Physical Therapist Case Study: Patient sustained a burn during interferential current therapy

Summary

This case involved a 59-year-old male patient who was undergoing treatment for an anterior cruciate ligament (ACL) injury resulting from a fall. He had a significant past medical history which included Type II diabetes and rheumatoid arthritis. The patient underwent a surgical repair of the ACL and was referred to physical therapy by his orthopedic surgeon. On the first day of treatment, the PT conducted an initial evaluation and developed a treatment plan, which included muscle strengthening exercises and interferential current (IFC) therapy to help manage pain and promote healing. During the evaluation, the PT failed to acknowledge the patient’s pre-existing medical conditions and therefore did not assess the patient’s sensory level nor did she inquire if he had signs of diabetic peripheral neuropathy, which the patient later testified that he had been experiencing. The first three sessions conducted by the PT, which included IFC treatments, were tolerated well by the patient. During the fourth session, the PT assisted the patient with his exercise routine and then delegated the remainder of the visit, including the IFC treatment, to the PTA. The PTA was newly hired and was “shadowing” the PT for a  two-week orientation period. The PTA had performed IFC treatments at the clinic where he was previously employed; however, the PT did not determine if the PTA was  familiar with the equipment being used on this patient.
 
The PTA set up the IFC machine and set the current based upon the PT’s recommendation and in alignment with the manufacturer’s guidelines. He then cleaned the electrode pads with alcohol and placed them on the patient. Approximately five minutes into the treatment, the patient reported that the pads were “stinging” and that he had not experienced this in the prior sessions. The PTA decreased the current settings twice, however, the patient continued to complain of pain. The PT happened to be walking by and heard the patient’s complaints. She immediately turned off the machine, removed the electrode pads and noted a circular skin discoloration under one of the pads. The PT observed that the pad in question was improperly placed on a bony prominence (fibula) and later educated the PTA regarding pad placement. The PT visually inspected the pads, and, although she did not observe any obvious defects, she discarded the pads as a precautionary measure. The clinic allowed for pad reuse, and the practice would be to discard the pads when they appeared worn or were losing adhesiveness. The clinic did not have a written policy delineating IFC procedures, i.e. pad maintenance and current settings, nor was there a written policy regarding the roles and responsibilities of the PTAs.
 
The PT believed that the patient was having an allergic reaction to the gel on the pad, so she placed an antibiotic ointment and gauze on the area and instructed the patient to “keep an eye on it.” However, after the patient left the clinic, he continued to have moderate to severe pain and presented to the hospital later that day. He was diagnosed with a third degree burn and was referred to a wound care clinic for debridement and ongoing burn care.
 
After two months of treatment, the patient was discharged from wound care and was able to resume physical therapy. He opted to go to a different physical therapy clinic. Several months later, he consulted with a plastic surgeon for scar revision and underwent laser therapy with some improvement in the visibility of the scar. It was at that time that the patient began to report that he was experiencing constant pain at the burn site and paresthesia down the anterior lateral aspect of his leg. He was referred to a pain specialist who diagnosed the patient with a peroneal nerve injury documenting that the nerve injury was caused by the burn. The patient underwent a dorsal root ganglion spinal cord stimulator implantation for pain control. A nerve conduction study was recommended to definitively confirm a peroneal nerve injury; however, the patient refused to undergo this test.
 
One year following the implantation of the spinal cord stimulator, the patient (plaintiff) filed a lawsuit naming the PT clinic and the treating PT. He asserted that the PT clinic owner failed to provide proper training and supervision of the PTA and that the clinic did not have written policies pertaining to proper use and maintenance of the IFC equipment. The plaintiff further asserted that the PT failed to conduct a comprehensive assessment regarding the risks associated with diabetes and failed to monitor the patient’s treatment.
 

Risk Management Comments

The plaintiff testified in his deposition that he informed the PTA that the pads were no longer adhering to his skin, but the PTA did not replace them. The plaintiff’s expert utilized this testimony to support his theory of liability that the pads were worn and lacked adhesiveness and that this allowed the current to generate excessive heat. The plaintiff also testified that the PTA inappropriately placed the pads directly over the bony prominence of the fibula head, which also contributed to the burn injury.
 
