4
Current status of accreditation for drug testing in hair Society of Hair Testing Gail Cooper a, * , Manfred Moeller b , Robert Kronstrand c a Forensic Medicine and Science, University of Glasgow, Scotland, United Kingdom b Saarland University Hospital, Homburg/SAAR, Germany c Department of Forensic Genetics and Forensic Toxicology, Linko ¨ping, Sweden Received 9 June 2007; accepted 3 July 2007 Available online 19 November 2007 Abstract At the annual meeting of the Society of Hair Testing in Vadstena, Sweden in 2006, a committee was appointed to address the issue of guidelines for hair testing and to assess the current status of accreditation amongst laboratories offering drug testing in hair. A short questionnaire was circulated amongst the membership and interested parties. Fifty-two responses were received from hair testing laboratories providing details on the amount and type of hair tests they offered and the status of accreditation within their facilities. Although the vast majority of laboratories follow current guidelines (83%), only nine laboratories were accredited to ISO/IEC 17025 for hair testing. A significant number of laboratories reporting that they were in the process of developing quality systems with a view to accrediting their methods within 2–3 years. This study provides an insight into the status of accreditation in hair testing laboratories and supports the need for guidelines to encourage best practice. # 2007 Elsevier Ireland Ltd. All rights reserved. Keywords: Hair testing; Laboratory accreditation; ISO/IEC 17025 1. Introduction Drug testing laboratories worldwide recognise the impor- tance of implementing quality systems to ensure the effective control of the testing services they provide. Laboratories are accredited or certified to both national and international (ISO/ IEC 17025) standards with guidelines readily available for urine workplace drug testing [1,2] and doping control in sport [3]. Questions relating to the accuracy or reliability of test results are frequently asked during cross-examination in court or by customers assessing the suitability of a laboratory service. The international quality standard ISO/IEC 17025, documents the criteria for testing laboratories wishing to demonstrate their technical competence in generating valid test results [4]. National accreditation bodies are responsible for evaluating analytical testing laboratories for compliance to the ISO/IEC 17025 standard including assessment of laboratory documenta- tion, proficiency testing, measurement traceability, personnel competence, and measurement uncertainty calculations. Accrediting methods for the analysis of drugs in hair represents a significant challenge to the analyst with respect to the lack of certified reference material, limited guidelines on best practice and reservations on the efficacy of hair testing. The Society of Hair Testing (www.soht.org) recognises the importance of addressing these issues and has published recommendations for good practice in hair testing [5] and conducts yearly proficiency tests [6–11]. In order to gain an insight into current practices within laboratories offering hair testing, the Society of Hair Testing (SoHT) circulated a short questionnaire on the subject of laboratory accreditation to its members and individual laboratories with an interest in hair testing. To ensure a consistent approach to the analysis of drugs in hair and the accreditation process, the SoHT aims to work with its membership to reach a consensus on best practice in hair testing and publish guidelines to be used by both laboratories and national accreditation bodies. www.elsevier.com/locate/forsciint Available online at www.sciencedirect.com Forensic Science International 176 (2008) 9–12 * Corresponding author. Tel.: +44 141 330 4574; fax: +44 141 330 4602. E-mail address: [email protected] (G. Cooper). 0379-0738/$ – see front matter # 2007 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.forsciint.2007.07.019

Current status of accreditation for drug testing in hair

Embed Size (px)

Citation preview

www.elsevier.com/locate/forsciint

Available online at www.sciencedirect.com

Forensic Science International 176 (2008) 9–12

Current status of accreditation for drug testing in hair

Society of Hair TestingGail Cooper a,*, Manfred Moeller b, Robert Kronstrand c

a Forensic Medicine and Science, University of Glasgow, Scotland, United Kingdomb Saarland University Hospital, Homburg/SAAR, Germany

c Department of Forensic Genetics and Forensic Toxicology, Linkoping, Sweden

Received 9 June 2007; accepted 3 July 2007

Available online 19 November 2007

Abstract

At the annual meeting of the Society of Hair Testing in Vadstena, Sweden in 2006, a committee was appointed to address the issue of guidelines

for hair testing and to assess the current status of accreditation amongst laboratories offering drug testing in hair.

