A Femoral Sheath Fatality | AHRQ Patient Safety Network

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Cases & Commentaries

Spotlight: A Femoral Sheath Fatality
After undergoing a scheduled percutaneous coronary intervention, a man with a femoral sheath still in place was admitted to the medical ward, where several beds had recently been converted to cardiac telemetry beds. Having limited experience with femoral sheaths, the nurse removed it but was unable to assess the patient every 15 minutes as required due to becoming busy with another patient. One hour later the patient was unresponsive, a code was called, and he was transferred to the intensive care unit where he died several hours later. In the commentary, Hildy Schell-Chaple, RN, PhD, of UCSF discusses bleeding events associated with femoral vascular access sheaths used for interventional cardiac diagnostic procedures and highlights how applying a systems approach to practice changes can optimize safety and performance improvement outcomes. (CE/MOC available.)

Cases & Commentaries
Published September 2019

A Femoral Sheath Fatality

SPOTLIGHT CASE
CE/MOC

Commentary by Hildy Schell-Chaple, RN, PhD

Case Objectives

The Case

A 57-year-old man with a past medical history of hypothyroidism, diabetes, and coronary artery disease was admitted to the cardiology service for monitoring after undergoing a scheduled percutaneous coronary intervention. Upon arrival to the medical ward, he still had a right femoral sheath in place.

The patient's bedside nurse received signout from the nurse in the cardiac catheterization laboratory and was instructed to monitor the patient and remove the femoral sheath when appropriate. Although the hospital had converted eight beds on the medical ward to cardiac telemetry beds, the nurses on that unit had not received additional training regarding the specific care needs for patients undergoing interventional cardiac procedures. The unit's charge nurse and nurse educator had raised concerns regarding the addition of cardiac beds without such training, but the hospital had moved ahead with the change anyway.

The patient's nurse had limited experience with femoral sheaths, having removed one for the first time only 2 months prior. At midnight, she removed the sheath and left the room after achieving hemostasis. She was supposed to examine and assess the patient every 15 minutes for the next hour but became busy with another patient. Almost an hour later, the telemetry technician noted that the patient's QRS complex appeared wide on the monitor and called the nurse. The nurse entered the patient's room and found him unresponsive and bleeding from the femoral access site. A code was called and cardiopulmonary resuscitation was initiated. The patient was intubated and transferred to the intensive care unit. He died several hours later.

The hospital convened a root cause analysis and identified that the nurses on the medical unit had not been adequately trained on required competencies for the care of patients after cardiac procedures.

The Commentary

by Hildy Schell-Chaple, RN, PhD

The rates of bleeding and vascular access site complications associated with percutaneous coronary intervention (PCI) and diagnostic cardiac catheterizations are variable due to nonstandard definitions. One study of more than 1 million PCI procedures from the National Cardiovascular Data Registry's CathPCI Registry reported a 5.8% rate of major bleeding complications within 72 hours of the procedure.(1) Major bleeding events include hematoma formation at the vascular access site, vessel injury (arteriovenous fistula, pseudoaneurysm), and retroperitoneal hemorrhage.(1,2) This surprisingly high rate of major bleeding events highlights the need for a comprehensive system to ensure safe and quality care for post cardiac catheterization patients, including initial and ongoing assessments and planning to identify the location, staff, and support structures.

Hospitals and health care systems that are expanding services to remain financially viable are faced with many challenges. Identifying available space, resources, and appropriately trained staff to care for patients is a typical first step when managing increases in patient volume. This case underscores the importance of using a systems approach for planning and implementing such changes. The patient safety risks associated with introducing a new patient population to an inpatient or outpatient care department should not be underestimated.

