Post Procedure Groin Complications: An Overview of Clinical Responsibility, Documentation, and Legal Considerations

This article received a double-blind peer review from members of the Cath Lab Digest Editorial Board.

(Clifford) Lane DeBruce can be contacted at lane.debruce@gmail.com.

As most of us know that have worked in the cath lab area, post procedure groin complications can be a nightmare. Anyone who has held pressure over an arterial site or deployed a closure device understands that “hemostasis” is our goal. As a legal nurse consultant, I’ve had the opportunity to work on some cases involving post procedure cath lab deaths resulting from groin complications.  Reviewing cases from a legal standpoint, I’ve noted some disturbing trends and gaps in procedures surrounding post procedure care that need to be addressed. When we take responsibility for a patient, we are forever linked to them — morally and legally as the caregiver. Complacency in our treatment and failure to use common sense can result in a scenario where you are sitting opposite an attorney and patient’s family explaining what happened and wondering did I do the right things?.

Location, location, location!

First let’s look at sheath removal and the process of holding pressure. You should review your facility protocol and practices, and have an intimate knowledge of the required procedural content related to post procedure sheath removal. The staff member removing the sheath must be trained in peripheral anatomy, emergent procedures, experienced in sheath removal¹, and, at a minimum, be advanced cardiac life support (ACLS)-certified. It is difficult to defend legal cases where competencies in these areas are not documented in the staff member’s personnel file. In reviewing various standard techniques from teaching institutions and educational reference books, standard pressure holding times varied but commonly were in the 20-minute range.^2,3 All the clinical references noting equipment required for sheath removal and personal protection standards are relatively standard. While almost all clinical references mentioned distal pulse check pre and post sheath removal, only a few stated checking the femoral artery pulse at the sheath site just prior to removal. Surprisingly, though, none of the references indicated the importance of documenting the successful location of the femoral artery. Only one of the references stated what to do if no femoralpulse was found.⁴  Red flag! It is critical that if you don’t palpate a femoral pulse, don’t pull the sheath! The sheath is not the landmark to hold pressure; therefore, you must focus on the femoral pulse as the landmark to hold pressure.^2,3 It is critical to know the location of the femoral artery, because its location may be masked by the direction of the sheath deep within the tissue, or the anatomy of the artery may have a medial or lateral curve. If the femoral artery cannot be located prior to sheath removal, there are some simple options available: using the Doppler³ or portable ultrasound allows you to acquire accurate artery location to ensure proper hand placement for pressure hold prior to sheath removal. Blindly pulling the femoral sheath, without first accurately assessing the femoral pulse, results in a high risk for bleeding and hematoma in the patient. As an example, one institution recommended that the clinician removing the sheath have the opportunity to review the patient’s femoral angiography.³ While this is a great idea, femoral angiography may not be a common practice during sheath insertion in all institutions. Further, the clinician removing the sheath may not have access to the archived video or may not be trained in reviewing femoral angiograms. 

Post procedure communication and documentation

 All communication about the patient’s procedure needs to be communicated via a “hand-off communication” process to the clinician who will be removing the sheath. This includes, but is not limited, to:

a)    Catheter French size;

b)    Length of sheath;

c)    Type of procedure;

d)    Number of attempts that were required to attain femoral artery access;

e)    Type of access used (Seldinger or modified Seldinger);

f)    Lab results;

g)    Types and dosages of narcotics used in the procedure;

h)    Anticoagulants used in the procedure and if discontinued, the time discontinued;

i)    An estimate of blood loss during the case;

j)    Type/amount of contrast and fluid administered in the case;

k)    Any complications prior to or during the procedure;

l)    Pertinent patient medical history (diabetes, previous back or abdominal pain, longstanding anticoagulant therapy, cardiac and surgical history, etc.);

m)    Any hematomas present prior to the procedure (at sheath insertion site or lower abdomen);

n)    Any known peripheral vascular disease or anatomical deviation of the femoral artery or injury to it;

o)    Vital signs during procedure;

p)    Distal pulses prior to sheath insertion.

Relaying these critical elements assists the clinician in adjusting treatment as necessary, involving the physician as appropriate, and in being prepared for any clinical situation. While hand-off communication is important and required by regulatory bodies⁵, if there is no record of what information was shared, it is hard to say with confidence that it occurred. I’ve had the opportunity to review many depositions of cath lab clinicians where the lack of this documentation contributed to the appearance of clinical care below standards. This ultimately can result in litigation, mediation, or settlement of the case. You and your facility should review the protocols for hand-off communication and documentation required in order to ensure all these areas are covered for the clinicians sending and receiving the patient. 

The old saying that “knowledge is power” holds true here — the more knowledge we have about the patient and his or her current medical history, the more power we have to ensure a positive outcome. 

Size matters!

