed by Accu-Chem. reasons for their conclusions an These problems included Accu-Chem's testing standards, f ailure asto adhere well astoits accepted failure t.orensic urine drug proceduresdescribedinitsownSOPmanual.g1 adhere to the Dr. Bogema succinctly summarized the problem with A:cu-Chem's analysis of Mrs. Proffit's specimen as follows: h The th t standard operating procedure (SOP) indicates identification of methamphetamine takes pla on It an underivatized extract of the urine sample.gg is very difficult to differentiate methamphet-amine from phentermine with such a procedure. That is because both compounds have the same molecular weight (149.24) and very similar mass spectra.... The misidentification of phentermine as methamphet-- amine to make.is aThis relatively easy error for a laboratory dure employed by is particularly this lab. true with the proce-The lab's SOP indicates that the unknown samples' ion ratio must be within plus or minus twenty percent (+/- 20% standards and positive c)ontrols....of the ion ratio of All standards and controls are within 20% of each other. Sample
#6805 is not within +/- 20% range of any of the standards or the positive control and, according to l'
Copies of the experts' opinions are attached to this report, together committee with for copies of the materials supplied to them by the their analyses. 12 compound "Derivatization" is the process into another substance for of converting a chemical 9 ability to make a proper chemical identification.the purpose of enhancing one's .b
I o e Staff Report Septrmber s 12, 1990 Pace 20 the SOP, should not have been identified as methamphetamine. Dr. Dubowsk3, citer setting forth a similar and more detailed analysis, summar' -i his conclusions as follows: What has been supplied gives rise to the conclusion that the laboratory in question and the approach ic has taken to the Nevertheless, it tasks at hand are both inadequate. is clear from the information and data supplied that the positive methamphetamine test result is not supported by those data and cannot be validly derived therefrom. Dr. Feltz agreed that the drug test resuls. jid not support a conclusler and that methamphetamine was present in the urine specimen commer.ted, "I should emphasize that the GC/(S methodology used by the laboratory that analyzed this specimen la not unlike method-ology that has been used (and to some extent continues to be used) by many toxicology laboratories, but it does not meet current forensic urine drug testing standards!" (Emphasis in criginal). Dr. Owens noted in a similar vein It is clear that this laboratory has nct correctly identified methamphetamine in the urine sample. Therefore the ind'.vidual, from whom this urine sample was collected, has been seriously m!streat-ed. It makes me wonder how many others have obtained the wrong results from this laoort:ory. As a personal comment, these data represent what can happen if drug testino is allowed outside of carefully controlled cond- ,or.. of checks and balances. Also, there is a <e.ious misconception in the drug testing communita : hat gas chromatography / muss spectrometry 'UC/MS) analysis is infallible. standardizing GC These data show the need for for immunoassays/MS .
" procedures, as has been done The independent experts were not asked to examine or comment en HL&P's handling of the test results after they were reported by Accu-Chem.
However, as noted abot'e, HL&P's fitness for duty pro-gram did not include review of test results by an KRO. In properly designed drug testing programs, an MRO reviews and interprets, at a minimum, every positive prinalysie test to assure a scientifically valid result and to dercrmine whether a legitimate medical explana-tion could account far a confirmed positive result. include conducting a medical interview with the individual, exami-The review may
Staff Report Ser* ember 12, 1990 Pag. 21 nation of the individual's medical history, or consideration of any other relevant biomedical factors. While Dr. Blankenship has served as HL&P's KRO since January 3, 1990, the assignment of this new responsibility to him was made pursuant to NRC regulations and only as of the date required by thosa regulations. Had a qualified KRO been reviewing HL&P test results during the period five months earlier in which Mrs.
~
Proffit's urine specimen was analyzed, it is unlikely that the
' confirmed methamphetamine positive in her case would have withstood scrutiny for the reasons described by the four experts above.
In this regard, it is important to note that under the NRC fitness for duty program, an MRO must be "a licensed physician ... who has knowledge of substance abuse disorders and has appropriate medical training to interpret and evaluate an individual's positive test result together with his or her medical history and any other relevant biomedical information." 10 CPR 26.3 (54 Fed. Reg. 24495, June 7, 1989). Based on a review of Dr. Blankenship's curriculum vitae and other professional data, it is unclear whether Dr.
-Blankenship meets the qualification requirements of the NRC regulations. Apart from a 1962 military correspondence course in clinical laboratory procedures and a current ponition as associate director and vice president of a Houston-based organization known as the American Drug Abatement Consortium, his 23 page curriculum vitae does not indicate any significant experience or training in the areae specified by the NRC regulations.
This is not to suggest that D . Blankensnip is not an able or qualified physician. In fact, he has been a practicing healta professional for more than 30 years. Dr. Blankenship graduated dental school in 1958, practiced dentistry from 1958-1960, earned his M.D. degree in 1963, interned in surgery from 1963-1964, did his residency in oral and maxillofacial sutgery from 1964-1965, and engaged in the private practice of oral and maxillofacial surgery from 1965-1975. Throughout this period, Dr. riankenship also held vtrious medical positions in the military reserves, primerily in the dental corps. He served in ne U.S. Navgl Reserve Medical Corps from 1975 until his retiretent on February 13, 1988. During that period, he developed a spec alty in eviation, diving and hyperbaric medicine and still maintains a private practice in this field. In addition, beginning in 1983, Dr. Blankenship became involved in the field of occupational and industrial medicine. Furthermore, information separately provided to the Committee ! by GL&P states that from 1977-1981, Dr.. Blankenship was involved in l- drug screening programs covering a total of 92,000 military l personnel. From 1981-1983, he served as Executive Officer and l L Director of Clinical Services at the U.S. Naval Hospital in Corpus Christi, reporting to the Commanding Officer with responsibility l for the drug screening program. And from 1983-1986, as associate l diractor of the Everhart Occupational Medicine Clinic in Corpus l l
Stags Report. Coptember 18, 1990 Page 22 Chricti, private which sector.was involved in drug screening programs for the However, the Committee has been given no information indicating the extent or nature of Dr. Blankenship's involvement while occupy-ing.these positions in the actual interpretation or evaluation of drug regulations. test results, the critical qualification in the NRC's And of the more than 80 published and unpublished papers, me.nuscripts, and presentations listed in Dr. Blank 0nship's curriculum vitae for which he claims authorship or co-authorship since 1977, not a single one appears to relate to pharmacology, toxicology, or the conduct of drug testing programs. Of the 25 such papers, manuscripts, and preseritations listed since his entry into-the field of occupational and industrial medicine in 1983, 19 relate field medicine to the field issues. of hyperbaric medicine and 3 relate to military In sum, the staff questions whether Dr. Blankenship is appropriately qualified to serve as EL&P's MRO under current NRC regulations or whether he would have been qualified to do so when fitness for duty Mrs.program. Prof fit's case was being handled by the conpu4y's
.in qualified to serve as an KRO under the NRC. regulations, theEven s absence of a qualified MRO prior to January 3, 1990 was, without question, a serious deficiency in the STP drug testing program.
Even more disturbing, it appears from the documents provided to the Committee that HL&P lacked any appropriately qualified company personnel fitness for duty to evaluate program. and interpret drug test results in the STP The best evidence of this quality gap lies in the obvious ignorance of the company personnel involved in reviewing Mrs. Proffit's test
- results as to the possibility that the presence of phentermine the. interpretation in Mrs. Proffit's of her GC/MS.urine might have caused an error in Instead, the company appeared to rely entirely on statements allegedly made and assurances allegedly given-by Dr.'Laseter of Accu-Chem to Diana Brown-at the Fitness for Duty Center following Mrs. Proffit's protests. Whether or not the statements it and assurances attributed to Dr. Laseter are accurate, is clear that either Dr. Laseter or Ms. Brown was seriously mistaken in his or her understanding of the drug test results.
First, Ms. Brown's notes state that Dr. Laseter "went on to
-explain Phentermine." that on (Mrs. Proffit's] test that it showed a positive However, in response to the Committee's questions, Dr. Laseter stated that "(alt no time was Accu-Chem requested by EL&P 61728."to analyze for the presence of phentermine in Specimen Number Similarly, HL&P stated that "No, Accu-Chem was not instructed to specifically test for Phentermine." Thus, it is inconceivable that Dr. Laseter would actually have known whether Mrs. Proffit'. specimen was positive fot phentermine, and either he was mistaken in saying so or Ms. Brown misunderstood him. As Jr.
4
.~.
Staff Report September 12, 1990 Page 23 Foltz pointed out in his review, whether or not phentermine is present"I can not determine from the data apparently no phentermine standard was analyzed."in the urine sample since Second, Ms. Brown's notes state that Dr. Laseter "said that they had done a thin layer chromatography [ TLC) to ensure the test results and that he was confident in the readings." However, if a TLC was performed evidence to so indicate. in this case, Accu-Chem has failed to produce any In fact, TLC is not the confirmation method of choice for amphetamines and methamphetamines, a point that apparently went unnoticed by HL&P's personnel, t Third, in the context of a forensic urine drug testing program, one would ordinarily expect that documentation with respect to a repeat test would were actually be provided to the company if such a repeat test performed. provided. In this case, no such documentation was Dr. Laseter's alleged assertion that he had reanalyzed Mrs.By H Proffit's specimen, but at no time did she or any other HL&P manager insist on seeing a report respect to the claimed repeat test.or other documentation with While these examples would suffice to call into question the competence of HL&P's fitness for duty staff the mec*. glaring demonstration of ignorance and arrogance on,thelies compan prescription diet medications used by company employees. entire premise of this inquiry was flawed from the start, The and the manner in which the results were used was highly inappropriate. that The Human Resources Department proceeded from the asaumption because there had been two methamphetamine positives recently reported on employees who claimed to be using diet medications, "thereused being may byhavesitebeen employees."a problem with prescribed diet medications In the two cases at issue, one of l which was Mrs. Proffit's, the company placed the burden of proving the absence pending of an illegal the receipt of such drug on the employees involved and, proof, action against both. took punitive and stigmatizing Even then, disparate. the treatment accorded the two employees was highly was suspended withMrs. While pay. Proffit was terminated, the other employee Ironically, the second case came to the Mr. the Odom's results of attention her tests. on the day before he forwarded to Mrs. Proffit Yet he neve: formed Mrs. Proffit-that a question had been raised regarding the pcssible interference of diet medications with HL&P's urine drug tests and~never offered to accord Instead, her the Proffit Mrs. same treatment given to the second employee. investigation of these matters from her pharmacist, who had alsolea sold the second employee her diet medication and had been separately consulted on that case.
Staf f Roport September 12, 1990 Pege 24 It is also evident that the company continued to rely entirelv on the prior opinions of Dr. Laseter in regard to Mrs. Prof fit's test,always not even af beter it became fully accurate.apparent that Laseter's reports might In the case of the second employee, Laseter was forced to concede that amphetamine and methamphetamine might be detectable in the urine of a test subject taking Didrex at the cut-off levels used by HL&P (300 ng/ml). This concession was based on unpublished research information provided by the manuf acturer of the diet medication at issue in that case. However, wer e it not for the aggressive ef forts of the second employee, hr:r pharmacist , and her physician, together with the f airly rcharkable cooperation of the manuf acturer, it is not clear that occurredeitherinLaseter or HL&P would the interpretation ever of the have known second that an employee's error had test result. But for this fortuitous discovery, that employee presumably would have been terminated as well. Moreover, it never seems to have occurred to HL&P following this incident that there was an immediate need to include a qualified KRO in the process of reviewing test results, or that other require Accu-Chem amphetamine and methamphetamine positives might reexamination. On the contrary, HL&P continued to insist that Mrs. Proffit in ef f ect prova that phentermine would cause a GC/MS positive for methamphetanine -- a suggestion that in retrospect turns out to have been ludicrous, since phentermine will not in f act cause a methamphetamine positive but, as Dr. Bogema properlyout, pointed run can and easily be mistaken for one in a GC/MS that is not interpreted. HL&P capped its performance on ,this matter by issuing to its STP their employees a warningdiet use of prescription of highly questionable propriety regarding medications. employees in a memorandum that It told these in a confirmed positive test for methamphetamines.""certain diet medications may r had any information concerning which medications other than DidrexIf the company might cause this result, it made no effort to list them. Instead, it advised employees using diet medications generally to contact their physicians about their respective medications and said, "(1]f there consult is a possibility of a positive for methamphetamines, please your physician control," since "(a) confirmed to discuss alternative positive test methods of weight result for methamphetamines may result in denial of site access." In a drug testing program with a deconstrably incompetent staff and no MRO at all, and in whi;h a serious question about the accuracy or interpretation of Accu-Chem's GC/MS results had recently been raised, it it fairly astounding that EL&P could dispense medical advice as cavalierly as this. At a minimum, the warning appears to run contrary to EL&P's own fitness for duty
- policy, which explicitly excluded from the definition of " illegal drugs" any drug " prescribed for current personal medical treatment
Staff Report September la, 1990 Page 25 by an .*ccredited physician." Moreover, it is highly questionable whether licensed physicians should be limited by employers in their ability to prescribe legal drugs that may improve the health or performance of their patients because laboratories are unable properly to identify and quantify urinary excretion products, or because testing programs are unable properly to interpret or evaluate urine test results. The Parties' Comments
- 1. (a) RL&P's Comments As indicated above, the Committee staff met by telephone with representatives of HL&P on several occasionsin person and spok during the month prior to issuance of this report. HL&P was provided with copies of the opinions rendered by the independent experts who reviewed Accu-Chem's test data (redacted to mask the experts' identities and affiliations). The staff alst discussed in depth its findings and conclusions with respect to both Mrs. Proffit's case and the STP drug testing program. HL&P was invited to submit any comments it might wish to make in response.
In a ?.tter to the staff dated July 10, 1990 and attached to this report Hall as an explained exhibit, HL&P Nuclear Group Vice President D.P. that the STP fitrass for duty program had been implemented in 1986 based on guidance published in 19f,5 by the Edison Electric Institute (EEI). time of Mrs. Proffit's urine drug test,Mr. Hall the noted that since STP fitness the for duty program regulations hadonbeen thisrevised to conform to the requirements of the NRC subject, 1990. which became effective on January 3, The two specific revisions cited by Mr. Hall are (1) the use of a laboratory that has been inspected and certified under the DHHS guidelines for federal workplace drug testing and (2) establishment results. of an MRO position for the evaluation of test In addition, Mr. Hall noted the staff's criticism of HL&P's use of cut-off levels far lower than those set by the DHHS guidelines for the screenin amine presence. g and confirmation of amphetamine and methamphet-In response to the staff's questions concerning the reliability of such low cut-offs, Mr. Hall observed simply that "the actual methamphetamine concentration found in (Hrs. Proffit's) sample discussed above exceeded the NIDA recommended cutoff level (500 ng/ml)." Finally, Mr. Hall noted that HL&P was in the process of obtaining a " reanalysis" of the remaining portion of Mrs. Proffit's urine specimen, which he stated had been frozen since June 1989. This reanalysis,laboratory DHHS-certified according tootherwJee not Mr. Hill- was being performed by a accordance with NIDA guidelines. associated with HL&P, in l
Staff Report SeptembGr la, 1990 Page 26 attached On Julyas an 19, 1990, exhibit, Mr. Hall informed the staff by letter, also p'etamines. that the retest was negative for metham-Based on this retest, HL&P stated that it would treat tus inconsistent results as " indeterminate," inform Mrs. Proffit of that decision, reemployment and discuss with her the possibilities for at STP. (b) Staff's Response Mr. Fall's defense of HL&P's drug testing program is premised largely EEI guidance on the company's reliance until January 3, 1990 on the 1985 document, which he asserts was adopted by the nuclear power industry during that period as a standard. It is a basic principle of tort law, however, that adherence to the custom of an industry does not necessarily constitute reasonLble care. Thus, such use of the EEI guidance cannot alone excuse HL&P's failure to properly design and carry out its own drug testing program if industry and customof reliability didresults. not provide adequate assurances of integrity Certainly there was ample information available to the electric utility January industry 1990 with and others in the private sector long before respect ' program. Even Mr. Hall's letter concedes thatto the design of a sound drug testing itself was adopted more tha' six months earlier the NRC regulation (and, nearly two months before Mrs. Proffit was terminated). incidentally, While the company review at was obviously not obligated by regulation to implement MRO that time, for example, there was considerable discussion accompanying function. the NRC's final rule of the importance of the MRO the NRC rule, widely disseminated both by NIDA and by others,A advised the inclusion of an KRO review in drug testing programs. In a similar vein, the certification of drug testing labora-tories by DHHS commenced well prior to June 1989, and such certifi-cation quality and rapidly came to be viewed in the field as a symbol of competence. While Mr. Hall attempts to defend the use of Accu-Chem by noting that it was certified under the Clinical Laboratory Improvement Act of 1967 (CLIA) and by the Health Care L Financing Administration (HCFA), it is well known that such CLIA and HCFA certification are not adequate indicators of a labora-tory's ability to perform forensic urine drug testing. If they were, i it would hardly have been necessary for Congress to mandate the establishment laboratories xn theoffirst a NIDA certification program for drug testing instance. In fact, it appears that the STP drug testing program was driven more by cost considerations than concern for the integrity of ficult its results or the treatment of its test subjects. It is dif-to imagine any other explanation for HL&P's failure, until absolutely mandated by regulation, to use a better qualified laboratory for the analysis of specimens and an MRO for the i L
. ._ _ _ _ _ _ - _ _ _ _ = _ _ _
Staff Report September AB, 1990 Page 27 verification of positive results. Mr. Hall appears to suggest that HL&P's 300 ng/ml cut-off levels were immaterial in Mrs. Proffit's case because Accu-Chem reported a methamphetamine concentration in her specimen above the NIDA- recommended cut-off level of 500 ng/ml for this drug. This suggestion is misleading and disingenuous. First, it conveniently ignores the fact that screening tests is 1000 ng/ml.the NIDA-recommended cut-off for amphetamine The levels found in Mrs. Proffit's screening tests were barely half that amount, meaning that adherence to the NIDA guidelines would have resulted in her specimen being reported as negative at the screening stage. Second, it assumes that Accu-Chem's quantification and report of her test were correct -- an assumption that is wholly unjusti-fled in light of the independent experts' rejection of the report itself. Indeed, the experts indicate that they could find no valid basis on which to conclude thet Mts. Proffit's specimen was positive for methamphetamine and, coreover, had no way of determining how the purported concentration of 621 ng/ml was derived by Accu-Chem. Third, it is significant that ht6P has made no effort to dis-pute the opinions of those experts. ?n fact, during discussions with the Commit c- 'taff, an i raprssentative admitted that the company had asket
-3 own consu. tant to review the data in question, consultant includar.v the opinions of the four experts, and that the people couldindicated differ."the results were a matter "on which reasonable sultant The staff invited HL&P to have its con-for action to be 'sken againststateaintest writing that-itonwould subject the basis be scientifically of a accepta result "on which r: asonable people could dif fer," but not surprisingly, has failed to produce such a statement.the company, Finally, and perhaps most important, the Committee is concerned not with Mrs. Proffit alone, but with a drug testing program that taken as a whole was demonstrably unfair and incompetent.
screening and confirmation cut-offs for amphetamines and metham-Setting phetamines at 300 ng/ml, for example, flies in the face of good science and ignores a considerable body of empirical evidence (including-Batte11t's probability study foratthe NRC) warning of an unacceptable of fsise positives that level. This evidence was widely available prior to June 1989, when Mrs. Proffit was tested, bVt it is obvious that no one at HL&P had the field to investigate or decide that question. gompetence in this 13
!c a great extent, this criticism is also properly directed at the NRC, which has permitted its licensees in their discretion to adopt cut-off levels lower than those recommended by NIDA -- or even those recommended by the fall 1989 NIDA consensus conference.
