Spotlight Case October 2010 Dangerous Dialysis

2 Source and Credits This presentation is based on the October 2010 AHRQ WebM&M Spotlight Case –See the full article at –CME credit is available Commentary by: Jean L. Holley, MD, University of Illinois, Urbana-Champaign –Editor, AHRQ WebM&M: Robert Wachter, MD –Spotlight Editor: Bradley A. Sharpe, MD –Managing Editor: Erin Hartman, MS

3 Objectives At the conclusion of this educational activity, participants should be able to: List common errors that occur in dialysis units Describe steps that can be taken by dialysis units to prevent these common errors Describe the role of the dialysis unit medical director in promoting patient safety in dialysis units List the regulatory agencies with a role in dialysis unit patient safety oversight

4 Case: Dangerous Dialysis A 48-year-old man with a long history of diabetes and end-stage renal disease (ESRD) on hemodialysis arrived at his outpatient dialysis center for his scheduled Friday morning session. Before starting dialysis, his nephrologist sat down next to him and stated that a serious error had occurred at the dialysis center. The nephrologist told the patient that, for several dialysis sessions, he had been dialyzed using a dialysis membrane that had been inappropriately reused, which meant that the patient had been exposed to another patient’s blood many times.

5 Case: Dangerous Dialysis (2) The dialysis center was actually not sure which dialysis membrane had been reused, so they couldn’t identify the specific patients affected by this error. Thus, they were informing all patients who had potentially been exposed to a communicable disease. At this dialysis center, many patients had HIV and hepatitis C, so it was conceivable that this particular patient had been exposed.

6 Case: Dangerous Dialysis (3) The patient was tested for HIV and hepatitis viruses and was treated for 3 months with post-exposure prophylaxis for HIV. Ultimately, repeated blood tests were negative for HIV and hepatitis, meaning that the patient did not experience any long-term consequences.

7 Hemodialysis in the United States In 2007, more than 500,000 patients were dialyzed in the United States Nearly 65% receive dialysis in dedicated dialysis centers Most patients must attend dialysis 3 times weekly and receive multiple medications while at dialysis See Notes for reference.

8 Dialysis Centers are Hazardous Various errors can occur: –Incorrect dialyzer/dialysis solution/water quality Transmission of infectious diseases, reuse programs Improper patient identification –Patient falls –Medication errors and omissions –Nonadherence to standard procedures –Vascular access–related events Excess blood loss, infection See Notes for references.

9 Prevalence of Errors One retrospective study found 1 error or adverse event for every 733 dialysis treatments –A typical center does 500 treatments per week In a national survey of dialysis center staff, 87% acknowledged a mistake or error in a dialysis treatment in the last 3 months See Notes for references.

10 What is Hemodialysis? Hemodialysis removes small solutes (potassium, blood urea nitrogen [BUN], creatinine, etc.) from patients utilizing a system in which the patient’s blood is pumped through a semipermeable membrane (the dialyzer) The dialysis solution (dialysate) flows countercurrent to the blood, resulting in the movement (diffusion) of solutes

11 Hemodialysis Basics Illustration © 2010 by Chris Gralapp.

12 Errors in Dialysis System Errors can occur at multiple points in system: –Contamination of the dialysate or water used to make the dialysate –Use of an incorrect dialysate for a given patient –Ill-fitting lines connecting the dialyzer –Dialyzer leaks –Problems with patient’s access (arteriovenous fistula, graft, or venous catheter) Errors may result in hemolysis, transmission of infection, or accumulation of toxins

13 Reusing Dialyzer Membranes The problem in this case involved the practice of reusing the dialyzer membrane Reuse involves sterilizing the dialyzer after each dialysis session to be reused on subsequent treatments for the same patient Reuse of dialyzer membranes increased significantly in the 1980s and 1990s, peaking in 1997, when 80% of dialysis centers reused dialyzers

14 Reusing Dialyzer Membranes (2) Reuse of dialyzer membranes creates opportunities for medical errors Dialyzers can be mistakenly reused on the wrong patient (as in this case) A formal system of patient identification and dialyzer matching should be in place See Notes for reference.

