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Dialysis line separation: maximizing patient safety through education and visibility of access site for patients on hemodialysis.

Q: What actions can nurses take to decrease the incidence of accidental line separation and venous needle dislodgement during hemodialysis?

A: Although hemodialysis has been simplified due to advances in dialysis technology, the process is not foolproof. Hemodialysis line separation is often fatal because very rapid and profuse exsanguination can occur if prompt detection and intervention is not taken. Line separation usually occurs at the site where dialysis lines are connected to the hubs of dialysis catheters or needles. It may also occur due to dislodgment of needles from the access sites.

It is therefore essential that line separation prevention precautions remain a top priority during hemodialysis. Policies must be put in place to ensure the access site and needle hubs are visible at all times and checked for bleeding during dialysis. This standard must be maintained and monitored through a Performance Improvement process.

Background

End stage renal disease (ESRD) is a debilitating disease; however, life can often be sustained for long periods of time with a kidney transplant or provision of dialysis. The two distinct forms of dialysis are peritoneal dialysis (PD) and hemodialysis (HD). Patients on HD must have a surgically created vascular access system through which blood can exit and return to the body. The preferred type of access is the arteriovenous fistula (AVF). In an arteriovenous graft (AVG), a biologic material (such as polytetrafluoroethylene [PTFE]) is used as a conduit between an artery and a vein to construct the access (Dinwiddie, 2008). When HD has to be provided in emergency, or if a fistula or graft cannot be constructed, a central venous catheter (CVC) is placed for HD.

Patients on HD are at increased risk for bleeding for multiple reasons, including over-anticoagulation, dislodgement of needles, rupture of the vascular access, dialyzer membrane rupture, failure to apply adequate pressure after needle removal, loose connections, and line separation (Hlebovy & King, 2008). Of these types of acute bleeds, line separation confers the greatest risk to the patient as a result of the high volume of blood being pumped back into the patient and because the bleeding may go unrecognized. Therefore, when HD lines separate, patients can exsanguinate in a very short period of time. Although line separation is not common, the fatality rate is very high, thereby underscoring the need for vigilant monitoring, staff, and patient education. Policies and procedures need to be in place to ensure that HD lines and access ports are visible at all times during the HD procedure (Fields, 2010; National Kidney Foundation [NKF], 2006a).

Incidence

Line separation is an emergency situation because of the high risk of death. Every effort must be made by all staff members to prevent its occurrence. The exact incidence of line separation during HD and the true toll of such incidents are not known.

Sandroni, Sherockman, and Hayes-Leight (2008) reported results from a small study involving 300 patients in an abstract at the 2008 American Society of Nephrology Annual Conference. The investigators found that catastrophic hemorrhages in the dialysis units at their hospital system occurred at a rate of 1 per 126,718 treatments. Of the three events that occurred, one was fatal. They also indicated that dialysis machines do not reliably detect venous needle dislodgement, so hemorrhage can occur without an audible alarm to alert the dialysis staff or the patient.

The rate of blood loss varies depending on the rate at which the blood is being pumped through the HD machine. According to the Kidney Disease Outcomes Quality Initiative (KDOQI) clinical practice guidelines for vascular access, dialyzer blood flow rates greater than 300 milliliters per minute are necessary to achieve the target single-pool Kt/V of 1.2. Given this high rate of blood flow during dialysis, if the lines are separated, the patient can exsanguinate if staff members do not immediately detect this situation and intervene (Mora-Bravo et al., 2008; NKF, 2006b).

HD machines cannot be relied on to detect venous needle dislodgement because the decrease in venous pressure may be inadequate to activate the alarm due to an initial low venous pressure. Individuals who are at increased risk for dislodgement include patients with dementia, restlessness or altered cognitive abilities, frequent occurrence of treatment side effects, difficult access cannulation, excessive hair or sweating, allergies to tape, and patients who dialyze alone (Van Waeleghem, Chamney, Lindley, & Pancrinova, 2008).

