In general, analytical reports were returned within
the window of the given time frame, but reports were
not received from all participants. Average response
for the analytical report-return was 77% (SD_: 10).
With the initial 4 PT surveys, report-return response
was close to 95%, but it subsequently decreased and
stabilized at around 70% with some degree of fluc-
tuation (Fig. 2). Since anonymity of the participants
and of their results is strictly maintained, it was not
possible to determine whether the remaining reports
were or were not received from the same participants
every time, or from different participants. Analytical
responses were dependent on the nature and condi-
tions of the specimens and types of analytes—for
example, ethanol in urine was correctly quantitated
by the majority of participants, whereas amphet-
amine and methamphetamine levels in blood were
reported by only a few of the participants. Some
incidences of false positives of concern were noted: They
were primarily associated with drugs of abuse. In rela-
tion to the qualitative analysis, more participants quan-
titatively analyzed those analytes whose analysis is
routinely carried out in toxicology setups—for ex-
ample, ethanol, cocaine, morphine, and THC-COOH.

DISCUSSION

PT programs play a critical part in the QA/QC
component of laboratories (Sohn, 1977; Walberg,
1977; Field, 1981; Suro and Thomas, 1997), and the
CAMI PT program is a timely, suitable program for
the field of postmortem toxicology. The suitability of
this program is clearly evident by its acceptance as
one of the recommended programs by the American
Board of Forensic Toxicology (ABFT) Laboratory
Accreditation Program, wherein successful participa-
tion in a PT program is required for the laboratories
to be accredited by the Board (ABFT, 1996). Such
inclusion of the PT program is based on the report of
the joint Forensic Laboratory Guidelines Committee
of the Society of Forensic Toxicologists, Inc., and the
American Academy of Forensic Sciences, Inc., and
on the additional recommendations of the Guide-
lines and ABFT’s Accreditation committees. The
national nature of the CAMI program is further
supported by the fact that its participants are from
different parts of the country, having a broad na-
tional geographic coverage and representing a wide
spectrum of the nation’s laboratory system.

10

The CAMI’s PT program is currently the only
program that addresses the postmortem laboratory
practice and entails the analysis of “true” postmortem
samples. It routinely provides materials of postmor-
tem nature as a challenge—for example, tissue
homogenates are not simple matrices and do require
a specific and appropriate analytical approach. Be-
cause postmortem toxicology services need such types
of challenges as a means of measuring their perfor-
mance, it is essential that such a program continue to
provide these challenges, to which the postmortem
forensic industry has access.

Findings from the PT surveys further supported
the fact that qualitative and quantitative analytical
responses are dependent on the nature and condi-
tions of specimens and the types of analytes. Natu-
rally, they are also dependent upon the common
usage of the drugs and related medicolegal implica-
tions. Quantitative values were in remarkably good
agreement with the respective target concentrations.
In the majority of the cases, the values were within
20% of the weighed-in amounts of the analytes and/
or within 2 SD, of the means of the reported values,
excluding any evident outliers, such as values with
decimal errors. On a few occasions, the presence of
some analytes not added in a particular sample was
reported. Those analytes could be construed as false
positives and be of concern, particularly if they are
controlled substances; however, finding those chemi-
cal substances might be genuine, as they might be
originally present in the matrix used for the prepara-
tion of a PT challenge. Although blood and urine
used for the sample preparation are initially screened
for the presence of commonly used drugs, the screen-
ing methods may not rule out the presence of those
drugs if they are present in amounts below the detect-
able limits of the assays. Other drugs, which cannot
be screened by the employed methods, may also be
present in the blood and urine, and veterinary drugs
might be present in the animal tissue homogenate
samples. In addition, macromolecules of animal ori-
gin in the tissue homogenates might interfere with
antibody-based screening methods, thereby leading
to false positives. Therefore, laboratories may occa-
sionally, and even correctly, find analytes other than
those added during the preparation of the PT samples.
Of course, such findings should be correctly sup-
ported by the analytical results obtained following
the participating laboratories’ standard operating


