In a review of claims closed by The Doctors Company, the following factors were commonly associated with patient harm and a subsequent malpractice claim:
- Patient factors—dissatisfaction with care or nonadherence with follow-up care.
- Technical performance—usually related to a known complication, however, patients often allege they were not aware of possible complications.
- Communication between the provider and the patient—poor rapport, lack of patient education, or failure to obtain informed consent.
- Patient assessment—failure or delay in ordering diagnostic tests or failure to reconcile signs and symptoms with test results.
- Documentation—insufficient documentation of informed consent or clinical findings.
To reduce the risk of patient harm and malpractice claims in dermatology, review practices and systems that surround these factors, and implement the following strategies.
Manage Patient Follow-Up
Use care in managing patients who require periodic follow-up examination or testing due to risk factors such as prior history. A lack of follow-up with appointments may result in allegations of delay in diagnosis or treatment. Implement a follow-up process that includes documenting efforts to schedule return visits.
If the patient does not respond and is not seen after three calls, send the patient a letter from the physician with return receipt requested that explains why the follow-up appointment is necessary and outlines the specific risks the patient may incur by not returning. File a copy of the letter in the patient’s medical record and track the patient’s response. If the patient does not respond to a letter, the practice may want to consider formally terminating the patient from the practice. (See our articles “Nonadherent and Noncompliant Patients: Overcoming Barriers” and “Terminating Patient Relationships.”)
If the patient refuses a test or biopsy for any reason (including costs) after being advised of its need and importance, document the refusal and the reason in the patient record. If, for example, you are concerned about a possible malignancy, document that the patient was advised of the specific risk or concern and include the patient’s comments. Consider asking the patient to sign a detailed refusal-of-treatment form. (See our sample form, “Refusal to Consent to Treatment, Medication, or Testing,” and our article, “Informed Refusal,” for additional information.)
Specimens and Reports
Ensure that you have a stringent specimen collection and labeling protocol in place that identifies responsibilities for each function in the collection and labeling process, and be consistent in its use. Use a courier or transport service that is reliable and provides receipts. A good practice is to include shipping information within the package in case the service delivers to the wrong lab. Create a mechanism to track when specimens are sent, and ensure that reports are returned. The provider initials or signs and dates results/reports when they are reviewed so the staff knows that the report may then be filed in the medical record. Advise patients they will be notified of the results of every test and should not expect that “no news is good news.” Document patient notification of results and any required follow-up.
In addition to preventing wrong-side or wrong-site procedures, take precautions against “wrong lesions.” Claims of misdiagnosis or delay in diagnosis have resulted from failure to document the exact location of a lesion and from the wrong lesion being excised. Be sure that you and the patient are clear about which lesion is being treated, and document locations carefully when the patient has multiple lesions in a particular area of the body. Use an intelligent dermatology imaging software to document cutaneous disease, aid in monitoring and diagnosing skin cancer, and assess response to therapy.
Safe Medication Practices
Be aware of look-alike, sound-alike (LASA) medications—in particular, those common to dermatology that have a LASA medication not typically associated with the specialty. Examples include Accutane and Accupril, Aldara and Alora, or Elidel and Elavil. If using an electronic health record, be mindful of selecting the correct medication and dose from the drop-down list.
The best practice is to avoid verbal orders. If a verbal order is the only option, spell out the drug’s name and require the receiver to document it first and then read back the entry. This prevents the order from being repeated back correctly but transcribed incorrectly. Write the brand and generic names on prescriptions and include the diagnosis or indication on the prescription. Not only does this help a pharmacist in the case of LASA medications, but it also helps a patient to recall the purpose of each medication.
Medications used for cosmetic or aesthetic procedures must be stored according to the manufacturers’ specifications. To help prevent infection from the misuse of multidose vials, a vial must be dated when opened and expired within 28 days after opening unless the manufacturer specifies a different (shorter or longer) date for that opened vial.
The human eye is more vulnerable to injury than human skin, but both are susceptible to laser injury. Ensure that personal protective equipment appropriate for the type of laser is worn by the user, the patient, and the staff. Practice read back when possible and repeat back during sterile procedures with technicians and assistants, especially for laser settings.
Whether you own the laser or use a vendor, the equipment must be maintained according to the manufacturer’s specifications. Keep a log of when maintenance is scheduled and performed. Be clear about the licensure and training needed to operate a laser, and verify that staff is properly trained. Maintain evidence of licensure, certifications, and laser training in employee files. Adequate supervision is required when the laser treatment has been delegated to staff other than the physician. Check state law and scope-of-practice requirements for the level of supervision required. Promote a culture of safety in which staff feel comfortable asking questions if a protocol cannot be followed.
More and more practices are adding cosmetic and aesthetic services. With the advent of these services has come an uptick in claims alleging improper performance of procedures. It is the physician’s responsibility to be fully trained and qualified to perform cosmetic and aesthetic services and to address complications. Physicians must ensure that all staff members are properly trained, qualified, supervised as necessary, and comply with state regulations for the service provided and the duties they perform. The physician should observe staff performing procedures to verify that the service is done correctly.
Almost universally, aestheticians are prohibited from performing medical treatments—which is typically defined as a treatment that breaks the outer layer of the skin. Many states prohibit aestheticians from performing microneedling. Consult state laws and regulations to determine if aestheticians or other unlicensed individuals are permitted to perform microneedling or other medical procedures and, if permitted, whether the physician or advanced practice clinician must examine each new patient and/or be onsite.
In some states, fee splitting is prohibited, so medical spa staff should not be compensated on a percentage of revenue arrangement for rendering medical spa services.
For staff who have professional licenses, it is the physician’s responsibility to verify that licensure is current and active. Conduct periodic performance evaluations that include observing staff as they perform procedures, and document evaluations in employee files. According to state law, the physician may be solely responsible for licensed personnel or held vicariously liable.
Informed consent is required when risks are associated with a procedure or medication. It is the physician’s responsibility to inform patients and provide them with the opportunity to ask questions. A patient must also give informed consent when the proposed procedure or medication is considered to be off label (that is, used in a way not mentioned in the FDA-approved labeling, such as platelet-rich plasma treatments). (Consider adapting our sample off-label use forms for devices and prescription drugs.) Use a shared decision-making model for patient informed consent to enhance the discussion, increase understanding, and improve rapport. (See our article “Informed Consent: Substance and Signature” and AHRQ: Shared Decisionmaking.)
For a discussion of telehealth considerations for dermatology, see our article “Dermatology: Patient Safety Strategies for Telehealth.” For questions or more information, contact Safety and Risk Management at (800) 421-2368 or by email.