Duties and responsibilities
Managing the medico-legal risks of placing a central line
Originally published December 2011
Central lines are widely and effectively used in clinical medicine. The cannulation of major veins allows physicians to manage and monitor inpatients and outpatients. The ability to place these lines safely crosses many specialties and includes trainees. Complications such as vessel laceration, pneumothorax, neurological injury, atrial perforation, retroperitoneal hematoma, venous thrombosis, and infection are infrequent, but can have serious consequences for patients.
From January 2000 to September 2011, 72 CMPA cases (64 closed, 8 open) involved the placement of a central line. Of the 64 closed cases, 47 (73%) were legal actions or threats of a legal action, and the remaining 17 (27%) were complaints to medical regulatory authorities (Colleges), hospitals, or inquests. In the 47 cases involving a legal action or the threat of a legal action, more than half (27) were dismissed, 18 were settled, and 2 proceeded to court with a judgment in favour of the physician. Of the 17 College or hospital complaints and inquests, 13 were dismissed or not pursued, and 4 resulted in further College action.
The CMPA's analysis reveals the following medico-legal concerns with central line placement: the standard of care, informed consent, delegation, and documentation. The following cases illustrate these themes.
Standard of care concerns
A 77-year-old female developed renal failure secondary to hypertension and was placed on dialysis. An A-V fistula was created in her left arm, but access to the fistula became increasingly difficult. As an interim measure, her nephrologist decided to establish temporary access by placing a hemodialysis catheter in her neck.
After consent was obtained, placement of the line was attempted in a procedure room of a satellite dialysis clinic. After landmarking a middle approach to the right internal jugular vein, a finder needle was used to locate the vein. The introducer needle was then used and a good flashback or return of venous blood was observed. However, resistance was encountered while attempting to thread the guidewire. Two subsequent attempts were unsuccessful, and after the third attempt the guidewire was withdrawn and noted to be kinked. The nephrologist requested a new guidewire and was provided one without a J tip. During the fourth attempt the patient became short of breath and hypotensive. The procedure was terminated and the patient was immediately transferred by ambulance to a nearby emergency department.
During transport the patient suffered cardiac arrest. A right-sided chest tube placed during the arrest drained 2,500 cc of blood. Despite these measures the patient could not be resuscitated. During the autopsy a 3 mm tear of the right brachiocephalic vein was identified. The patient's son filed a complaint with the College and initiated a legal action alleging that the line placement constituted negligence and that no consent discussion had occurred.
The College initiated an investigation and retained a nephrologist as an expert. In her opinion, the vein laceration most likely occurred secondary to forceful attempts to thread the straight guidewire. She concluded that the issue was not that a complication had occurred but that standards outlined in the literature and advised by the Kidney Disease Outcome Quality Initiative were not met. She said the nephrologist's clinical practice, behaviour, and conduct were appropriate, but in future the doctor's approach to line placement needs to include the appropriate use of diagnostic imaging techniques. Consequently, the College issued a verbal caution and mandated that the nephrologist obtain additional training in line placement. For the legal action, expert support was sought for the physician but could not be obtained. The CMPA, on behalf of the nephrologist, paid a settlement to the family.
Informed consent and delegation concerns
A 63-year-old female with a history of multiple myeloma was admitted to hospital for surgical stabilization of a pathological fracture of her left humerus. Post-operatively she developed renal failure requiring hemodialysis.
Before discharge, her nephrologist decided to place a permanent tunnelled dialysis catheter. This task was delegated to an experienced physician, a fellow in nephrology. Prior to the procedure, an explicit consent discussion was documented that included the risk of vessel laceration and pneumothorax.
The right internal jugular was identified under ultrasound guidance. On the first attempt, a free flow of blood was obtained through the introducer needle, and the guidewire was threaded without difficulty. During the introduction of the vein dilator, resistance was encountered at 6 –7 cm. The dilator was withdrawn, but the same difficulty was encountered on the second attempt. Shortly afterwards the patient became hypotensive and bradycardic. Resuscitation was unsuccessful. At autopsy, a large hemothorax was identified secondary to a 1 cm laceration of the superior vena cava, as well as a laceration to the right upper lobe.
A year later the patient's family lodged a complaint with the College against the fellow and the attending nephrologist. The family alleged that the procedure had been performed negligently and without supervision.
