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November 2006

Richard A. Savage

Q: Is it acceptable to do a batch sign-out of surgical pathology reports in an anatomic pathology system? The pathologist who hand signs the reports would like to electronically sign out batches. Does this jeopardize patient safety and raise legal issues for the hospital?

A: I have several clients who work this way. They indicated that they have reviewed their processes and, in their legal opinion, they are providing quality patient care and laboratory practice since the physician uses the printed, signed report to perform patient care operations. Their anatomic pathology systems have solved the issue by not requiring electronic signature. A “verify process” is used to “release” the report, rather than electronically signing it.

Other vendors solved this problem by assigning a status to a report as “printed for signature.” If it is changed after that status but before it is released or signed out, the system flags the report for followup.

I know of a few pathologists in anatomic pathology labs who do not want to use electronic signature and will physically sign out each case and then let a clerk release an entire batch of reports in one step.

Hal Weiner
President, Weiner
Consulting Services LLC
Florence, Ore.

The CAP does not expressly prohibit batch sign-out of reports, so long as the laboratory has specified procedures that ensure each report has received attention by the signing pathologist and that the report has not been changed from the time of that review until final verification. Pathologists are responsible for the content of those reports, whether they release a single report or a batch of reports at one time.

This is addressed in the CAP anatomic pathology checklist question ANP.12100 Phase II, which reads, “Are all reports reviewed and signed by the pathologist?”

The note to this section reads:

The inspector must review 15–20 recent surgical pathology reports. When diagnostic reports are generated by computer or telecommunications equipment, the actual signature or initials of the pathologist may not appear on the report. It is nevertheless essential that the laboratory have a procedure that ensures and documents that the responsible pathologist has reviewed and approved the completed report before its release. In the occasional situation when the diagnosing pathologist is not available for timely review and approval of the completed report, the laboratory may have a policy and procedure for review and approval of that report by another pathologist. In that circumstance, the names and responsibilities of both the pathologist who made the diagnosis and the pathologist who performs final verification must appear on the report.

You can download a copy of any CAP checklist questions from the CAP Web site. at www.cap.org.

The laboratory is advised to consult its risk management and legal representatives in developing such a practice.

Edward Gruber
Senior Technical Specialist
CAP Laboratory Accreditation Program
Northfield, Ill.

Although many clients may use the paper copy for patient care, we must assume that some physicians are relying on an electronic version. If the pathologist is relying on review of the paper copy before sign-out (for most of us, it is easier to review a printed page than a computer screen), a process must be in place to ensure that the computer-based image of that report is not modified after the paper is printed and before it is verified. With such a program feature and with administrative procedures that ensure the clerical staff is verifying only those reports the pathologist has signed, we can be confident that we are complying with regulatory requirements that the pathologist review each report before it is issued.

Raymond D. Aller, MD
Contributing Editor, CAP TODAY

Q: What are the best tests to assess the risk of developing acute renal failure from accumulating myoglobin in the kidney following rhabdomyolysis? This is a good question, to which there is no definitive answer.

A reasonably well-documented review from a recent case report noted that the clinical course of rhabdomyolysis varies depending on the underlying cause.1 Early recognition is important to prevent such severe complications as renal failure, electrolyte abnormalities, disseminated intravascular coagulation, and compartment compression syndrome.2

Acute renal failure complicates up to 15 percent of rhabdomyolysis cases.3 The release of large amounts of myoglobin has been linked to developing acute tubular necrosis and, ultimately, renal failure, although there is no statistical correlation between level of serum creatine phosphokinase and serum or urine myoglobin.4 Urine alkalinization and forced diuresis prevent tubular pigment reabsorption, helping to preserve renal function and prevent other life-threatening complications. In one study of exercise-induced rhabdomyolysis, no patients developed acute renal failure after forced bicarbonate diuresis within the first six hours of admission.5

Serum and urine myoglobin certainly presage the possibility of renal failure, but timely and appropriate aggressive clinical intervention—including hydration, diuresis, and alkalinization of the urine—can prevent this complication.

References

  1. Sauret JM, Jaen CR. Rhabdomyolysis in a teenage boy: a case report. J Am Board Fam Pract. 2000;13(1):66–69.
  2. Line RL, Rust GS. Acute exertional rhabdomyolysis. Am Fam Physician. 1995;52:502–506.
  3. Feinfeld DA, Cheng JT, Beysolow TD, et al. A prospective study of urine and serum myoglobin levels in patients with acute rhabdomyolysis. Clin Nephrol. 1992;38:193–195.
  4. Sinert R, Kohl L, Rainone T, et al. Exercise-induced rhabdomyolysis.  Ann Emerg Med. 1994;23:1301–1306.
  5. Akmal M, Massry SG. Reversible hepatic dysfunction associated with rhabdomyolysis. Am J Nephrol. 1990;10:49–52.

Additional Reference

Ward MM. Factors predictive of acute renal failure in rhabdomyolysis. Arch Intern Med. 1988;148(7):1553–1557.

Raymond D. Aller, MDDavid S. Wilkinson, MD, PhD
Professor and Chair
Department of Pathology
Virginia Commonwealth University
Richmond

Member, CAP Chemistry
Resource Committee