In recent years, the healthcare environment has undergone unprecedented change. With it, the practice of podiatric medicine is also evolving. The healthcare environment promotes the delivery of care outside the hospital in ambulatory care centers, in podiatric practice sites, or virtually. Even though the practice of podiatry is expanding as it incorporates more complex procedures, podiatrists are often forced to spend less time with their patients.
Keeping patients safe is a significant concern for all podiatrists. To identify factors leading to patient injury, we analyzed 162 podiatric claims that closed from 2015 through 2019. We report the findings here and provide strategies to help podiatrists enhance safety and mitigate risk.
Our study revealed that the top two allegations in podiatric claims were improper management of the surgical patient (41 percent) and improper performance of surgery (26 percent).
Allegations of improper management of the surgical patient involved clinical decisions and care provided to the patient postoperatively. Patients alleged improper management when they experienced injuries. The most common were infections (18 percent), pain (13 percent), malunion (10 percent), fracture (6 percent), and nerve damage (6 percent). These issues resulted in delayed recovery and often required surgical repair.
Allegations of improper performance of surgery were often made when the outcome of the procedure differed from the patient’s expectations. The most common surgical procedures leading to the allegation were bunionectomy with osteotomy of the first metatarsal (17 percent), repair of hammer toe (7 percent), bunionectomy (7 percent), excision of lesion (6 percent), and fusion of the foot (6 percent).
We examined each claim for factors that contributed to patient injury. Here are the top factors in podiatric claims:
63% Technical performance
55% Patient factors
36% Communication between provider and patient or family
31% Patient assessment
29% Selection and management of therapy
23% Lack of documentation
(Note that each claim may have more than one contributing factor.)
We provide additional details about each contributing factor below.
To comprehend all that the technical performance factor encompasses, it is important to understand the breadth of the classification. Technical performance issues include the inherent risk of the procedure; technical or equipment problems; poor technique; wrong-procedure, wrong-site, or wrong-patient errors; and retained foreign bodies. An individual claim might include a combination of these issues.
A closer look into the data on technical performance suggests that causes may be due to inexperience or inadequate training, failure to plan, misidentification of anatomical structures, lack of adherence to time-out protocols, failure to employ surgical checklists, or distractions.
Patient factors contributing to claims are, in effect, a three-legged stool: patient understanding of their condition or prescribed therapy, patient adherence to recommended therapy involving medications or other types of treatment, and patient satisfaction. Each factor may relate to healthcare literacy problems, ineffective communication styles, a patient’s unrealistic expectations (e.g., cure versus improvement), or a lack of response to patient concerns.
Communication Between Providers and Patient or Family
Communication breakdowns between providers and the patient or family occur when there are health literacy or language barriers or when visits or explanations are rushed. Breakdowns in communication may also play a significant role in patient noncompliance. Additional communication issues that contribute to claims include inadequacies in informed consent, discharge instructions, follow-up instructions, and information regarding the risks of medications. Another issue—poor rapport—may influence a patient’s willingness to ask questions.
Patient assessment factors that contribute to claims included inadequate histories and physicals, failure or delay in ordering diagnostic tests, failure to establish a differential diagnosis, misinterpretation of diagnostic studies, failure to respond to a patient’s repeated concerns or symptoms, failure to consider clinical information available in the medical record, and failure to address abnormal findings.
Selection and Management of Therapy
Selection and management of therapy contributes to claims when a patient is not a good candidate for a procedure or therapy. For example, elective surgeries on patients with conditions such as uncontrolled diabetes or fevers or those who are heavy smokers may lead to poor outcomes. Other examples include failing to order medication, ordering medication that is inappropriate for the patient, or prescribing a medication that causes an adverse reaction.
Lack of Documentation
Insufficient documentation contributes to patient harm and claims if the podiatrist’s medical record entries lack detailed clinical findings. Other documentation issues include incomplete histories, inadequate informed consents, lack of notations regarding telephone advice, inadequate discharge instructions, and failure to document follow-up efforts or patients’ refusal of treatment.
Risk Mitigation Strategies
The following strategies can enhance patient safety and mitigate some of the risks discussed in this analysis:
- Universal protocol. Adhere to universal protocol (conduct a preprocedure verification process, mark the procedure site, and perform a time-out) to verify correct patient, procedure, side, and site. Confirm correct patient, procedure, side, and site from all sources (such as radiology images, laterality details, consent forms, and medical records). Be consistent in preprocedure verification and site marking in the pre-op area prior to administration of medication and skin preparation. Mark the surgical site with the patient. Include all team members in the time-out protocol. Minimize distractions and interruptions during the time-out—including those from personal electronic devices. Surgical safety checklists are available from sources such as the Association of periOperative Registered Nurses and the World Health Organization. Review a sample and tailor it to your needs to create a tool that supports your activities.
- Office equipment. Establish accountability for adherence to equipment maintenance protocols for surgical equipment. Vet new clinical equipment before use and comply with the manufacturer’s recommendations for use and maintenance. Monitor all recall notices. Comprehensive oversight of in-office clinical equipment can reduce risks to patients.
- Infection control. Adhere to strict sterilization and office cleaning protocols. If bone surgery is done in the office, ensure proper airflow and filtration of particles. (For advice specific to COVID-19, see our article “COVID-19 and Patient Safety in the Medical Office.”)
- Patient understanding. Allow ample time to encourage patients and families to ask questions. If they feel rushed, they might suppress asking a question. Implement the Institute for Healthcare Improvement’s Ask Me 3 educational program to help verify the patient’s understanding by asking the patient to verbalize: (1) What is my main problem? (2) What do I need to do? and (3) Why is it important to do this?
- Informed consent. Implement an effective informed consent process that supports shared decision making. Informed consent should also occur for in-office surgery as well as in hospitals and ambulatory surgery centers. Informed consent cannot be delegated and must be done by the podiatrist. Include the risks and benefits and discuss the option of not having surgery. Risks should include those material to the procedure. Give patients the opportunity to ask questions. If the patient brings someone to the appointment, include that person’s name and relationship in your medical record. The informed consent is actually the conversation between the podiatrist and patient, and it needs to be documented in the patient’s medical record. Use a form to help document the process. (For additional information, see our articles “Informed Consent: Substance and Signature” and “Informed Refusal.”)
- Patient assessments. Obtain the patient’s complete history—including other current treating physicians, recent procedures, and any visits to the emergency department. Review key documents from other providers, the results of laboratory and diagnostic studies, and current medications. The review must take place prior to performing surgeries or procedures or prescribing new medications.
- Treatment complications. Quickly recognize and address complications from treatments or surgeries. Do not delay in the hope the complication will go away. Openly discuss concerns with patients and seek consultations from appropriate specialists such as vascular, infectious disease, or wound care.
- Emergency response. Maintain an emergency cart or kit to ensure that emergency equipment, supplies, and medications are readily available. Hold regular simulation drills to train staff to respond in emergency situations.
- Documentation. Document clearly and completely in the patient medical record. Complete documentation is essential for continuity of care so that any subsequent treating providers or caregivers have a clear understanding of the patient’s evaluation and treatment. Document any family members or other individuals present during a visit.
Further Information and Assistance
For additional information and assistance, see our complimentary, on-demand continuing education activities—including our Managing Risks in Podiatry course—or contact the Department of Patient Safety and Risk Management at (800) 421-2368 or by email.