A short questionnaire was circulated amongst the membership and interested parties. Fifty-two responses were received from hair testing

laboratories providing details on the amount and type of hair tests they offered and the status of accreditation within their facilities.

Although the vast majority of laboratories follow current guidelines (83%), only nine laboratories were accredited to ISO/IEC 17025 for hair

testing. A significant number of laboratories reporting that they were in the process of developing quality systems with a view to accrediting their

methods within 2–3 years. This study provides an insight into the status of accreditation in hair testing laboratories and supports the need for

guidelines to encourage best practice.

# 2007 Elsevier Ireland Ltd. All rights reserved.

Keywords: Hair testing; Laboratory accreditation; ISO/IEC 17025

1. Introduction

Drug testing laboratories worldwide recognise the impor-

tance of implementing quality systems to ensure the effective

control of the testing services they provide. Laboratories are

accredited or certified to both national and international (ISO/

IEC 17025) standards with guidelines readily available for

urine workplace drug testing [1,2] and doping control in sport

[3].

Questions relating to the accuracy or reliability of test results

are frequently asked during cross-examination in court or by

customers assessing the suitability of a laboratory service. The

international quality standard ISO/IEC 17025, documents the

criteria for testing laboratories wishing to demonstrate their

technical competence in generating valid test results [4].

National accreditation bodies are responsible for evaluating

analytical testing laboratories for compliance to the ISO/IEC

* Corresponding author. Tel.: +44 141 330 4574; fax: +44 141 330 4602.

E-mail address: [email protected] (G. Cooper).

0379-0738/$ – see front matter # 2007 Elsevier Ireland Ltd. All rights reserved.

doi:10.1016/j.forsciint.2007.07.019

17025 standard including assessment of laboratory documenta-

tion, proficiency testing, measurement traceability, personnel

competence, and measurement uncertainty calculations.

Accrediting methods for the analysis of drugs in hair

represents a significant challenge to the analyst with respect to

the lack of certified reference material, limited guidelines on

best practice and reservations on the efficacy of hair testing.

The Society of Hair Testing (www.soht.org) recognises the

importance of addressing these issues and has published

recommendations for good practice in hair testing [5] and

conducts yearly proficiency tests [6–11].

In order to gain an insight into current practices within

laboratories offering hair testing, the Society of Hair Testing

(SoHT) circulated a short questionnaire on the subject of

laboratory accreditation to its members and individual

laboratories with an interest in hair testing.

To ensure a consistent approach to the analysis of drugs in

hair and the accreditation process, the SoHT aims to work with

its membership to reach a consensus on best practice in hair

testing and publish guidelines to be used by both laboratories

and national accreditation bodies.

Fig. 1. Number of hair samples tested annually.

G. Cooper et al. / Forensic Science International 176 (2008) 9–1210

2. Materials and methods

The questionnaire was designed in two parts: to gain an insight into the scale

of hair testing offered by laboratories and to provide more detailed information

on the prevalence of quality assurance procedures within the field of drug testing

in hair.

In the interests of confidentiality, the names of the laboratories taking part

were not disclosed. Each response was given a unique identifier and information

from the questionnaires was collated and stored on Microsoft Excel spread-

sheets ensuring anonymity. General background questions asked for details on

the country where the laboratory is based, the number of hair samples tested

each year, the types of testing offered and what proportion all of the testing

carried out within the laboratory involved hair testing.

Specific questions were asked in relation to quality assurance; does the

laboratory follow guidelines on hair testing, the extent of their laboratory

accreditation and finally details of any plans to implement accreditation or

extend the current scope.

3. Results and discussion

A total of 59 completed questionnaires were received, 7

from laboratories who at present do not offer hair testing

services. Five of the seven laboratories were accredited to ISO/

IEC 17025 and although they were excluded from this initial

study there input will be sought for future studies.

The remaining 52 laboratories offering hair testing were

selected for analysis. The country of origin of the laboratories

that responded to the questionnaire is summarised in Table 1.

The vast majority of responses were received from European

countries with only five laboratories (10%) responding from

North America.