Consequences of Line Separation

HD machines are capable of delivering blood at pump speeds as high as 500 mL/minute, which implies that an adult patient with total blood volume of 5000 mL could exsanguinate in 10 minutes. The actual amount of blood loss depends on how quickly the separation is detected (The Renal Network, 2008).

An analysis of bleeding during dialysis in Veterans Administration (VA) dialysis centers from March 1, 2002, through April 30, 2008, showed that 40 of these events were serious bleeding episodes, and some resulted in fatalities. Two major risk factors for bleeding during dialysis were found: 1) 75% of the most severe bleeds occurred in patients who were restless, confused, agitated, or uncooperative, and 12.5% in patients who were asleep; and 2) approximately 50% of severe bleeds occurred outside of the chronic dialysis unit (in the ICU or in isolation rooms). In 50% of severe bleeds, the access site was not visible at the time of the event, and in the remaining 50%, the visibility of the access site was not documented in the root cause analyses (Veterans Health Administration, Patient Safety Advisory, 2008). Consequently, line separation is an emergency situation because of the high risk of death.

Influence of Recent Conditions of Coverage

The Medicare Final Rule for Conditions for Coverage states that "the access sites and line connections should remain uncovered to allow staff to visually monitor these areas to ensure patient safety" (U.S. Department of Health and Human Services [DHHS], & Centers for Medicare & Medicaid Services [CMS], 2008, p. 20384). Therefore, all dialysis personnel and patients should be educated about the relevance of keeping the access site visible at all times. This may be challenging at times in patients with groin or lumbar access. Staff and patients should not rely on venous pressure alarms because these are not consistently reliable in detecting line separation. The patient should not be in a position where the access site cannot be monitored. Examples include isolation rooms, which should be modified or designed to allow easy inspection of the bloodlines through glass during HD (Veterans Health Administration, Patient Safety Advisory, 2008; Van Waeleghem et al., 2008).

Influence of an Unexpected Death

In February 2009, a patient came to the hospital inpatient acute dialysis unit for HD. The patient had a right internal jugular tunneled dialysis catheter that was intact with no signs of abnormality prior to dialysis. The dialysis treatment was initiated at a blood flow rate of 300 mL/minute. During the treatment, the arterial side of the dialysis catheter became disconnected, and the patient started bleeding. The problem was identified through staff member visual observation of patient. The staff members noted blood was on the patient's gown and along the dialysis catheter side of his bed. The dialysis staff then discovered that the arterial side of the dialysis catheter was open. The catheter connection site was not visible, which delayed recognition of the bleeding.

The patient's side of the arterial port was clamped, and the blood rinsed back from the machine to the patient. Attempts to bolus saline to the patient from the machine failed because the air detector safety mechanism was engaged and clamped down. The patient became hypotensive and unresponsive. Despite advanced cardiac life support (ACLS) protocols, the patient expired unexpectedly.

Analysis of the Problem

The death was classified as an unexpected, preventable death, and as a result, the Department of Performance Improvement conducted a root cause analysis. The goal of the root cause analysis was to look for root cause(s), analyze the current process, determine why it failed, and put in place risk reduction strategies to prevent future recurrence.

The following root causes were identified:

* The catheter connection site on the patient side was not visible, which delayed recognition of the bleeding. The standard of care demands that access or catheter ports remain visible.

* Dialysis machine alarms did not alarm and are not always reliable in giving early signs of patient bleeding or line disconnection. There was no written evidence of patient education on keeping the HD catheter visible.

* There was no column on the Dialysis Flow Sheet's monitoring form where arterial pressure is documented.

Action Plan

In view of the findings during the root cause analysis, it was very important to establish awareness among staff members and patients on the importance of keeping access lines and access sites visible during dialysis treatment. Since blood pump speeds are often greater than 350 mL/minute in case of accidental line disconnection, the blood loss can be rapidly fatal if undetected.

We minimized access disconnection during dialysis by using the Fresenius HemaClip[R] connecting device, which is shown in Figure 1. The Patient Safety Alert for this device stated that "The HemaClip should prevent a catastrophic disconnection and blood loss at the dialysis machine pump rate, which is typically at 400 to 500 mL/minute" (Veterans Health Administration, 2010, p. 3).

