Download Legal Liabi Cytopathc lity in the )logy Labor atory

CE UPDATE—LEGAL ISSUES II
Legal Liabi lity in the
Cytopathc )logy Laboratory
Theresa M. Somrak, JD, CT(ASCP)
Cytodiagnosis involves a tiered system of screening, interpretation, and
diagnosis. Cytotechnologists and cytopatbologists should be aware of the
medical and legal consequences of
their actions when performing their
duties in the laboratory. This
article describes actions for which cytopathology laboratory personnel may
be held legally liable in a court of law.
In addition, practical approaches to
reducing the risk of liability are
offered.
Editor's Note: The views expressed in
this article should not be considered
legal advice or construed as the opinions of the American Society of Clinical Pathologists.
From the Cytopathology Laboratory, University Hospitals of Cleveland, Cleveland. Ms
Somrak is now with the Cytopathology Education Consortium, the American Society of
Clinical Pathologists, Chicago.
Reprint requests to Ms Somrak, The Cytopathology Education Consortium, ASCP,
2100 W Harrison St, Chicago, IL 60612.
IV yi edical and legislative communi1 \ / 1 ties and the general public are
1 V 1 concerned about the reliability
of cytological interpretations, especially
those in gynecologic cytology. Cytotechnologists in particular are concerned
about liability, because they are responsible for the initial examination and the
interpretation of about 90% of gynecologic cytological specimens with test results within normal limits (with no
evidence of abnormality). A false-negative Pap smear interpretation could delay appropriate follow-up and medical
treatment.
It is critical that laboratory personnel
review and interpret each cytological
specimen accurately; a misinterpreted
specimen could result in excessive or insufficient treatment and consequently
harm the patient.
As a cytotechnologist, I used to wonder
whether I could be sued for misinterpreting a cytological specimen. The physician
with whom I worked was often asked to
review cell studies that were the subject
of potential litigation. Before he reviewed
a case, a laboratory cytotechnologist
would screen the cell study as if it were
a routine case. The cytotechnologist
would comment on the processing and
adequacy of the specimen and mark
648 Laboratory Medicine Vol. 23, No. 10 October 1992
what were believed to be abnormal
areas on the slide. Only after this process would the physician review the cell
study and make his diagnoses.
Because cytodiagnosis involves a
tiered system of screening, interpretation, and diagnosis, cytotechnologists
and cytopathologists should be aware
of the legal consequences of their actions. I review those actions for which
cytopathology laboratory personnel
may be held legally responsible and offer practical approaches to reducing the
risk of liability.
1 A #ho Is Responsible?
\ / \ / My work as an attorney and
V V as a cytotechnologist gives me
a unique perspective on medical and legal issues. As an attorney, cytotechnologists often ask me about the scope of
their liability. Before addressing the legal
responsibilities of the cytopathology laboratory, however, I should define the
word liability. According to Webster's
Ninth New Collegiate Dictionary, liability is something for which one is obligated according to the law; it is
synonymous with responsibility.
Laboratory personnel are not the only
responsible group in the cytology setting;
patients and the clinicians performing
the examinations also share responsibility.
The Patient's Responsibility
Women who are or who have been sexually active and women aged 18 years
or older are responsible for scheduling
annual pelvic examinations, including
Pap smears. Physicians suggest an annual
cervicovaginal smear examination for a
variety of reasons: the natural course of
cervical malignancies is unpredictable;
the clinician, the patient, or both might
be unaware of the patient's risk level;
and there is a small, but significant percentage of false-negative reports.
The Physician's Responsibility
Physicians who perform pelvic examinations and obtain cervicovaginal smears
are also responsible. A cellular sample's
diagnostic use depends on various factors: using the appropriate sampling
method, obtaining and relaying relevant
clinical information, and sending the
specimen to a quality cytology laboratory.
Physicians should advise their patients when to obtain Pap smears. Menstruating women should schedule their
examinations for the second half of
their menstrual cycles to avoid obscuring the cytological sample by blood or
exudate. Women should also be advised
that to prevent alteration of the cellular
sample on Pap smears, they should not
douche at least 24 to 48 hours before
their examinations. A cellular sample
should be obtained from the ectocervix
and the endocervical canal. Physicians
or their staff members should obtain all
the relevant clinical information and relay it to the laboratory.
Finally, the cellular sample should be
sent to a quality cytopathology laboratory. Physicians should consider a laboratory's licensure and accreditation,
personnel qualifications, work load,
operations standards, and service costs
when selecting a cytology laboratory.
