Q & A

May 2002

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
Chicago

Q.  Can you comment or send me references on the validity of determining a lipid profile during the first 24 hours of myocardial infarction?

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 weeks.

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.

References
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
National Center
for Environmental Health
Centers for Disease
Control and Prevention
Atlanta

Consultant, CAP Chemistry
Resource Committee

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 report.

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 patient care.

Reference
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
Fullerton, Calif.

Chair, CAP Surgical
Pathology Committee