Factors Influencing the Action Plan

This incident was an unexpected preventable death, and the purpose of the plan was to:

* Establish awareness among staff and patients on the importance of keeping access lines and access sites visible during dialysis treatment.

* Educate staff members and patients that blood pump speeds are often greater than 350 mL/minute, and if the access is accidentally disconnected, the patient can lose blood rapidly, leading to death if not detected quickly.

* Minimize access disconnection during dialysis by using a connection-securing device (Fresenius HemaClip) to prevent accidental dislodgement. In our case, the dialysis staff discovered that the arterial side of the dialysis catheter was open.

[FIGURE 1 OMITTED]

Incorporating the Findings into a Corrective Action Plan

After analysis, several actions were adopted.

To prevent the reoccurrence of the event in the future, all catheters will be secured with a Fresenius HemaClip (see Figure 1), a disposable device that consists of two slips with a length of plastic between them. The HemaClips lock onto the dialysis tubing on either side of each joined port, preventing inadvertent disconnection.

Effective immediately, all catheter connections were made visible during dialysis. HemaClip placement and integrity were documented upon initiation of dialysis and every 30 minutes during treatment on the Dialysis Flow Sheet. Visual observation of all patients for disconnection or detecting problems during dialysis by all staff is a continuous process (see Figure 2).

Although there was a Dialysis Assessment Form to record a patient's activity during dialysis treatment, the access site and catheter line visibility were not included in the form until after the incident. The form was revised to include access site and catheter line visibility validation every 30 minutes.

The Dialysis Flow Sheet was also revised twice to check and document findings of arterial lines pressures every 30 minutes.

Policy revisions were made to reflect the new process change, including the use of the Fresenius HemaClip device to secure access site.

[FIGURE 2 OMITTED]

Dialysis staff members were trained on the use of disposable Fresenius HemaClips and were required to demonstrate competency in use of the device. The Patient Safety Alert on the use of HemaClip also recommends that even with the use of the HemaClip, dialysis staff members must continue to use the correct technique by firmly attaching the bloodline locking luer connector to the catheter (Veterans Health Administration, 2010).

Staff Responsibilities

Nursing staff members placed and secured access sites with Fresenius HemaClip at the arterial and venous line upon initiation of dialysis. They also checked and documented findings, including arterial line pressures every 30 minutes, on the Dialysis Flow Sheet. They documented patient education on the importance of keeping access site and lines visible in progress sheets and hospital patient education forms.

Unit leadership monitored compliance of these corrective actions by randomly selecting 20 Dialysis Flow Sheets per month to monitor. The leadership will continue this monitoring indefinitely and present compliance in the unit's performance improvement meetings.

The performance improvement manager for the dialysis department randomly monitored all corrective actions put in place to reinforce compliance and report data at the departmental performance improvement meeting. Compliance with the corrective actions was reported to our hospital-wide Provision of Care Committee.

Implementation of New Patient Education Strategies

A new patient education form was created for patients to read and sign. If the patient cannot read, the staff reads the form's content to the patient at the beginning of each dialysis treatment. The new form emphasizes the following points:

* Your access and lines must be kept uncovered and visible at all times.

* Your healthcare provider will monitor your access and lines every 30 minutes or as needed. In the event that blood is seen coming from the site or from the line(s) you must inform staff immediately.

* For patients who refuse to sign, the nurse re-iterates the importance of exposing the arm and document the patient's refusal on the monitoring form as well as in the progress note.

* Patients are encouraged to inform caregivers if they feel cold. They are informed that blankets are available, and gloves may be worn to keep hands warm.

* Patients are also encouraged to speak up if they have concerns about exposing their access site.

Results of Action Plan

A total of 572 treatment encounters over a period of 18 months were monitored from April 2009 to September 2010. Results of an audit of performance improvement changes (shown in Figure 3) included:

* No incidence of catheter site/lines disconnection since the incident case.

* 100% compliance of HemaClip application on HD catheter lines.