The PT clinic owner and treating PT testified that they believed that the PTA was experienced and competent to perform the IFC treatment. However, both admitted that they did not provide a comprehensive orientation regarding the IFC equipment that was being used at this clinic. The PTA testified that he did not receive formal training and was not informed of the manufacturer’s warning not to use alcohol products for cleaning the pads, as it may cause degradation of the adhesive. He testified that he cleaned the pads with alcohol because this was the procedure used at his previous place of employment. The PTA did not recall the patient’s complaint that the pads were not sticking properly.
 

Plaintiff’s experts:

The plaintiff’s PT expert testified that the PTA’s failure to follow the IFC manufacturer’s cleaning guidelines caused the pad’s adhesive covering to degrade resulting in an increase in electrical current resistance and an increase in heat at the point of skin contact. The plaintiff concluded that the improper IFC treatment was the direct and proximate cause of the burn and resultant nerve injury and noted the following causative factors:

• Excessive intensity
• Improper electrode placement over a bony prominence
• Failure to test patient’s sensory levels
• Damaged/worn electrodes

 
The plaintiff’s PT expert was also critical of the PTA for not immediately turning the current off and notifying the PT when the patient first complained of pain. The expert highlighted the fact that the patient was diabetic and had reduced sensation which limited his perception of the heat and that this should have been taken into consideration. The PT expert opined that the PT should have been supervising the PTA more closely and if she had, she would have intervened sooner which likely would have prevented the burn. The lack of documentation was a defense challenge in this case. The standard of care would be to document IFC settings, staff member performing the treatment and the patient’s response to each treatment.
 
The plaintiff’s pain medicine expert opined that the patient sustained a permanent peroneal nerve injury as a result of the third-degree burn surrounding the knee. This expert was critical of the PT for attempting to diagnose and treat the injury, for not immediately notifying the patient’s orthopedic surgeon once she identified the skin discoloration underneath the pad and for not giving the patient instructions on what to do if the condition worsened.
 

Defense experts:

The defense expert in physical therapy was unable to support the care provided in this case. She was critical that the PT did not assess the patient’s sensation given that he was a diabetic. She also opined that the PT should not have delegated the IFC treatment to a newly hired PTA. There was minimal documentation regarding any of the IFC treatments, which was viewed by the PT expert as a departure from the standard of care. The PT expert noted that burns during IFC therapy may be caused by excessive current intensity, improper electrode placement, or damaged electrodes that deliver an uneven distribution of current.
 
The neurology expert for the defense opined that the permanent neurological damages being claimed were unsubstantiated by objective diagnostic testing and more likely than not were related to the patient’s pre-existing diabetic neuropathy. The expert also noted that the patient was involved in a motor vehicle accident several months after the burn incident, which may have also contributed to the injuries being claimed. However, as previously mentioned, the patient refused to undergo a nerve conduction study to definitively determine the cause of his symptoms.
 
The defense team noted the following weaknesses in this case:

• There were no written policies pertaining to conducting IFC treatment, including inspecting the pads for defects and maintaining the integrity of the equipment.
• The pads used for this patient were immediately discarded, impeding the ability to demonstrate that the pads were not defective.
• The clinic did not have a formal training and orientation program for newly hired PTAs. There was only a 2-week shadowing protocol in which they were allowed to conduct patient care independently.
• The PT failed to properly delegate and supervise the PTA.
• The IFC treatments were poorly documented, lacking information about the type of treatment, name of the provider and the patient’s response to the treatment.
• An incident report was completed, but the result of the treatment was not documented in the patient’s healthcare information record.
• The PT failed to refer the patient for follow-up care and diagnosed the injury as an allergic reaction rather than a burn.
• The PT failed to complete a sensory test before recommending IFC treatment.
• The PT did not communicate with the PTA to inform him that the patient may have limited heat sensitivity related to his underlying conditions.

 

Resolution:

Burns identified during or immediately following an IFC treatment are difficult to defend. A complicating factor in this case was that the PT discarded the electrodes. The defense team believed that a jury may infer that this was an intentional act to “cover-up” liability. Therefore, based upon this and the above-noted weaknesses in the case, the defense team concluded that there would be a low potential for a defense verdict. The testimony of the defense  expert in neurology was instrumental in mitigating the damages aspect of the case enabling this case to be settled in mediation.

