Correspondence
Serratia liquefaciens Infections at a Hemodialysis Center
N Engl J Med 2001; 345:921-923September 20, 2001
- Article
To the Editor:
Dr. Grohskopf and her colleagues (May 17 issue)1 and the editorialist who commented on their study of Serratia liquefaciens infections at a hemodialysis center2 missed an opportunity to evaluate the errors in the system that contributed to this “near miss.” The Institute of Medicine report3 on the epidemiology of error in medicine shows us the importance of looking for root causes. The authors and editorialist enumerate the human errors or proximate causes that led to the adverse event. There are also remote causes or latent errors that are beyond the control of the health care workers. Training and meticulous adherence to aseptic technique are important, but if the safety of patients depends on error-free performance, then these outbreaks are inevitable.4
Analysis of root causes usually identifies multiple problems in a system. In the case of this incident there were are least four problems — the fiscal need to conserve the drug; the absence of preservative in the vial; the pooling of multiple vials; and the practice of “topping off” contaminated hand-soap dispensers.
Currently, in spite of the 2.4 percent increase, the composite Medicare reimbursement rate covers only 93 percent of the cost of providing dialysis services. The facilities that provide these services make up the difference from ancillary revenue — primarily from the administration of epoetin alfa.
Eighty-two percent of respondents to the survey conducted by the Centers for Disease Control and Prevention (CDC) stated that they used some variation on this practice. Preventing similar events requires more than finger pointing. It requires reporting, reviewing, and analyzing adverse events and near misses in a blame-free environment to determine their root causes. We have undertaken a national initiative to enhance the safety of patients with end-stage renal disease in order to promote this culture of safety.
4 ReferencesPeter B. DeOreo, M.D.
Centers for Dialysis Care, Cleveland, OH 44106
pbd2@pop.cwru. edu Alan S. Kliger, M.D.
Yale University School of Medicine, New Haven, CT 065111
Grohskopf LA ,Roth VR ,Feikin DR , et al. Serratia liquefaciens bloodstream infections from contamination of epoetin alfa at a hemodialysis center. N Engl J Med 2001;344:1491-1497
Full Text | Web of Science | Medline2
Weinstein RA . Lessons from an epidemic, again. N Engl J Med 2001;344:1544-1545
Full Text | Web of Science | Medline3
Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human: building a safer health system. Washington, D.C.: National Academy Press, 2000.
4
Leape LL . Error in medicine. JAMA 1994;272:1851-1857
CrossRef | Web of Science | Medline
To the Editor:
The report of an outbreak of S. liquefaciens is a reminder of the risk associated with use of the contents of vials that have been previously punctured. This risk is often not fully appreciated in developing countries, where outbreaks caused by the extrinsic contamination of medication are commonly underrecognized and underreported. In a multicenter study in Mexico, Macias and colleagues found that 2.1 percent of intravenous infusions administered to patients were contaminated, and the researchers evoked the multiple use of drugs from vials designed for a single use as a possible risk factor for such high rates of contamination.1
In April 1999, over a three-day period, we isolated gentamicin-resistant Klebsiella pneumoniae from the blood cultures of two neonates with septicemia in a four-bed ward and from a partially used vial of 50 percent glucose to which calcium gluconate had been added. The contents had been administered to many babies in that ward.
In many developing countries, instruction in infection-control procedures and the implementation of these procedures are low on the list of health care priorities. Throwing away a vial that is half full is considered wasteful. Taking multiple doses from large-volume vials is perceived as more economical by the purchasing staff, who are often not based in the hospitals. Laminar-flow cabinets are not available in most hospital pharmacies, and mixtures for intravenous use are prepared in the wards. Moreover, the relatively high ambient temperature also favors the multiplication of bacteria in contaminated vials. Unfortunately, if every vial were required to be used only once, some patients in developing countries might not receive certain lifesaving treatments at all.
1 ReferencesMohammad I. Issack, M.B., Ch.B.
Victoria Hospital, Candos, Mauritius
missack@intnet.mu 1
Macias AE ,Munoz JM ,Bruckner DA , et al. Parenteral infusions bacterial contamination in a multi-institutional survey in Mexico: considerations for nosocomial mortality. Am J Infect Control 1999;27:285-290
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To the Editor:
The report by Grohskopf et al. on the link between an outbreak of S. liquefaciens and the multiple puncturing of vials and pooling of preservative-free epoetin at a dialysis center stresses the need for the federal government to reevaluate its composite rate of reimbursement and the effect of this rate on the quality of care. Initially, the dialysis program cost $229 million and treated approximately 16,000 patients. By 1998, the cost of the program had increased to $12 billion for 249,000 patients and accounted for 5.7 percent of Medicare payments while benefiting only 0.6 percent of the population covered by Medicare.1 To encourage efficiency and to reduce expenditures, the federal government has essentially left the composite rate to be eroded by inflation, forcing providers to seek out new avenues of revenue and cost trimming to maintain profitability. An evaluation of the three largest publicly traded chains of dialysis facilities reveals a growing dependency on epoetin alfa as a revenue source, with the medication now accounting for about 23 percent of total revenues. Studies find that growing quantities of epoetin alfa are being used.2 If for-profit dialysis centers are deriving a growing and substantial portion of their revenue and profits from epoetin alfa in the face of a Medicare composite rate that has been eroded by inflation and mounting pressures from managed care, it seems unlikely that these centers would order vials of epoetin alfa in sizes that better match patients' prescriptions, although they might be able to improve their pooling practices to prevent such outbreaks. Thus, as some suggest,3 if profits are a driving factor in for-profit dialysis clinics, we must have federal legislation that mandates clinical changes with regard to the pooling of epoetin alfa rather than depending on clinics to take the right action.
