Q. Our laboratory recently lost potential business for
Pap test interpretation. The chief reason the gynecologist cited
was that the competing lab sent out complimentary "happy cards"
to all patients with negative Pap tests and that this reduced the
number of calls to his office and the number of mailings to his
patients. I have heard that the practice of sending cards of this
type might represent an illegal inducement because it could be viewed
as supplying a service at no charge in exchange for business. What
is your interpretation?
A. Arguably, the "happy cards" are simply an enhanced
service of the laboratory, a method of conveying the testing information.
Under that interpretation, the cards would in no sense be a financial
inducement. Even if the happy cards were viewed as a value-added
service, the cost of the cards and the financial benefit to ordering
physicians are so small that a prosecutor is highly unlikely to
pursue this practice as an illegal financial inducement.
James C. Dechene
Sidley & Austin
Q. Can you comment or send me references on the validity
of determining a lipid profile during the first 24 hours of myocardial
A. Acute myocardial infarction is associated with
a variable decrease in total cholesterol and low-density lipoprotein-cholesterol
concentrations in serum.1 The change depends on the original
level of cholesterol in serum, with little change at serum levels
below 5.17 mmol/L (200 mg/dL).
In one study, cholesterol measurements obtained within 24 hours
after a myocardial infarction changed little from those made before
the myocardial infarction.1 Thereafter, the serum cholesterol level
decreased gradually to a lower level for an average of six to eight
In a second study, investigators observed that the lipid state
of the individual could be assessed accurately during the first
48 hours after an acute myocardial infarction, but that after two
days, significant decreases were observed in total cholesterol and
LDL-C serum levels.2 Therefore, measuring cholesterol
within the first 24 hours after a myocardial infarction is a reliable
way to assess a patient's serum cholesterol level and a possible
screen for hypercholesterolemia. This is also of note from a practical
standpoint since blood is likely to be collected during the first
24 hours of myocardial infarction for various other biochemical
tests and less likely to be taken routinely months after the attack.
1. Gore JM, Goldberg RJ, Matsumoto AS, et al.
Validity of serum total cholesterol level obtained within 24 hours
of acute myocardial infarction. Am J Cardiol. 1984; 54:722-725.
2. Ryder REJ, Hayes TM, Mulligan IP, et al. How soon after
myocardial infarction should plasma lipid values be assessed? BMJ. 1984;289:1651-1653.
Gary L. Myers, PhD
Chief, Clinical Chemistry Branch
Division of Laboratory Sciences
for Environmental Health
Centers for Disease
Control and Prevention
Consultant, CAP Chemistry
Q. What are the latest CAP recommendations regarding
surgical pathology reports? I am familiar with "addendum" and "amended"
reports, but I have heard that CLIA now requires use of "corrected"
reports. Does this terminology apply to anatomic pathology reports
or should it be used only for clinical laboratory numerical results?
A. Whenever a pathology report is revised or amended
it is essential to ensure that the treating physicians clearly understand
that the report has been changed and the nature of the change. This
need for clarity is as important for anatomic pathology reports
as it is for clinical laboratory reports. The College's Laboratory
Accreditation Program does not specify the terminology used to designate
report types, but LAP does require that such reports be clearly
designated and that "corrected" results reports clearly state that
the new result is a change from a previously reported result (see
LAP checklist No. GEN.43700).
In some cases, the terms used for report types are determined
by the laboratory computer system and cannot be altered. For example,
in the Meditech system, all pathology reports issued subsequent
to the final report are called "addendum" reports. Nevertheless,
the laboratory can clearly identify such reports as representing
a "corrected" or "revised" report in the printed text.
The following descriptions of report types are taken from the
new CAP Quality Improvement Manual in Anatomic Pathology1:
- A "final" pathology report is a completed report that becomes
part of the permanent medical record. It includes the final diagnosis
and all necessary diagnostic information.
- A "provisional" (or preliminary) report is used when the pathologist
anticipates a delay in producing the final report. A report could
be delayed for a number of reasons, such as the need to obtain
special stains or review archival or outside material or to seek
expert consultation. A provisional report should describe what
is pending before the final report can be issued and should clearly
state that the findings are preliminary and may be changed in
the final report.
- An "addendum" report is issued when new information becomes
available after the final report has been issued. Newly obtained
clinical information, findings on additional histologic sections
or review of archival material, the results of special studies
such as immunohistochemistry, and the results of consultations
may be included in an addendum report. An addendum report may
or may not change the original diagnosis; when issued after a
provisional report, the addendum report may actually represent
the final report.
- "Revised" (or amended) reports are issued when the final diagnosis
changes or other important pathologic information becomes available.
The reasons for the revision must be explained in the report and
the clinician(s) notified because a revised report may significantly
affect patient care.
- "Corrected" reports are issued when transcription, patient identification,
specimen site, or other related reporting errors are found. A
corrected report differs from a revised report because the diagnosis
usually remains unchanged. Corrected reports should be clearly
identified and the reasons for the correction included in the
Regardless of the specific term(s) used, communication with the
treating physicians and a clear explanation of the purpose of the
new report are essential, particularly when the change may affect
1. Nakhleh RE, Fitzgibbons PL, eds. Quality Improvement
Manual in Anatomic Pathology, 2nd ed. Northfield, Ill.: College
of American Pathologists; 2002.
Patrick L. Fitzgibbons,
St. Jude Medical Center
Chair, CAP Surgical