(Footnote continued)
e- . Staff Report September la, 1990 , Page 28 ; Several observations are also in order concerning HL&P's decision to retest Mrs. Proffit's frozen specimen. While the Committee staff appreciates HL&P's interest in reexamining Mrs. ' i Proffit's case, the staff was careful to point out to the company's representatives that the Committee's interest in this matter trans-cended this particular incident. Rather, the incident is illustra-tive of the progrmms problems associated with private sector drug testing that are currently unregulated, particularly those administered field. by corporate personnel who lack competence in this Regardless of the outcome of the retest in Mrs. Proffit's particular case, it was evident that serious and substantial questions of fairness and competence were raised with respect to not only HL&P's program, but that of the entire electric utility industry (since drug testing at non-nuclear facilities remains unregulated) and presumably others in the private sector. Employees, job applicants, and other test subjects should not have to that seek a congressional investigation in order to secure assurances they have been treated properly by a drug testing program, much less to obtain vindication et other relief. Moreover, as Dr. Owens pointed out to the staff when consulted on this question, it is appropriate to judge HL&P's performance on the basis of the data supplied by Accu-Chem, since that was the basis on which HL&P judged Mrs. Proffit. In addition, experts consulted by the staff on this matter expressed great doubt as to the reliability of a retest under the circumstances of this case had the result been positive. They indicated that neither the Committee nor Mrs. Proffit could have any assurance that her specimen had not been tampered with or that another specimen had not been substituted for hers at some time during the last several months. One expert, in particular, advised that substitutien would be relatively easy for a knowledgeable person to accomplish and that such substitution, if done well, could not be detected except by an FBI-type DNA analysis. While the Committee staff had no evidence to sug or substitution had occurred in this case, gest thethat staffsuch wastampering careful to point out to HL&P representatives that, as an evidentiary matter, a positive result on a second test, conducted at this late date in the wake of a congressional investigation, could not be considered highly reliable. Notwithstanding a retest. Yet these admonitions, EL&P elected to proceed with in his July 19 follow-up letter, Mr. Hall attempted to cast doubt on the validity of the resulting negative test by suggesting tnat HL&P had an " understanding that there was a clear 13(continued) l This issue will be addressed further in the next section of this ! report, entitled " Policy Implications and Recommendations." I i l l I l
, Staff Repott l- Septembst 12, 1990 Page 29 probability that the passage of time had caused degradation of (Mrs..Proffit's) specimen to the point that the methamphetamine and metabolites tectable by an confirmed in the original 1989 testing might be unde-understanding,y testing method now."it If in factisHL&P hadtosuch difficult an imagine why the co have-been so anxious to retest Mrs. Proffit's sample, particularly after a positive the staffresult. cast doubt upon the minimal value it would place on It is also important to note that Mr. Hall's questionable scientific with assertion on this point respect to specimen degradation is of value. acknowledge that The HIDA guidelines, for example, "some analytes deteriorate or are lost during freezing" respect but thers is little evidence that this is the case with to methamphetamines and amphetamines specifically. In addition, Hall's letter itself is internally contradictory, refer-ring (emphasis in anotheradded), paragraph not to ato "the possibly degraded sample" "probably" degraded sample. ting HL&P that has been quite candid with the Committee staff in admit-when it it had little or no in-house competence in this field embarked upon and conducted its drug testing program. It nakes much of its reliance on the EEI's 1985 guidance. While the Committee is pleased to note that HL&P has-made changes in its program since the time of Mrs. Proffit's test, those changes were compelled by regulation and were not adopted until required by law. In addition, Dr. Blankenship's qualifications to serve as the STP's KRO under the NRC regulations are open to question, raising the-concern that HL&P continues to opt for price rather than quality. However, if the nuclear industry in fact adopted the 198S EEI guidance as a standard and adhered to it unchanged until the effective date of the NRC regulations, such adherence during that entire callousness periodatonworst. the industry's par't bespeaks ignorance at best and This suggests that the Committee should be wary of the nuclear industry's claims and representations in connection legislation such withas consideration H.R. 33, of pending drug testing laboratory
- 2. (a) Accu-Chem's Comments Accu-Chem, for its part, in a letter to the Chairman dated Junecommented 21, 1990.on the staff's investigation In that letter, g' Dr. Laseter of Accu-Chem describes in great detail what appears to have been an-experiment conducted by Accu-Chem in an effort to defend earlier. the A results co obtained in Mrs. Proffit's case nearly one year documentation,py of Dr. Laseter's letter, with accompanying is attached to this report as an exhibit.
"a portion of the original GC/MS confirmation analytical dataThe lette generated senting information on urine sample "collectes 6C05 in July 1989" and the second repre-using the identical instrumentation, 1
q Staff Report-
-September 12, 1990 Page~30 GC' 1989." column,cand analytical conditions as those employed in July The'1atter-set according to Dr.-Laseter, "are mixtures of pure 6805."drug standards that correspond to those observed in sample The three " surrogate" test samples in the second group.were spiked, said Dr.-Laseter, with concentrations of phentermine ranging from zero in one case to 1000 ng/ml in another to'5000 ng/mi in the third.
Each of the three was also spiked with known concentrations ng/ml). of amphetamine (300 ng/ml) and methamphetamine _(600 Cyclizine was used as an internal standard in all cases. Dr. Laseter suggests that when the three surrogate samples were analyzed in the GC/MS's full scan mode, the expected methau-phetamine : ion ratios were lacreasingly forced out. of the " expected reporting termine in window each sample of (+ increased. or -) 20%" as the concentration of phen-Lwas also observed in srmple 6805." He claims that "this phanomenon He_further claims that the actual value of methamphetamine present in Mrs. Proffit's specimen was ng/ml."
"most likely >1000 ng/ml and may be as high as 3000 to 3500 In his letter, Dr. Laseter concedes that in his_ original report to HL&P, "the-presence of amphetamine was noted as negative." He now claims, however, that amphetamine "is indeed-present but below the 300 ng/ml reporting limit." Based on an excerpt from a NIDA monograph stating that "(a) positive amphetamine analysis indicates previous use of amphetamine or methamphetamine, generally within the -previous . 24-48 hours," tur concludes that "the presence of this recognized metabolite (amphetamine) in sample 6805 strongly supports the intake of methamphetamine."
Laseter's letter also dismisses-the independent experts' criti-cismsample out that Accu-Chem. 6805. failed to adhere to its own' SOP in reporting permits _the. certifying scientist He cites a provision in the SOP that allegedly to_ allow for some " deviation" from
.theTreporting criteria.
"When all the cvidence is evaluated together," Laseter concludes, "there is little doubt that methamphetamine is present in urine sample 6805 in levels well above the-300 ng/ml threshold reporting limit."
(b) Staff's Response i In spite of Dr. Laseter's efforts to defend the results of'Mrs. f
- Proffit's original test, his letter fails to address the major criticisms contained-in the' experts' reviews and contains several misleading assumptions and logical flaws. These gaps in his response, coupled with the'results of'HL&P's retest, strengthen the conclusion that misinterpreted. Mrs. Proffit's test results were mishandled and I
First, Dr. Laseter relies heavily on the notion that sample
, - - , , , , - , , ,,,.~,,.n . - - - . , . - - . - - .y - - . - ~ . - - - . --- - - - - - - - - - - - - - -
T Staff RGport September 12, 1990
-Page 31 !
6805 contained amphetamine and then suggests that the presence of this methamphetamine metabolite helps prove the existence of methamphetamine in the sample. Yet he conveniently ignores the fact that Accu-Chem reported the sample negative for amphetamine precisely because that substance could not be detectedlat levels above the (already excessively-low) cut-off of 300 ng/ml. Thus, it is inaccurate for Laseter now to claim that amphetamine was in fact "present" in Mrs. Proffit's sample, since he has no reliable sgientifte basis for drawing that- ; co'ntrary conclusion one year ago. conclusion Accordingly, and in suggestions any fact drew a of a methamphetamine positive based on the presence of amphetamine in the sample must be dismissed out of hand. Second, Dr. Laseter's experiment is designed to show that as increasing amounts of phentermine are added to a specimen spiked with methamphetamint, the latter drug are shifts in the "anticipsled and relative normal" retention and ion timesare ratios for forced-out of range. His r, piked surrogate samples hypothesize the presence of 1000 and 5000 ng/ml of phentermine respectively. -How-ever, he conceded to the Committee at an earlier date that Accu-Chem'never tested Mrs. Proffit's specimen for phentermine, and he not be-reiterates that point in his June 21st letter. Thus, it would if any,possible for him to know what concentration of phentermine, would have been found in sample 6805, removing any basis for comparison in his experiment. with the results obtained on the surrogate samples Third, his suggestion that the laboratory's certifying scientist-is permitted to deviate from the reporting criteria in the lab's SOP raises serious questions. Dr. Foltz, in commenting on this notion, took the position that laboratories "should be strongly discouraged from reporting results that are not fully supported by their own SOP." Dr. Dubowski observed that the "plus or minus 20 percent"; window in the SOP already provides the leeway needed to~ assure accuracy in the results of a test and that "either the SOP.is inadequate and should be changed, or it should be adheredito." The staff also notes that the volume.of the SOP containing the statement quoted by Laseter was never supplied to the Committee, leaving in doubt at least its context, if.not its. existence. dataFourth, on sample Dr.6805 Laseter whencontradicts his own internal laboratory he states that "the actual value of methamphetamine present is most likely >1000 ng/ml and may be as high as 3000 to 3500 ng/ml." In' fact, Accu-Chem's own worksheet on Mrs. Proffit's specimen contains the figure "621 ng/ml". If Dr. ' Laseter is prepared to stand behind the statement in his June 21, 1990 letter, he should have explained why the worksheet reports the presence of methamphetamine at only a fraction of the'1evel.he now suggests. 'Certainly HL&P should be interested in resolving this discrepancy, l
Staff Report September 25, 1990 Page 32 In addition to these contradictions, faulty assumptions, and logical gaps, Laseter's letter fails to address several deficien-cies in his analytical procedure noted by the experts. For example, nowherc does he address Accu-Chem's failure to derivatize Mrs. experts. Proffit's specimen, a critical defect noted by all of the He makes no mention of the failure to analyze Mrs. Proffit's actual specimen in the GC/MS's full scan mode, although he appears to have conducted his experiment using that preferable method. Similarly, he fails to explain adequately Accu-Chem's use of cyclizine amine analysis. as an internal standa:d for amphetamine /methamphet-This, too, was a subject of criticism by the experts, some of whom noted that deuterated methamphetamine would have been the most appropriste internal standard, Dr. Dubowski was particularly critical of this last lapse in discussions with the Committee staff. He suggested that the reason for Accu-Chem's use of cyclizine was in all likelihood simply a matter of cost. Sigma Chemical Co. of St.According to the 1990 price list published by the deuterated D-5 methamphetamine costs $146; Louis, Missouri,250 by contrast, a mere 10 milligram milligrams standard -- of costs cyclizine -- 25 times the quantity of the deuterated only $6.40. as well, with volume purchases. The savings increase Undoubtedly, substantial]y, this savings was reflected enabling it in the price Accu-Chem charged for its services, thus to capture business for which its more competent con atitors would have had to charge considerably more. In sum, Dr. Laseter's attempt to validate Mrs. Proffit's test result fails to withstand serious scrutiny. Moreover, it is disappointing that Dr. Laseter failed either to raise any question with HL&P about Mrs. Proffit's results after her disclosure of phentermine use was revealed to him by the company or at least to retest her specimen after derivatizing the remaining portien. This , is particularly true in light of expert opinion that mistaking metnamphetamine for phentermine is a relatively easy error for a ; laboratory to make with an underivatized sample. Policy Imolications and Recommendations HL & P ,. like all nuclear licensees, has been governed since January cesting. 3, 1990 by the NRC's fitness for duty regulations on drug It is reasonable to assume, however, that its drug testing program prior to that date was not unlike many condL9ted in the private sector -- characterized by the use of low cut-off levels, on-sito screening, and a mediocre if not incompetent L laboratory for confirmation of screening results; the absence of an l I KRO or other qualified professional to interpret, evaluate, and j verify confirmed accorded to test subjects positives; and a lack of fairness and due process who challenge the accuracy or evaluation of their test results. 1 u , ._. _ _ _ __. _
Staff Report September 12, 1990 Page 33 While Mrs. Proffit's case has the limitations of any case study, several broad themes emerge from these facts that suggest the need for tighter regulation of drug testing laboratories and the manner in which test results are handled. The major implicationsther addressing of this case and the staff's recommendations for are set forth below. Laboratories Drug testing must meet the standerds demanded for forensic credibility, not only because test results may be challenged in a court or other legal proceeding, but because a false positive or false negative can have devastating consequences. The need for accurate, fluid or tissuereliable, and therefore spec! mens precise analysis of appropriate body lies at the heart of a well-designed forensic urine drug testing program. However, except for drug testing performed on federal, transportation, and nuclear pcwer workers pursuant te federal regulation, there are no federally mandated quality standards and procedures that currently govern non-medical drug testing. The need for such standards and procedures is acute, as Mrs. Proffit's case demonstrates. Even to the extent that federal lab standards and procedures exist in this field, they are not uniform. NIDA, DO", and NRC each have imposed requirements that, to a greater o' lesser extent, differ from one another. Private sectoc drug testing programs not coverrl by these regulations are free to impose whatever can agree other upon. sta> iords and procedures they and any laboratory Th u lack of uniformity has begun to pose an intolerable burden oa even qualified laboratories, as new clients c3use diffecent chain of custody procedures, cut-off levels, dru; panels, reporting requirements, and other aspects of the testing process to multiply. A single set of laboratory standards and procedures for all forensic urine drug testing will help ensare the accuracy of results, reduce the perception of unfairness in the treatment of different test subjects, and eliminate the burden imposed on laboratories by clients' differing demands. Few issues in this field have generated as much controversy as the question of whether the screening and confirmation cut-off levels for each d:ug analyzed should be set by regulation uniformly for all drug testing programs. Mrs. Proffit's case illustrates the importance of doing so. In that case, an obviously ill-informed employer selected cut-offs for amphetamines and methamphetamines that the best available information suggests were clearly inappropriate: i It is particularly ironic in light of HL&P's conduct in Mrs. Proffit's case that the NRC regua. ions, after setting
- Stall RG; ort Septembes 13, 1990
- Page;34 maximum cut-off levels, give to licenseesflike EL&P the option of setting their own: lower cut-offs -- without any limitation as to how low they can go. .The NRC, in doing so, obviously-Ignored the results of the Battelle study it commissioned to assist it in its rulemaking process.
Clearly, EL&P was wholly unqualified to make any judgments with respect'to cut-off levels, and there is no reason to believe that-HL&P is-alone among licensees or private sector
- employers in this regard.
The staff is aware from its work in this field of many other employers and industries who set extremely low cut-off levels in their-drug tosting programs in the apparent belief that-by doing<so obtaining. false negative they will eliminate the possibility of results. The unfortunate corollary to this belief from a scientific standpoint is that such low cut-offs significantly increase _the risk of unacceptable false 7 positive results. This-presents a major public policy dilemma.: ;A regulatory process that sets uniform-cut-off levels on the basis of an apptcpriate examination by experts of the available scientific and technical evidence will provide the best means of balancing the public policy-objectives of-enhancing safety and eliminwting illegal drug use1against that 7 flow from the.need to prevent the devastatire consequences false positive results. While new technology-and methods may,-over the course of
=
time, enhance a qualified laboratory's ability to detect the presence of drugs at ever-decreasing concentrations-in urine, this is an argument-for periodic regulatory review of uniform cut-offa set by-regulation, not for abandoning this ,~
< decision to the whims of corporate-managers. The report of the NIDA consensus conference, for example, recommended the reduction of the cut-off= levels set-for various classes of
' drugs by the'NIDA guidelines at either the screening stage, the confirmation stage,=or:both, and NIDA is now examining L those recommendations.
. Interestingly, no change was
= recommended for' amphetamines and methamphetamines from the r 1000 ng/ml screening cut-off and the 500 ng/ml confirmation cut-off now-in place. This casts even greater doubt on-the
- wisdom of HL&P's decision to use a;300 ng/ml cut-offlat both stages and -the RRC's decision to sanction a licensee free-for-all on-this subject.
-Uniform. drug testing standards and procedures alone will mean-little in7the absence of an effective-means of enforcement. - A ,
federal certification program is the most" logical and appropri-
-ate method for ensuring both a laboratory's ability to meet the standardsfand its continuing compliance with those standards.
