Expert Commentary

Avoiding legal pitfalls of hysteroscopy


 

References

Complications associated with glycine solution include water intoxication with hypervolemia and hyponatremia. Once a fluid deficit reaches 750 mL, the surgeon should check electrolytes, give a diuretic, and complete the procedure as soon as possible. When deficits exceed 1,500 mL, stop the procedure immediately (assuming adequate hemostasis) and give another diuretic.

When using bipolar technology, isotonic distention media is suitable, and the deficit can safely reach up to 2,000 mL.1-3

Managing water intoxication

Treating patients with water intoxication involves removing excess fluid and correcting serum sodium levels.

Some experts have argued the case for expectant management, which consists of water restriction and spontaneous diuresis. Others counter that patients with severe hyponatremia warrant immediate therapy, since they can deteriorate rapidly with little warning of seizures and respiratory arrest.

Legal outlook: Informed consent, thorough documentation are key

MR. LINDHEIM: I assume a proper informed consent document has been signed. Only the risks and complications listed on that document can be assumed to have the patient’s consent.

To avoid a claim associated with the consent process, the form should describe the exact procedure and alternatives, as well as the potential risks and complications, and it should be signed by the patient. Remember that informed consent is not just the physician’s recitation of this information, but the patient’s articulation of her understanding in response.

In this case, the facts surrounding all events should be well documented. The OR nurse should record the time, amount, and concentration of distention media given, preferably initialized by the person actually administering the medium. If this is not possible, the nurse should note that she was present at the time of administration and observed the medium being given. If a nurse or physician is later asked to explain what medications or fluids were administered, and this information was not documented, it opens the door to fanciful speculation on their part and cross-examination by the plaintiff’s attorney.

FIGURE Which complications are most common? Bleeding and perforation lead the pack, but others warrant vigilance, too



Do not attempt to insert these entries later. Handwriting specialists and other experts can detect when a record has been altered. Never try to change entries or erase them—by hand or using correction fluid. The chart is the first thing the plaintiff’s attorney will request and receive once a suit is initiated. Tampering with it is a surefire way to incur punitive damages.

Since this patient was kept for observation, the reasons for doing so may warrant an entry (eg, to monitor fluid intake and output [I/O]). If serial labs are drawn, each one should find its way into the chart.

Thorough recordkeeping is essential. Any time an item is lost or not included, the plaintiff’s attorney will argue that something is being hidden. Fluid levels are just as important as lab studies. Make sure the I/O chart is properly filled in, especially when fluid overload could give rise to litigation. These I/O sheets and medication (diuretic) forms should include the time of each assessment or administration.

Key ingredients of informed consent

DR. WILLIAMS: Could you describe an adequate informed consent form?

MR. LINDHEIM: In general, the body of the document should list all benefits and risks of the procedure, including anesthetic risk, infection, injury to organs and the need to repair them surgically, fluid overload and specific complications related to the type of distention media to be used, air emboli and their treatment, and long-term complications such as scarring and infertility.

Consent forms are usually signed at the end of the document, but you may want to insert a line next to each risk for initialing or signing by the patient, as well as a witnessing line at the end. This would make it clear the patient agreed to the procedure and was aware of all benefits and risks, and would present a strong defense to a later claim of lack of consent. I also recommend a notation in the progress records reemphasizing the consent process.

Provide patient-education articles

MR. WEITZ: Another effective technique is to mail or provide the woman with patient-oriented articles about the procedure and risks. Since most patients undergo hysteroscopy on a scheduled basis rather than emergently, they have an opportunity to read these articles before signing the consent form. Reference to these materials in the form is also an effective way to minimize medicolegal risk.

Factors leading to litigation

DR. LINDHEIM: Under what conditions would a legal action be initiated?

MR. WEITZ: All negligence claims require 4 elements:

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