A high proportion of the responses were received from

laboratories based in Italy. This is most likely a result of the

number of laboratories participating in the HAIRVEQ external

quality control program, which is actively involved with

improving the standard of hair testing in Italy [7]. In 2002, the

Istituto Superiore di Sanita of Rome (ISS), in cooperation with

the Institut Municipal d’Investigacio Medica of Barcelona

initiated HAIRVEQ to evaluate the performance of laboratories

offering hair testing within the Italian Health System and

Institutes of Forensic Medicine. In the latest round in 2006 [12],

Table 1

Questionnaires returned by Country

Country N

Austria 1

Canada 1

Finland 1

Luxembourg 1

Sweden 1

Spain 1

France 2

Greece 2

Poland 2

Belgium 3

Switzerland 3

USA 4

UK 6

Germany 9

Italy 15

a total of 32 laboratories participated and although there were a

number of false positive and false negative results reported,

overall there has been a marked improvement in the quality of

hair testing since the introduction of the HAIRVEQ program.

Laboratories were asked to estimate, on average, the number

of hair samples they tested each year and what proportion of all

the samples they tested were hair samples. The results are

summarised in Fig. 1 and Table 2, respectively. The vast

majority of laboratories tested less than 500 samples each year

with over half of all laboratories testing as little as 100 or less

hair samples per year. Ten (19%) laboratories reported testing

greater than 1000 samples annually with eight of the

laboratories based in Europe.

Hair, as an alternative matrix, has historically been offered

as an additional specialist test by laboratories already providing

routine tests for medico-legal purposes and this is certainly the

profile of the laboratories in this study. Forty-one (80%)

laboratories reported that the number of hair samples analysed

each year represented 25% or less of all the samples they tested.

Four laboratories provide hair testing exclusively. The effort

required to achieve accreditation can put considerable strain on

resources [13] and for laboratories testing less than 100 hair

samples per year, this is understandably not an area of priority.

The advantage of hair analysis is its ability to provide

historical detail of an individuals’ exposure to drugs following

chronic use [14,15] or a single exposure [16,17]. To better

understand the variety of hair testing offered, laboratories were

asked to indicate the types of hair testing they carried out from

the following categories: criminal investigations, workplace

drug testing, monitoring of drug use, research and driving

licence renewal. The findings are summarised in Table 3.

Eighty-seven percentages of the laboratories offered testing in

two or more categories most commonly criminal investigations

(drug-related deaths, child protection) and monitoring drug use

with 36 (69%) research active laboratories. Driving licence

Table 2

Proportion of samples tested within laboratories is hair samples

% of hair testing N

0–25 41

>25–50 3

>50 5

100 2

Table 3

Categories of hair testing offered by laboratories

Category N

Criminal investigation 39

Research 36

Monitoring drug use 32

Workplace drug testing 24

Driving licence renewal 21

Table 4

Accreditation held by laboratories

Standard N

ISO/IEC 17025 16

ISO9001 7

WADA 1

National regulation 7

Not accredited 27

G. Cooper et al. / Forensic Science International 176 (2008) 9–12 11

renewal testing was offered by 21 (40%) laboratories

throughout Italy, Switzerland, Germany and France where

legislation exists to sanction the use of hair for this application

[18–20].

Hair testing laboratories recognise the importance of

guidelines detailing best practice. Forty-three (83%) of the

52 respondents follow guidelines on hair testing from different

organizations including the SoHT, the GtFCh1 and SAMHSA2.

The majority of the laboratories recognised the SoHT who

published a consensus on the examination of drugs in human

hair in 1997 [5]. During the annual meeting in Heraklion, Crete

in 2003, representatives from 15 countries gathered to discuss

some issues involved with the analysis of hair samples for drugs

of abuse. As a result of these discussions, the SoHT published

recommendations for hair testing in forensic cases [21].

It is not the purpose of this study to carry out a detailed

comparison of the different guidelines for hair testing but it is

important to note the main differences. The GtFCh and SoHT

guidelines are aimed at laboratories offering general forensic

hair testing, while the draft guidelines from SAMHSA are for

laboratories in the United States offering federal workplace

testing. Six laboratories in this study reported using both SoHT

and GtFCh guidelines.

When asked whether their laboratory was accredited, 25

(48%) laboratories stated they had accreditation with 16 (31%)

accredited to ISO/IEC 17025. Laboratories were asked to state

all accreditation types held by the laboratory and these are

summarised in Table 4. The ISO/IEC 17025 standard [4] is

specifically for ‘‘testing and calibration laboratories’’ while

ISO9001 [22] is a general standard, dealing with the

fundamentals of implementing a quality management system.

