From the Hudson River to the Hematology Wards: Why Simulation of Intrathecal Chemotherapy Can Save Lives

Let's start with two case examples:

1. "Mr. M" is a 36-year-old male with newly diagnosed B-cell acute lymphocytic leukemia (ALL) who presents with diplopia, a classic feature of central nervous system (CNS) involvement. During his first of several planned intrathecal (IT) chemotherapy sessions, he undergoes placement of the lumbar spinal needle under fluoroscopic guidance. Free-flowing cerebrospinal fluid was not attainable despite several adjustments by the radiologist and an x-ray confirming accurate placement at L3-L4 vertebrae. A dilemma ensued: Should the methotrexate (MTX) be instilled? Mr. M had received platelets, been fully consented, and was ready on the neuroradiologist's table. A decision had to be made; the procedure would be aborted. An MRI later revealed that he had congenital narrowing of his spinal canal below the L2 vertebra. The next day, his IT chemotherapy was successfully performed above L2 with free-flowing cerebrospinal fluid and with no side effects. He went on to have an uneventful hospitalization.

2. "Mrs. J" is a 55-year-old female with standard-risk B-cell ALL who presents for her first IT chemotherapy with MTX through an Ommaya reservoir. This had been placed because of extensive prior lumbar spinal surgery following a motor vehicle accident and repeated painful and unsuccessful lumbar punctures. Within a few minutes following instillation of the MTX, Mrs. J begins to complain of a headache and her right arm began to twitch leading to full tonic-clonic seizures. Aggressive maneuvers are initiated, but she quickly loses consciousness, lapses into a coma, and succumbs within 24 hours due to rapid neurological deterioration despite full support.

What happened? What are the lessons learned? What could have been the outcome had we plunged ahead with Mr. M, a recent patient on the hematology ward? What was missed for Mrs. J, a recent patient in the simulation center during an IT chemotherapy procedural workshop?

Despite a comprehensive checklist in hand, the fellow had failed to notice that the small vial labelled "15 mg of MTX" contained a light amber – not pale yellow–colored fluid and missed this case of an MTX overdose (FIGURE).

So, here's how and why I teach simulation-based training for IT chemotherapy.

Getting It Wrong is Typically Fatal

Over the last several decades, many cases of accidental IT overdoses of MTX and systemic toxicities have been reported. These overdoses result in seizures, respiratory failure, coma, and death. Numerous reports of inadvertent IT administration of parenteral drugs have also been described with dozens of cases involving vincristine, as well as a few reports with a variety of other drugs, such as daunorubicin, asparaginase, vindesine, doxorubicin, and dactinomycin. Nearly all cases have been fatal or resulted in severe irreversible neurologic impairment, and, sadly, these cases predominantly occur in the pediatric population.¹

Most recently, three fatal reports of mistaken IT bortezomib infusion have been described in adults.

The overwhelming conclusion one can draw from these tragic yet avoidable errors is the need for greater safety processes and adequate training of all members of the health-care team involved in these high-risk procedures.

Simulation in High-Risk Environments Saves Lives

Simulation has been used since the early 1900s in the military, and for more than 50 years in pilot training and law enforcement. Captain Chesley "Sully" Sullenberger set his maimed Airbus down on the Hudson River in a perfectly executed emergency landing in January 2009 after a flock of geese caused the engines to fail. He saved the lives of 155 people. Captain Sullenberger credited this "Miracle on the Hudson" in part to the many days he spent at the controls of a flight simulator, a requirement for airline pilots, while midair disasters happened all around him.

Simulation training boosts confidence and elevates competence by providing a safe and supportive environment for learning and applying critical procedural and decision-making skills. These skills are essential for operating in high-risk environments. The investment made in simulation appears to be paying significant dividends in the airline industry and in the military, and can deliver similar benefits to the healthcare community as well.

Medical errors and preventable patient harm is the third-leading cause of death in the United States, affecting roughly 200,000 patients per year, or the equivalent of 20 jumbo jets crashing every week.³

As a recent guest speaker at the inaugural Forum on Emerging Topics in Patient Safety at Johns Hopkins Armstrong Institute, Captain Sullenberger discussed how "the same critical skills of team communications, simulation-based training, and documented procedures that saved many lives that day can and should be applied to the health-care industry to help improve patient safety." He indicated that one person's heroic efforts are not enough: "A team of experts needs to be replaced by an expert team."³

ACGME and ABIM Require Safe and Effective Training of Procedural Skills and Access to Simulation

Current ACGME requirements include technical procedural skills, such as: bone marrow biopsies, delivery of chemotherapy through all routes, and supportive knowledge to consent patients and safely perform the required technical and non-technical skill set. These skills are assessed through a formal evaluation process that must include objective performance criteria. Fellows must also have access to simulation training.⁴ Additionally, the Next Accreditation System now requires all training programs to use milestones-based assessment and reporting through descriptive and observable behaviors for the evaluation of invasive procedure skills.⁵

Board certification in hematology from the ABIM has a similar procedural requirement; in the future, this requirement may be included in maintenance of certification (MOC), similar to requirements that our colleagues in procedural specialties must fulfill.

