Whose name should go on this report anyway? Protecting ourselves and our practices in the current legal environment
Margaret Havens Neal, MD
The importance of legal matters in everyday pathology practice is in the news
again. A class-action lawsuit brought in 2003 alleges that a hospital issued
Pap reports bearing physicians' names in cases that were never reviewed by a
physician, and it has caused concern for all laboratories that review cytology
slides. The list-serve and the CAP are flooded with questions from laboratory
professionals worried that their practices will need to be revised.
Fortunately, the basic requirements are straightforward and sensible. They represent sound medical and legal practice. The report should clearly identify all who have reviewed the slides, and should not include the name or signature of anyone who has not reviewed the slides.
The Clinical Laboratory Improvement Amendments of 1988 require that a physician review all cases of cytologic abnormality, reactive or reparative changes, squamous intraepithelial lesion, and higher, and that the name or signature of the reviewing pathologist be clearly identified on the report. The cytology records should also indicate others who reviewed the slides. Cytotechnologists should be identifiable by name, initials, or other identifier in laboratory records. Their names are not required but may be included in the actual report.
A pathologist’s name or signature must never appear with the diagnosis on negative Pap reports unless he or she has personally reviewed the slide, and, in fact, this is true for anyone who did not personally examine the cytopathology slides. The legal issue remains for pathologists who have their name on a report. If a Pap case comes to litigation, they are likely to be named in the suit.
Although the medical director's name may appear on the report, it should not be associated with the diagnosis unless this director actually evaluated the case. The medical director's name must be clearly differentiated from the name of those who review the slides.
Cases with results generated by an instrument must be reviewed and verified by a laboratorian with appropriate training and authorization. A record of who performed this data verification must be maintained as an internal laboratory record according to regulations stipulated in CLIA ’88. It is preferred that the name of this person not be included in the cytology report. If local laboratory policy mandates inclusion of the name, it must be clearly stated and understood from the report that this person did not screen the slide. If the slide is not screened manually, as with automated primary screening instruments, there should be no name on the report that can be misconstrued as a person who examined the slide.
A new CAP cytopathology checklist question (CYP.05316) with explanatory notes
addresses these issues and can be found on the CAP Web site at www.cap.org.
- Department of Health and Human Services, Health Care Financing Administration
Clinical Laboratory Improvement Amendments of 1988; Final Rule. Federal
Register. 2003(Jan 24):7169 [42CFR493,1274].
- Suit claims hospital’s Pap tests falsely certified. www.cnn.com/2003/HEALTH/12/19/pap.tests.ap/index.html
- Solomon D, Nayar R (eds). The Bethesda System for Reporting Cervical Cytology—Definitions,
Criteria, and Explanatory Notes, 2nd ed. New York: Springer-Verlag, 2004.
Dr. Neal, a member of the CAP Cytopathology Committee, is with KWB Pathology Associates, Tallahassee, Fla.