ENFORCE30621

• Permit No: M1988112
• IBM Index Class Name: Enforcement
• Doc Date: 7/17/1993
• Doc Name: NEWSPAPER CLIPPING
• Media Type: D
• Archive: No

HDli TECHIduLpGIES IPI~=. TEL-O-~~-,a=-5~_,-,_. ?ul !~ _~_' _~:1_~ fJO.001 F.Oa
- ~ • •
administering a test, the leborawry should ac ]east be able w
establish that:
• The particular instrument or equipment used wns in proper
workiry; order and properly talibraled;
• The sample wns taken and maintained properly -including
maiatonance of a proper "chain of cuswdy" - prior w testing; '
• The test was administered properly; )
• The operator x•ae compRwnt and qualified; and
• Adequnw contemporaneous records of procedures,.and
recalls exist.
Akhough these criteria sound simple w Rntisiy, complying with
them can be exacting. Sampling and handling prowcels can
confuse even the most experienced laboratory and 9cld persun-
neL
For scone tests, composite sampling ie allowed, while for others
it isnet. Some samples are light-sensitive; Rome arc temperature•
sensitive. Some mUSt bR analyzed imme.dialely while others can
wait. Different substances require that different amounts be
tested w result in legally defensible data. Some samples can be
held in glace containers, while others must be conktinad in
plastic. Some sampling procedures or wstiag procedures arc
prone wcross-contamination problems.
Given these concerns, n lnbarnwry should be able w produce
doemnentalion and proof that internal procedures for main-
taining sample infkgrity were followed fur a particular bawh of
samples. Finally, the most defensible data comes before a court
wilt a curnpleta chain•of-cuswdy. The failure w meal all
requirements nrccssary fur legally defensible analytical data
does not auwmatically menu that the data will be unaaepfable 1
- but it certainly goes to file heart of the data's credibility.
IL is aasicat fora leborawry to establish first correct'
protedures were used Cur a particular act of samples if uniform,
detailed and written procedures for handling and analysis of the
samples exist at the laboratory; if proof that these prucedurRs
netmlly were followed for a pariitular set of samples exists; and
if it can be shown [hot all personnel handling the samples and
pcrbrming the analyses were trained and caonblc.
'm avoid facing n charge of profeRRinnril negligence, a
eornalLant's best defense is w use "due diligence" when selecting
a laburawry for a client. This means that the consultant made a
compmhensive s}'stamatie and documented investigation prior to
retening the laborawry'9 aPrv1CBP. ThR IdCe] audit is rigorous
enmgh to reveal uperalional f1awR of the laboratory that would
affect itR ability w produce accurate, legally defensible data.
fie consultant's audit also should be Lailorod w ferret out
those laboratories likely to produce data that ere inwneiewnt
with the client's strategic objectives.
Finally, the consultant should provide thR contract laboratory
with a precise and written scope of work that sets forth lire fasts
w ba run, the substances w be tested, methodologies w be used
and the documentation and cerlificalions required. If something
goes awry with the lest results, the scope of work may assist in
Cuing logs! liability.
'the following scenarios illustrate potential Consultant liability
arising from indefensible data. The laboratory with the lowest
anaysis price is nut necessarily lyre beef managed one. If an
insdequntely trained chemist xt that laboratory produces
erroneous dnw, the laboratory and consulting firm that chose it
could expect w be bald liable for damages.
to a second seenmio a laboratory produces acenrale reRU1tR.
Rol when those results are challenged in court, Llrey arc rejected
!or insufficient documentation. Again, this might subject the ~
consulting firm w allegal.ionR of legal liability. If fire laboratory
followed ifs normal procedures, which du not tequire extensive
documentation, it might have a reduced degr~e of liability, or,
depending on the written scope of work, no liabrlity at ell.
Another case might involve a laboratory that carefully followed
internal procedures and documentation. Nevet'dheless, ono ot'the
]aborawry+e analysts made an error that was not detected by the
labomtory/a quality' control system. If rho ~ consulting firm
Conducted a thorough investigation of rho laboratory and
moniwred its protocols over time, Lhe coneult~nt might be less
liable if the error resulW in damages to the client. The laburawry,
than, would be the most likely liability target.
Also, since analytical laboratories are cettifi on n subetance-
epecific basis, the lab audit should determine' Lhe substance in
question is covered by Lhe certifieatiun. he certification
reyuirement for all Lhe target substances shoal be incorporawd
into one written scope of work for the lab.
These examples underscore the potential pe ~ls that flow from
what aL first blush seems like [ur easy tae - eelect.ing a
laboratory. Tltey further illustrate Lhe need to d mood proof from
the leborawry of its good practicee and w w to a precise and
appropriate scope of work
The Contract Laboratory Program (CLP) adrr~inisured by EPA
servos as a model fur producing legally defeneibl~b. analytical data.
Data from the CLP are classified as Level IV da~a, in o hierarchy
of EPA's analytical programs. At Level IV ( LP), ane._;t:~s!
procedures used w determine concentration an~thc operational
nnnued un pn,Ye a6
THE TRIANG E
LABORATORIES ROUP
Your Analytical Source
DIOXINS/CUBANS • ORGANICS • INORGANICS
Research Triangle Park, NC (9119) 544-5729
Houston, TX (7
1
3) 240-5330
Columbus, OH 7
1
(6 4) 791-8008
Atlanta, GA [phone]
IIRY/A lJ(i I1ST 1592 Clrcte 40 on card. 45