It would appear that there is some confusion surrounding the

definition of laboratory accreditation and this was also a finding

1 The Society of Toxicological and Forensic Chemistry, Germany

(www.gtfch.org).2 Substance Abuse and Mental Health Services Administration, USA

(www.samhsa.gov).

highlighted in a recent paper by Malkoc and Neuteboom [23].

The authors collated data from questionnaires sent to members

of the European Network of Forensic Science Institutes

(ENFSI) regarding accreditation status. Membership to ENFSI

is restricted to government or police laboratories. Nine

laboratories (17%) were accredited to ISO/IEC 17025 with

eight laboratories citing an ISO9000 or regional regulation. The

authors of this study concluded that ‘‘quality assurance and

accreditation brings about confusion among some forensic

science laboratories’’ and suggest some form of an initiative at

the European level to educate laboratories on the requirements

for laboratory accreditation.

Nine hair testing laboratories (17%) were accredited to ISO/

IEC 17025 for general testing and had extended their scope to

include hair testing. Significantly, 33 laboratories (63%) stated

they were developing a quality management system for

accreditation with 13 planning to implement within 2–3 years.

Two laboratories had already arranged their first audit for 2007.

The future of accreditation and ultimately the quality and

standard of hair testing is secured if this can be measured by the

commitment of the laboratories currently offering hair testing

who responded to this questionnaire. The importance of agreed

guidelines for best practice in hair testing cannot be over stated

and was echoed by the attendees of the recent Society of Hair

Testing Annual Meeting, held in Cardiff 14–15th May 2007.

4. Conclusion and recommendations

With over 90% of the laboratories who responded to the

questionnaire, based in Europe, we cannot assume that the

findings in this study reflect hair testing worldwide but they do

provide us with a good profile of a typical European hair testing

laboratory.

It is encouraging that the vast majority of laboratories (83%)

recognise hair testing guidelines and have plans to implement

accreditation. Although only nine laboratories are currently

accredited to ISO/IEC 17025 for hair testing, this is not

surprising when we consider the findings of this study. A typical

laboratory tests less than 500 hair samples per year and this

constitutes a small fraction of the general toxicology tests

offered by the laboratory.

Implementation of accreditation requires significant finan-

cial commitment for laboratories but the importance of

improving the quality is overwhelmingly acknowledged by

laboratories in this study, with 33 committed to achieving

accreditation within 2–3 years. This is further supported by the

Society of Hair Testing Proficiency Testing Program [6,24]

where both qualitative and quantitative results are improving

year on year.

With a significant proportion of hair testing laboratories

active in research and committed to implementing accreditation

the outlook is positive for establishing excellence in the field of

hair testing.

The Society of Hair Testing in association with its member’s

hope to provide laboratories offering hair testing and

accreditation bodies with recommended guidelines for hair

testing. With this aim in mind, the next stage in this process is to

G. Cooper et al. / Forensic Science International 176 (2008) 9–1212

contact the laboratories already accredited to ISO/IEC 17025

and prepare draft guidelines for approval by the membership

and Board of the Society of Hair Testing.

Acknowledgements

This study could not have been conducted without the

support of Society of Hair Testing or its membership. Special

mention must go to all 59 representatives from the laboratories

who took the time to complete and return the questionnaire,

many of whom have already agreed to provide additional

support in preparing the draft guidelines.

References

[1] European Laboratory Guidelines for Legally Defensible Workplace Drug

Testing, Version 1.0, 2002, www.ewdts.org/guidelines (June 2, 2007).

[2] Mandatory Guidelines for Federal Workplace Drug Testing Programs,

SAMHSA September 1, 1994, www.workplace.samhsa.gov/Resource-

Center (June 2, 2007).

[3] World Anti-Doping Code—2007 Code Amendments, June 1, 2007, World

Anti-Doping Agency Code Version 2.0, www.wada-ama.org (June 2,

2007).

[4] ISO/IEC 17025:2005 Incorporating Corrigendum no. 1, Published under

the authority of the Standards Policy and Strategy Committee on June 29,

2005, ISBN 0 580 46330 3.