The Laboratory's Responsibility
According to the Clinical Laboratory
Improvement Amendments of 1988
(CLIA '88) and health care accrediting
agencies, a cytopathology laboratory
should be able to demonstrate the
following:
• Compliance with government licensure and/or accrediting agencies;
Legal Terms Relevant to the Cytopathology Laboratory
Term/
Concept
Definition
Application to the Cytopathology
Laboratory
Liability
Something for which one is
obligated according to the law:
responsibility*
The technologist's, pathologist's,
and facility's responsibilities to the
patient
Plaintiff
One who commences a personal
action or lawsuit to obtain a
remedy for an injury to his (or her)
rights*
The patient
Negligence
The failure to exercise the care
that a prudent person usually
exercises*
Failure to exercise due care in conduct
toward the patient so that no harm
results
Breach
Infraction or violation of a law
by either commission or omission*
Violation or omission of duty to the
patient
Tort
A wrongful act for which a civil
action will lie, except one involving a
breach of contract *
An injury in which a technologist,
pathologist, or facility is claimed to
have injured a patient
Respondeat Latin, literally, "let the master answer."
superior
A master is liable in certain cases for
the wrongful acts of his servant, and
a principal for those of his agent'
The concept that in some cases, the
facility may be held responsible for
the wrongful acts (of the
cytotechnologist) that occur within
the sccipe of employment
Reasonable
man
(person)
standard
The technologist must act within the
laboratory's accepted guidelines
The standard that one must
observe to avoid liability for
negligence under all circumstances,
including the forseeability of harm
to one such as the plaintiff*
*From Webster's Ninth New Collegiate Dictionary, © 1991, Merriam-Webster, Inc.
'From Black's Law Dictionary With Pronunciations, © 1983, West Publishing Co, Inc.
• Employment of qualified, certified cytotechnologists;
• Maintenance of a reasonable work
load;
• Cell studies screening under the supervision of an on-site cytopathologist or certified pathologist who is
available for consultation and review of
all abnormal cell studies; and
• Cytological diagnosis monitoring using an established quality control and
quality assurance program.
The Cytotechnologist's Responsibility
I am asked frequently, "What is the extent of a cytotechnologist's liability?" and
"Is there protection by the 'deep pocket'
of the pathologist?" These questions indicate concerns about who will pay the
monetary settlement should a court find
that a patient has been harmed by an
incorrect cytological diagnosis.
Is the cytotechnologist protected from
personal liability because the pathologist
is in a better position to pay (his or her
"deep pocket") for monetary damages?
Not necessarily. Fortunately, lawsuits
that are directed specifically at cytotechnologists and cytopathologists
are rare. Cytopathology laboratory personnel and other health care workers,
however, can be the targets of lawsuits
if they are negligent in performing their
required duties.
Several factors, including the scope of
practice, the standard of care, professional responsibility, and the person or
persons alleged to be responsible for
harming the patient (plaintiff) must be
considered when choosing the defendants
in a court proceeding. The scope of
practice generally refers to the guidelines that define a cytotechnologist's duties and responsibilities. Standard of
care includes sound medical practices
that ensure quality patient care. Liability can be incurred by deviating from
the established standard of care, which
Laboratory Medicine Vol. 23, No. 10 October 1992 6 4 9
can occur in a cytopathology laboratory if its operation is not reasonable
(compliant with the accepted operational standards), is in violation of the
law, or is in violation of the laboratory's
internal quality control and quality assurance system.
Evaluations of standard of care and
professional responsibility traditionally
have focused on the physician or
pathologist supervising the laboratory
in the particular locale where the professional works. The locality rule is a
regulation that monitors professional
conduct by comparing technologists'
work with that of other technologists
within a specific locale. Most states
have expanded the locality rule to a
similar locality rule or to a national
standard, which monitors professional
conduct by comparing the work of laboratory personnel on a national basis.
This wider focus becomes more applicable to the cytopathology laboratory
as procedures and protocols become
standardized. Courts will use legislation
such as the CLIA '88 and the Health
Care Financing Administration's regulations to determine what is acceptable
laboratory practice. Deep pockets alone
will not protect cytotechnologists who
have been negligent in their duties as
laboratory professionals.
Examining the extent to which a cytotechnologist may be held liable requires an explanation of the legal
theories and concepts that affect cytotechnologists in the work place (Table).