Such-alprogram is already in place and is being used for urine drug testing-in the federal, transportation, and nuclear workplaces. l As of July 3, 1990, NIDA had certified 52 l l
-o.iw .pwp q n:.
r y +-- y 9 -r -- jy." a A % ,,, _a -___m_--._m-
Staff Report September 13, 1990 Page 35 laboratories across the nation as meeting the standards set by the NIDA guidelines for drug testing of federal employees. DOT and NRC have both mandated that testing rules use NIDA-certified labs as well. entities subject to their drug In addition to the 11IDA program, CAP accredits laboratories under its own forensic urine drug testing program. While the standards and procedures used by CAP and NIDA to approve laboratories differ to come extent, tt.e two organizations have made substantial progress in minimizing those differences. The recently published report of the NIDA consensus conference held ingthe in anyfall of A989 will hopefully form some basis for eliminat-significant remaining differences. As noted above, a single set ensuring of strong that all standards in this area is essential to uniformly. Thus, test subjects are treated fairly and programs should continueefforts to to berationalize the CAP and NIDA encouraged. While GC/MS is currently considered the confirmation technique of choice for quality drug testing, forensic GC/MS results are only as good as the methodology used to obtain them and the personnel applying that methodology. At the present time, no L uniform standards or guidelines exist for proper GC/MS analysis. As Dr. Owens pointed out in his critique of Accu-Chem's results here, Mrs. GC/MS Proffit'satcase procedures, least illustrates the need for standardizing to the degree necessary to ensure the proper preparatic7 interpretation or theofGC/MS specimens data:and the proper laboratory i I The Toxicology Sciences Section of the American Academy of Forensic last year approved a set of "Recommtended Guidelines for Forensic GC/MS Procedures in Toxicology Laboratories Associated with Officss of Medical Examiners and/or Coroners." l Development of similar guidelines for forensic ! urine drug testing should form a part of any effort to develop a certification program for drug testing laboratories. At a minimum, such guidelines should include requirements for the derivatization of specimens where appropriate, the running of I specimens,the proper usestandards of proper and controls internal with each standards for batch of I comparison with the unknown (including a deuterated analyte I whenever one is availabla), and use of a full-scan identifi-cation method rather than a selectec or single ion method. Even in the absence of uniform guidelines for GC/MS analysis in the drug testing context, there can be no excuse for a procedures. deviation from its own standard operating laboratory's As Dr. Foltz pointed out in commenting on i ! Accu-Chem's June 21 response to tre Committee, "the laboratory should be strongly discouraged from reporting
. .- . - - - - - - - - - . - - - - . - . - - - -. . - - - ~ - . - - -
\
;S8aff Report September'la,;1990 Page 361 results-that are not fully supported by their own SOPl"
. (Emphasis in original).
Regulation-is also necessary-t'o ensure that laboratory
-directors, technicians, and.other personnel are properly-
- qualified in the fields- of forensic urine drug -testing,- forensic toxicology, or other--relevant disciplines -that these qualifica-tions are monitored and-maintained;s and that personnel-receive appropriate continuing education to keep abreast of recent developments in.their= field.
A major _ impediment _ to the, reexamination of' Mrs. Prof fit's test: results by the Committee's experts was the apparent-absence of-any'back-up1 documentation indicating-how Accu-Chem concluded-that her specimen contained 621 ng/ml of methamphetamine. In fact,-it is not apparent 1that_such documentation ever existed.
= Quant'itation should:beLincluded in all= positive GC/MS results-
-reported by laboratories, regardless of whether the client ;
requests or-prefers otherwise, since this1information is a critical element in an MRO's: analysis. In addition, however, elaboratories-should be required-to maintain all test data inclu~ ding calibration curves;and any calculations used-in determining test 1results, for a period of time sufficient to enable either--.the clientfor the test subject-to challenge a test report.- Test subjects as well as employers should be_ entitled. to access to and copies of such documentation upon_ request. Because: corporate personne11 officials'may act in reliance on their-failure to' hear'within a relatively.short period of time i that a, test result was_ positive -- for example, by offering ' permanent; employment to-an applicant.-- laboratories should-be _ requiredcto ;performLdrugz tests and report results back : to the j N, sappropriatesofficial/promptly. Similarly, test subjects _havera-
-tight-to expect a= prompt.reportEof-their results, both so that L stheir drug-free status-may be affirmed and so that their-natural '
anxiety over the possibility of.a false? positive may be-alleviated 1within-the shortest practicable' period of time.- j
' Employers-and Oth'er-Drug-Testing Programs '
LEmployers=and other conducting drug testing programs must be *
. required to employ or~ contract-for-theTservices of an MRO to review drug test results. The. report of!the NIDA. consensus conferencessummarizes_well the importance of_the MRO - '
"TheLMedical Review Officer is an integral part of-any employee. drug. testing program based en concerns for health 9 4 '
7 and safety in'the workplace and for. drug' deterrence. .The MRO assessescand determines whether an alternate medical explanation can: account _for a drug test result. Additional-important functions of the-MRO are to review = fairness and L
~ -
. Staff Report o I
September 12, 1990
'Page-37 i 1
1 l cri /l2ty of test an6 .onsidentiality of the employee's personal medicalresultsi hiscory during the course of reviewing-drug test results. , The-MRO is the lynch-pin (sic) between the client , which requires' diplomacy, understanding technical social issues, and being able to insure all aspects of a = urine' test result are valid.
-While the question _of whether MROs should be required to review 1 all_ negative, as well en positive, results is controversial and j i
beyond the scope of this case study, there is no question that-4 still<be) a. serious deficiency.the absence of a qualified MRO in]
*- A-well-designed blind perfocmance testing-(PT) program is essential'to assessing the true proficiency of a laboratory.
However, this case illustrates that satisfactory performance in blind are notPT'does being reported. not in and.of itself assure that false positives 1 i blind PT contain.onl The spiked specimens generally used in-program is testing. y those drugs or. metabolites,for which tne- j drug.that is closely related:but notRarely will a specimen be spiked with a 1 diet medication 2~in methamphetamir a program that tests for amphetamines and'the same -- i
~
-properly to dc .inguish between the two.- :in order to assess the lab's ab'ility Econtrol and performance testing must be developed to compensateOthe for:thisLlimitation on the use of clind'PT.
a There'is no reason.for_a drug testing laboratory either to know ~ the nase of a test subject or to.have any other. personal E enti-fying'informationf_about the-subject. -Accu-Chem in this case acknowledged thatLit hadHno need for such data-in order to i analyze a. specimen 1or to' report the resultsioffits. anal " s ! Yet,HL&P freely _providedethis-information-to Accu-Chem-ysis. - and L -thus, presumably, to all> Accu-Chem personnel, as wellnas.to/all a ' l lab personnel handling the specimen or-the results-on-site. ? Specimen containers,--test requisit' ions, and.results should be h, ' tracked using only<special identifying or? accession l numbers;
& <there"is-~no; valid: purpose to2be~ served-in otherwise identif Leonfidentiality..thectest1 subject:or. compromising the subject's privacy--a n The laboratory. documentation provided: byf EL&P to Mrs.3 Proffit-in-L this case.following her termination was11nadequate.to enable:
L even_an expert.to draw anysproper of:her conclusions:with respect-to-the accuracy or, inaccuracy test result. Among;other things,'the package sent to Mrs. Proffit. lacked-documentation of '; s controls,1 standards, and laboratory procedures.- -Although these L materials,_at a minimum, would be necessary to enable any test subject successfully toJchallenge an-alleged' positive test, most testLsubjectsLwould not.have the sophistication in.this field '
- m. . . . _- _ . _ , . . __ _ _ _ . . . _ _ . ___ . _ . _ . . __ _
Staff-Report i September la, 1990 ] Page 38 necessary to seek such documentation. In this case, it took a congressional request to obtain these materials, and even then Accu-Chem only reluctantly provided its SOP. Test subjects who request their drug test results and records following a positive result right. should be entitled to obtain this material as a matter of To the extent an employer or other drug testing program must obtain such documentation from the laboratory in order to meet a test subject's request, the employer or other party should similarly-be entitled to obtain the material from the laboratory as a matter of right. When a positive result is challenged on the ground that another drug taken legally by the test subject may have interfered with the test, the subject should be entitled to obtain not only a reanalysis for the illegal drug as to which a positive is claimed, but also a proper GC/MS analysis of his or her specimen for the legal drug in question where thorn is any serious possibility that the illegal drug may have been mistaken for the legal one. While the presence of a legal drug does not necessarily mean that the positive result was false, it may greatly assist the MRO in determining whether an alternate medical explanation for the result exists. While the EHS guidelines do not require split specimens at this time, this case illustrates the utility such a procedure may have when results are contested. Obviously, the availability of another portion of the same specimen, taken at the same time as the first, would enable a drug testing program to seek analysis of the specimen at another qualified laboratory immediately without fear of tampering, substitution, or other evidentiary difficulties. Although HL&P sought such a reanalysis in this case, it did not do so until nearly one year after Accu-Chem first reported the result of Mrs. Proffit's test to the com
-- and after the Committee had launched its investigation. pany NRC Regulations i
i In an effort to standardize procedures for employee drug testing l in the nuclear utility industry, NRC issued its final rule and statement of policy for fitness-for-duty programs on June 7, 1989. The rule took effect on January 3, 1990. - Although many aspects of the program are indistinguishable from similar regulations and guidelines issued by DOT and DEES, several points unique to the NRC policy are :ause for serious concern. In several respects, the NRC guidelines have sacrificed confi-dentiality and fairness for test subjects in favor of cost-cutting measures and a false sense of security. The major differences in-NRC policy, as ccmpared to that of the other agencies, are as follows: The NRC regulations set cut-off levels for drug testing i
-p , . - ,, -- - , , - . - -
Staff Report September 12, 1990 Page 39 with respect to five classes of drugs but permit individual licensees to use their own discretion in settin drugs.g more stringent cut-offs for these and other The unfairness and danger of this policy is exemplified by the case of Mrs. Proffit. The use of cut-off levels that are too stringent can lead to false positives and the confusion of certain foods for related drugs (e.g., poppy seed bagels). A crazy-quilt pattern of inconsistent cut-offs also discourages establishment of effective blind performance testing programs that compare referencealaboratories. laboratory's performance with that of peers and The NRC regulations fail to establish a set listing of substances for which chemical tests may be conducted. While some greater flexibility may be warranted than that provided by the DHHS guidelines, the NRC grants permis-sion to test for any variety of unspecified substances. A licensee's ability to use cut-offs of its our choosing also allows the licensee to "obtain data on any trace amounts of drugs for persons." medical evaluation of at-risk (Fed. Reg., June 7, 1989, at p. 24484). This policy could lead to the use of urine tests by licensees to detect unrelated prescription drugs that would have little thoseor that noan adverse emplo effects in the workplace, including reasons of privacy.yee may decline to disclose for levels and the abilityInto this test way, discretionary cut-off for many unspecified substances leave licensees free to investigate confidential aspects of an employee's medical history. The NRC allows performed for on-site ' drug screening, which may be by a licensee. This policy is grossly inequitable to job applicants, since employers may seek to avoid spending funds on expensive confirmation of positive screening results when other applicants are available to fill an open position -- a particular concern screening in light of the potential for unduly stringent cut-offs. The policy is also potentially damaging to empicyees, who are subject to the risk of premature results. or unauthorized release of unconfirmed test , The NRC has indicated that its Office of General Counsel (OeC) believes t. hat the fitness for duty regulations do not prohibit a licensee from petmitting non-management h personnel from taking action against an employee on the basis result.of an unconfirmed positive initial screening test OGC 1riformed the agency that the intent to preclude the une of on-site testing for any purpose other than screening specimens for forwarding to a certified laboratory was not stated in the present regulation with i
4 Staff Report -- September:12, 1990-Page 40 sufficient use - clarity to test of preliminary make a case against the licensee's results. proposed rule on Friday, August 31, 1990 (55 The NRC issued a 35648 designed to clarify the NRC's criginal intentfed, Reg.in this-r)egardc but two of the current four Commissioners expressed doubts about the wisdom of the proposal. The NRC should review consideration of the this Staff Report-in proposed rule. connection with In view of the sufficiently reliable to justify action being taken oncompe that basis (nor to justify the' stigma and emotional distress resulting from such action), clarification of the current NRC regulations appears advisable. Licensees any person are required licensed underto10 notify CFR the PartNRC of "any acts by supervisory personnel...r 55...or by any tests on such persons....esulting in confirmed positive
- the NRC Operations CenterNotifications by telephonemust be24 within made toof hours the discovery of the event by the licensee." (10 CFR 26.73).
needs to be informed of such events, the use of verbalApar for error and unauthorized-public releaserelay A more of such informa deliberate-approach to this relay process,. involving appropriate warranted protections-against such releases, would be here.
-visors in skills seen as helpful to detection ofNRC also pro c
behavioral irregularities in employees. supervisors-are initiating correctiv required to be :, aught procedures for'The managers and assistance programs.e action and referral-to employee While these' aspects of the NRC regulations 1are commendable, the-regulations fail-to-required:to document an. employee's behavior. require that a This policy, contrary _to'that ado
-portation industry, carries pted by DOT-for the trans-mana the serious potential for-
/L .for gement' testing.harassment of employees 1by threats of~ referral - Conclusion
.Mrs. Proffit's case is symptomatic of'the problems unregulated;and poorly regulated drug testing' programs. posed by Legislati'n imposing standards on drug testing laboratories, requiring use of laboratories certified as meeting those standards, and mandating verification of test results by a qualified fairness and medical or scientific accuracy for test subjects. authority is necessary to assure R.R. 33, the
Staff Report September la, 1990 Page 41 Dingell-Bliley drug testing standards bill, would. provide apt, q appropriate regulatory f ramework for addressing the,s.e issues,7x, possibilities with Mrs. Proffit as a result of the questions,t raised by the Committee's inquiry. Monday, September 10, 1990, The staf f has learned that'.9n ; was wrongfully terminated, Mrs. moreProffit than thirteen months af ter she and received com returned to work at STP merit increase, pensation from HL&P and paid vacation time. in the form of back pay, a s,s I-eJ 5.- L
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x, In my-opinion, the alleged " methamphetamine" identification was based on the 58, 56, and 65 mass ions at a retention time of 9.444 vith relative confirm intensities of 2% and 7% which are too lov to identification. Impact mass spectrum as phentermine has an identical Electron does methamphetamine. One of the ingredients in Vicks Inhaler and of s )me amphetamine-like non-prescription drug products also can give the same mass spectrum. I could find no evidence that tests were made to establish whether the results were due to phentermine or how the methamphetamine
" positive, 300 ng/ml GC/MS detection limit" was determined.
The DHHS Guidelines give the initial cutoff for amphetamines of 1000 and ng/ml and confirmatory cutof f s of 500 ng/ml f or amphetamine methamphetamine. reached. Phentermine There is no evidence that these cutof fs were is not included as a drug of abuse in the Guidelines. In my opinion the submitted documentation did not confirm the identification of methamphetamine, amphetamine, or any other drug in the urine specimen and is inadequate, lacking documentation of controls, Guidelines.)standards, procedures, etc. (see Documentation in DHHS I have lists of been Urine Forensic unableDrug to findTesting
" ACCU-CHEM Laboratories" Laboratories on the accredited or certified by American National Institute Pathologists (cap). on Drug Abuse (NIDA) or College of that aThis case and others that I have reviewed led me to believe review of laboratory data and documentation by scientists knowledgeable in testing procedures and independent of the testing laboratory, employer, and employee is needed to protect the employer andLemployee from insupportable testing I would appreciate investigation of this case.your comments and the results of any request of you or the committee..I will be pleased to respond to any v
Arthur J. McBay, ph.D. Forensic Toxicologist 919-929-4954 Dec. 7, 1989.
/,
The Light corapany Houstoo Lighting & Powe, South Tenu Project Electric Generating Station P. O. Bos 108 Bay City. Texas 77414 August 24, 1989 Judy H. Proffit 18 Navidad Road Bay City, TX 77414
SUBJECT:
Drug H. Judy aniProffit Alcohol Screening Program Test Results SOUTd TEXAS PROJECT ELECTRIC GENERATING STA
Dear Ms. Proffit:
In response results, to your request received on August 3, 1989, for test the attached information in provided. c el ,
!ohnW. Odom, Manager Human Resources-Nuclear Attachments JB h JWO/CSM/kmg l
l i A Subsidiary of Houston industries Iteporated
2. SOUTH TEXAS PROJECT FITNESS FOR DUTY CENTER DRUG SCREENING PROCEDURES AND TEST RESULTS SUB.7 ECT : JUDY _R. FROFFIT. ELEP INTERVIEW SOCIAL SECURITY No. 225-82-4945 1.ABORATORY TEST REPORT FORM CHAIN OF CULTODY (ATTACHMENT I) ATTACHMENT I IS A PHOTOCOPY OF ONE OF THE THREE F OUT BY THE THIS FORM SUBJECTBYEMPLOYEE IS IDENTIFIED SAMPLE NUMBER, PRIOR TO DRUG SCREENING IDENTIFICATION NUMBER, AND EMPI4YER. EMPLOYEE NAME AND RESULTS INDICATE THAT SAMPLE SUBSTANCES No. 51728 WAS NEGATIVE FOR ALL EXCEPT AMPRETAMINE8. IT ALSO SHOWS A SPECIMEN TEMPERATURE OF COLLECTION. OF ib_1 DEGREES FAHRENHEIT FOR THE SPECI i ON JUNE 29, THE AT 113.1 TESTS 1115WEREP.M.COMPLETED AND INFORMATION RECORDE BY KAREN BISHOP, TECHNICIAN. LABORATORY EACH SPECIMEN COLLECTED AT THE STP ON-SITE FACILITY I AND TRACKED TO INSURE IDENTIFICATION RELIABILITY. IN THE PRESENCE i OF A LABORATORY ASSISTANT, THE EMPI4YEE PROVIDES THE URINE SPECIMEN l IN THE CONTAINER PROVIDED AND TRANSFERS A PORTION OF COLLECTED TO THE SPECIAL TRANSPORT CONTAINER. (THE ON-SITE SPECIMEN IS SEALED WITH A BLUE SCREW-ON CAP.) THE EMPLOYEE AFFIXES TAMPER EVIDENT TAPE AND SAMPLE IMMBER To EACH CONTAINER. USING A l BLACK MARKER THE EMPI4YEE COPIES THE_ SAMPLE NUMBER CONTAINERS AND INITIALS THE CONTAINERS. BOTH ON AT THIS TIME THE EMPLOYEE IS ASKED To SIGN THE CHAIN OF CUSTODY FORM TO VERIFY THA UNIQUE SAMPLE NUMBER ON BOTH THE CONTAINERS IS THEIR NUMBER. LABORATORY THE EMPLOYEE ASSISTANT. THEN TRANSFERS CUSTODY OF THE SPECIME IF A POSITIVE TEST IS INDICATEO, THE SAFETY SEALED TRANSPORT CONTAINER DALLAS, TEXAS, IS SENT TO THE OFF-SITE LABORATORY, ACCU CHEM LABORATO FOR CONFIRMATION. l THE FORM SIGNED BY JUDY E. PkOFFIT INDICATES SHE PERSONALLY DELIVERED HER SPECIMEN, SAMPLE NO. i 61728 12:23 TOP.M.KATRY LAW 8ON, LABORATORY ASSISTANT ON JUNE 28, 1989 AT [ KATRY LAW 8ON TRANSFERRED CUSTODY OF THE SPECIMEN TO SITS LABORATORY AND RECEIPT WAS ACKNOWLEDGED BY ROLLY OLAYBOURN, LABORATORY SUPERVISOR, ON JUNE 28, 1989 AT 12t30 P.M.
