Patient Safety Strategies for Dermatology

The Doctors Company reviewed closed dermatology malpractice claims and identified the following factors as commonly associated with patient harm and a subsequent malpractice claim:

• Diagnosis-related errors (failure, delay, wrong)
• Improper performance of a treatment or procedure
• Improper management of a treatment course or a procedural patient
• Medication-related issues

Review your dermatology patient care practices and office systems and implement the following strategies to increase patient safety and reduce malpractice claims.

Documentation

Documentation issues, including insufficient or a lack of documentation, increase risks for the patient and practitioner and adversely impact defense efforts in the event of malpractice litigation. Document a thorough patient assessment, informed consent for treatment, clinical treatment provided, patient’s response to treatment, and aftercare instructions given.

Informed Consent

Informed consent is not a form signed by the patient; it is the shared decision-making process between the practitioner and patient. Every patient must be fully informed of the risks and benefits of treatment, including alternative treatments, if available, and agree to the treatment plan. Informed consent is evidenced by the practitioner’s medical record documentation prior to the procedure, stating the patient has been advised of the risks—including potential complications such as bleeding, infection, scarring, and non-healing—the benefits, and alternate treatments. The patient should always be offered an 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 to your specific needs. 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 Decision Making.)

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 appointments may result in allegations of delay in diagnosis or treatment, or a delay in referring to a specialist for further evaluation. Implement a follow-up process that includes documenting efforts to schedule return visits. (See our “Quick Check Tool: Appointment Management.”)

If the patient does not respond and is not seen after two calls, send the patient a letter from the practice by first-class mail. If the examination, lab report, or follow-up is of an urgent nature, send one letter by first-class mail and a second letter by certified mail with a return receipt. The letter should document why the follow-up appointment is necessary and outline specific risks the patient may incur by not returning as requested. 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. Be consistent in the collection and labeling process and use a dependable courier or transport service that 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.

Initial or sign and date results/reports when they are reviewed so it is clear in the EHR, or so that staff know a paper report may be filed in the medical record. Advise patients they will be notified of the results for every test. If they do not hear from the office or see results in the EHR patient portal within 14 days, they should contact the office. Never tell a patient, “No news is good news.” Document patient notification of results and any required follow-up.

Lesion Precautions

In addition to preventing wrong-side or wrong-site procedures, take precautions against wrong-lesion errors. 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 diagnosing and monitoring 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 EHR, 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 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 in the medical office for cosmetic or aesthetic procedures must be stored according to manufacturers’ specifications. To help prevent medication errors from misuse of multidose vials, a vial must be dated and initialed when opened and the expiration date noted, which is 28 days after opening unless the manufacturer specifies a different (shorter or longer) date for an opened vial.

Review the patient’s medications prior to a procedure or surgery and implement a practice protocol that identifies high-risk patients and procedures where a preoperative evaluation by another practitioner is indicated. Evaluate the risks of using a local anesthetic for patients with a history of anticoagulation medications or bleeding.

Laser Safety

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.

During sterile procedures with technicians and assistants, use read-back of what the assistant wrote when possible, and verbal repeat-back when necessary, 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.

Cosmetic/Aesthetic Services

Many dermatology practices perform cosmetic and aesthetic services. With the advent of these services has come an uptick in claims alleging improper performance of procedures. It is the practitioner’s responsibility to be fully trained and qualified to perform cosmetic and aesthetic services and to address complications. Practitioners must ensure that all staff members are properly trained, qualified, and supervised as necessary, and comply with state regulations for the service provided and the duties staff perform. The practitioner should observe staff performing procedures to verify that the service is done correctly.

Almost universally, aestheticians are prohibited from performing medical treatments—which are typically defined as treatments that break 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.

Licensed Staff

For staff who have professional licenses, it is the practitioner’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 practitioner may be solely responsible for licensed personnel or held vicariously liable.

For questions or more information, contact Patient Safety and Risk Management at (800) 421-2368 or by email.