The Five Steps for Effective Simulation

So, how do I teach simulation-based training for IT chemotherapy via lumbar puncture and Ommaya reservoir? By applying these five steps for effective simulation:

STEP #1: Create a safe environment for the learner to foster a positive and low-stakes experience. Set the learner up for success by preparing and sharing all teaching materials in advance including relevant articles, videos, protocols, and assessment checklists. Review the key teaching points at the beginning of the session. Emphasize how and when assessment will occur, as well as the lack of academic consequences from errors that are committed and remediated in this setting.

STEP #2: Create stations to master the execution of the technical/procedural portion of the skill set first. Set the stage for the learning environment with appropriate task trainers (a.k.a. dummies) to teach the technical aspect of lumbar puncture and accessing an Ommaya reservoir before adding the patient-centered scenarios.

STEP #3: Create realistic scenarios and patientcentered sets that include essential components of competence. Patient assessment, clinical diagnostic reasoning, application of judgment, and decision-making regarding management should play a role in each of the case scenarios. Further supplement the scenarios with elements of non-technical skills, including interpersonal communication skills. These could highlight team communication and teamwork by engaging all participants as learners through role assignment (i.e., fellow, neurosurgeon, radiologist, hematologist, pharmacist, nurse, advanced-level provider, and patient). Identify physical space within your set where all participants in the group actively work together toward the stated objectives (i.e., a pharmacy, the bedside, a workroom for computer/ medical record review).

STEP #4: Create an immersive experience with high-risk patient narratives, which is critical for engagement. Adhere as closely as possible to realistic situations and experiential immersion, where educators purposefully engage learners in direct experience and focused reflection in order to increase knowledge and develop skills. This is best done by deliberately inserting errors along a carefully crafted protocoled checklist. Follow these steps when planning: (1) obtain informed consent, (2) verify patient information and therapy plan, (3) verify the delivery vehicle (Ommaya or lumbar puncture), (4) verify and acquire chemotherapy, (5) conduct a procedural pause, (6) access and/or deliver chemotherapy, (7) provide post-procedural instructions, and (8) complete required procedural documentation.

STEP #5: Create comprehensive checklists to assess key components to evaluate and document competency in real-time, while providing immediate feedback and supportive remediation. To be competent, the learner must: perform every step of the checklist, recognize inserted errors and their consequences, and remediate errors immediately. Errors are remediated by either repeating the procedure with a different patient scenario, or describing the error, its consequences, its management, and how to avoid it in the future.

From Simulation to the Bedside and Beyond

The principles described in simulation-based training of IT chemotherapy can and should be applied to all procedures we perform. It is clear that the technologies and processes needed to reduce patient harm already exist and have been proven in other industries time and time again. We can address safety-related challenges by designing highly reliable systems of care delivery through simulated training of protocol-based processes that should then become generalized practice guidelines. We should endeavor to find ways to effectively disseminate and incorporate best practices in the areas of safety and quality – championed by our subspecialty societies. We also need to develop performance measures that are meaningful to patients and health-care providers, such as reduced errors, reduced complications, and increased patient satisfaction. Whether performing diagnostic tests, delivering chemotherapy or breaking bad news, we, as hematologists, can experience our own "Miracle on the Hudson" every day on the wards. When we arm ourselves with strategies based on hands-on experience through training, we can masterfully deal with whatever "flock of geese" we may face at the bedside of the patients we are called to serve.

References

1. Gilbar PJ. Intrathecal chemotherapy: potential for medication error. Cancer Nurs. 2014;37(4):299-309.
2. European Medicines Agency. Recommendations to prevent administration errors with Velcade (bortezomib). 2012 January 19. Accessed from www.ema.europa.eu/ docs/en_GB/document_library/ Medicine_ QA/2012/01/WC500120701.pdf.
3. Szczerba RJ. Captain ‘Sully' Sullenberger and Johns Hopkins tackle patient safety. Forbes. 2013 October 2. Accessed from www.forbes.com/sites/robertszczerba/ 2013/10/02/captain-sully-sullenberger- and-johns-hopkins-tackle-patientsafety.
4. Accreditation Council for Graduate Medical Education Program Requirements for Graduate Medical Education in Hematology and Medical Oncology (Internal Medicine). Accessed from acgme.org/ acgmeweb/Portals/0/PFAssets/2013-PRFAQ- PIF/155_hematology_oncology_int_ med_07132013.pdf.
5. Accreditation Council for Graduate Medical education, The Internal Medicine Subspecialty Milestones Project. Accessed from acgme.org/acgmeweb/Portals/0/PDFs/ Milestones/InternalMedicineSubspecialtyMilestones. pdf.