THE First SEVEN YEARS (1991-1998) OF THE FAA’s PostMORTEM
ForRENSIC ToxICOLOGY PROFICIENCY-TESTING PROGRAM

INTRODUCTION

During fatal aircraft accident investigations, post-
mortem biosamples collected from the victims at
autopsy are submitted to the Federal Aviation
Administration’s (FAA’s) Civil Aeromedical Insti-
tute (CAMI) for forensic toxicological evaluation
(Public Law, 1988). In forensic toxicology, acquiring
accurate analytical data is the main objective to seek
the chemical basis for the cause of accident (or
death). Strict adherence to quality assurance/quality
control (QA/QC) procedures is essential to achieve
that objective, and external proficiency-testing (PT)
programs are independent, effective ways to authen-
ticate such internal QA/QC procedures of laborato-
ries (Sohn, 1977; Walberg, 1977; Field, 1981; Schaller
etal., 1991). These PT programs are instrumental for
the laboratories to scientifically achieve their primary
objective of acquiring accurate analytical data on
biological evidence. Participation in such programs
allows laboratories to withstand the professional and
judicial scrutiny of analytical results, and thus, be
able to validate their performance. Although there
have been several external proficiency programs for
drug analysis, none of them was specifically designed
for postmortem forensic toxicology. They mainly
focus on clinical toxicology and forensic testing of
drugs of abuse, including alcohol (Boone etal., 1977;
Flores and Moulden, 1977; Sohn, 1977; Walberg,
1977; NIDA 1988; Osselton et al., 1990). These
programs have been utilizing preserved plasma, se-
rum, urine, and/or occasionally, blood samples: They
do not include tissues and/or putrid samples. The
majority of those programs encompass only specific
groups of certain drugs, or volatiles, in only one type
of biological fluid. Therefore, there was a critical
scientific need for a program that could realistically
address analytical issues and accommodate challenges
encountered in postmortem forensic toxicology situ-
ations (Bost, 1990).

The principal function of a forensic toxicology
laboratory is to analyze any available postmortem
tissue samples or bodily fluids, but many such samples
are in an advanced stage of decomposition.

Decomposed biosamples are common not only with
aviation accident cases but also with medical examiner/
coroner cases. Being primarily responsible for the toxi-
cological analysis of postmortem aviation specimens
(Public Law, 1988), CAMI initiated the needed PT
program in 1991. This program is tailored for drug
analysis in different types of preserved and decomposed
biological samples. This initiative was taken with a view
that the PT program will permit CAMI and the partici-
pating laboratories to evaluate proficiency of postmor-
tem forensic toxicology testing and, thereby, assess
methods of analysis applicable to the discipline. Ini-
tially, laboratories that had prior professional contacts
with CAMI were invited to participate in the program.
Later, this program was announced in two toxicology
newsletters (Chaturvedi, 1991a, b) and in the 1991
Meeting of the American Academy of Forensic Sciences
in Anaheim, CA. Consequently, additional laboratories
joined the program, making it fully functional in July
1991. Since then, about 30 laboratories, including
CAMI’s Toxicology and Accident Research Labora-
tory, have been participating in this program. In this
report, details of the FAA’s Civil Aeromedical Institute
(CAMD) postmortem forensic toxicology PT program
and findings of the PT surveys during its first seven years
are summarized.

GENERAL DESCRIPTION

In the program, biological samples containing (or
not containing) drug(s) are submitted to the partici-
pating laboratories for analysis on a quarterly basis,
ie, in January, April, July, and October. These
samples may also contain possible primary
metabolite(s) of the drug(s) and/or other chemical
entities—for example, caffeine, nicotine, B-
phenylethylamine, tryptamine, etc.— frequently en-
countered in postmortem forensic samples to give an
appearance of a “true” specimen. However, there are
not more than 5 analytes in any given survey speci-
men. Analytes included in the program are volatiles,
controlled substances—such as amphetamines,


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samples by keeping them at ambient temperature for
selected periods. To some specimens, putrefactive
agents are added. Stock solutions of analytes in desired
concentrations are prepared in appropriate solvents.