5* EMPLOYEE CONSENT AND AUTEJRIZATION FOR DRUG AND ALCOHOL ANALYSIS (ATTACHMENT H) THE ATTACHMENT SUBJECT H ISIS EMP14YEE A PHOTOCOPY OF ONE OF THE THREE FORMS REQUIRED TO COMPLETE PRIOR To DRUG SCREENING PROCEDURES. EMPLOYEE NAME AND IDENTIFICATICH NUMBER, AND EMP14YER. EMPLOYEES ARE REQUESTED TO PROVIDE INFORMATION REGARDING ANY MED ARE CURRENTLY TAKING. UPON COMPLETION OF TMS FORM, THE LABORATORY ASSISTANT WITNESSES THE EMPI4YEE SIGN THE FORM CONSENTIN TCSTS AND TO THE RELEASE OF INFORMATION REIE /E TO THE PRO THIS FORM, IDENTIFIED BY SAMPLE NO 51728. WAS SIGNED BY JUDY H. PROFFIT 11:59 A.M.AND WITNESSED ON JUNE 2 8. 1989.BY KATRY LAWSON. LABORATORY ASSIS STP FITNESS FOR DUTY PROGRAM DRUG SCREEN TEST REQUISITION (CHAIN OF CUSTODY) (ATTACHMENT IH) ATTACPMENT THE SUB7ECT EMPLOYEE I U IS A PHOTOCOPY OF ONE OF THE THREE FORM SCREENING PROCEDURES. IS REQUIRED TO COMPLETE PRIOR TO THE DRUG EMP14YEE IDENTIFICATION.tHIS FORM IS IDENTIFIED BY SAMPLE NUMBER AND ONCE THE SAMPLE IS PROVIDED THE LABORATORY THE IDENTITY OFASSISTANT THE SPECIMEN. WITNESSES THE EMPLOYEE SIGN THE FOR STP FITNESS FOR CUTY PROGRAM LABORATORY SPECIMEN / RESULT LOG (ATTACHMENT H) WHEN PERSONNEL, A SPECIMEN IS PLACED IN THE CUETODY OF ON-SITE LABOR AN ENTRY IS MADE IN THIS I4G IDENTIFYING THE SPECIMEN BY SAMPLE NUMBER, EMPLOYEE NAME AND EMPI4YEE IDENTIFICATION NUMBER. THE IN AND RESULTS OF THE SEPARATE TESTS ARE ENTERED AS THEY ARE CO JUDY PROFFIT'8 CASE, THE SCREENING TEST INDICATES POSITIVE RES'.7LTS FOR AMPRETAMINE. THIS FORM ALSO INDICATES THAT JUDY PROFFIT'8 SPECIMEN WAS SHIPPED FOR CONFIRMATION (CONFIRM) TESTS ON JUNE 29(_ 1989 AND UNDER
" COMMENTS" IT IS NOTED THAT THE LONFIRMATION TESTS AT THE OFF FACILITY WERE POSITIVE FOR METRAMPHETAMINE.
COMPUTER-GENERATED CALIBRATION AND TEST RESULT DATA (ATTACHMENT I) PRELIMINARY URINE EMIT-COCAINE SCREEN THE ATTACHMENT I IS A PHOTOCOPY OF THE ACTUAL DATA OBTAINED FROM THE SYVA-EMIT SYSTEM USED AT THE ON-SITE LABORATORY. DAILY CALIBRATION PRINTOUTS AND EMPLOYEE DATA PRINTOUTS ARE SHOWN. NUMBERS INDICATED AS BATI ON THESE PRINTOUTS REPRESENT THE INSTRUMENT SAMPLE. READING FOR THE CORRESPONDING CALIBRATOR OR EMPLOY RATE VALUES ARE RELATED TO CONCENTRATION.
O
/
FOR THE INSTRUMENT WAS CALIBRATED AT 9 : 54 A.M. ON JUNE 29, 1989 AMPHETAMINES USING SIX SAMPLES (CALIBRATORS) OF KNOWN CONCENTRATION AS RECOMMENDED BY THE MANUFACTURER SYVA: SAMPLE fl NEGATIVE AMPHETAMINES CALIBRATORS, 0 ug/ml SAMPLE $2 NEGATIVE AMPHETAMINES CALIBRATORS, 0 ug/ml SAMPLE (3 LOW AMPHETAMINES CALIBRATORS, SAMPLE $4 LOW .3 ug/ml AMPHETAMINES CALIBRATORS, .3 ug/ml SAMPLE f5 MEDIUM AMPHETAMINES CALIBRATORS, SAMPLE f6 MEDIUM 2.0 ug/ml AMPHETAMINES CALIBRATORS, 2.0 ug/ml THE CALIBRATION ESTABLISHED BY TAKING THE AVERAGE PRINTOUT INDICATES A CUTOFF RATE Of 53 3. RATES. OF THE TWO 50 ng/ml CALIBRATOR TESTED THE FOR BATCH AMPHETAMINES TEST_ RESULTS ON JUNE 29,PRINTOUT 1989 AT 10 02 A.M. INDICATED THAT SPECIMEN USING THE PREVIOUSLY ESTABLISHED CUTOFF RATE OF 533.6. HS. PROPPIT'S SPECIMEN IS IDENTIFIED AS SAMPLE NO. AND SHOWS POSITIVE FOR AMPHETAMINES WITH A RATE OF 5 6 5. 615/61728_, ABOVE THE CUTOFF RATE OF 533.6. WHICH IS SAMPLE NUMBER n WHICH INDICATES A RATE OF 376.6 IS A LOW CALIBRATOR RUN AT THE END OF EACH EATCH OF SPECIMENS TO A INTEGRITY OF THE PRICEDING TEST RESULTS. THE INITIALS E INDICATE THAT EAREN BISHOE READ THE TEST RESULTS AND RECORDED THE THE LABORATORY SPECIMEN RESULT LOG. REPEAT POSITIVES INDICATE THAT SAMPLE NO. POSITIVE FOR AMPRETAMINES. 15/61728 WAS 10:39 A.M. THE REPEAT TEST ON J.UNE 29, 1989 AT 162.4._ CONFIRMED THE INITIAL POSITIVE FINDING WITH A RATE OF THE INITIALS D INDICATE THAT KAREN _ BISHOP READ THE TEST RESULTS LOG. AND RECORDED THE SAME IN THE IABORATORY SPECIMEN ACCU CHEM, DALLAS LABORATORY RESULTS REPORT (ATTACHMENT IIA AND I H) THIS REPORT REQUESTED TO INDICATES THAT ACCU CHEM, DALIAS LABORATORY WAS RUN CONFIRMATION TESTS (CONFIRMATION FOR AMPHETAMINEB. TESTING IS ACCOMPLISHED BY THE CHROMATOGRAPHY / MASS SPECTROMETER GAS (GC/KS) COMPUTER.) THIS REPORT INDICATES H. PROPPIT. WAS FURTHER THAT THE SPECIMEN, SAMPLE NUMBER 61728, FOR J_D.X 1989._. THE COLLECTED AT THE ON-SITE IABORATORY ON JUNE28, CONFIRMATION TEST RESULTS WERE POSITIVE METRA){PRETAMINES. FOR
NON-M A MU E
.mooo #78) Sov'" TT.xAs enest.cT ucmc CN" *
- NEW EE ACCOUNT NO. -
FITNESS FOR DUTY PROGRAM SIGN-IN SHEET COsnRM AT10N NO.
** CONFIDENTIAL ** ~
LABORATORY TEST REPORT FORM , sAuPLE 80. l A urine drug screen ond breothclyter test wcs conducted on the below listed emplope using I certify that this specimen wcs provided by me l ond wos not of tered, the Syve/EMlT/interolper sptem. Substances tested for and results are os indiccted. 00 NOT SGN UNTIL DIRECTED BY LAS ASSSTA Emplope Nome: 7u.o v Confirmo que los muestros fueron entregodos M. 84cA F/ r- por m!'y no hon sido combiodes de ninguno Emplore No. 22 D menero. NO P.RME ESTE DOCUMENTO HASTA ENSENADO POR El. ASSTENTE DEL LABORAT Soc.Sec.No. O A'5~~ TA ~ W W
/// M S1gnoture O O N - N ;
Contrector: Employer # /MY W NEGATIVE RESULTS POSITIVE RESULTS REPEAT RESULTS Propoxyphene g gg Methequclone q .,n Amphetemine O Qg ,.o / Qdj,[ Opicte
%&ry Bort >1turote ~O hhn Coccine Metobellte q r)
Phoneyclidine
<f W Connobinoid WWM o
Benzodiozepines W *M intoxoly2er 090 Comments: CHAlN OF CUSTODY Specimen received b- Specimen transferred t Y h Dete/Ti D V W Dfh- 4 M.WM vue. &::-au 9 /2I Date% vue. ~-u- e 9~: Screen performed b am Specimen Temperoture ('F) Q'h Date/Tirnerl' M - 39,. a W M4 l ' l S' hD Report to HL&P Fitness for Outy Coordinctor: Confkmotion e f Octe of Report h-N Time. I'IE M Octe/ Time 4 M'E l'l \ vtle' OA (Loboretcry Technicion) \Y
% g g M h h f,p p k [
/ M M O Y YI'F} M 3
3.w 395001 (12/BB) SOUTH TEXAS PROJECT E2CTRIC CLNERATING STATION (. / d
- ?:'TNISS :?O:R JU"'Y ?:ROG:Rw S AMPLE NO.
EMPLOYEE CONSENT AND AUTHORl2ATON FOR DRUG AND ALCOHOL ANALWIS I, ACFM/7' LAST Ju.c / M. EMPLOYEE NO, UM FIRST MI WORKING FOR // d 9 M NAME Of EMPLOYER 00 HEREBY GlW MY CONSENT FOR HL&P AND METPATH, INC., TO PERFORM APPROPRIATE TEST AND EXAMINATONS ON ME FOR DRUGS AND ALCOHOL PURSUANT TO PROTOCOLS DEVELOPED BY HL&P AND/OR METPATH, INC., AND TO RELEASE THE RESULTS OF THE TESTS TO MY EMPLOYER. I UNDERSTAND THAT IF THE TEST RESULTS IND'CATE THE PRESENCE OF DRUGS OR ALCOHOL, I WILL BE SUBJECT TO DISCIPUNARY ACTION OF. TERMINATION BY MY EMPLOER. I AM TAKING THE FOLLOWING MEDICATION: CHECK ONE (di NAME OF MEDICATION'. OWR THE IF PRESCRIPTION, UST COUNTER PRESCRIPTION PRESCRIBING PHYSICIAN: b L' t L / Ph en ru m a ,/ ov run.& DO NOT WRITE BELOW THIS LINE UNTIL INSTRUCTED TO DO SO. BADGE NO. bb W.RIF1ED: YES NO Wka abu & CacM iJ. 1%dl u * "ess oc"^taat or cue'overta"o itstro DATE- TIME II '" OTHER IDENTIFICATION _ - -- - ATTACHME LT ll --
es[e H [P/SP - ' DH9 MetPa; DR. D NKENSHIP [AD Complete Reverse Side for [- . 7483 teepose 512-972-8444 Actows nomte 60179-' Patient or Insurance Billing mm PATIENT DATA L nm. j - gi sw. tenses he==1A ta.s= ewee
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- CHAIN OF CUSTODY (For Client Use) l . Pt: ACE F M L
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IceWy maj the specimen beng Sent e the Laboratory b lashng u e soecrvn and me Pat >ent Data 240 h M , b.o(above)gM concet p os IDENTIFIERI 26005 (o .~lk ACCESS 10 pg,nt,og3,g%m g om 06/29/09 DATE/ r tw McPaws 'Chan et Custotr hsruceons Ior Soecenen 1 cerie Cose:non, Preparaton and Kanng of Onsg Sctemng SanWes* fu
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msncnons & specmn Coarctxe, Prepveten aM Handhag dDvg Screenng Samples?' ChertW4was %d%tYe AW" O IN_l' _ Catt L ABORATORY REQUEST INFORMATION PWase pq Desred P%e/ Test CNAIN OF CUSTODY (For Laboratory Use) g g, M50 Devg Screen, Urina, tor Drugs of Abuse (10 Drug PanoO Mth Confirmation of Posittw Meeutts j# / / l,3 h [ - 2 / ArW*arre es, Barte, raws, Benscuazocines Cocare. #" / Wa wana (se Terahyorocannabrot (THCR Machaousione, g Met %oone, Opsies, Phenc';d$ne (PCPL Tr@ F*N Laborgery Symure Osa Commun M31 Same As WSC Above Mthout CortArmatlon M52 Drug Screen, Udne, tor Dfuge of Abuse (8 Drug PaneQ - with Confirmation of Positive Resulta g,,,,ngn, Ampheamret Barbarates, Benzodaropnet, Cocers, u arpana (ThCL Weeagualor.a, Openas, PCP g' Laborasyy S y Jare Date M51 Same as W32 Above, Mthout Conermetion M5a Labosm$,M Date Drug Screen, Urine, ter Drugs of Abuse (7.Onag Pane 0 with Confirmauon at Poetun noeutta Ampheumsws. BartArmee, tenrodazophes,,C9eerm ' Marwana (THCk Womaqualone,Opasses ConArmauon
] us3 'a Sam As uS4 A% mthout ConArmauen -
- 1. NE --
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7 ATTACHMENT VI B
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i 1 EXHIBIT B ACCU-CHEM RESPONSE TO COMMITTEE REQUEST (DECEMBER 28, 1989)
0..3 ACCU CHEM LABORATORIES C- - December 28, 1989
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The Honorable John D. Dingell, Chairman U.S. House of Representatives Committee on Energy and Commerce Room 2125, Washington, DCRayburn20515 House Office Building
Dear Representative Dingell:
VIA: COURIER On December 18, 1989, I received the Committee on Energy and Commerce your letter on behalf of From your communication it dated December is my understanding that you1989. 8, are examining Number 61728 the forensic urine (Social Security drug testing records for Specimen employee at Number 225-82-4945), a past operated the South Texas Project Electric Generating Station by Houston Lighting and Power Company (HL&p) . We are responding be of assistanceto your request to you and with this correspondence in order to the Committee. that we have releases appropriate been assured by the administration Please of HL&P be advised th t all have been executed a authorized by all concerned to and we are fully laboratory records. discuss the individual's The following through 13 constitutes our rssponse in your letter dated December 8, 1989. to questions 1 1. patient's medications From time to staff by the time ofAccu-Chem the Fitnesshas beenCenter for Duty advised of at HL&P prior according to our to records, conducting GC/MS confirmations. However initially providedOn confirmation. forAugust Specimen Number 61728 when itno medication prof 2, actived for prescription drugs along with 1989, we were sent a list of 16 with this individual. A copy of the list is attached.over-the-counter drug personnel and related are aware of the possible Accu-Chem interference sympathominetic amines with the of phenterrine methamphetamine in urine specimens. confirmation or 2. At no time was Accu-Chem requested by HL&P to analyze for the presence of phentermine in Specimen Number 61728 . A Drvtston O!l H $ inc
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l i The Honorable John D. Dingell, Chairman-December and the 28, Committee 1989 on Energy and Commerce Page 2 3. Accu-Chem acted only as a subcontractor through MetPath abuse urine of specimens Texas to provide suppliedGC/MS by HL&P. confirmation
- data for drug of GC/MS _- cutoff MetPath established specimens sent values to in March, 1988 for. Accu-Chem to use in'al1 Accu-Cham. unless otherwise so Amphetamine ng/ml. /methamphetamina have confirmation cutoffsadvised. set at300
-4. We were advised by MetPath that Dutyrather Program' HL&P Fitness for i but havedid not wish reports readto have absolute quantitative values ,
cutoffs-described in. response number 3 above." Positive" or " Negative" using 5. ng/ml .for Specimen 6805--indicates a computed value of 621 methamphetamine GC/MS data. and 194 ng/ml for amphetamine . f rom Amphetamine is a recognized and common ' metabolite found in urine following. methamphetamine ingestion. A copy of the Drug Confirmation Laboratory Worksheet dated July 13, 1989 is included. Amphetamine was reported as non-detected , it was-present below the 300 ng/ml cutoff. (ND) because ' 6. p Please refer to your Attachment III which is a l. copy of61728. Number the original MetPath HL&P- Test Requisition for. Specimen ! accession number is 26805.Please note our internal compater generated unique p E isf located on this document on the left hand side -of the p The time-and date thatlabel. the sample was received in.our laboratory ( is also-printed the identifying on this 1 This accession number is used as-L laboratory through each _ analyticalsample_ ~ number-- from .at_ specimen the- .a process to the final report. L Attachment _VI B , containing the chromatograph and mass spectrum
-read-out number 26805 also. incorporates in ~ association the last four-digits of the: accession.