Although many areas of the law may
affect health care professionalism, tort
law has the greatest effect on health
care staff members. A tort is a civil injury, in which one person is claimed to
have injured or harmed another. Two
subgroups exist under the general heading of tort law: intentional torts, such
as trespassing and defamation; and
unintentional torts, which are defined
as negligence.
Negligence and Legal Duty
Negligence occurs when one fails to exercise the degree of care that an ordinarily prudent person would exercise
under similar circumstances. Cytotechnologists can be named codefendants in
a court proceeding if they have been
negligent in performing those duties
that are considered legal responsibilities.
Cytotechnologists have a legal duty to
screen and evaluate accurately cytologic
specimens and to report any abnormal
findings to the pathologist.
Negligence is a broad legal concept,
but can best be thought of with regard
to the reasonable person standard—
that is, an objective standard to determine appropriate legal behavior. The
negligence theory is based on every person's duty to exercise due care in his or
her conduct towards others so that no
harm results. The legal definition of
negligence is either the omission to do
something a reasonable person would
do or the act of doing something a reasonable person would not do. Negligence
is commonly characterized by thoughtless or inattentive behavior. Legal doctrine dictates that for an act or the
omission of an act to be found negligent,
the following elements must be satisfied:
• A legal duty must exist; cytotechnologists have legal responsibilities to the
patient and to the hospital or laboratory for which they work;
• A breach (a violation or omission) of
duty must occur;
• The breach of the duty must be the
cause of harm or injury;
• Harm or injury must occur; and
• The person harmed must suffer actual
damages.
It is not difficult to establish that a duty
exists. If a patient visits a clinician for a
pelvic examination, which includes a
cervicovaginal smear, the duty is created
when the cytopathology laboratory
agrees to process and interpret the smear.
Because cytotechnologists are responsible for the initial examination and the
interpretation of about 90% of gynecologic cytology specimens, they have a
legal duty (to patients) to evaluate cytological samples accurately. Failure to do
so constitutes a breach of duty to the
patient. To determine that a cytotechnologist has breached his or her duty to
the patient, the patient (in court, the
plaintiff) must present expert testimony
provided by an expert witness. Considering the technical nature of such allegations, which are not commonly
understood by persons outside of the
profession, an expert witness is needed
to ascertain whether the cytotechnologist has failed to perform his or her
duty.
6 5 0 Laboratory Medicine Vol. 23, No. 10 October 1992
A breach of duty can result from
reporting a false-negative test result; issuing an inaccurate report; or using
substandard sampling, processing, or
testing techniques. Cytotechnologists
generate false-negative reports in two
main situations. The first instance occurs when a patient has an abnormality
and the abnormal cells on the slide are
undetected. The results of the cell study
are reported as negative or within normal limits. The second instance occurs
when a patient has an abnormality such
as a high-grade cervical intraepithelial
neoplasm, but the abnormal cells are
not on the slide.
In the first situation, the cytotechnologist obviously would have breached
his or her duty to screen accurately the
cellular sample and report the abnormal
findings to the pathologist. The second
scenario is not as clear-cut. In this case,
the cytotechnologist would have
breached his or her duty if the specimen
submitted was clearly unsatisfactory for
evaluation, but reported as negative.
The cytotechnologist would not be in
breach of duty, however, if the cellular
sample was adequate with no abnormal
cells on the slide and subsequently, the
patient was found to have a lesion.
I have been asked to review Pap smears
that were reported as negative and give
my opinion as to whether the cytotechnologist acted within the scope of practice. I have reviewed cell studies with
virtually no cellular material to evaluate,
and others that were so poorly stained
that I could not evaluate the smear accurately. In such instances, the cytotechnologists involved, by reporting clearly
unsatisfactory specimens as negative, are
obviously failing to perform their duties.
I have been involved in other cases in
which, in my opinion, an adequate specimen was properly reported as negative.
A cytotechnologist who issues an erroneous report also breaches his or her
duty. In this instance, a specimen may
be properly screened and evaluated, but
results are reported inaccurately. This
could occur if the cytotechnologist generating the report types or enters the
test results inaccurately. In another instance, reports on the wrong slides are
issued because the slides and requisitions were separated or mixed.
The use of substandard techniques to
process cellular samples also constitutes
a breach of duty. Improper staining and
processing techniques can render a cellular sample useless for proper evaluation. For example, excessive "cornflakes"
on a cervicovaginal smear can mask underlying abnormalities. Air bubbles and
clearing slides improperly can also limit
a cytotechnologist's accuracy in screening cellular specimens.
addition to their regular employment,
can be held personally liable for erroneous cytological specimen evaluations.