Sample Distribution

Blood (plasma or serum) samples in 2 (or 3) x ~7.5-
mL portionsare shipped in 10-mL glass tubes. Tubes are
placed into Styrofoam holders (2 or 3 tubes/holder).
Urine or homogenate samples in ¥70-mL quantities are
sent in 100-mL plastic bottles. Each sample is shipped
with frozen gel bags in an insulated box to every pattici-
pant by an air courier service for next-day delivery;
samples are hand-delivered to CAMI’s Laboratory on
the day following shipment.

Result Summaries

After receiving the analytical report sheets from
the participants, the results are compiled, tabulated,
and statistically analyzed; summaries are prepared
and distributed to all participants. This process takes
approximately 4 weeks. Each summary provides the
participants with the information related to the re-
sults ofa particular PT survey. The summary includes

analyte weighed-in amounts; qualitative and quanti-
tative analytical respondent percentages; individual
results of all participants, along with types of analyti-
cal methods used; and range of the reported quanti-
tative results for analytes of interest, with mean and
standard deviation (SD, ) values. If sufficient data are
available, related histograms and Shewhart charts are
also included. Analytical values that are clearly deter-
mined to be outliers are excluded from the statistical
analysis. Results in the summary are without identi-
fication of their specific laboratories of origin. If
necessary, participants’ remarks, a brief description
of the sample preparation method, and relevant com-
ments, are incorporated in the summary.

RESULTS

The PT program participants represent a broad
cross-section of the country, and consist of laborato-
ries functioning under various county, city, state, and
federal governmental agencies. Non-governmental
commercial organizations and educational institu-
tions are also included in the participating laborato-
ties (Fig. 1). Two federal, 22 other governmental

University
13%

State
Toxicology
16%

6%

Police
16%

Commerical
138%

Coroner
9%

Medical
Examiner

21%

Health
Department
6%

FIG. 1—Types of laboratories participating in CAMI’s PT program.


cannabinoids, cocaine, opiates, and phencyclidine—
and prevalently used prescription/nonprescription
medications. Types of biological samples intended
for inclusion in this program are serum, plasma,
whole blood, urine, and tissues, though the former 2
types are not generally preferred. As is the situation
with the majority of the aviation accident fatalities
and medical examiner/coroner cases, serum/plasma
cannot be easily obtained from decomposed bodies.
To represent PT samples as “true” blind postmortem
specimens, case histories are not provided with their
submissions. A particular PT sample consists of only
a single type of biological specimen, and the turn-
around for reporting the analytical results is 4-5
weeks, It is anticipated that participants take routine
necessary precautions during the handling of biologi-
cal specimens and properly discard the samples after
the completion of the analysis. Types of specimens
and of analytes and their concentrations fora particu-
lar PT sample are selected on the basis of (i) current
analytical and toxicological issues, (ii) problematic
topics and analytes mentioned in the literature, (iii)
inputs from the participants and other forensic toxi-
cologists, (iv) CAMI forensic toxicology analytical
and aircraft accident research findings, (v) drugs
prevalent in the general population and their rel-
evance to aviation, and (vi) general trends of the use
of various categories/types of drugs.

Participating laboratories have an option to con-
duct qualitative or quantitative analysis, using their
standard analytical procedures for the presence of
only those analytes routinely identified in a given
specimen type in their setups or to defer the analysis
of a particular sample because of any other reasons.
However, it was anticipated that the analytical report
sheets would be received from the participants, re-
gardless of the inclusion or exclusion of analysis
results, Receiving responses from them assures that
they received, and responded to, a particular PT
sample. The anonymity of participating laboratories
is strictly maintained.