Laboratory Report - supplied with each. ion- fragment. The y number 26805 and-the._ Specimen Number 61728.-to HL&P contains both the accession correlate is number- the specimen accessian number with HL&P's specimen. ~I achievable -throughout . DThe , L Therefore, no omission exists. the analytical process. 7. the name of :anyAccu-Chem individual has never requested- nor .does it require undergoing confirmation testing. 4 tracking and identification.Please, refer to the above_ numerical seque 8.. Accu-Chem is neither certified under HHS
-Drug Testing Program.-mandatory guidelines nor. accredited under the C However, our laboratory does participate
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The Honorable John D. Dingell, Chairman { and the Committee on Energy and Commerce December 28, 1989. Page 3 in the AACC/ CAP Porensic Urine Drug Testing (Confirmatory) Interlaboratory Comparison Program. Also, our laboratory has undergone quarterly onsite audits supervised by an HL&P senior QA/QC officer supported by outside technical expertise. It should be noted that HL&P has provided blind external quality control urine specimens to Accu-Chem on a regular basis.
- 9. Accu-Chem nothodology calls for cyclizine to be routinely used as an internal standard with amphetamine and
, methamphetamine confirmations. Based upon our September-1989 CAP Interlaboratory . Comparison Program, our methamphetamine results were within 0.3 participating of a standard deviation of these data from 186 laboratories.
- 10. Accu-Chem has possession of Specimen 61728. Number The original chain-of-custody sealsplastic tamper-proof specimen bag with all intact is also in our possession. A copy.
of which is enclosed.
- 11. Accu-Chem does not release copies of any portion of its ' SOP Laboratory Hanual as part of its normal course of business. However, if provided with a confidentiality statement, we will release this.information to the Committee.
- 12. To our knowledge,, the committee has in its possession or is to Specimen Number 61728.
included in.this document all materials'related-I
- 13. The only agreement Accu-Chem executed was an agreement to abide . by the provisions _ _of the contract - -between ,
MetPath'and HL&P. Enclosed is a copy.- We believe the above responses answer the questions posed by Humber the Committee concerning the confirmation analysis of Specimen 61728. We hope this information is helpful to the Committee. Sincerely your ha. u.A %r. . f L. Laseter, Ph.It Laboratory Director JLL/bl i
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o ll, Chairmannd Commerce The Honorable John D. Dingeand the Committee on 1989 December 28, . Page 4 Enclosures i Officer cc: Mr. Don D. Jordan Chairman and Chief Execut veHouston Li Mr. Howard PyleFederal Relations Director, ighting and Power Co. Houston L The Honorable Steve BartlettU.S. House
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-l Houston, Lighting, and Power company R.P.521 Hwy Carris, FH Administrato?, contracts Division Bay City, Texas 77414
Dear Mr. Carris:
I have reviewed between the Purchase HetPath,-Inc. and Houston, OrderLighting, (Contract and Services) Power Company acting as Project Manager for South Texas Project Electric Generating station, dated 1/22/88, order number ST-300433. Accuchem, as subcontractor to MetPath in perf ormance of confirmatory testing, and I as an authorized Division of representatige E.H.S., of Accuchem Laboratories, a Inc., agree that all work specified herein shall be performed by Accuchem, where applicable, in accordance with the provisions of this contract. > Accuchem Laboratories l - Authorized signature: w
~q rG hj) .
i'
Title:
- L.O DTencUL o Date: OLTVb\D 6- W8% ( Notary Yl , 44 4. /C -[-[ l Date i My commission espires on 3 l 2o- 9f ,
+' ,4 ROSA LEE VINCEN Natur rw.c i
- ENVIRO.NEA1,TH SYSTDLS
. INC. (a Texas corporation) STATE Or tggAg i
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t EDlIBIT C ACCL'-CHD! SUPPLEMENTAL RESPONSE TO COMMITTEE REQt'EST (JANUARY 12, 1990)
N (- i ACCU CHEN1
. LABORATOldL5 . . . ,- .. .
January 12, 1990 @)dn*7,',$f dff, DO Ee*S$5IdcN" I i 1 The Honorable John D. Dingell, Chairman U.S. House of Representatives t Committee on Energy and Commerce Room 2125, Rayburn House office Building Washington, DC 20515 VIA: COURIER
Dear Representative Dingell:
The encl'Js ed completes our response to you letter dated December 18, 1989. I believe we have fully addressed all of the points requested by the Committee. Sincerely you ,
+
M,7LO L. Laseter,.Ph.D. Laboratory Director J LL/bl Enclosure cci Mr. Alan J. Roth Counsel Committee on Energy and Commerce l l l A boon ot t H S . Inc
k:cu-chem IAtcratories Drug of Abuse Stardard operating Procatare (SOP) Section IV Tehruary 9,1987 (Pavision 2) SICTICH IV ODb7IFATICU OF 1ASIC IRC used'Ihis general for basic procatare drugs sat as: of sectraction ard rea:rary my be A W tamine MethsT. hetamine Methadone Methaqualene Propc0 Thane nwcfelidine (PCP) Ho,mver, the final oc/Ms certfimaticri steps will vary dae to the vide rarge of rela:ular stru:ture within the grtup. The extraction prtoedare is based cri the use of tutyl chloride (1-chloro-butane) as the extracticri solvent. CNantitatical in urine to 300 rg/ml of these basic czugs can be accacplished. pCF may be identified and gaantified to 5300 rg/ml. This confirnaticri is to be used to identify and, if present, qJantitate these classes of drugs in urine sanples decenstrated as positive by the initial DUT testirg puc=dare. I.n each case 2 ml of urine is regaired. All sa::ples (unknowns) atst be aralyzed in a batch, alcrg with quantitatlan stardards and both positive and negative controls, internal stardard. In ea2 case, the cyclizine selected is used as the ian fragments for each drug ard the relative ratios calculated. internal standard anz tertitored and the The results are reviewed to de onstrate ion ratio requirments. ocmpliarce with cpality centrol, cpantitation, ard _ _ - _ _ - - - - - - - ---- - ~
i A:ca-chem 1Aberatories D:"Jg of Abuse Standard Operatirg Procedare (SOP) section IV Febraary 9,1987 (Revision 2) SECTICtl n'A - CDtTMTIOf 0F MGMPI%MDE MC MPIHWJM.uMINE A. BAO M O O! Arphetamine (Benzadrine, Dexsirine) is a syrpathat*iretic phenethylamine darivative with major central 3 ne2vous system stimlant activity. Anphetamine has been use:1 sircerartelapsy. and the 1930's in the medical treatment of hypotansion, obesity Arphetamine will increase the heart rate ard blood pressure. It is ccrr:enly abused ard is referred to as dexies, hearts, whites, or black baauties by those who abuse. Self-attirdstration is either orally or by intravercus injection in arcunts up to 2000 ng/ day in adiicted in11viduals. 7blerarce has been reported with psycholcgical deperderce as a p:ssibility. Arphetamine is available in althar the d- or di- iscanarie forts with the d-isanar p,saamming several Hmm more activity than the la fom. Follcwirq a sirgle oral dose of 10 ng of d-arphetamine sulfate in an adult, biccd carcentraticris reach a taxir.um of 0.035 ug/ml (35 ng/ml) at 2 hcurs. A half-life of 11 to 13 hcurs was reported. The half-life can be rotaced approxirately 40% by enhancirg elimination via acidificaticri of the urine. Plasma corcentrations of arphetamine have been reported as high as 0.59 ug/ml (590 rg/ml) at one hcur follcwing intravercus administration of 160 rg of.dl-arrhetamine. If 1000 i rg of aghetamine is orally irgested en a daily basis, a steady-state biced oorcentration of 2 - 3 ug/ml is observed. Arphetamine is metabolized to riaamhated and hydzuxylated products. A significant portion of aqtsetamine (20-30%) is i excreted as the urr.atabolized parunt <==rd with appruximataly 25-30% excreted as benzoic acid ard its glucurtnide and glycine conjugaticn proirts. Small aucunts of anphetamine are oxidized j to rcrephedrine. i Free anphetamine has been ziparted in urine up to 29 hours folicwirg a sirgle oral done of only 5 ag. i Metha::thetamine (nnam and Methandrine), the N-methyl 6erivative of anphetamine, ynis also a central narvous system stirulant. Metharphetamine is also kncwn as uppers, pop pills, bennies, moth, crank, speed, meth, and crystal by those the abuse. Althatgh it is usually taken orally, intravenously, or by snortirg, more Isoant DEA reparts sh:W an increased use of c:ckirg as a preferred rtute of methanthetamine use by abusers.
l t Ao::u-chem laboratories Drug of Abuse Stardard Operatire Pn:catan (SOP) l section IV Tabruarf 9,1987 (Revision 2) The d-iswer as the H3 salt is utilized as a treatment for obesity. The 1-isent, with less OG activity but ircreased sympathomimetic activity is used in decorgestants. The d-ismer, is twoeiving irmwnon-prescriptico an abused substarce in recent years. attention as Metha phetamine is excretM prirarily (44%) as the urretaboli:ed parent errm2M with amzudmately 4-74 excreted as the active retabolite arphetamine. Curir excretion of free retharphetamine will in::rsase.gAfter icw pH, the chronic intravercus administration, ah'a m have shcwn methart hetamine IcVels of 25 - 300 u;Vml ard arphetamine ocnoentrations of 1 - 90 ug/mi in urine. B. ANALYTICAL CONSIDTRATIONS: Reasonably high corcentrations of arphetamine ard metharlahetamine can be detected in urine fzun 23 to 29 hours follow:.rg a single oral dose. Chronic use will result in higher levels. Syva DtIT screening i reagents (polyclonal) have a degree of cross ruactivity with a 1
- number of over-the-countar preparutions and prescription drugs (benrphetamine, v p.iith, ard phantarv.ine to name a few exarples). In <-acac when mathephetamine is hwed by GC/MS techno1cgy, the presence of small anounts of the prinary retabolite arphetamine should als9 m gad..
C. PTJGNPS: t
- 1. NH 4 CE - saturatM (28-30%) reagent grade, A.C.S.
(WR Scientific) Ftability 6 BERTthe
- 2. Ntyl chloride (1-chlorobutane) - glass distilled, purified (Aldrich Omnical Co., Milwaukee, WI)
- 3. Oiloroform - glass distilled (D! Science)
- 4. HCL (1 N) - reagent grade acreantratM (amrcocimataly 38%) (WR Sclerrtific)
H::L (1 N): Eighty-three (83) al of ctroentratM 3:'L when mixed with sufficient deicnized water to make 1 liter will yield aggthtaly 1.0 N H:'L.
Acx:u-chem laboratories Drug of Abuse Standard operatirg Procedars (SOP) Section IV Tebruary 9,1987 (Revisicn 2) D. STANIARDS: d-a phetamine and d-tnetharphetamine att mixed together in e7aal concentrations for use. i Stock standard 1000 ng/ul (each)-True base equivalent Workirg standard 100 nq/ul (each)-FIwe base eqaivalent Internal standard (ISID): Cyclizine Stock ISTD 1000 ng/ul (each)-Tree base equivalent Working ISID 100 rg/ul (each)-Prue base eqaivalent All standards ars inade in absolute ethanol - glass distilled, purified (WR Scientific / DI Science) Each lot (or batch) of stcck standard will be assayed by GC/M3 (full Scan and SD4 inethods) prior to use in order to certify the quality of the standards. All-h:h / Applied Scien:e (Stata College, PA) or Sigma (St. I.cuis, m) is the sourte of amphetamine and metharthetamine materials and cyclizine. Whe:wver a new working standard is acployed frun each lot (or batch) a separate analytical run by GC/MS (full Scan) will be perfomed to certify the integrity and suitability of the new stardard. E. PREPARATICN OF S'IANIARDS/CENITOIS: l 1. Steck Starrbmis: 'Iha solid mais of d-anphetamine-hcl and d-tnetha:phetamine-hcl are weighed separately with 10.0 Ing of each free base equivalent (12.72 ng d- ! arphetadne-hcl ard 12.45 ng d-eathan#wtamine-HC1) ard dissolved separately with 10.0 ml of. absoluta etharel (use volumetric flask) resulting in a 1000 rtivul solution. Stability is three months at -10'C to ~20'C. l 2. Stock Intarnal Starad (IsID): Stock ISID is prepared l by dissolving 10.0 ng of cyclizine in 10.0 ml of ethanol (use volumetric flask) resulting in a wcmiLation of 1000 rg/ul. Stability is 6 nonths at -10'c to -20'C.
- 3. Workira StarAMs Stock stardards of d-anphetamine ard d-tnetha:phetamine are diluted 1:10 with otharel ard mixed 1:1 resulting in a curm>Lation of 100 ng/ul.
Stability is 1 mtrrth at -10*C to -20*C.
- 4. Workirn IFID: Stock ISID cyclizine is diluted 1810 l
with etharel zwsulting in a wc4mLatico of 100 ng/ul. Stability is 3 acriths at -10'C to -20'C. l l
1 i. L l l Acx:u-obem Iaboratories I Dng of Abuse i Stardard Operatirg Proceduru (SOP) Section IV l 1 February 9,1987 (Revision 2) Workirg positive stardartis are set at 300 rg/ml, 500 rg/ml, ard 1000 rg/ml. It is su;p;pested that a duplicata at the 300 1 rg/ml or 500 ng/ml be irclu$ed. Any result estimated to be abcne 1000 rg/zr] shall be tiportad as >1000 rg/ml of aghetamine or meta ghetamine. 5. An ooan neontive urine crintrol aust also be ircluded in i aa m analytical run ()fyoor Bicznedical, Inc., Garden GIUve, CA) .
- 6. An e.xtarwitl nositive confinnaticin ocmtrel (Ptyoor Bicrnadical, Inc.)- with a target value of aptux. 600 rg/ml should also be ircluded in each analytical run.
E. MPAPATICN OF SWPm FOR Q[NFIRb9&ICH BY GC/MSt 1.- Allcw urines to riat room tarryeraturn. Allow standartis and ocritrols to defrost prior to use.
- 2. label 16 x 150 mm glass test tubes acquipped with teflon-lined scriw caps agrupriataly for standartis, blank, control ard unknown magles. ' All tubes with unknowns ard their extracts aust be- labeled with the
'last three digits of the lab accessionire rumber. 'Ihis numerical labaling process will be used thrcughout the analytical, data riducticri, ard reportirq pro Intemal blird ocntrols will apear as unknowrs. gram. 'Ihe '
wavt== rumber of total standards, cat.rols, blanks, and unknowns should not exceed 25 per analytical run.
- 3. Spike the ISID at a canoontration of 100 ng/ul to agt) sanple tube to yield in a 300 rg/ml final concentration.
- 4. Pipet 2 al of urine into the %,lately labeled t:abes. . Ib the tube marked stardards, add 2 al of blank urine. Add standards (mixture of d Jsh- and d-methaghetamine) in apropriate aucunts to yield the 300 rg/ml threshold, 500 rg/ml calibration standarti, and 1000 rg/ml positive atmtrol workirq ocncentrations.
)!ycor is used as the ocurce of an ediitional certified positive ocritrol sanple.
- 5. -
With a Dispapipet add 3 drgs saturated )M4CE. A precipitant will develep. Vortax wall and add 10 ml of butyl chloride.-
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l l Accu-chern Laboratories Drug of Abuse 1 Stardarti Cyerating Procedart (SOP) Se: tion IV rebruary 9,1987 (Revisicn 2)
- 6. Vortax 30 secords, invert 50 times, ard shake on a no::hmical shakar for 5 mirutas. CentrifL*ge for 5 min.rtes at full scale (2000 rpn).
- 7. Transfer the butyl chloride layer to ancewr set of agropriataly labeled (16 x 150 m) glass tubes.
- 8. Add 5 ml of 1 N hcl to extract, vertex 30 seccrds, and ituert 50 tires. Shaks for 5 mirutas and centrifuge for 5 minates at 2000 rpn.
- 9. Discard the butyl chloride layer (top layer) fran each tube.
- 10. IAbel a Mries of 12 al graduated ccnical tubes (17 x 130 m) for stardartis, blank, controls, and ur0;rowns.
A. Ai! to each tube 0.8 al NH 4 GI. B. Transfer the ICl layer obtained trun step f 9 to the conical tubes. C. Add to nach tube 100 ul of pure ChC1. 3 Tightly stcyper the tubes, vertax 30 seccnds ard shake for 5 mifutas, then centrifuge for 5 mifutas at 2000 rpn.
- 11. Imediataly transfer a@rtocimataly 70 ul frorn the botta layer into labalm$, ocnical vials (12 x 32 m) ard tightly seal. CmrICN: betract is extranelv volatile.
G. INSWJMDTr CNDmcN9: A Hewlett-Packard 5890 GC using a Hewlett-Packard ALS with a Hewlett-Packard 5970 () tid) MS ecpiped with a Hewlett-Packard 9133 data systan will be used for the analysis stap. '!his h=icn is designed to provide general operaticral acrditions to be used in the auphetamine and methaM. assay. 'Ihe manufacturer's cparation maruals shculd also be er: ployed as a scuros of informaticn.
'Ibe gas chrunatogregh will be operated in a splitiess mode.
A high resolution glass capillary eclunn (30 m x 0.25 m id) with i a DB-17 ligaid phase (or e vill be used. Helian l pressure is set at 10 psi. qpivalent) 'Ibe wen tacperaturn is set fran i 100'C to 260'C at 10.0'CVairuta usirg a 4.0 miruta initial hold. An injection tanparaturn of 250'C ard an auxiliary (transfar) of amrtiximataly 280'C are to be employed.