Thus, self-employed cytotechnologists
should have professional liability insurance, which can be obtained from organizations such as the American Society
for Cytotechnologists and the American
Society of Clinical Pathologists.
The Facility's Responsibility
No discussion of negligence theory
would be complete without addressing
the legal responsibilities (to the patient)
of the hospitals and laboratories that
employ cytotechnologists. When acting
within the scope of duties as defined by
the employer, the cytotechnologist is not
solely liable; there may be another party
with greater liability. This concept is
called respondeat superior, which means
literally, "let the master answer." It renders employers responsible for the negligent acts of their employees that occur
within the scope of their employment.
The legal employer-employee relationship renders the employer responsible
for hiring a competent staff.
M
Courts have held that pathologists
heading hospital laboratories can be responsible for technologists' negligent
acts. In addition, pathologists may be
held liable regardless of whether they
are employees of that hospital.
The threshold issue relates to whether
an employer-employee relationship exists. According to legal doctrine, this relationship is legally established if the
following criteria are met: the employer
selects the employee; the employer pays
the employee's salary, deducting taxes
and social security; the employer has final control over the employee's working conditions and protocols; and the
employer has the power to discharge
the employee.
Many cytotechnologists employed by
hospitals or private laboratories might
be protected from personal liability for
their negligent acts under the respondeat
superior concept if the act or omission
was within the scope of their employment. An example of a negligent act
that is not within the scope of employment is if, for some reason, a cytotechnologist harms a patient while giving
him or her an injection.
Self-employed cytotechnologists, including those who have other jobs in
anaging Liability
The aforementioned examples
of actions for which cytopathology laboratory personnel could be
held liable can be controlled by developing and adhering to proper quality
assurance procedures and protocols.
Some of the quality assurance and quality control methods of the laboratory in
which I worked are prospective, concurrent, and retrospective, and consequently beneficial in providing quality
patient care. The laboratory directors
try to anticipate problems that will be
encountered outside of the laboratory
by educating staff members about
proper specimen procurement and the
importance of clinical information.
Staff members also monitor performance
continually within the laboratory. The
directors also have implemented a passaround system, in which a different cytotechnologist rescreens certain cases
before they are documented.
A detailed procedures manual is periodically reviewed and updated. Slides
are monitored daily for proper staining
and for cornflakes; unsatisfactory specimens are reported as such; and patient
files are accessible and maintained to
include patients' medical histories.
Physicians and technologists correlate
histological diagnoses with cytological
diagnoses, and then review the discrepancies. Ten percent of all negative Pap
smears are reviewed, and a pathologist
reviews all nongynecologic specimens.
This list of quality assurance measures
is by no means exhaustive, and quality
improvement protocols are continually
being instituted.
Ascertaining that a patient has been
harmed is generally not difficult. Patients who think they have been harmed
as a result of a misinterpreted cellular
study can have all of their previous
records reviewed to confirm the alleged
misinterpretations. The issue of actual
cause of harm is the most difficult to
prove. It must be shown that a cytotechnologist's failure to act reasonably caused the patient's harm.
Cytopathology laboratory personnel
can reduce the number of mistakes in
the laboratory and thereby reduce the
risk of liability. They can accomplish
this by participating in peer review accreditation programs such as those offered by the American Society of
Cytology and the College of American
Pathologists, and by establishing ongoing quality improvement protocols.
Communication between the laboratory and the referring physician is an
important part of managing liability.
The laboratory, using concise, descriptive, and unambiguous terminology,
should report all cytological findings to
the physician who submits the specimen for interpretation. The main purpose of diagnostic technology is to
communicate to the referring physician
all of the information necessary to ensure
proper patient care.
C
onclusion
The cytopathology laboratory and
its personnel are integral components of the health care team. Physicians
and their patients rely on the accurate
evaluation of cytological specimens. Although liability in the cytopathology
laboratory cannot be eliminated, it can
be reduced and effectively managedQ
Selected Readings
Belsey R, Greene M, Baer D. Managing risk
in the office laboratory. JAMA. 1986;256:
1338-1441.
Furrow BR, Johnson SH, Jost TS, et al.
Health Law. St Paul: West Publishing; 1987.
Somrak TM, Sorensen K, Abdul-Karim FW.
The Pap Smear: Collection, Handling, and
Quality Assurance. Chicago: American Society of Clinical Pathologists Press; 1990.
Laboratory Medicine Vol. 23, No. 10 October 1992 651