In the shipping carton along with the specimen,
there are an instruction sheet, a blank analytical
report sheet, an inner confidential-report envelope,
an outer mailing return-envelope, and an attention
sheet with a business reply label. The participants are
requested to send the empty shipping box back, using
the enclosed business reply label. Analytical report
enclosures have no identification code numbers re-
lated to the participants. After completing the analysis,

the participants record the analytical findings on the
analytical report sheet, place the sheet in the inner
envelope, and seal it. They then return the inner
envelope in the pre-addressed, postage-paid outer
envelope. The outer envelopes are opened by a differ-
ent, assigned person than the inner envelopes. Fur-
thermore, the inner, as well as the outer, envelopes are
discarded and, thus, are not retained in the records.
Such a methodical process ensures minimizing the
establishment of a possible link between the analyti-
cal report (data) and its originating laboratory.

Participation in this program is on a voluntary
basis and is presently free of charge. Participation can
be discontinued at any time if a participant chooses
to do so; however, at least a 4-week notice is desired.
Commitment to the activities under this program
does not imply endorsement of any functions or
capabilities of either the participating laboratories or
CAMPI’s Laboratory.

MATERIALS AND METHODS

Materials

Human urine is either obtained from commercial
sources or collected from volunteers; human whole
blood, plasma, and serum are supplied by a local
blood bank. Commercial human urine is drug-free. It
is determined and certified by the supplier to be
“drug-free,” based on immunoassay screening tech-
niques. Other matrices are screened in CAMI’s Labo-
ratory to rule out the presence of commonly used
drugs, and those determined to contain drugs are not
used for the preparation of PT challenges. Tissues are
purchased from local slaughterhouses. Tissue
homogenates are not subjected to drug screening.
Drugs, metabolites, and chemicals are obtained from
Sigma Chemical Co., St. Louis, MO; Alltech-Applied
Sciences, State College, PA; and/or any other suitable
commercial sources.

Sample Preparation

Urine, plasma, serum, and blood need no initial
preparation prior to adding measured amounts of
analytes. However, tissues are weighed, cut into small
pieces, homogenized in deionized water in a large
Waring blender, and then analytes are added, mixed,
and allowed to equilibrate for at least 24 hours. The
final tissue homogenate mixture generally contains 1
g of tissue per 3 mL of homogenate (1:3 w/v).
Sometimes, putrefaction processes are initiated in the


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DOT/FAA/AM-99/11 The First Seven Years (1991-1998)

Of the FAA’s Postmortem Forensic
Office of Aviation Medicine

Washington, D.C. 20591 Toxicology Proficiency-Testing Program

Arvind K. Chaturvedi

Civil Aeromedical Institute
Federal Aviation Administration

Oklahoma City, Oklahoma 73125

April 1999

Final Report

This document is available to the public
through the National Technical Information
Service, Springfield, Virginia 22161.

Q

U.S. Department
of Transportation

Federal Aviation
Administration


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entity, 5 commercial, and 3 university laboratories
are now part of the PT program. Out of these, 16%
do only antemortem toxicology; the remaining labo-
ratories also perform postmortem toxicology. At the
program’s inception, there were only 21 participants,
but this number subsequently increased to 34, and it
is now 32 (Fig. 2). Two laboratories discontinued
their participation because of an increase in workload
and/or change in mission. No attempts were made to
enlist more laboratories in the program. During the
1991-1998 covered period, the average of the num-
ber of participants was 33.

As is summarized in Table 1, various types of
specimens with or without exogenous analytes were

40

submitted to the participating laboratories. Analytes
included in the surveys were abused drugs, prescrip-
tion and non-prescription drugs, and common sub-
stances (e.g., caffeine, nicotine, and ethanol), covering
a wide range of pharmacological agents, from mood
altering to those used to cure diseases and to lose
weight. Other substances, like putrefactive bases and
methanol, were also included. Out of the total of 28
samples, there were 1 plasma, 8 whole blood, 13
urine, 1 kidney, and 5 liver specimens submitted for
the surveys. Twenty-one percent of the samples were
without added analytes and/or contained only non-
reportable analytes, such as low amounts of caffeine
or nicotine.