A systems approach to a new practice of recovering patients after interventional cardiac procedures on the medical acute care unit would have identified nurse training as an important gap for the hospital in this case to address. Yet, training alone may not have prevented this harm event. Systems thinking is essential for achieving safe and high-quality care when implementing small or large changes in dynamic and highly complex hospital environments.(3,4) A systems approach that could be used for introduction of a new therapy into a practice area is outlined in the Table, using this case as an example. Implementing practice changes such as in this case requires participation from key stakeholders, including operational leaders and frontline clinical experts. Such practice changes are ideally led by a clinical nurse specialist who is uniquely trained in leading system improvements and is an expert in the care of the patient population affected by the change.(5)

Clinical competence has been defined as the ability to integrate knowledge and skill in particular situations.(6) Benner's stages of clinical competence (novice, advanced beginner, competent, proficient, and expert) describe the levels of skill acquisition that nurses traverse in their professional growth.(7) This hierarchy helps explain why an outcome may be different when a new or junior nurse is involved as compared to an expert nurse, even when both have completed the same competency validation for a new procedure. Unlike the novice nurse, the expert nurse has experiential knowledge and can anticipate needs or take actions that can positively impact outcomes. Although complex nursing care is provided to high-acuity patients across the country, there are no national regulatory requirements for hospital-based training or competency validation processes for basic and specialty nursing practices. While hospitals have nursing education programs and methods for evaluating competency on a number of skills and procedures, the resources required to provide initial training and ongoing competency validation can challenge the nursing budget.(8)

Rigorous competency validation programs include competency-based objectives with defined criteria, methods of learning, and methods of evaluation (e.g., knowledge test, case-based test of critical thinking, simulation test, demonstration).(9) The frequency of competency validation should reflect the risk level of the skill or therapy and the volume of experience with the procedures. While the removal of arterial and venous sheath catheters would be both a high-risk and high-volume procedure for nurses in cardiac catheterization laboratory settings, it would be high risk and low volume for acute care nurses. It is also important to consider the likely frequency of a nurse having a patient assignment with the high-risk therapy when determining the volume. One quality improvement study discovered that fewer than 5% of the acute care telemetry nurses would ever remove postprocedure sheath catheters. Despite aggressive education, the complication rates did not decrease until the hospital created a holding area in the catheterization laboratory where a core group of skilled staff removed sheaths and monitored patients for 1 hour before transferring them to the acute unit.(10)

Cardiac nursing specialization is acknowledged through the American Association of Critical-Care Nurses (AACN) Certification Corporation. The Cardiac Medicine Certification (CMC) is the subspecialty certification that validates knowledge, skills, and abilities required for safe and effective nursing practice in provision of direct care to adult cardiac patients. This certification requires a specified number of hours in direct care of cardiac patients and passing an exam that covers cardiovascular patient care problems; related other organ system patient problems; therapeutic interventions (procedures, devices, pharmacology, multisystem organ support); and monitoring and diagnostics (hemodynamics, stress tests, echocardiogram, blood gas interpretation). This certification is not a requirement for employment in hospitals or cardiac procedural units.(11)

To create standard procedures for nurses, hospitals either use procedures written by their own staff nurses or use procedures from a published procedure manual. The AACN Procedure Manual for High Acuity, Progressive, and Critical Care has a procedure for femoral arterial and venous sheath removal with an explanatory footnote, "This procedure should be performed only by physicians, advanced practice nurses, and other healthcare professionals (including critical care nurses) with additional knowledge, skills, and demonstrated competence per professional licensure or institutional standard."(12) This evidence-based procedure outlines the steps, rationale, and reportable conditions for patient education, preprocedure assessment and preparation, arterial and venous sheath removal, and patient assessment during and after sheath removal. Training and preprocedure checklists should include review of the risk factors associated with bleeding complications (larger size of sheath catheter, anticoagulant or antiplatelet medication use, prolonged activated clotting time result, obesity [for femoral sites], and hypertension). The postprocedure patient assessment includes vital signs, hemodynamic status, access site, and distal limb perfusion, sensation, and movement. The frequency of assessment after sheath removal—every 15 minutes x 4, then every 30 minutes x 2, then every 1 hour x 4 hours—is consistent with many hospital procedures and published references.(12-14) Additional training is required if nurses monitor patients with and/or apply mechanical compression devices used to achieve hemostasis. The care plan differs for patients with radial artery vascular access sites or when a percutaneous plug, suture, or staple/clip closure devices.(12,14)

This case also highlights the harm that can occur when assumptions are made by physicians about nursing standards of care and hospital levels of care. Many clinicians seem to believe, incorrectly, that a patient on telemetry receives a higher level of care (over and above the alerts for significant cardiac rhythm or rate changes) than a patient on a standard ward. In this case, it is unclear if there was a belief that changing eight beds to cardiac telemetry beds would translate into those beds being staffed by trained and experienced cardiac telemetry nurses. Although physicians are asked to determine and order the level of care for their patients, how many have seen and are familiar with their hospital's nursing standards of care for acute care, transitional/progressive/step-down, and critical care units? The standards of care outline the basic level of care (assessments and interventions) that the patient can expect to receive per the level of care assignment/unit. These environment and system-based assessments and interventions are used in conjunction with the care plan, procedures, and orders in the provision of care by nurses. Nurse leaders in high reliability organizations ensure the medical staff, typically medical directors, review the standards of care and are familiar with the details of what comprises the respiratory and neurologic assessments and routine safety checks completed by nurses.