[5] Society of Hair Testing, Statement of the Society of Hair Testing con-

cerning the examination of drugs in human hair, Forensic Sci. Int. 84

(1997) 3–6.

[6] C. Jurado, H. Sachs, Proficiency test for the analysis of hair for drugs of

abuse, organized by the Society of Hair Testing, Forensic Sci. Int. 133

(2003) 175–178.

[7] H. Sachs, Quality control by the Society of Hair Testing, Forensic Sci. Int.

84 (1997) 145–150.

[8] S. Pichini, M. Ventura, M. Pujadas, R. Ventura, M. Pellegrini, P. Zuccaro,

R. Pacifici, R. de la Torre, HAIRVEQ: an external quality control scheme

for drugs of abuse analysis in hair, Forensic Sci. Int. 145 (2004) 109–115.

[9] M. Deveaux, P. Kintz, J.-P. Goulle, J. Bessard, G. Pepin, D. Gosset, The

hair analysis proficiency testing program of the French Society of Ana-

lytical Toxicology, Forensic Sci. Int. 107 (2000) 389–394.

[10] S. Pichini, M. Ventura, M. Pujadas, R. Ventura, R. Di Giovannandrea, P.

Zuccaro, R. Pacifici, R. De La Torre, C. Jurado, Letter to the editor:

HAIRVEQ 2005: an external quality control exercise for drugs of abuse

analysis in hair in cooperation with Society of Hair Testing, Ann. Toxicol.

Anal. 17 (2005) 307–309.

[11] F. Musshoff, B. Madea, New trends in hair analysis and scientific demands

on validation and technical notes, Forensic Sci. Int. 165 (2007) 204–215.

[12] M. Ventura, S. Pichini, C. Stramesi, R. Ventura, M. Pujadas, R. Di

Giovannandrea, P. Zuccaro, R. Pacifici, R. De la Torre, HAIRVEQ

2006: evolution of laboratories performance after different educational

actions, in: Oral Presentation, Annual Meeting of the Society of Hair

Testing, Cardiff, UK, May 14–15, 2007.

[13] United Nations Recommended Guidelines for Quality Assurance and

Good Laboratory Practices, V.94-28575, UN Publication ST/NAR/25.

[14] P. Kintz, Value of hair analysis in postmortem toxicology, Forensic Sci.

Int. 142 (2004) 127–134.

[15] E.J. Cone, Legal, workplace, and treatment drug testing with alternate

biological matrices on a global scale, Forensic Sci. Int. 121 (2001) 7–15.

[16] M. Cheze, M. Villain, G. Pepin, Determination of bromazepam, clona-

zepam and metabolites after a single intake in urine and hair by LC-MS–

MS: application to forensic cases of drug facilitated crimes, Forensic Sci.

Int. 145 (2004) 123–130.

[17] M. Villain, M. Cheze, A. Tracqui, B. Ludes, P. Kintz, Windows of

detection of zolpidem in urine and hair: application to two drug facilitated

sexual assaults, Forensic Sci. Int. 143 (2004) 157–161.

[18] F. Pragst, M. Balikova, State of the art in hair analysis for detection of drug

and alcohol abuse, Clin. Chim. Acta 370 (2006) 17–49.

[19] M. Montagna, C. Stramesi, C. Vignali, A. Groppi, A. Polettini, Simulta-

neous hair testing for opiates, cocaine, and metabolites by GC–MS: a

survey of appliants for driving licenses with a history of drug use, Forensic

Sci. Int. 107 (2000) 157–167.

[20] Hair analysis for driving licence, Consensus of the French Society of

Analytical Toxicology (SFTA), Ann. Toxicol. Anal. 16 (2004) 229–230.

[21] Society of Hair Testing, Recommendations for hair testing in forensic

cases, Forensic Sci. Int. 145 (2004) 83–84.

[22] ISO 9000:2005 Quality management systems: fundamentals and vocabu-

lary, www.iso.org. (June 2, 2007).

[23] E. Malkoc, W. Neuteboom, The current status of forensic science labora-

tory accreditation in Europe, Forensic Sci. Int. 167 (2007) 121–126.

[24] C. Jurado, Proficiency Test Results, 2006, in: Presented at the Business

Meeting of the Society of Hair Testing Annual Meeting, Cardiff, May 14–

15, 2007.