Obese patients present a more complex challenge to sheath removal and hemostasis. Remember the greater the patient’s body mass index (BMI), the greater degree of difficulty in sheath removal, thus the greater care needed in regard to patient safety.⁶ Although some of the material I reviewed addressed how to remove a sheath or hold pressure in the obese patient, it mostly failed to cover one very important area. Upon arrival to the cath lab, typically non-obese patients are both transported and the procedure completed on a gurney with a stiff mattress. Because of their size, obese patients may arrive with a thicker, air-type mattress and post procedure, are placed back on those beds. This type of mattress works against the dynamics involved in holding pressure post procedure in an obese patient. This mattress factor is a significant variable in potential post procedure complications. Pressing down on a large patient’s groin resting on a thick mattress actually pushes the entire patient further down in the bed, thus not attaining the correct amount of pressure you need to maintain control over the arterial puncture site. This gives a false sense of creating hemostasis, when in actuality the clinician is possibly not maintaining any control over bleeding. The size of the patient, the thickness of the soft mattress, plus the previously mentioned potential difficulty in locating the femoral artery create the trifecta of complexity in these obese patients. An obese person can easily bleed into the lower abdominal cavity and not show any signs of an external hematoma, no matter how long the pressure is held. Corrective methods can easily be applied to help reduce the mattress factor risk. In addition to the potential assistance from using the Doppler³ and ultrasound to locate femoral pulse prior to sheath removal, it may be advantageous to gently roll your patient to one side and place a CPR board or other patient-compatible board underneath them. Then you have a solid surface to push against — the same mechanics utilized during successful CPR. This is the key! Pushing against a solid surface serves to assist in maintaining consistent pressure on the arterial site as well as ensuring better control. 

Another difficulty in the obese patient involves the abdominal pannus. If a patient has a large pannus, it may require a two-person team to remove the sheath safely; one to hold the abdomen back and the other to remove the sheath and hold pressure. Unfortunately, it will be uncomfortable for the patient in the short term, but you have increased your ability to maintain hemostasis, thus lowering the risk of bleeding post procedure in the obese patient. 

Although I am highlighting the challenges encountered with the obese patient in the cath lab here, there are other important clinical indicators that also may compound the complexity of any given procedure, such as hypertension and patients with previous multiple groin procedures, which may cause the formation of scar tissue at future access sites, thus complicating hemostasis. 

Post procedure monitoring

We all have busy days in the cath lab where sometimes we do things unconsciously or out of habit, especially in high-volume labs where 15+ procedures may be completed in a day. Patients are brought into the lab, put on monitoring devices, and upon completion of the procedure, unhooked from those monitoring devices and transferred out to the ICU, Recovery/Holding area, or PACU, and the next case begins.⁷ In some cases, that transfer to the next level or area of care is delayed — sometimes a bed isn’t readily available, sometimes transport personnel are tied up, or any number of other possibilities. From a legal perspective, one of the first things I do when reviewing the documentation in a cath lab procedure is to develop a clinical timeline of patient care and clinician activity to paint an entire clinical picture. This is an area where I have noticed a disturbing trend — the unmonitored period post procedure. The time period while the patient is waiting for sheath removal, had a closure device placed, or is simply waiting for transfer to the next level/area of care, can be a time when documentation is missing. In case review, these post procedure periods without patient monitoring were sometimes in excess of 60 minutes without EKG, without documented vital signs, and without documented clinical monitoring. This gap in the clinical timeline is undefendable! 

No matter the type of procedure the patient received in your facility, the patient is your responsibility until handed off to the next clinician. There needs to be a documented CONTINUOUS CLINICAL PICTURE for each patient from point A to point B, even if it is the uneventful heart cath or procedure. While there may be a physical delay in the patient’s arrival at point B, there should be little to no delay from the end of the case to the next alternative recordable monitoring system⁸ I use the term “Clinical Picture” because that is what we need to show the next clinician in order to evidence that your documentation mirrors your verbal report. If there are changes involving the patient after you have verbally given your report, but prior to physical handoff of the patient, it is your responsibility to update the report both verbally and in writing. If you are transporting your patient a long distance post procedure within the facility, use a monitor that has blood pressure, SpO2, pacing, defibrillating, and EKG recording capabilities so that you have the total package both for monitoring the patient and the necessary equipment if the patient has an untoward clinical event en route.⁷ For those of us who have been in the hospital setting for several years, you know how quickly a patient’s condition can change post procedure — all time periods need to be monitored and recorded. Attorneys only work with the documentation in the patient’s records — everything else that was said, meant to do, thought you did, or wished you did, doesn’t count. Even in today’s time of electronic medical records, we can hand-write vital signs, note any changes in our patient’s condition, and have it scanned into the patient’s record. So when you transport that patient you cared for from the cath lab to the next caregiver, the entire clinical chronology needs to be documented, and complete and accurate.⁵ If there is a delay in transport, let the receiving staff know of the delay, the reason for the delay, and an estimate of time of delivery, and RECORD it! Also review your facility’s policy on monitoring post procedure — if they do not have one, I highly recommend developing one, as it too will be used in legal proceedings. The American Heart Association’s recommendations involving monitoring the patient post heart catheterization and post myocardial infarction are a good place to start.⁷ 