In this case example, the nurse was unable to complete the frequent postsheath removal assessments since she became busy with another patient. Unfortunately, this is a reality on a hospital ward, and it is not predictable. This highlights a training and culture improvement opportunity: Nurses should be encouraged to call the charge nurse or another colleague for assistance to ensure that all patient needs are met. If the charge nurse cannot provide assistance, what is the chain-of-command escalation plan during the day and night shifts? Typically, a supervisor can assist with reallocating nurse resources within the hospital when needed. The moral distress that nurses, physicians, and other clinicians experience when they raise a concern that is not addressed and a harm event occurs can be devastating. Hospital leaders in high reliability organizations respect employees, value their frontline wisdom, and know that their employees want to learn and improve safety and operations.(15) A safety culture that encourages speaking up along with training on who to escalate to and how to do so will reap benefits for patients and team members. A systems approach and strong culture of safety could have prevented this unfortunate event and the long-lasting negative impact on the family members and clinicians involved.

Take-Home Points

Education and training for high-risk procedures in and of itself does not ensure safe and high-quality care.
Postprocedure arterial and venous sheath removal by experienced and skilled clinicians who also monitor these patients in a designated observation area/unit can minimize vascular access complications.
A systems approach to practice changes is essential to optimize safety and performance improvement outcomes.
The systems approach for planning, implementation, and evaluation of practice and system improvements requires an interdisciplinary team of frontline clinical experts and operational leaders.
The strength of a hospital's or unit's culture of safety is influenced by the standards and expectations for voicing and escalating concerns set by leadership as well as the follow-up response.

Hildy Schell-Chaple, RN, PhD
Clinical Nurse Specialist
Patient Safety & Regulatory Affairs
University of California, San Francisco, Medical Center
Clinical Professor, UCSF School of Nursing

Faculty Disclosure: Dr. Schell-Chaple has declared that neither she, nor any immediate member of her family, has a financial arrangement or other relationship with the manufacturers of any commercial products discussed in this continuing medical education activity. In addition, the commentary does not include information regarding investigational or off-label use of pharmaceutical products or medical devices.

References

1. Rao SV, McCoy LA, Spertus JA, et al. An updated bleeding model to predict the risk of post-procedure bleeding among patients undergoing percutaneous coronary intervention: a report using an expanded bleeding definition from the National Cardiovascular Data Registry CathPCI Registry. JACC Cardiovasc Interv. 2013;6:897-904. [go to PubMed]

2. Rymer JA, Kaltenbach LA, Kochar A, et al. Comparison of rates of bleeding and vascular complications before, during, and after trial enrollment in the SAFE-PCI trial for women. Circ Cardiovasc Interv. 2019;12:e007086. [go to PubMed]

3. Clarkson J, Dean J, Ward J, Komashie A, Bashford T. A systems approach to healthcare: from thinking to practice. Future Healthc J. 2018;5:151-155. [go to PubMed]

4. de Savigny D, Adam T, eds. Systems Thinking for Health Systems Strengthening. Geneva, Switzerland: WHO Press; 2009. ISBN: 978-9241563895.

5. Lewandowski W, Adamle K. Substantive areas of clinical nurse specialist practice: a comprehensive review of the literature. Clin Nurse Spec. 2009;23:73-90. [go to PubMed]

6. Fukada M. Nursing competency: definition, structure, and development. Yonago Acta Med. 2018;61:1-7. [go to PubMed]

7. Benner P. From Novice to Expert: Excellence and Power in Clinical Nursing Practice. Upper Saddle River, NJ: Prentice Hall, Inc.; 1984. ISBN: 9780201002997.