A::ce-em IAberatories Dr".y cf Abuse Studed operatirg Prem+2re (SOP) sa: tim IV rahnu.ry 9,1987 (Arvision 2) i Prior to each batch of aralyses, an "Autotune" is to be dcne ' on the MS. Perfluorotributylamine (PFTBA) is to be used as the ca.hihtation ccrpourd. An I/z of 502 is used to meet the
! "Autetune" guidelines sR,a;p;pested by the marufacturer's marmal.
The Pfn%.Tr/r 502 len aburdance should em:med -14 of the base peak of Also nitregan (n/z 28) should be less than 50% the haight of the n/t 69 ion of PPTBA. The "Autotune" recortis are to be printed cut ard maintained as part of the analytical reprt for a given run (batch) of unkrewn sanples. i
':he retantion time of d-acphetamine, d-setharshetamine, and the IFID are detamined usirq the SIM mcde of MS cperation. A ' pare stardard is to be used. This activity nust be acconplished i prier to the analysis of each batch of unkran sanples to verify the a:q,tisition " vin &w" to be used. The acquisition wirdow (i frun 0.5 to 1.0 min) should e>dtibit all the appropriata lors.
If the "Autotune" is saceptable arri the acquisitien wirdew is apprtpriata
- for eacts of the mm$s with all the icms present at the su;p;peated prcceed with the analytical run. relative ratics, the operator may In same instareas, it may be recessary to repeat the ecmpleta "Autocune" premhi a smacrd or.
third tiano in ordar to cettieve noosptable conditions. If "Autotune" cannot be acttieved, theinstrumental suparvisor should be retified. The Oparatienal Check List must be coupleta$ by the cperator prior to initiatirg the analytical run of unkncWn sanples. A i copy is ircitded in this section. Also an Analytical Run Form nust be cmpleted that associatas the accessicn rambers of unkno.'n sacples to be analyrad with their pocition in the AIS sanple tny. This information aust be generated en a sanple-by-aanple vial basis follovirg canful inspection by the analyst of each vial waamion raaber. This process is rupeated a sacend time afteristhe This steo 4 tabulaticn has been insertad into the ocmputer. W.
' Injecticn volume should be set at 2 ul. The sangle syrirge is to be washed a minban of 20 times prior to ihitiatirg the GO-MS analytical sequence. The presance of acarry-over" is established by inspectirq the open no;pative ocotrol (loosted l follcwisq .the positive ocntzel) for any evidence of ico fragments known to be m iated with amphetamine or l
methanphetadne fragmentation pattarns. If evidence of across-cuar" is rotad, the wash cycle shculd be adjusted by a factor of 2x and the prmaan repeated. l
Accu-chem Laboratcries Drug of Abuse Standard operating Pn:codure (SOP) Section IV ) Tebruary 9,1987 (Revision 2)
'1he analytical sequence should be as follows:
1.
- 2. retention time wirdew and data acquisition check sanple 300 rg/mi threshold standard
- 3. 500 rg/ml calibration stardard
- 4. ca.rtified positive ocritrol
- 5. 1000 rg/ml calibration stardard
- 6. cpen negative urine acrttrol
- 7. hm sarples, internal ard external blird controls
'Ihe results will be integra*A by nuutal or automated c:rputar methods.
for a positive result. All results must meet the folicwing criteria Base peaks will be selected, follovirg validation ratio checks, to perform quantitative calculations. H. ,qEITERIA 70R RDuuuC A_10 STRIVE OTIMD&ICff:
- 1. All corpounds of interist must appear in the ion chrunatcgram.
2.
*Ibe icos used to identify each w_md nust be present in ratios that are ocn11stant ($ 20%) when occpared with ion ratios in stardards ard positive ocntrol specimens used to calculate the quantitation table in the same batch. Also, relative retention times should be within a
0.01 mirute vindow h carpared to positive centrols in the quantitatico table in the same batch.
'Ibe follcuing ari used as a guide for eqecta$ relative icn abundances:
1 Anphetamine: Base peak: 44 Wz l oaalifying peaks: 65 vs 5% 91 Wz 4% l Metharphgtemins:
- l i
. Base peak: 54 Wz Qualifying peaks: 91 Wz 4%
65 Wz 3% 56 V: 2% l I i i - - . .- . .. . . - _ _ . _
Dnx; of Abase Stardard Operating Procedure (SOP) Section IV February 9,1987 (Revision 2) Cyclirine Base peakt 99 Wz Galifying peakst 194 n/z 79% 207 nVz 79%
- 3. The intamal stardard (cyclizine) nust be present arti appear in eat sacple, contzel, ard stardard ana.lyzed.
4. Ctrplete icn fragment sets (base peaks ard qualifiers) associated with acphetamine or methanthetantas should rot appear in the negative urirm control.
- 5. The Operation Check List, Analytical Run Forms, Instnrent Icgs, ard any other generated h=nantation nust be initialed ard dated by eat ta&nician ard rvviewer.
6. Sarples that have e-mive gaantities >20,000 rt;[/ml) of arphetamine or methanthetamine pruee(nt any exhibit disto.tc4 icn fragment ratios. The sanple extract must he dilute 1 and ruinjected or the original urine sanple must be dilutad with negative urine ard then ruextracted and anal/ za$ ' with a following batch of sanples. dilution factor must be incorporatad into The the calculati m
j l Accu-chem IAtcratories l Dng of Abuse Stardard operatirn Pr:catare (SOP) ! Section IV Tebruary 9,1987 (Rwisicri 2) SDmCN n'B - xum2m E. Ary;Tard, L.M. Gunne, ard F. Niklases1. Gas chrtretcgra; hic deteminaticn of a@betamine in blood, tissue, ard urine. Scard. J. clin. Tab. Irwest. 25 137-143, 1970. R.C. Zus41t ard R.H. Cravey. A u.4pdium of therapartic ard toxic oorcentraticris of toxicolegically significant cinrys in huran biofluids. J. Aral. h. It 81-103, 1977. R.C. Baselt ard R.H. Cravey. Disresition of 'Itv.le Dnns ard Oe.icals in Man. Year Chicago, pp. 875, 1989. Etok Medical Publishers. Irc. , A.H. Beckett ard H. Rculard. Uritary excretion kinetics of arpheta:d.ne in man. J. Itam. ftarrec.12: 628-639, 1965. Departrent of Health ard }t.t:an Servloes. NIIA PFM) Moncgraph 73, Urine testire for_ dnns of abuse, Ed. R.L. Hawks ard C.N. Chiarg, @. 121, Rockville, 10., 1986. L.G. Dring, R.L. Smith, ard R.T. Williaos. The metabolic fate of aqhetamine in ran ard other species. Biotern. J. 116: 425-435, 1970. P. Icbish, B.S. Finkle, ard J.W. Brackett, Jr. Detamiration of arrhetamine, retjarthetamine ard tv. lated aminos in blood ard urine by cyas chrtrategraphy with hydr: gen-flame icnir.ation detector. Clin. Chem. 16 195-200, 1970. S.B. Matin, S.H. Wan, ard J.B. ) hight. Quantitative determination of enantiomeric Wrds. Bicred. Mass. Soec. f 118-121, 1977. M. R:wlard. A@hetamine blcod ard urine lwels in man. J. Fharm. E E: 508-509, 1969. P.S. Sever, J. Caldwell, L.G. Drirg, ard R.T. Williams. The j metabolism of arphetamine in d@erdent subjects. Eur. J. Clin. Mam. f t 177-180, 1973.
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j . 1 l ASIERICAN hlEDICAL LABORATORIES, INC.* i 1.10vi Mu Street, P.O Box 188, Fairfax, Wginia 22030 0188 / Telephone: (703) 6919100 March 5, 1990 Alan J. Roth Counsel 1 Committee on Energy and Commerce U.S. Heuse of Representatives Room 2125, Rayburn house Office Building l Wash <ngton, D.C. 20515 ,
Dear Mr. Roth:
I have reviewed the documents for the gas chromatography-mass spectrcretry confirmation of methamphetamine from the case described in your letter of February 13, 1990. The standard operating procedure (SOP) indicates that identification cf methamphetamine takes place on an underivatized extract of the urine saraple. It is very difficult to differentiate methamphetamine from phentermine with such a procedure. That is because both compounds have the same molecular weight (149.24) and very similar mass spectra. I have enclosed a copy of the mass spectra of both compounds for your review. The misidentification of phentermine as methamphetamine is a relatively easy error for a laboratory to make. This is particularly true with the procedure employed by this lab. i Because these compounds have the same molecular weight, their retention times on the gas chromatograph - (GC) are very similar. In this case, the relative retention times (RRT) of the three standards and controls (300 ng/ml, 500 ng/ml. and Hicor) are very censistent at 0.5266, 0.5264 and 0.5268, respectively. The l patient sample (6805) has a RRT of 0.5317. This is the first ! Andication of a problem. L The SOP indicates that the ions used to identify and also qualify methamphetamine are 58, 56 and 65 - If you look at the
-two mass spectra I have enclosed, you will see that phentermine does have a smaller 56 ion than does methamphetamine. The SOP i indicates that the 56 ion to 58 ion ratio must be calculated.-
SAMPLE 300 Standard 500 Standard HICOR 6805 56/56 Ratio 6.08 5.97 6.19 1.83 The ratio for the standards and Hicor control are very consistent. The patient sample (6805) is significantly lower at
.1.83, which indicates the 56 ion is present in lower relative 1
1
.ubwnaludJane i% 9 4 Uodsm 7%
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3 Alan J. Roth March 5, 1990 Pg. 2 - abundance than in the actual methamphetamine samples. This indicates that the compound in sample #6805 is most likely phentermine rather than methamphetamine. The lab's SOP indicates i
' that the unknown samples ion ratio must be within plus or minus twenty percent (1 20%) of the ion ratio of standards and positi a controls.
56/SB Ratio Minus 204 Plus 204
-300 standard 6.08 4.86 7.30 500 standard 5.97 4.78 7.16 Hicor control 6.19 4.95 7.42
, f6805 1.83 All standards and controls are within 20% of each other. Sample
#6805 is not within the 1 20% range of any o' the standards or the positive control and, according to the SOP, should not have been identified as methamphetamine.
If I can be of help in the future, please contact me. Sincerely, h \; e , .
, b..h - 7 V' t l- Stuart C. Bogema,'PhsD. #
i Director, Toxicofogy and Therapeutic Drug Monitoring SCBigmh L-ROTH , i
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- y. . . , . . . ., y . y w.'.:'- v n :n :: e:: u: nt-May 19,1990 Alan J. Roth U.S. House of Representatkes Committee or: Energy and Commerce Room 2125, Rayburn House Office Building Washington, D.C. 20515
Dear Mr. Roth:
I have studied the information that you sent to me relating to a urine specimen that was submitted for a drug test and was reported as positive for methamphetamine, in my opinion, the drug test resuhs provided to me do not support a conclusion that methamphetamine was present in the urine specimen. Neither the gas chromatographic retention time nor the mass spectral non ratios obtained on the peak identified as methamphetamine in sample 6805 agrees with the corresponding values reported for the methamphetamine standards anaYzed in the same sample batch, in fact, as you can see from the data in the following table, the identification of methamphetamine does not meet the laboratory's own SOP requirements for drug identification, which are: 1) the relention time should be within 10.01 mbutes of the reference standard's retention time, and 2) the drug's non ratios must be within 120% of the corresponding reference standard's ion ratios. Inble. GC/MS Data for 300 na'mL Standard and for Samnia 6805 Methamehatamina inf amal Standard ICvelhinei lens (m/zi: M M M 12 ,L93 EQ2 300 ne/mL Standard Peak Retention Time: 9.35 9.35 9.36 17.8 17.8 17.8 Peak Area: 387617 23558 26684 205727 196774 161973 lon Rats: 6.1 % 6.9% 95.6% 78.7 % Samsle 8805 Peak Rotentbn Time: 9.44 9.40 9.45 17.8 17.8 17.8 Peak Area: 1377654 25200 103139 242915 238941 206698 lon Ratio: 1.8 % 7.5% 98.4% 85.1% i can not determine from the data whether or not phentermine is present in the urine sample since apparentY no phentermine standard was anaYzed. However, phentermine is isomeric with methamphetamine and its retention time and mass spectrum ecat~s:c ocuro .. . : :. . :.. n. : a
__...________._.__m. ._ _ __. _ . . _ _ _ _ _ . _ ._ - _ - O 8 l Page 2 are similar to those cf methamphetamine, so that it is easy to mistake one for the other in a GC/MS analysis,if the assay is not well designed. The GC/MS assay used for the ana!ysis of Inis specimen has ,everal deficiencies. For example, cyclizine is a relatively poor choice for an internal standard. An internal standard should have similar physical and chemical properties to the drug being analyzed. As you can see from the table, cyc.,zine's retention time is very different from that of methamphetamine. Another problem with the assay is that, without derNatizatbn, amphetamine drugs give mass spectra that are highly subject to interferences that can affect ion ratios and quantitative measurements. This prob'em is very apparent in this specific case. The ion current profile (mC") obtained for sample 6805 shows two very large peaks in the area where methamphetamine elutes, Neither of the peaks have lon ratios or relention times in sufficiently good agreement with those of the methamphetamine standard to permit a l conclusive identification of methamphetamine it is possible that methamphetamine is present in this sample, but the data do not meet current drug testing standards for reporting the specimen as positive. 1 ft is not at all clear to me how the laboratory calculated the reported methamphetamine concentration of 621 ng/mLl? There are other, less critical problems with the data, but I believe the points already discussed cast sufficient doubt on the l reliabihty of the test results. I should emphasize that the GC/MS methodology used by the laboratory that analyzed this specimen is not unlike methodology that has been used (and to some extent , continues to be us9d) by many toxicology laboratories, but it dces nQJ meet current l forensic urir e drug testing standards! l I hope that these comments are helpful. Please call me if you have questions I regarding my conclusions. Sincerely, , M e. '$ l Rodger L Foltz, Ph.D. i l
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'tnu9 Tfic University ofOHafwma OH&.a Cip* Campu Hea!!h 3:ienw Center Fontwsic sciawee LAsonatonies conese or ue0, cine out M ouboweni. Pm o Geo'pe Lynn Cross Aesee'th Professor of M60iCine and citectet June 1. 1990 Alan J. Roth Esq. Counsel Comittee on Energy. and Comerce U. S. House of Representatives I Rayburn House Office Bldg., Room 2125 Washington, DC 20515
Dear Mr. Roth:
\ This is in response to your letter of 15 May 1990 with enclosures, requesting I
- me to review those submissions and the validity of the drug -test report to which they pertain. An undisclosed laboratory reported the presence of methamphetamine at an unspecified concentration in an unspecified specimen {
(presumably urine). The initial , testing was reportedly by duplicate EMIT f homogeneous enzyme imunoassay on site, and confitsatory testing was performed _
- at a- different location by gas chromatographic / mass. spectrometric analysis. 1 The tested subject had disclosed use of medically prescribed phentermine.
At the time in issue, the employer's drug-use testing program =did not include - ' review of test results by a medical review officer. A. 'DrugJ Confirmation Worksheet GC/MS" bearing Accession #5070-26805 and i en = analysis = date of 7/13/89 contains :the following - entries: " AMPHETAMINE ND ng/ml" and ' METHAMPHETAMINE 621 ng/ml".
-1 have examined the information accompanying your letter of L15 May 1990 in detail. and subjected both the anal . '
- Drotocol (50P) excerpts- and analytical data records to close- scrutiny. Based on my examinations .and findings. the ~ presence of tethamphetamine in the (presumed urine) specimen analyzed is not established and cannot be supported -by. the documentation -
and the analytical data provided, at- any concentration.- In my opinion. ! a valid positive confirmatory result for methampheter.tne cannot be derived-
- from the - reported- data and information supplied to u and furnished by the
- confimation laboratory.
In particular, the mass - spectrometric data obtained from - the unknown 'd6805 specimen do not yield consistent and proper 1v corrtisponding ion mass ~ ratios properly: attributable to methamphetamine in comparison to known positive methamphetamine controls and methamphetamine standardst nor do the~ pertinent gas chromatographic. peak elution' (retention) times for the : unknown #6805 ; specimen correspond to those- for the . target analyte methamphetamine within j , the specified tolerance of the laboratory's own analysis protocol. There ; I was no indication that an unextracted authentic methamphetamine standard 1 had been run with .each sample batch, nor was there a record of inclusion- ; in the ~ batch of the 1.000 ng/el. methamphetamine standard required by the j i i Post Othce Don 24901 Research DwHahng. Room 30 m ontohoma City Okiemome 73190 MG M1.@M'
l l l Alan J. Roth, Esq. June 1, 1990 Pago Two laboratory's own protocol. Other lapses, omissions, and inadequacies of the analysis process and documentation are evident. Your 15 May 1990 letter addressed several other, related matters and raised additional questions. The laboratory's 50P (Standard Operating Procedure) is indeed open to serious questions on both substantive and procedural grounds. The analytical procedure, both inadequately described and documented, is inappropriate and inadequate for the intended purpose and effect, in my opinion. It lacks appropriate derivatization of the target cnalyte(s) and employs an inappropriate internal standard compound instead of deuterated methamphetamine and/or other isotopically substituted internal standa rds. Cyclizine is not, in my opinion, an acceptable internal standard for the instant analysis. Concerning the possibility of confusion of phentermine for methamphetamine in this (or any) GC/KS analysis, these two compounds are almost made-to-order for confusion in such analyses. They are isomeric com atomic composition (C oH l 15N ) and molecular weight (149.23) pounds
; and their of identical chemical structures are very similar. Such cenpounds tend to have similar gas chromatographic physical separation characteristics, including relative retention times, as indeed these two compounds have. Failure to use a retention index identification scheme or to use more than one gas chromatographic column makes positive differentiation or identification more difficult and less certain. Nor is the mass spectrometric differentiation or positive identification by m/s simple. Both compounds yield ccepa rable or nearly identical fragmentation patterns under electron impact mass spectrometry. Absence of a full-scan m/s spectrum, as in this instance, compounds the difficulties of unambiguous, valid identification. Both compounds have base (* most intense) peaks at m/z
- 58. Other mass spectral peaks appearing for both compounds are at m/z values of 91, 56, 65, 42, differing only slightly in their respective relative abundances at some m/z values. The m/s identification criteria selected by this leboratory for the underivatized target analyte methamphetamine, namely a m/z 08 base peak and 91, 65, and 56 m/z " qualifying" peaks, are inadequate to differentiate methamphetamine from phentennine under their analysis protocol conditions.