Conclusion

This article is important for several reasons, but mostly because the discussion above deals with potential post procedure negative outcomes and possible ensuing legal actions. As I stated, complacency is the enemy and our patient can be negatively affected. It is just as important when we act as how we act. As a member of the clinical team, it is our duty to act when we recognize our patient is in trouble. Any delays in care, in monitoring, or in intervening can have grave consequences. I was a firefighter/paramedic for many years prior to becoming a nurse. When an emergency came in to the station, a distinctive alarm went off, and we immediately reacted to begin care for a patient. In the hospital, we are trained to look for those emergencies in our patient. When that mental “alarm” goes off, we should act — our duty is to monitor, treat, assess, and DO any and all things necessary to care for our patient. Sometimes when that alarm goes off, there are clinicians that delay treatment to seek permission from another source, taking time away from the immediate needs of the patient. We see that even though the purpose of seeking permission is the wellbeing of the patient, treatment is delayed. Treatment delayed is treatment denied. Your competency, training, education, and experience, as well as your gut instincts, should prepare you to act appropriately on behalf of your patient. Even if it means someone else has to wait, or it makes another department unhappy — these are all better alternatives than a negative patient outcome. 

As a seasoned clinician in the cath lab, our days tend to be a roller coaster of activity, with peaks and valleys. It is important to remember these critical elements — documentation, post procedure patient monitoring, and communication. In the unlikely event that you are sitting across from an attorney being asked questions about what you did and when you did it, it is ideal to be able to pick up the medical record and read an accurate, complete chronology of events. Being vigilant, aware, educated, and informed prepares you and your patient for a positive outcome. 

References

1. Merriweather N, Sulzbach-Hoke LM. Managing risk of complications at femoral vascular access sites in percutaneous coronary intervention. Crit Care Nurse. 2012 Oct; 32(5): 16-29; quiz first page after 29. doi: 10.4037/ccn2012123.
2. Barwon Health. Center for Education and Practice Development Learning Module. Femoral Artery Sheath Management: For Registered Nurses Division 1. 2008 Feb. Available online at https://www.cathlabdigest.com/images/fa.pdf. Accessed June 12, 2015.
3. Vanderbilt University. Cardiology Femoral Sheath Removal Protocol. Revised 09/10/2003. Available online at https://www.mc.vanderbilt.edu/documents/7north/files/SHEATH%20PULL%20PROTOCOL%209_10.pdf. Accessed June 12, 2015.
4. Thatcher J. Groin bleeds and other hemorrhagic complications of cardiac catheterization: a list of relevant issues. Cath Lab Digest. 2008 Mar; 16(3). Available online at https://www.cathlabdigest.com/articles/Groin-Bleeds-and-Other-Hemorrhagic-Complications-Cardiac-Catheterization-A-list-relevant-is. Accessed June 12, 2015.
5. The Joint Commission. National Patient Safety Goals. Available online at www.jointcommission.org. Accessed June 12, 2015.
6. Kern M. Reducing complications in the very high ‘BMI’ patient. Cath Lab Digest. 2012 Oct; 20(10). Available online at https://www.cathlabdigest.com/articles/Reducing-Complications-Very-High-%E2%80%98BMI%E2%80%99-Patient. Accessed June 12, 2015.
7. Drew BJ, Califf RM, Funk M, Kaufman ES, Krucoff MW, Laks MM, et al; American Heart Association; Councils on Cardiovascular Nursing, Clinical Cardiology, and Cardiovascular Disease in the Young. Practice standards for electrocardiographic monitoring in hospital settings: an American Heart Association scientific statement from the Councils on Cardiovascular Nursing, Clinical Cardiology, and Cardiovascular Disease in the Young: endorsed by the International Society of Computerized Electrocardiology and the American Association of Critical-Care Nurses. Circulation. 2004 Oct 26; 110(17): 2721-2746.
8. Sanborn TA, Tcheng JE, Anderson HV, Chambers CE, Cheatham SL, DeCaro MV, et al. ACC/AHA/SCAI 2014 health policy statement on structured reporting for the cardiac catheterization laboratory: a report of the American College of Cardiology Clinical Quality Committee. J Am Coll Cardiol. 2014 Jun 17; 63(23): 2591-2623. doi: 10.1016/j.jacc.2014.03.020.