* 98% compliance from patients on exposure of access sites and lines.

Lessons Learned

Access site and line visibility are very important during dialysis treatment to identify disconnection immediately.

In the case described, the patient catheter connection was not left visible, and this probably delayed recognition of the bleeding. This is a recognized problem in dialysis units, and the standard of care demands that the access and catheter ports remain visible. Some problems encountered include:

* Refusal by a few patients to expose arm for visibility of access site and lines despite education.

* Difficulty of catheter exposure for patients with groin access. Staff members were educated to frequently check the area for bleeding.

* Nursing staff members were concerned about the excessive paper pile up as a result of the required patient signature for each treatment.

Subsequent Changes to the Original Plan

Initially, all patients had to sign a patient education form at the beginning of each treatment. Nursing staff members were concerned about the excessive paper accumulation as a result of the required patient signature for each treatment. A process change was made for patients to sign the educational form on the initial treatment and reinforcements at subsequent sessions, with documentation in the patient education teaching record. The education process is ongoing and vital to sustaining positive outcomes.

Implications for Nursing

The root cause analysis revealed that the standard of care was not met. Patient safety is critically important, and this kind of incident shows that staff members need to be more vigilant in observing and educating patients concerning safety during treatment.

Adhering to unit policy and re-enforcing policy with staff members and patients are crucial because access sites and lines must be visible at all times without compromise: this is matter of life and death for patients. If any patient refuses the use of HemaClips or refuses to leave his or her access site or lines visible, it must be documented in the progress notes and monitoring form while staff members continue to encourage the patient to comply by educating the patient.

Patient safety is first and must be enforced by all staff members. Regular visual patient observation of access sites and keeping bloodlines clearly visible are extremely important. When the dialysis machine alarms, the needle site, vascular access, and bloodlines must be inspected prior to resetting that alarm. Careful attention to taping of needles and proper anchoring of dialysis lines are important for patient safety.

We must also remember that HD machine technology is imperfect, and reliance on audible or visual alarms is not enough. Assessment of the patient and the access is an important component to providing quality care. Nephrology nurses must be concerned with identifying the problem, putting corrective action in place, and continuing to educate both staff members and patients about the importance of compliance with procedures regarding patient safety.

Key Words: Hemodialysis, medication error, bloodlines, access site, dialysis catheter, root cause analysis, continuous quality improvement.

References

Dinwiddie, L. (2008). Vascular access for hemodialysis. In C. Counts (Ed.), Core curriculum for nephrology nursing (pp. 741-748). Pitman, NJ: American Nephrology Nurses' Association.

Fields, R. (2010). When needles dislodge, dialysis can turn deadly. Retrieved from http://www.propublica.org/article/ when-needles-dislodge-dialysis-can-turn- deadly/single

Helbovy, D., & King, B. (2008). Complications of hemodialysis: Prevention and management. In C. Counts (Ed.), Core curriculum for nephrology nursing (pp. 704-716). Pitman, NJ: American Nephrology Nurses' Association.

Mora-Bravo, F.G., Mariscal, A., Herrera-Felix, J.P., Magana, S., De-La-Cruz, G., Flores, N., Perez-Grovas, H. (2008). Arterial line pressure control enhanced extracorporeal blood flow prescription in hemodialysis patients. Biomed Central--Nephrology, 9(15), 1-8.

National Kidney Foundation (NKF). (2006a). What you need to know about your access: Getting the most from your treatment. Retrieved from http://www.kidney.org/atoz/pdf/Your Access.pdf

National Kidney Foundation (NKF). (2006b). NKF KDOQI clinical practice guidelines and clinical practice recommendations 2006 updates. Guideline 7.1. Retrieved from http://www.kidney. org/professionals/kdoqi/guideline_uphd_pd_va/va_guide7. htm

Sandroni, S., Sherockman, T., & Hayes-Leight, K. (2008). Catastrophic hemorrhage from venous needle dislodgement during hemodialysis: Continued risk of avoidable death and progress toward a solution. Paper presented at the meeting of the American Society of Nephrology (ASN) Renal Week, Philadelphia, November, 2008.