It is difficult to summarize briefly all of the steps which should have been taken to avoid the problem initially, or to resolve it once the question of misidentification had been raised. Foremost is the need for a substantially different method of analysis, incorporating suitable derivatization and use of an isotopically-labeled internal standard, i.e., deuterated methamphetamine DS . Strict adherence to the identification criteria of the protocol, especially the relative GC retention time and the acceptable 220% correspondence of ion mass ratios, was mandatory and did not occur. The data handling system may well have been inadequate or improperly prograisned. Once questions about the validity of the identification had been raised, a full and adequate reanalysis was required, it should have included the above items and a full-scan mass spectrum (as would indeed also be preferable for the initial confirmatory analysis), and authentic methamphetamine and
Aiaa J. Re % , Esq. June 1, 1990 Page Three phentemine standa rds and controls, separate and mixed. At least two suitably different gas chromatographic columns and probably two different cerisatizations should have been used in any such reentlysis. More than the tese peak and 3 other m/s peaks should have been searched for and compared in this situation. Chemical ionization mass spectrometry would have been the preferred Rearalysis method of analysis given availability of necessary instruments. should controls negative also have included unextracted drug standards and blind and positive for both methamphetamine and phentervine, to check the ability of the analysis and the analysts to differentiate between them and quantitate them correctly. Search for the respective pertinent metateittes was indicated. Neither of the two foregoing comments are represented to be complete and all-inclusive. Your concluding question, reason to question concerning other aspects of this case giving me the positive results, if any, also cannot be answered exhausthely here. There are major omissions from the material furnished by the laboratory, compared with what should be available and forthrightly provided. The qualifications of the reviewer (s ) of the analytical data anc the responsible laboratory director are certainly open to question. Tne protocol (SOP) excerpts indicate major inadequacies, and faulty choices in those respects which are addressed. Absence of performance data at or near the time in issue, such as proficiency test results including doctmentation that the laboratory can and did acceptably quantitate the target analytes, is striking and unacceptable. The failure to document how quantitative results we re derived and to record them in a readily traceable manner, for both unknown specimens and controls, is unacceptable. So is the failure to report a quantitative result, together with the quantitative criterion (threshold concentration) constituting a ' positive" metnamphetamine finding in this instance. Nowhere is the nature of the specimen - presumably urine - clearly stated. References for the method of analysis are not clearly cited, nor are 50P initial and review dates and identity of a qualified S0P revieser shown. There is no evidence of appropriate and adequate quantitative calibration and construction and use of calibration tables. A ' quantitation table" vaguely referred to in the 50P under ' Criteria for Reporting a Positive Confirmation" never appears. Nearly all of the references given in the 50P are alike in one respect - they are outdated and mostly long superseded. In overall stama ry, the information and data supplied by the laboratory are wholly inadequate, especially in a contested test result situation, i What has been supplied gives rise to the conclusion that the laboratory l in question and the approach it has taken to the tasks at hand are both inadequate. Nevertheless, it is clear from the information and data supplied that the positive methamphetamine test result is not supported by those data and cannot be validly derived therefrom. Given the constraints imposed in the situation set forth in your letter of 15 May 1990, I hope the foregoing consideration and discussion a re adequately useful. , Sincerely yours; Kurt M. Dubowski, Ph.D. Distinguished Professor of Medicine KMD/pb
L -'
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June 8,1990 I University of J Roth n Arkansas ^I"" on ,;i for Medical Committee on Energy and Commerce U.S. House of Re resentatives
- Sciences Rayburn House Cfffice Building
- Washington, DC 20515
Dear Mr. Roth:
This letter is a follow up to our recent conversation concerrdng the urine drug testint aboratory l data you sent to me on May 15, 1990. After a careful miw Marknam review of tiese data, it is clear that this laboratory has not correctly identified t.m acen Arkans*5 methamphetamine in the urine sample. Therefore the individual, from whom this ' W5M - urine sample was collected, has been seriously mistreated. It makes me wonder how many others have obtained the wrong results from this laboratory, t '
.. There are many problems with the data from this laboratory' however, I will only briefly summarize the most serious problems. First, the retention time for the n Hyeor positive control sample was out of the limits of quality control. The ;l I' retention time is not within the t 0.01 retention time of the reference standards.
This criteria is stated in their SOP manual. Second, the ion ratios of the patients sample for methamphetamine do not meet the i 20% criteria, as stated in the SOP manual. Third, the ion ratios and total ion current for the patients sample do not support their conclusion that the sample contains methamphetamine. Fourth, I cannot determine how they calculated the reported concentration of 621 ng/ml. Using their data for the 300 and 600 mg/ml standards I was not provided the data-for the 1000 ng L 56 amu base ion /ml standard), I constructed a sta and RT of approximately 9.45. Based on these data I would have E . calculated over 3,000 ng/ml of methamphetamine! It appears they probably used area data from other qualifying lons, again not following their own 50P. Finally,- the person who signed off on these data also missed these serious mistakes. , p s Some of the other problems with the data concern their choice of OC/MS l le extract before l
.analyzing procedures. it. This would For instance, they have reduced someshould have inter of the probable derivatized the sa '
they are detecting at these low molecular weights. Also since phentermine and methamphetamine have. the - - same molecular weiht anc are - isomeric, derivatization would have helsed to clearly distinguish setween them. I cannot ' determine from these data if p sentermine is in the specimen. As a personal comment, these data re > resent what can happen if drug l testing is allowed outside of carefully control ed conditions of checks and ba ances. , Also, there is a serious misconception in the drug testing community that gas =i chtomatography/ show the need for standardizing mass spectrometry GC/MS proce (OC/MS)dures, as has been d immunoassays. i An sba! opp 0N%fy svoytf ^
. _ ., _ _ . . _ _ _ _ . . _ _ .....~._-..-m-._._..,.- .--_,.___ _ _ _- -. m-,., m. . , , , -
I ~ Alan J. Roth 4
- June 8,1990 j Page 2 -
l' If you need further clarification of these points or if I can be of further usistance in i the future please let rne know Sincerely, - 7
/ .
W# I S. Michael Owens Ph.D. j Associate Profe::o,r i D artment of Pharmacology and Toxicology (5 ) 686 5487 Office (5 ) 686 5521 FAX . i 1 3 s l i
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l I l l l l 1 l l 1 1 l 1 1 EXHIBIT E ACCU-CHEM RESPONSES TO EXPERTS' OPINIONS t I l e , u -.- . . . , , m., ,y e.-,, #- _,%.. . . - ~ u- _ - c.-.. . - .- ,_- . - - - - -- -. .
ACCU CHEM LABORATORIES I June 5, 1990
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The Honorable John D. Dingell, Chairman U.S. House of Representatives Committee on Energy and Commerce Room 2125, Rayburn House Office Building Washington, DC 20515
Dear Chairman Dingell:
We are in receipt of your letter dated May 30, 1990 regarding the case of a former Houston Lighting and Power employee that tested positive for methamphetamines. aboveAt described this time we have matter. no additional comment concerning the However, we do appreciate your invitation to do so. Your consideration is most appreciated. Sincerely op s .
~ hOs -
Jo L. Laseter, ph.D./ ratory Director " JLL/t l a o - m s.,, _ _ _ _ _ _ _ _ _ - - _ - - - - - - - - - - - - - - - -~ ^ ~
'i ACCU CHEM IABORATORIES June 21, 1990 ."A*n*Y!L Mi" gg4 5412 The Honorable John D. Dingell, Chairman U.S. House of Represent:tives Committee on Energy and commerce }
i Room 2125, Rayburn House office Building Washington, DC 20515
Dear Representative Dingell:
I am sending this letter and associated analytical documentation to eliminate any confusion about the forensic u urine drug Security testing ret Ords for Specimen Humber 61728 (Social Number
- 225-82-4945). This sample identified by our laboratory with accession number 6805.is additionally The set enclosed documents are grouped in two sets. The first represents a portion of Chromatography / Mass the original Gas Spectrometry GC/MS) confirmation analytical (Figures Adataandgenerated B). ca urine sam (ple 6805 in July 1989 (Figures C, D, and E) The second set of GC/MS information were collected using the identical instrumentstl<., GC column, and analytical conditions as i
those employed in July, 1989. However, the latter set are ! mixtures observed -inofsample pure drug standards that correspond to those 6805. For the sake of clarity the following notations are used to identify the drugs characterized in both data sets. (Table I) 1. Table I Notation used for standards employed in the GC/MS analysis of the surrogate test sarple and sample 6805. i a - Amphetamine l ! p - Phentermine a - Methamphetamine c - Cyclizine (internal standard) l A omson dt.ns. w
L I page 2 As each drug standard is added to the surrogate sample, its position (absolute and relative easily observed and calculated. retention times) can be This experiment was designed using concentrations of drugs that approximate those values reported for sample 6805. Ion fragment ratios can also be observed and calculated. As the levels of phentermine any irpact (p) are increased in successive analytical runs, on retention times and ion ratios used to identify the various drugs can also be observed and ultimately compared to the original sample 6805. An obvious handicap mentioned by the technical reviewers of our original submitted documentation was the lack of information on the chromatographic retention time and fragmentation pattern for phentermine (p). The individual being tested acknowledged taking this prescription drug. It should be pointed out that it was never the intent or mission of the drug confirmation program in our laboratory to characterite any urine sample for prescription drugs such as phantermine. The salient qualitative results from sample number 6805 and the surrogate test samples are illustrated in Table II. Letters A through D refer to the figures in the attached appendices from which the analytical information was extracted. It should be noted that within a given batch of analyses, there was virtually no detectable variation in the retention times associated with the internal standard. When one compares the retention time for " methamphetamine" in sample 6805 (Figure A) with the methamphetamine standard in the corresponding calibration run (Figure B) there is a difference of 0.094 minutes. This is outside the expected renge for methamphetamine. times are compared, thereEven when the relative retention is a shift of 0.006 minutes. However, such shifts are anticipated and normal if a high concentration of an additional drug (such as phentermine, peak p) elutes just prior to methamphetamine. This chromatographic phenomenon is made abundantly clear through the use of the surrogate test samples analyzed under the same conditions as the original sample from July 1989. For example, the methamphetamine peak (m) initially eluted at 9.469 minutes (Figure C) . When approximately 1000 ng/ml of phentermine (p) standard was introduced into the sample (Figure :. 0.012 m. ates. the retention time became 9.4 91 -- a shif t of Likewise, as the concentration of phentermino (p) increased to approximately those levels observed in sample 6805, the retention time of methamphetamine m) was extended to E). This repres(ented a total change9.530 minutes of over 0.06 minutes. (Figure l
I page 3 The response described above is identical to that observed in the data set for sample 6805. An analysis of chromatographic retention data illustrates that the shif ts are due to migration of the methamphetamine peak only. The retention times, relative retention times, and ion fragment ratios for the paak labeled "p" in all analytical runs are consistent witn the drug phantermine. All phentermine, amphetamine, and methamphetamine standards have been individually subjected to GC
' the full scan mode. In each case /MS analyses the spectra operatedare observed in I p consistent with published information. It should also be !
noted that there is good agreement (i 20%) between the 56 l m/z / 58 m/z ion the absence ratios when methamphetamine is analyzed in of phantermine. I However, as the phantermine levels increase in concentration, the ion ratios are 'orced l I out of the expected reporting window of i 204. (See table II) This phenomenon was also observed in sample 6805. Due l to the 1_ack of an appropriate 1000 ng/ml positive standard i present is sample to use with 6805, the actual value of methamphetamine i most likely >1000 ng/ml and may be as high as 3000 to 3500 ng/ml in urine sample 6805. In the original laboratory report the presence of amphetamine was noted as negative. However, as can be seen '
; in Figures F and G, amphetamine (a) is indeed present but below the 300 ng/ml reporting limit. There is excellent agreement between the positive standards i (Figure F) and I sample 6805 (Figure G) for ion ratios, retention times and ,
relative retention times. As reported in the National I Institute on Drua Abuse Research Monocraoh Series 73 l entitled " Urine testing for drugs of abuse" (1987) on page 96, l "A positive amphetamine analysis indicates previous use of amphetamine or methamphetamine, ! previous 24-48 hours". generally within the Therefore, the presence of this l recognized metabolite in sample 6805 strongly supports the l intake-of methamphetamine. l \ , l ! An additional point brought out by a reviewer was that our l laboratory did not follow each and every detail in the I laboratory's manual, Sop manual in reporting out sample 6805. Our statement as that is common in most if not all SOP's, is a allows for some deviation in reporting following a review by the certifying scientist. "c. All l data deviating from the reporting criteria must be reviewed by a certifying scientist. Any decisions, corrective action, etc. must be documented following approval release of these data." (Drue Procedure Manual _, Sectionand 9, February 1, 1987 Criteria pp. 9-9) l
Page 4 In summary, when all the evidence is evaluated together, there is little doubt that methamphetamine is present in urine sample 6805 in lovels well above the 300 ng/ml threshold reporting limit. This conclusion is further supported by the fact that lov levels of the methamphetamine metabolite amphetamine are also present. I hope the enclosed information and associated tables and text have established the facts. Please advise me if additional information may be necessary. ! Si rol
#- .0 ,
hn . Iaseter, Ph.D. Director of Laboratory l l JLLips l Enclosure l l cc: Mr. Alan J. Roth Counsel, Committee on Energy and Commerce l l se l N
h
'IN EE II Annuary of rebertim ad relative icin=a lat timwa arti len Lafi==iadm results hun soupla 6805 ed '
w e ,---f *rtiswa m the ages relatkrddp of metteghebu=Irie ad hertemim t NYMTrN IDER 6805 SER09 TIE ' ESP SMHE , puly,1999) purie,1990)
==mi. aurvir+ % r%11Wim std wa 6805 t Figtze Wirus B A C D in w iv E i Fm:iiQe :rie lhe!rtwruirle ;ia;Qe ._:re :J.Qe ;rie thertsvinitie It!ttiemghsherirle Ihertwwwirle @r:e "iOO m&1 >1000 m&1 >1000 ru/ml 600 ruMal 1000 ruini 600 ruAm1 5000 mMI 600 ruel IMatim Tiime 9.350 9.220 9.444- 9.4@ 9.275 9.481 '
otin.) 9.221 9.530 x ISID 14!teritdon Tim (Min.) 17.761 17.762 17.560 17.562 17.565 cru,4,,e t Itklative lh2ErtlGt Time pain.) 0.526 0.519 0.532 0.539 0.sas o.540 o.sas o.ss3 niuxnsIn Im Mien 6% 2% 4% 3% ** pet 56 m/z / 58 m/z i ' i 20% Itage 4.8 - 7.2 062-Iturpe 3.2 - 4.8 Out h Ott-of-5tege [
- ' - _ . ---=---___-____.:
j APPENDIX 4
APPENDIX FIGURES A. GC/MS computer processed results for forensic urine sample number 6805, July, 1989. B. GC/MS computer processed results for a 500 ng/ml positive the abovecalibration sample analyzed in the batch with (A) sample. This sample is spiked with amphetamine (a), methamphetamine (m), and cyclizine (c) as an internal standard. C. Surrogate test sample spiked with approximately 300 ng/ml amphetamine (a), 600 ng/ml methamphetamine (m) and cyclizine solvent was use(d.c) as an internal standard. Chloroform D. Surrogate test sample spiked with approximately 300 ng/ml amphetamine (a), 600 ng/ml methamphetamine (m), 1000 ng/ml internal phentermine (p), and cyclizine (c) as an standard. E. Surrogate test sample spiked with approximately 300 nsj/ml amphetamine (a), 600 ng/ml methamphetamine (m), 5000 ng/ml phantermine (p), and cyclizine (c) as an internal standard. F. Graphic presentation of computer processed results of a single GC/MS scan (f549 at 8.703 minutes taken from sample number 6805. Relative abundances) ofthe ion fragments monitored in the SIM mode are also listed. G.
~ Graphic presentation'of computer processed results of a single GC/MS scan (#549 at 8.702 minutes) taken from the 300 ng/ml threshold standard of amphetamine (a) run with the batch containing sample number 6805. Relative abundances of the ion fragments monitored in the SIM mode are also listed.
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1 l l i I i EXHIBIT T ; HL6P SUPPLEMENTAL COFMENTS
The Light c o mLighting Houston p a &nPower ySouth Tetas Projeu Electric venerating Station P. O. Boa 289 Wadsworth Tesai 77483 July 10, 1990 Alan J. Roth, Counsel Committee on Energy and Commerce U. S. House of Pepresentatives Room 2125, Rayburn House Office Building Washington, D.C. 20515-6115
Dear Mr. Roth:
Thank you for continuing the discussions with Houston Lighting
& Power (HL&P) representatives concerning the South Texas Project i Electric Generating Station it relates to drug testing. (STPEGS) Fitness For Duty Program as HL&P appreciates your willingness to discuss these items as well as the opportunity l to provide I
information and procedures. for Congressional use concerning d:mg tosting standards At the meeting with Messrs. Al Gutterman and Howard Pyle, you testingHL&P invited to submit additional information about the STPEGS drug I. program. We trust that the information provided v'11 be useful to you in your efforts. Backaround Information: STPEGS, HL&F is one of four owners ' and is the Project Manager of
- c. two unit nuclear power plant in Matagorda County, Texas.
t In January,1986, HL&P instituted a Fitness For Duty Program which consists of a Drug and Alcohol Testing Program, continual Behavioral Observation Program (CBOP) and, to support our employees in these areas, an Employee Assistance Program (EAP) . The Drug and Alcohol Testing Program requires baseline / pre-employment, random and for-cause testing. CBOP furnishes Supervisory training which enables Supervisors to recognize and encourage employees to seek appropriate counseling when there is indication an amployee is experiencing difficulties which is reflected in behavior or job performance. i STPEGS Fitness For Duty Program includes policy which I . prohibits employees misusing from using legal, controlled illegal drugs and from abusing or substances. This is an effort to protect the safety of individuals, other workers, plant equipment and the public from the consequences of worker impairment from l substance abuse. A Subsidiary of Houston inoustries incorporated
+4 h $
Page 2 1989,To the meet the requirement applicant for em for a pre-employment test, in June, provided a urine specimen. ployment consented to the analysis and a syvaThe Emit sample was firstkit. immunoassay analyzed at the on-site laboratory using The analysis found amphetamine-above the 300 ng/ml cut-off level specified in the Fitness For Duty Program. It was standard practice for the Fitness For Duty staff to take no action regarding_ amphetamine preliminary positives. The sample was forwarded to an independent testing laboratory which positive analyzed the sample and reported to HL&P that the sample was for methamphetamine. r Upon receipt. of the confirmed positive test result, the Fitness For Duty Staff discussed the results with the job applicant and encouraged. the applicant to identify use of any additional medication that could explain the positive test results. Internal procedures
' when there Lis enable the Fitness-For a~ confirmed positiveDuty test staff to assist employees accounted-for by listed medications. result which can not be The job applicant was also advised to consult the _ applicable personal physician and the dispensing pharmacist for assistance. The list of medicines provided. by_ the applicant. was forwarded to the independent laboratory which advised HL&P that none of the medicines could-explain the . analysis results. Based on the positive analysis results, and the job applicant's inability to satisfactory provide .a explanation, by _ procedure requirements, HL&P terminated the individual's employment status.