3 ReferencesJohn D. Sullivan, Ph.D.
Boston University, Boston, MA 02215
jsulliva@bu.edu 1
1999 HCFA statistics. Baltimore: Health Care Financing Administration, April 2000. (HCFA publication no. 03421.)
2
Greer JW ,Milam RA ,Eggers PW . Trends in use, cost, and outcomes of human recombinant erythropoietin, 1989-98. Health Care Financ Rev 1999;20:55-62
Web of Science | Medline3
Garg PP ,Frick KD ,Diener-West M ,Powe NR . Effect of the ownership of dialysis facilities on patients' survival and referral for transplantation. N Engl J Med 1999;341:1653-1660
Full Text | Web of Science | Medline
To the Editor:
I worked for a short time for a large dialysis company, and the pressure to pool epoetin alfa was tremendous. When I voiced my concern over such a poor nursing practice, I was no longer scheduled to work.
Kathleen Kremer, R.N., C.N.N.
3535 Edenbower Blvd., #133, Roseburg, OR 97470
kramsey@mcsi.net Author/Editor Response
The authors reply:
To the Editor: We agree with Drs. DeOreo and Kliger that the prevention of adverse events requires the evaluation of all contributory factors. The primary goal of our investigation was to terminate the outbreak quickly and to prevent additional adverse events. Thus, we focused on determining the causes of the bloodstream infections. Although our terminology may differ from theirs, we were conducting an analysis of root causes. This led to the identification of the practices of health care workers and reimbursement issues as factors that contributed to this outbreak. Although we could not change the reimbursement system, we implemented infection-control measures in order to terminate the outbreak, thereby improving the safety of the patients.
One of the proximate causes — multiple punctures of preservative-free vials and pooling of residual medication — can cause serious adverse events, including bloodstream infection. In international settings, where resources are much more limited than in the United States, the reuse of medical equipment, repeated entry into solutions, pooling of medications, and other practices inconsistent with current recommendations have been repeatedly reported. Enhanced programs of education regarding infection control may help reduce the prevalence of such activities.
This outbreak was the result not simply of a failure of asepsis but rather of a failure of asepsis in the administration of a preservative-free medication. Although single-dose vials (used as such) are considered preferable in order to avoid contamination,1 multidose vials (when available) are preferred when multiple doses must be taken from one vial. Since the retail cost of single-use, preservative-free epoetin alfa and multiuse, preserved epoetin alfa is similar, a prudent choice if the medication is going to be administered to multiple patients is the multidose, preserved medication. This outbreak might have been avoided had multidose, preserved epoetin alfa been used.
The findings of our survey indicate that the motivation to conserve epoetin alfa is pervasive. The economics of health care are quite complicated, and often the requirements of best practices are in opposition to those of cost containment.
Our aim was not to ascribe blame but rather to focus attention on an important issue of patient safety. Dr. Sullivan's data and Ms. Kremer's experience are further evidence of the pervasive economic pressures. The recent Institute of Medicine report emphasizes the need for change in our health care system. Providing high-quality care and improving patient safety should be goals of every health care system and should not be subordinated to cost constraints and profit incentives. Although we look forward to the results of the safety initiative for patients with end-stage renal disease, current patient-safety initiatives may be hampered until our health care delivery systems are changed, reimbursement of health care costs is improved, and tort reform is enacted so that patient safety and improved outcomes and services are the goals of health care delivery.
1 ReferencesLisa A. Grohskopf, M.D., M.P.H.
William R. Jarvis, M.D.
Centers for Disease Control and Prevention, Atlanta, GA 30333
lkg6@cdc.gov 1
Pearson ML, Hospital Infection Control Practices Advisory Committee
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Author/Editor Response
The editorialist replies:
To the Editor: Drs. DeOreo and Kliger bring an important perspective to the outbreak of serratia bacteremias in a Colorado dialysis center described by Grohskopf and colleagues. Analysis of root causes is a popular tool for activities associated with quality assurance,1 but it was not required in order to learn the important lessons of this outbreak. In fact, all four root causes and problems in the system listed by DeOreo and Kliger were identified by the CDC investigators and reviewed in my editorial.
Dialysis units have done a superb job of decreasing the spread of blood-borne viruses during the past 20 years by greatly improving infection-control practices. The tools that promoted these improvements, even before the availability of the hepatitis B vaccine, were attention to basic hygiene and emphasis on the improvement of performance. The use of such tools can prevent — and has prevented — other major infection-control problems. However, incomplete attention to or lack of education about infection control and a prime directive focused on cost containment rather than patient safety — the most critical problems with the system in the case of the Colorado outbreak — threaten these gains. This is not pointing fingers or laying blame; it is assessing priorities.
Dr. Issack points out the very real competing priorities of infection control and provision of medication in developing countries. Although difficult dilemmas are created by the tensions between the ideal hygienic practices and the day-to-day practical needs of hospitals, some problems in developing countries can be and have been solved at a local level.2
2 ReferencesRobert A. Weinstein, M.D.
Cook County Hospital, Chicago, IL 60612
rweinste@rush.edu 1
Black SR ,Weinstein RA . The case for face masks: Zorro or zero? Clin Infect Dis 2000;31:522-523
CrossRef | Web of Science | Medline2
Berg DE ,Hershow RC ,Ramirez CA ,Weinstein RA . Control of nosocomial infections in an intensive care unit in Guatemala City. Clin Infect Dis 1995;21:588-593
CrossRef | Web of Science | Medline
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