The total incurred for this case, including the expenses associated with defending the claim, was more than $500,000.
(Monetary amounts represent the payments made on behalf of clinic, the employed PT and the PTA)
 

Risk Management Recommendations for Physical Therapists:

• Be vigilant about protecting patients from burns associated with commonly used treatments, such as hot packs, cold/ice packs and electrical stimulation therapies.
• Utilize evidence-based burn prevention measures for IFC treatments including but not limited to the following:
  • Regularly inspect pads and refrain from reuse beyond the manufacturer’s recommendation. Electrode pads that are overused and/or have lost their adherence increase the risk of burns due to the increase in current in the portion of the pad that is adherent to the skin.
  • Clean skin and pads thoroughly in alignment with the manufacturer’s approved method before applying pads to ensure optimum conductivity. Assess skin integrity in the area where the electrode will be placed and avoid placing on irritated skin.
  • Ensure that staff are supervised when adjusting current intensity, starting with a low current and increasing gradually, while constantly monitoring the patient.
  • Ensure that the selected treatment is clinically appropriate and that there are no contraindications for their use, such as pregnancy and the presence of metal implants, among others.

• Monitor patients closely according to their specific condition giving special attention to the elderly, pediatric, or other patients with specific clinical needs.
• Perform a comprehensive assessment in order to recognize underlying medical conditions, co-morbidities and any additional risk factors that may affect patients’ ability to participate in the PT treatment plan, including but not limited to orthopedic conditions/surgery, diabetes, sensory loss, vision and hearing loss, neurological impairments, dementia, age-related risks, cardiopulmonary disease and side effects of medications.
• Seek opportunities for continuing education regarding handling patient injuries, and notify the patient’s medical provider of any untoward reactions to treatment.
• Document all pertinent patient information in the healthcare information record in an objective, concise manner. Maintaining consistent, comprehensive, and timely documentation of services provided is one of the physical therapist’s primary professional responsibilities, as noted in Principle 7E of the American Physical Therapy Association Code of Ethics for the Physical Therapist. Consider the following recommendations, among others, when documenting physical therapy notes:
  • Document patient assessments, equipment settings and operator of equipment, observations, communications, treatments, patient education.
  • Prior to initiating treatment, evaluate and document the patient’s skin integrity, neurological status, and sensory status and their ability to perceive pain and to communicate with staff. 
  • Include the results of objective tests and any evaluation of the patient’s  sensory, and cognitive status, if applicable.
  • Document reexaminations and revisions to goals/treatment plans, including data from repeated or new examination elements, to provide useful context for evaluating progress and modifying treatment plans.
  • Refrain from altering the healthcare information record, and enter late entries only when pertinent to patient care.

 

Risk Management Recommendations for Business Owners

• Develop and implement an incident management policy ,including how to handle equipment-related incidents and sequestering of the evidence.
• Remove any equipment that appears defective, label and store in a safe location. Review the policy in annual staff training sessions and when onboarding new staff members.
• Conduct, at a minimum, annual performance reviews for each employee, including a review of errors, “near misses,” and documentation, as well as directly observed competencies. Provide physical therapy staff with coaching and mentoring, as needed.
• Develop and implement written policies to ensure consistency of operations and adherence to standards of care. Review and update policies annually to ensure that they are in alignment with current practices.
• Provide ongoing education for all physical therapy staff members regarding policies and procedures, including incident reporting, documentation and patient emergencies, upon hire and ongoing thereafter.
• Ensure that appropriate job descriptions are in place, including supervisory expectations for all staff members.
• Be knowledgeable about the levels of supervisory responsibility of a PT and know when it is acceptable for a PT to have general, direct or direct personal supervision of physical therapy assistants, aides, students and any other clinical providers working at your place of business.
• Ensure that clinical and operational practices comply with state and federal standards and those endorsed by physical therapy professional associations, such as the American Physical Therapy Association (APTA) Standards of Practice, including but not limited to, the following:
  • The physical therapy service has a written and implemented plan for continuous improvement of quality of care and performance of services.
  • The physical therapy service has written policies and procedures that align with the APTA Standards of Practice that are implemented, reviewed regularly and revised as necessary, and reflect the operation, mission, purposes, goals, objectives, and scope of the Standards of Practice for Physical Therapy.
  • The physical therapist communicates, coordinates, and documents all aspects of patient care, including the results of the initial examination and evaluation, diagnosis, prognosis, plan of care, intervention, responses to intervention, changes in patient or client status relative to the intervention, reexamination, and episode of care summary.

 
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