Revision 1of Fitness For Duty Procram:
.On June 7,-
1989, the -Nuclear Regulatory - Commission (NRC) adopted'a-new regulation, 10 CFR Part 26, which requires fitness for duty programs at nuclear power plants. The NRC regulations required each plant to adopt,. by January 3, 1990, a fitness-for Lduty program consistent with the new NRC requirements. The South Texas Project Fitness For Duty Program .was revised to conform to the new NRC requirements.
-Procram' Chances
- 1.
Questions
-testing. regarding analysis- performed by the independent-laboratory.
At:the time of the 1989. testing, HL&P did not require that the laboratory 'doing the confirmatory testing be certified by the Department of Health'& Human Services (DHHS). - However, HL&P took steps - to ensure that the ; laboratory was competent and produced accurate results. These steps included quarterly audits of the confirmatory laboratory by HL&P's Quality Assurance Department. There was also the submission of blind performance samples to the
- - . . - .-- . = - - - - . - . . - ~ - . - . - .~.- .- .. _ .--. - . ~
- Homum 1.@hng & Power (:ompam i Page 3 confirmatory -laboratory- for analysis. The confirmatory laboratory was Improvementand continues-to Act ' of 1967 be certified-under the Clinical Laboratory (CLIA)
Administration (HCFA)- by DHHS. and the Health . Care Financing As required by the new NRC regulation, the confirmatory HL&P Fitness For Duty- Program now requires that analysis be done by - a - laboratory that has been-
-inspected and: certified under DHHS. Mandatory Guidelines' for Federal Workplace Drug Testing Programs, 53FR 11970. As a result, the current confirmatory performance testing laboratory is also subject to the testing and on-site inspections requirad- for maintenance of DHHS certification.-
2. Questions analysis results. regarding HL&P review of the-independent laboratory
-The STPEGS Fitness For Duty-Program _ implemented in 1986 was developed from guidance published by the Edison Electric Institute -
(EEI 1985 Guide to Ef fective Drug and Alcohol / Fitness for Duty Policy Development) - which was adopted by the commercial nuclear industry as.a standard. This guidance.did not specify the use of , a_Hedical--Review. Officer. ML&P relied _upon the scientists at_the independent. testing laboratory to review the over-the-counter-and prescription drugs disclosed by the individual and-determine if a positive : confirmatory . test result could - be explained by the - consumption- of such legal drugs.. In addition, _ HL&P's Fitness For Duty Staff attempted - to identify alternate explanations for the
- positive test'. result through interviews with the employee and consultation with the scientific- staff at the independent laboratory..
'In. compliance with 'the- 1989 NRC regulation, HL&P- has i established:a Medical Review officer. position with responsibility for'l evaluating ' alternate explanationsfor test results.
l required byi the '. regulation, the Medical Review . Of ficer is -As _
--a -
licensed physician 7with: knowledge , of t substance _ abuse; disorders. Where appropriate, the : Medical Review Officer interviews the-individual, reviews. the individual's medical history and other relevant biomedical- factors.. The- individual; is given the opportunity'to provide any. additional infor1 nation to the Medical Review Officer which may explain a. positive test result. Other Questionst-
- 1. . Cutoff levels used in screening and confirmatory testing..
The-STPEGS Fitness- for Duty Program established cutoff levels for on-site screening and confirmatory testing,.some offwhich are lower than the . levels recommended by the NIDA guidelines. You
- questioned the reliability of testing at-such-levels and the new NRC regulations which permit the use=of lower cutoff levels were discussed. 'In the case of interest it is noted that the records provided:to the committee:by'the confirmatory. laboratory indicate-e s " mv *-s - , , n a, , - , .*n v. -,,-v-c-w--,---- o- e. ----n -,-~-w,- e,v----,-re --e a u ..,,-,e>
- , w-,- , - -e n w w - m a m----e
lh ulditti l .tgIllitig N b ih t*f ( Itlltij).llit Page 4 that the actual methamphetamine concentration found in the sample discussed above exceeded the NIDA recommended cutoff level (500/ng/ml). '
- 2. On-site screening.
You expressed a general concern about the use of on-site screening laboratories, citing questions concerning the reliability of the immunoassay screening tests used in on-site laboratories, and your concern that the company may take action against the individual based on preliminary positive test result. In this particular result, case, although there was a preliminary positive test no action was taken against the individual until confirmation of the result by means of GC/MS testing had been obtained explanation for that result. and efforts had been made to identify an alternate The NRC Regulation does not permit any action positive test result. against an ettployee based solely on a preliminary Peanalysis of Samelei HL&P is obtaining a reanalysis of the remaining portion of the urine specimen which has been frozen since June, 1989. The reanalysis is being performed by a DHHS-certified laboratory not otherwise associated with HL&P, in accordance with NIDA guidelines. We expect to receive the results of the reanalysis by mid July, 1990, and will advise you of the results promptly after receipt. We trust that the information contained in this letter is useful to you and to the committee in the examination of corporate drug testing standards and procedures. HL&P and STP are proud of the accomplishments of our dedicated work force in supervising, operating and maintaining this large nuclear power site. The unforgiving nature of nuclear power requires true interest and dedication on the part of employees at all levels. We are confident that STPEGS' Fitness For Duty Program contains adequate controls to protect all our employees and job applicants from unwarranted actions by the Company, other employees, or contractors. In this industry with unique safety requirements, the STPEGS Fitness For Duty Program is an essential element in achieving the goal of a drug-free workplace. If you have any additional questions, please do not hesitate to call me. V truly yours,
. Hall Group Vice President, Nuclear DPH:jlh
1 l' l l 1 EXHIBIT G HL&P REPORT ON RETEST OF FR0 ZEN SPECIMEN l l: [ l l (.- l c li i ! l t I l l
The Light cg o m p a ng p9 y South Texas Project ElectricP. O.Generating Bom 289 Wadsworth. Tenai 77483 Station I July 19, 1990 Alan J. Roth, Counsel Committee on Energy and Commerce U.S. House of Representatives Room 2125, Rayburn House Office Building Washington, D.C. 20S1S-6115 Dear Mr. Roth 1 Hy letter of July 10, 1990, referred to an individual who had been denied employment in 1989 at the South Texas Project Electric Generating Station (STPEGS) on the basis of a confirmed positive test result for methamphetamine under the Fitness for Duty program (FFD) then in effect. communications in December 1989, I outlined In that letter and in for you the steps taken to assure the accuracy of the testing and the care with which the matter was handled to protect the interests of the individual involved. These facts gave us confidence in the original positive determination; we retain that confidence. , However, there was a remaining portion of the original specimen which had been frozen since June, 1989. Although it was our understanding that there was a clear probability that the passage of time had caused degradation of that cpecimen to the point that the methamphetamine and metabolites confirmed in the original 1989 testing might be undetectable by any testing method now, we decided to have the specimen retested to put this matter to rest. We selected a laboratory certified by the Department of Health and Human Services (DHHS), which is not otherwise associated with Houston Lighting & Power Company (HL&P), to do the rotesting under the NRC's new FFD regulations and in accordance with the National Institute of Drug Abuse (NIDA) quidelines. EL&P's undertaking to conduct a further analysis at a NIDA certified laboratory, notwithstanding the possible degradation of the sample, reflected a determination thet, although the events of this case pre-dated the adoption of the NRC's new FFD regulations, we would follow that gujdance to the extent feasible. (See 10 CFR Part 26, Appt.ndix A, Section 2.7(j).) The analytical results show that the possibly degraded sample is negative for methamphetamine. A Subsidiary of Houston Industries incorporated
Homion Lighting & Power Compans Alan J. Roth, Counsel July 19, 1990 Page 2 l In these circumstances, as permitted by the NRC, we have ! decided to treat the conflicting results as indeterminate, to so advise the affected individual, and to discuss with that individual opportunities for employment at STPEGS. An individual seeking employment at STPEGS must, of course, comply with the_FFD program, which we believe plays a vital role in protecting the health and safety of our employees and the public. In particular, before being granted unescorted access to the site an individual and for-causemusttesting be tested for drug use and is subject to random thereafter. We appreciate your interest in this matter. rul yours,
/
- e. P. all Group Vice President, Nuclear
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t. l l l l
EXHIBIT H HL&P DOCUMENTS RE: DIET MEDICATION IhTESTIGATION
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8-23-89/ Received c:nfirmed pcsit:ve test fer Me:hamphetami.as : .- specimen provided by HI.&P empicyee, Medication listed by (Didrox), was not kncvn to tes: positive for Methamphetamine.
-In view of the fact this was the second confirmed positive for Methamphetamine in 8 weeks, and that again there was no listed medication known to test positive for Methamphetamine, the Human Resources Department became concerned that there may have been a problem with prescribed diet medication being used by site empicyees. A particular cencern was the fact that both individuals had their diet medication prescriptions filled at the same pnarmacy. The following chronological events occurred as a par ef the effort to determine if there was a problem and if corrective action was necessary, was interviewed by John. Odom, Human Rescurces cecartment Mana er, and Cindy McClary, Fitness for Duty Supervisor, as advised of the confirmed positive fer Me:namphetamines and the interview process to determine if-she had
, '.isted all of her medications or if she had taken a friend's cr co-l werker's prescription diet medication was completed. N stated she had not taken any other medication and that she could not explain the confirmed positive test result. Because of the -developing concern about prescription die: that her site access ! redications, John odom-informed w:uld be suspended, with pay, unt:. M' a determination could be made
- .f there was a possibility her DIDREX prescription would centir .
i pcs;-ive for Methamphetamine. She was advised she should centac: , the prescribing physician and her pharmacis: to enlist thei l- assistance. i Actions taken by Human Resources. L 5-25-89/ A flyer was distributed te all site employees requesting i :na: anyene taking prescriptien diet medications centac: :ne 7;; ness fer Duty Center. The empicyees were advised tha: thers iculd :e n punitive acti:n taken against anycne who cacperstad ..
- .s :...vestiga:icn. (See-A :achmen: *) .
; su:-/ey celf.acticn :f samples was d:ne arcund-the-clock. This 'as
- 1. eff::: :: .de:ers:.ne :? here vas t :cr. men :ss: r e su '. : :.. t
;2 ::.:u12: :.:7 4 y a -- ' -" ' ' ' -- -"- e r : f a d rug :: p r e s cr;;;;. :ns n..ai 1: in/ :ne pha::acy.
Samples were collected from individuals who gave netification :ney were taking the following medicatiens: Adipex.y fastin Diethylpropi:n Ph e nt ai r=in e Didrex Tenuate Despan Tepanil 10 Twenty-seven sampics were collected from 4:20 pm on Friday, August 25, 1989 to 5:00 pm on Sunday, August 27, 1989. These prescriptions were filled at six different pharmacies. None of the samples confirmed positive for Methamphetamine. Based upon these results, Human Resources was not able to identify a problem regarding a certain brand name drug, generic drug or a pharmacy. Cindy McClary had numerous conversations with Dr. Joe Cannon, physician, and Ron Garza, the pharmacist who filled the prescript on. Through the ef forts of these two gentlemen, Upjohn, the manuf acturer of DIDREZ, released test data indicating that this medication does have a potential to test positive for Methamphetamine. Upjohn forwarded this information to Dr. Joe Cannon on 8-29-89 who telefaxed it to C. McClary on 8-30-89. (See Attachment 2) This infomation was forwarded to Dr. John Laseter by FAX on 8-30-89. On 8-31-89 Dr. Laseter telef axed his review and opinion on the data from Upjohn and it was determined the DIDRZX would account for the positive. (See Attachment 3) h was informed the Upjohn information was adequate and she would have her site access reinstated. 9-8-89/ A memo from Human Resources to all site employees was distributed. Recognition of the cooperation received was acknowledged. (See Attachment 4) Additionally, employees currently taking prescription diet medications were advised they she:1d r =ct their physician or pharmacist to determine if there ve,4 2 .antial their medication could possibly test positive for Methamphetamines. NOTE: Mrs. Judy Proffit was aware of this activity. The
'Pharuacist referenced J. Proffit to when she came in
- to get his assistance.
During subsequent and numerous telephone calls to the FFDC by Mr. - and Mrs. Proffit, they have been told repeatedly that any data or informatio.: provided by the manufacturer of Phantermine that would suppcrt a determination of a positive for Methamphetamine when using Pt.entermine would be adequate to account for the positive rest rr.sult. To :! ate, their efforts have been targeted at invalidating the Site
~_acerat ry and the Ocnfirmation Labcrat:ry positive test results.
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August 29 1989 Joe Cannon, MD VA Medical Center Bey City TX Cear Dr. Cannon: 010Rix' TABI,tTS - HETAB0LIC PRODUCTS IN HUMAN URINE I am res::ndin
.c'toclic proc.g te ye.r recent inquiry concerning informatior about the ."
cts of O!DREX Tabiets (benzphatamine hydrochlorice) i- ht e . that ne discsssed on the telphone on August 29, 1989. Stuai ts coa.dacted by The Upjohn Company have shown that following t.'.;'s c:: c al acMnistration of 75 mg tritium. labelled senzphetamine hydrcen'or'ce :c r.ormal hwman male voluntee-s excretion and total recevery,wereseven day2.57% 82.77%, cumulative urinaryrespecth anc $6.34%, excretton, e*y.fact' Excretion of tritiated water accounted for less than 15 of the total radicactivity.' Of the ben 2phetamine dose administered orally. 5 51% *ss excreted in the urine as amphetamine and 1.84% as metamphetamine.1 The 1.pjohn. Company is providing you with this material as an informatica service and professional courtesy. The findings and opinions presentet is this material are those of the original author (s) only. .This information '; .
'rttrded to provide pertinent data that will assist you in forming yest r.-
conclusiens and making your own decisions.
,es'ses for our profucts. The-Upjohn Company It is not intended to recomm :
cannct promote the ase :( sr product for any indication, claim, dosage, or route of administratier tna ' not covered in the package insert (enclosed). We appreciate the opportunity to respond to yoWr inquiry. If we may se c/ further assistance, please centact us. Sincep., ..- THE 4'PJOHHpSANYl' [ Q ~../ ,/ .
'vM. . /
o . Ernes- .'. Gu . w.S., Pharm.3.
- ,r.;g cf:r.tacten Clinical P5armacist
's's Refe"*rces
- 1. ln-nouse data.
d
.;CCU CHE.\l W3ORATORlE5
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. . rw < . n 1 a August 31, 1989 gsjy4 * ';
Ms. Holly Claybourn Metpath 9 South Texas Project TitneJs for Duty Center P.O. Bcx 289 b'adsworth, TX 77483 Oear Ms. Claybourn!
- have received a copy of the August 29, 1985 ccr.munics:.--
from Mr. Ernest Gurwichsf the Upjohn Company to Dr. Joe ::an .:: on the subject of Didre @'netabolism. Trom a review of the limited inhouse research described ir i the above comr.unicatien, it appears that both methanphetami..e n-i l 2phetsmine can be produced as nelabolic products f ollow:.*g th - oral adninistration of Didre@ (b6nzphetamine). Urinar I excretion is the primary route of removal from the body. Tr:- l these data, one wculd cenclude that normal theraputic _deses : ! Didre>.I' would result in readily detectable levels of amphetani..e I and methanphetanine (>300 ng/ml) in the urine during a rout t-- drug-of-abune screen. Such inf ernation is valuable in the interpretation of dru-cf abuse testing results. I appreciate you sharing 4: hit unpublished research informatien with us. Sincerely yours, I A d k [hD hchpL.Laseter,ph.D. erstery Director JLL/b1 l-i i i
, . :.. .. : . t ; -
l
F 1ston Lighting & Power 'ompany tiiICE M EMOR WDUM O 70 Sito E=ployees Secte cer 8, 196; Acm John W. Odem
. Sudan Prescriptien Diet / Appetite control Drugs 80075 TEXAS PROJECT ELECTRIC GENERATING STATION The Human Resourcer Department appreciates the cooperation received from employees during the recent investigation of prescription diet medications.
data providedThebyinformationsome gathered during the investigation and manufacturers of prescription diet nedications has prompted this caution about the use of prescription diet / appetite control drugs. It has been determined that due to a molecular breakdown during the manufacturing process and possibly an individual's metabolization, certain diet medications may result in a confirmed positive test for methamphetamines. Anyone currently using a prescription medication for diet / appetite control should contact their physician or pharmacist to determine if a prescribed diet medication will result in a breakdown for methanphetanines. metha phetamines, please If there is a possibility of a positive for consult your physician to discuss alternative methods of weight control. A confirmed positive test result for methanpnatamines may result in denial of site access. JWo/cM/kmg e e
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