Before writing his response, the fellow contacted the CMPA for advice. He responded to the College stating that he sincerely regretted the tragic outcome. He also emphasized that he had carefully performed this procedure and had never previously experienced such a complication. The College reviewed the complaint and obtained an expert opinion with respect to the central line insertion. The College concluded that informed consent had been obtained and that vessel laceration, a rare but recognized complication, does not mean the procedure was performed in a substandard manner. The College also stated that the delegation of this procedure to the fellow was appropriate. The complaint was therefore dismissed.
Standard of care and documentation concerns
A 61-year-old male had surgery for an enterocutaneous fistula. Two weeks later the patient presented with an abscess at the surgical site and a possible recurrence of the fistula.
His surgeon consulted a gastroenterologist with respect to total parenteral nutrition (TPN). The gastroenterologist agreed that TPN was indicated and requested that a peripherally inserted central catheter (PICC) be placed by the IV team. The insertion was difficult, but on the third attempt the tip of the catheter was in the distal left subclavian vein as reported by the radiologist. The nurse contacted the gastroenterologist to ensure that this placement was adequate. The gastroenterologist did not personally review the X-ray studies.
TPN was initiated using a full strength 17% dextrose solution. One week later the patient's arm became red and swollen. Over the ensuing four days the swelling progressed and the supraclavicular fossa was noted to be swollen and hard. A duplex scan showed an extensive clot in the superior vena cava and the left brachiocephalic vein. The PICC line was pulled and anticoagulation was initiated. The following day the patient developed progressive numbness and weakness in the left arm. The patient's medical record did not include documentation of these events. A neurologist who was consulted diagnosed a profound brachial plexopathy secondary to soft tissue swelling.
Despite aggressive physiotherapy the weakness of the arm did not improve. Several years later the patient launched a legal action. Experts for both the plaintiff and the defendant thought the brachial plexus injury was caused by edema secondary to thrombosis and possible extravasation of hypertonic TPN fluid. Expert support could not be obtained for the decision to initiate full strength TPN without verifying that the PICC line was in the vena cava. The patient received a settlement, the payment of which was shared by the CMPA on behalf of the gastroenterologist and the hospital.
Lack of documentation concerns
On a Friday evening, a 19-year-old female passenger was involved in a high speed car crash. Her past medical history included transposition of the great vessels surgically corrected with a Mustard procedure.
On arrival in the emergency department, she was alert and had normal vital signs. There was an obvious compound fracture of the right ankle. Attempts at establishing a peripheral intravenous were unsuccessful and an 8.5 French central venous catheter was placed in the right internal jugular vein by the emergency physician. A chest X-ray obtained following the line insertion did not reveal any specific injuries. However, no specific comment was made concerning the line position.
The patient was admitted to the orthopaedic service and underwent surgery the following day. A radiologist reviewed her films 60 hours post-admission and noted that there were no signs of trauma and that a central venous catheter had been placed. The radiologist did not comment on the location of the distal tip of the line. In addition, the radiologist was not provided with any information about the previous cardiac surgery.
Four days after her surgery, the patient became hypotensive and hypoxic. A physical exam revealed the absence of air entry to her left chest. On the suspicion of a pneumothorax, a 14-gauge needle was inserted in the upper left chest, which immediately drained clear fluid. A chest tube was placed which drained 1.5 litres of clear fluid. The attending physician repositioned the central line and consulted thoracic surgery. At thoracotomy, perforations were found in the left atrium and pericardium. These were repaired, however, the patient died later that day.
A subsequent legal action named all the physicians involved. Evidence could not be found to support the actions of the emergency physician and the radiologist. As a result, the patient's family received a settlement. The payment of that settlement was shared by the CMPA (on behalf of the two physicians), the hospital, and the driver's insurer.
Risk management suggestions
The following risk management suggestions are based on the CMPA's analysis of the expert opinions in the cases reviewed:
- Conduct an informed consent discussion with the patient and document it in the medical record.
- Determine whether the patient's coagulation status should be assessed.
- Know the institution's policies on elective central line insertion and the use of imaging.
- Determine whether there are complicating anatomic features. If difficulties are anticipated in placing the line, consider using diagnostic imaging.
- Consider whether the procedure should be performed by a colleague who is more experienced with central line insertion.
- If the procedure is being delegated, be satisfied that the person performing the procedure has the requisite knowledge and skill to safely attempt the insertion.
- Have adequate resources and assistance available in case of complications.
- Verify the positioning of the line prior to starting an infusion.