8. The KPMG Healthcare & Pharmaceutical Institute. KPMG's 2011 U.S. Hospital Nursing Labor Costs Study. [Available at]

9. Levine J, Johnson J. An organizational competency validation strategy for registered nurses. J Nurses Prof Dev. 2014;30:58-65. [go to PubMed]

10. Gonzales L, Fields W, McGinty J, Gallo AM. Quality improvement in the catheterization laboratory: redesigning patient flow for improved outcomes. Crit Care Nurse. 2010;30:25-32. [go to PubMed]

11. American Association of Critical Care Nurses Certification Corporation. Cardiac Medicine Subspecialty Certification Exam Handbook. May 2019. [Available at]

12. Shaffer RB. Femoral arterial and venous sheath removal. In: Wiegand DL, ed. AACN Procedure Manual for High Acuity, Progressive, and Critical Care. 3rd ed. St Louis, MO: Elsevier; 2011:664-671.

13. Kern MJ, Sorajja P, Lim MJ. The Cardiac Catheterization Handbook. 6th ed. Philadelphia, PA: Elsevier; 2016. ISBN: 9780323340397.

14. Merriweather N, Sulzbach-Hoke LM. Managing risk of complications at femoral vascular access sites in percutaneous coronary intervention. Crit Care Nurse. 2012;32:16-29. [go to PubMed]

15. Weick KE, Sutcliffe KM. Managing the Unexpected: Sustained Performance in a Complex World, 3rd edition. San Francisco, CA: John Wiley & Sons; 2015. ISBN: 9781118862414.

Table

Table. Systems Approach for Planning and Implementing a Practice Change.

System element	System assessment	Case example
Patient population	Age group(s) Diagnosis and commonly associated comorbidities Treatment types (surgical, interventional, medical) Anticipated volume: number of patients, admission frequency, length of service	Adult cardiac disease patients Coronary artery disease, heart failure Diagnostic cardiac catheterization and percutaneous coronary intervention with anesthesia care or moderate sedation 4 patients per week, cases on Tuesdays and Thursdays, 1-day LOS
Patient care needs	Type, level, and frequency of monitoring Management of therapies and interventions Care support service needs (respiratory care, rehabilitation services, social work, nutrition, case management, pharmacy, palliative care) Primary medical service Medical/surgical consultative service	Postprocedure monitoring of vital signs, cardiac telemetry (rate, rhythm), pulse oximetry, vascular access device and site, and limb perfusion, sensation, movement including increased frequency post sheath removal General care and monitoring of coagulation status (point-of-care ACT and labs), signs of bleeding, signs of cardiac ischemia, arrhythmia identification, signs of vasovagal response and interventions, and emergency responses for potential complications (cardiac ischemia, lethal arrhythmias, bleeding) Is the interventional cardiology or another service the primary service for the patient when on the unit?
Support systems	Informatics (EHR orders, flowsheets, integration with other systems) Provider contact/call structure Emergency plan (code blue, rapid response activation)	Are postprocedure order sets with specified monitoring criteria and notification parameters needed? Can the nurses use the same flowsheet that the cath lab uses or is there an improvement opportunity for nursing informatics? Is the procedure record and report accessible to view by the team? Is the provider contact information easily accessible in the EHR or site used on the unit? Have the rapid response and code teams been alerted to the new population on the medical unit?
Environment	Adequacy and safety of physical space for patients/family and staff Equipment/supply storage and access Emergency supplies (code cart, etc.)	8 beds on medical unit with adequate space in rooms, code cart present Are the 8 beds in a high-visibility section of the unit? Are pressure dressings, sheath/CVC removal kits, Doppler devices, blood administration sets with hand pump available?
Resources	Insurance authorization/reimbursement Equipment and supply budget	Insurance coverage reviewed Need additional telemetry transmitters and a central monitor for unit; POCT device and cartridges for ACT monitoring; mechanical compression devices
Evaluation	Does this practice change require a quality improvement program or short-term quality-monitoring plan? Identify quality and safety metrics.	Identify a tracking method to evaluate volume and measure identified care indicators (e.g., monitoring documentation) and outcomes (complications, LOS).

LOS length of stay; ACT activated clotting time; ECG electrocardiogram; EHR electronic health record; CVC central venous catheter; POCT point-of-care test