Participants vs Analytical Reports

154

0 to

16 19 22 2 28

Sample Numbers
FIG. 2—Numbers of participants and of analytical reports received from the partici-
pating laboratories during the first 7 years of the PT program.




procedures, including the possible re-analysis of the
sample. The genuine presence of those analytes can
also be deduced by the evaluation of the analytical
results of other participants tabulated in the analyti-
cal summary reports. Obviously, if several partici-
pants found the particular analyte(s), then it could be
concluded as “true positive(s),” otherwise it may be
viewed as an isolated incidence.

This program permits the FAA and the participat-
ing laboratories to evaluate proficiency for forensic
toxicology testing and assess methods of analysis
applicable to the field. This PT program does not
fulfill any regulatory and/or certification require-
ments, but it allows for (i) the professional develop-
ment and maintenance of technical currency on a
voluntary, interlaboratory, and self-evaluative basis,
and (ii) the quantifiable assessment of methods in the
presence and absence of interfering postmortem sub-
stances. Indeed, it serves as an independent tool for
the FAA to monitor its internal forensic toxicology
proficiency in relation to the outside forensic toxicol-
ogy laboratories, Although the laboratories are pres-
ently not charged any fee for their participation in the
PT program, all participants, including the FAA,
mutually and effectively share scientific and techni-
cal information that reflects the proficiency in
bioanalytical practices.

In view of its origin, nature, field, and scope, this
program can be referred to as the FAA’s Postmortem
Forensic Toxicology Proficiency-Testing Program.
Administered by the FAA’s Civil Aeromedical Insti-
tute (CAMI), this program has two components:
goods and service. The preparation of samples and
their distribution, including necessary instructions,
come under the goods category, while the collection
of analytical report sheets, compilation, tabulation,
and analyzation of results, and preparation and dis-
tribution of result summaries fall under the service
category. Having a potential for being registered
under both of the categories, this program could be
registered as “FAA’s CAMI PFT-PT Program” with
the trademark (TM) to cover the goods activity, as well
as with the service mark (®) to cover the service
activity. The registration would be achieved follow-
ing the agency’s proper procedures in coordination
with the FAA’s Office of Research and Technology
Applications. After the registration, the program could
be turned over to a qualified licensee in the private
sector, with some degree of the FAA’s oversight to

guarantee and maintain the program’s quality; or, it
may continue to be administered by CAMI. Whether
the program is in the private or public sector, it will
remain an effective, flexible, practical, and applicable
instrument for measuring the performance of foren-
sic toxicology operations and enhancing efficiency. A
QA/QC program must be effectively implemented
and maintained in order to withstand professional
and judicial scrutiny of analytical results. To achieve
that goal, PT programs are crucial.

REFERENCES

ABFT (1996). American Board of Forensic Toxicology
laboratory accreditation program— program out-
line and appeals process. Colorado Springs, CO:
American Board of Forensic Toxicology, Inc.

Boone DJ, Guerrant GO, Knouse RW (1977). Profi-
ciency testing in clinical toxicology: program spon-
sored by the Center for Disease Control. Journal
of Analytical Toxicology 1: 147-50.

Bost RO (1990). Impending laboratory certification
(CLIA) regulations. News & Views—A forum for
forensic toxicologists. Colorado Springs, CO:
Toxicology Section of the American Academy of
Forensic Sciences, Number 26, October 1990,
Page 3.

Chaturvedi AK (199 1a). Analytical/forensic toxicology
proficiency testing program. News & Views—A
forum for forensic toxicologists. Colorado Springs,
CO: Toxicology Section of the American Acad-
emy of Forensic Sciences, Number 28, Spring
1991, Page 11.

Chaturvedi AK (1991b). Analytical/forensic toxicol-
ogy proficiency testing program. The Toxicology
News Letter. Pittsburgh, PA: Duquesne Univer-
sity School of Pharmacy, Volume 17, Number 4,
February 1991.

Field PH (1981). Quality assurance and proficiency
testing. In: Cravey RH, Baselt RC, editors. Intro-
duction to forensic toxicology. Davis, CA: Bio-
medical Publications, pp. 182-98.