15 Standards for Dialyzer Reuse The Association for the Advancement of Medical Instrumentation (AMMI) established standards for dialyzer reuse Reuse standards include protocols to reduce the risk of errors, including standards addressing: –Patient identification –Dialyzer labeling –Environmental and processing procedures See Notes for reference.

16 Preventing Reuse Errors Multiple steps can be taken to reduce errors associated with dialyzer reuse: –Barcode labeling of dialyzers –Staff education –Avoiding reuse in patients with infectious diseases –Staggering dialysis treatments to limit overlap of patients starting dialysis sessions –Using specific protocols for collection, storage, and cleaning of dialyzers See Notes for reference.

17 Medication Errors at Dialysis Units Patients are often given many medications at dialysis centers The most common medication errors involve: –Patients not receiving prescribed medications –Patients receiving the wrong dose See Notes for references.

18 Falls at Dialysis Centers Falls are common–nearly 50% of patients had a fall in person-years of follow-up Risk factors for falls in dialysis centers include: –Patient age –Total number of co-morbidities –Predialysis systolic blood pressure –History of falls

19 Preventing Falls There have been multiple recommendations to prevent falls at dialysis centers: –Assess fall risk up front –Use exercise programs to increase strength –Reduce the use of neuropsychiatric medications –Avoid hypotension

20 Medicare Oversight To be paid by Medicare, dialysis centers must measure, track, and analyze quality indicators Medicare incorporated AAMI standards for dialysate, guidance on the reuse of dialyzers, and specific instructions on infection control See Notes for reference.

21 Organizations Involved in Oversight of Patient Safety in Hemodialysis Units Centers for Medicare & Medicaid Services (CMS) Conditions of coverage include specific quality indicators. Surveyors from State Department of HealthCan close units that do not meet standards of care. End-Stage Renal Disease (ESRD) Networks18 geographically organized committees under CMS supervision. Responsible for quality assurance and improvement in dialysis facilities within the network. Medical directors are given periodic assessments of unit morbidity and mortality compiled by the networks through CMS. United States Renal Data System (USRDS)A repository of data collected on each chronic dialysis patient covered under Medicare. An annual yearly report is published including special studies examining morbidity and mortality of dialysis. Data provided by USRDS may determine ESRD Network quality improvement projects and lead to development of standards of care. Association for the Advancement of Medical Instrumentation (AAMI) Sets standards for water quality, dialysate, and reuse procedures. Centers for Disease Control and Prevention (CDC) Sets standards for infection control in dialysis units and provides standards for indwelling catheter-associated infections.

Role of the Medical Director The medical director is responsible for assuring that: –Facility policies, procedures, monitoring, and auditing are congruent with Medicare standards –The dialysis unit staff is adequately trained in and adheres to the policies and procedures –The unit’s practices result in favorable patient outcomes 22

Additional Factors Influencing Safety within Dialysis Facility 23 Dialysis Facility Dialysis Facility Governing Body Dialysis Unit Medical Director  Interdisciplinary Patient Care Team  MD and non-physician practitioners  Nursing, dietary, social work  Technical (water, reuse) Dialysis Unit Manager Patients and Dialysis Unit Staff

24 Take-Home Points The potential for adverse events and medical errors in hemodialysis units is high due to the procedure itself, the need for medications, the risk for falls, and the co-morbidities of the patient population. Safety in the hemodialysis unit is under the oversight of the facility’s medical director and manager supervised by the ESRD Networks, state, and national organizations under CMS.

25 Take-Home Points (2) Reducing errors in dialysis units is a focus of quality improvement projects supported by the ESRD Networks and is mandated by CMS under Medicare’s conditions for coverage. Future investigation into the occurrence and prevention of adverse events and errors in dialysis units is needed.