The Renal Network (2008). The naked arm. Renal Outreach, 16(3). Retrieved from http://www.therenalnetwork.org/services/techassist_access.php

U. S. Department of Health and Human Services (DHHS), & Centers for Medicare & Medicaid Services (CMS). (2008). Centers for Medicare & Medicaid Programs; Conditions of coverage for end stage renal disease facilities; Final rule (42 CFR Parts 405, 410, 413 et al.). Federal Register, 71(73), 20384. Retrieved from http://www.cms.hhs.gov/CfCsAnd CoPs/Downloads/ESRDfinalrule0415.pdf

Van Waeleghem, J., Chamney, M., Lindley, E., & Pancirove, J. (2008). Venous needle dislodgement: How to minimize the risks. Journal of Renal Care, 34(4), 163-168.

Veterans Health Administration, Patient Safety Advisory. (2008). (AD09-02). Bleeding episodes during dialysis. Retrieved from http://www.patientsafety.gov/alerts/BleedingEpisodes DuringDialysisAD09-02.pdf

Veterans Health Administration. (2010). (AL10-05). Patient safety alert: Fresenius HemaClip used during dialysis. Retrieved from http://www.patientsafety.gov/alerts/AL10-05www.pdf

The Clinical Consult department is designed to provide answers to questions concerning clinical problems and to report innovative clinical practices. Readers are invited to submit questions to be answered by a guest consultant. Questions should provide background information and state specific information requested, Answers will be referenced. Manuscripts that address clinical problems or present innovative ideas are also invited. These should be between 400 and 600 words and contain one to three references. Address correspondence to: Charlotte Szromba. Clinical Consult Department Editor, through the ANNA National Office: East Holly Avenue/Box 56; Pitman NJ 08071-0056; (856) 256-2320. The opinions and assertions contained herein are the private views of the contributors and do not necessarily reflect the views of the American Nephrology Nurses' Association.

Rachael Saibu, RN, is a Utilization Review and Quality Assurance Senior Coordinator and Performance Improvement Manager, SUNY Downstate Medical Center, Brooklyn, NY, and a member of ANNA's Big Apple Chapter. She may be contacted via e-mail at Racbsa@gmail.com

Patricia Mitchell, RN, is an Assistant Director of Nursing, Acute Dialysis Unit, State University of New York Downstate Medical Center, Brooklyn, NY, and a member of ANNA's Long Island Chapter.

Jocelyn Alleyne, RN, is Senior Associate Administrator, State University of New York, Downstate Medical Center, Brooklyn, NY, and a member of ANNA's Big Apple Chapter.

Jaycinth Blackman, RN, is Director of Performance Improvement, State University of New York, Downstate Medical Center, Brooklyn, NY.

Kathleen DeConcilio, RN, is an Associate Administrator, Parkside and Acute Dialysis Unit, State University of New York, Downstate Medical Center, Brooklyn, NY, and a member of ANNA's Big Apple Chapter.

Anthony Joseph, MD, is Medical Director, Acute Dialysis Unit, State University of New York, Downstate Medical Center, Brooklyn, NY Moro O. Salifu, MD, is a Professor of Medicine and Chief, Division of Nephrology, and Director of Transplant Program, State University of New York, Downstate Medical Center, Brooklyn, NY.
Figure 3

Audit Results of Performance Improvement Changes

                                   Compliance Rate

               Second    Third     Fourth    First     Second    Third
              Quarter   Quarter   Quarter   Quarter   Quarter   Quarter
                2009      2009      2009      2010      2010     2010

Hemaclip        100       100       100       100       100       100
Access Site     100       100       100       100       100        98
Access Line     100       100       100       100       100        98
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Title Annotation:Clinical Consult
Author:Saibu, Rachael; Mitchell, Patricia; Alleyne, Jocelyn; Blackman, Jaycinth; DeConcilio, Kathleen; Jose
Publication:Nephrology Nursing Journal
Article Type:Report
Geographic Code:1USA
Date:Nov 1, 2011
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