Flores AL, Moulden, JV (1977). The National High-
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hol proficiency test program. Journal of Analyti-
cal Toxicology 1: 139-41.


Technical Report Documentation Page

1, Report No. 2. Govemment Accession No. 3. Recipient's Catalog No.
DOT/FAA/AM-99/11

4, Title and Subtitle &. Report Date

The First Seven Years (1991-1998) of the FAA’s Postmortem Forensic April 1999

Toxicology Proficiency-Testing Program 6, Performing Organization Code

7. Authors) 8. Performing Organization Report No.
Chaturvedi, A.K.

9. Performing Organization Name and Address 10. Work Unit No. RAIS)

FAA Civil Aeromedical Institute

P.O. Box 25082 1. Contract or Grant No.
Oklahoma City, OK 73125

12. Sponsoring Agency name and Address 13. Type of Report and Period Covered
Office of Aviation Medicine

Federal Aviation Administration

800 Independence Ave., S.W. 14. Sponsoring Agency Code
Washington, D.C. 20591

15. Supplemental Notes

This work was accomplished under approved tasks AM-B-91-TOX-65, AM-A-92-TOX-71, AM-A-93-TOX-71, AM-B-
94-TOX-71, AM-B-95-TOX-201, AM-B-96-TOX-202, AM-B-97-TOX-202, and AM-B-98-TOX-202.

16. Abstract

Postmortem biosamples from the victims of aviation accidents are submitted to the Civil Aeromedical Institute (CAMI)
for forensic toxicology, wherein acquiring accurate and authentic analytical data is the primary objective. Adherence to
quality assurance/quality control (QA/QC) procedures is essential to achieve that objective, and_proficiency-testing (PT)
is an integral part of QA/QC of laboratories. However, there was previously no suitable PT program that could address
the complexity of forensic toxicology. Existing PT programs do not include decomposed samples and solid tissues, and
the majority of aviation (and to some extent, even medical examiner and coroner) case samples are putrid and of
multiple types. Therefore, CAMI in July 1991 started such a needed PT program. This program is used to (i)
professionally develop and maintain technical currency on a voluntary, interlaboratory, and self-evaluation basis and (ii)
quantifiably assess methods in the absence and presence of interfering substances. There ate currently about 30
laboratories in the program, including CAMI’s Toxicology and Accident Research Laboratory. Functioning under
various governmental/non-governmental agencies and academic institutions, these laboratories represent a broad cross-
section of the country. PT samples are distributed quarterly, and result summaries are sent to the participants, while
maintaining their anonymity. Since the inception of the program, 28 PT samples encompassing whole blood, plasma,
urine, kidney, or liver, with (or without) drugs and common chemicals (nicotine, caffeine, &-phenylethylamine, etc.)
have been evaluated by the participants. Analytical findings were generally consistent with the anticipated values, but
they were dependent on the nature and conditions of the specimens and types of the added analytes. Some incidences of
false positives of concern were noted, as well. This is a nationally recognized PT program: It is one of the few programs
recommended by the American Board of Forensic Toxicology in which laboratories may participate for their
accreditation by the Board. Although participation in this program is currently free of charge, it has a potential for
commercialization through the private sector. Whether the program is in the private or public sector, it will continue to
play a critical part in supporting the QA/QC component of forensic toxicology, thereby enhancing operational
performance.

17. Key Words 18. Distribution Statement

Quality Assurance/Quality Control, Proficiency Testing, Document is available to the public through the

Postmortem Forensic Toxicology, Aircraft Accident National Technical Information Service

Investigation Springfield, Virginia 22161

19. Security Classif. (of this report) 20. Security Classif. (Of this page) 21. No. of Pages 22. Price
Unclassified Unclassified 15

Form DOTF 1700.7 (8-72) Reproduction of completed page authorized



NOTICE

This document is disseminated under the sponsorship of
the U.S. Department of Transportation in the interest of
information exchange. The United States Government
assumes no liability for the contents or use thereof.


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