May 24, 2010
Premier Safety Institute - Safety Share Newsletter

Check out our tools on readmissions, safety culture, safety data, CMS dashboard and more.
Gina Pugliese, editor

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Bloodstream infection rates at nearly zero for three years

Updated report Ninety Michigan intensive care units (ICUs) reported the reduced rates of catheter-related bloodstream infections achieved in an initial 18-month study were sustained for an additional 18 months. The mean and median rates of catheter-associated bloodstream infections (CLABSI) decreased from 7.7 and 2.7 percent at baseline to 1.3 and 0 percent at 16-18 months, and to 1.1 and 0 at the 34-36 month post-implementation period, representing a greater than 60 percent reduction in infection rates from baseline sustained at the end of the 36-month period.    

Period Mean Median
Baseline 7.7 2.7
16-18 months 1.3 0
34-36 months    
Post implementation 1.1 0


Previously the New England Journal of Medicine, December 2006, reported that the Keystone ICU project interventions, a group of five evidence-based recommendations known as the CLABSI reduction "bundle," resulted in a 66 percent decrease in the rates of CLABSI across 103 ICUs in the state of Michigan. The current Keystone ICU study reported on the18-month post-implementation period, which included CLABSI rate measurement and feedback to the ICU teams. (Pronovost et al. 2010)

Process During the sustainability period, ICU teams were instructed to integrate the interventions into staff orientation, collect monthly data from hospital infection control staff, and continue reporting infection rates to appropriate stakeholders. The authors found that the reduced rates of CLABSI achieved in the initial 18-month post-implementation period were sustained for an additional 18 months as participating ICUs integrated these quality improvement interventions into standard practice. These reductions in CLABSI represent a greater than 60 percent decrease in infection rates when compared to the baseline measurement reported prior to the combined 36-month period.

Although implementation of CLABSI bundle is becoming common practice in ICUs, few quality improvement projects have evaluated their sustainability on a large scale. The authors attribute their success to the continued utilization of the quality improvement model from the Keystone ICU project including maintaining a team safety culture, orienting new staff, collecting monthly data and reporting infection rates to appropriate stakeholders after the initial evaluation period. The authors also note that integration of the CLABSI "bundle" into practice in all ICUs across the country could result in significant reductions in the estimated 82,000 infections and $2.3 billion costs of CLABSI annually. See: Safety Share: "New techniques dramatically decrease ICU infections" and Safety Share: "Michigan's success in preventing infections expanded to 10 states"


More resources: See Premier Safety Institute's Bundling - Evidence-based practices

 

 

Baxter to recall COLLEAGUE infusion pumps

On May 3, 2010, Baxter International announced that it will recall all COLLEAGUE infusion pumps from the U.S. market as part of an existing 2006 consent decree with the Food and Drug Administration. Baxter noted in its press release that it will work with the FDA to ensure the recall process provides customers appropriate alternatives for supporting patient needs, including an offer to exchange COLLEAGUE pumps for Baxter's Sigma SPECTRUM.

Baxter's action was prompted by an FDA order for the company to "recall all of the COLLEAGUE infusion pumps currently in use in the United States" because of a "longstanding failure" to correct problems with the pumps. The FDA estimates that there are as many as 200,000 of these pumps currently in use. FDA and Baxter are still working out the specific details of the recall.

ECRI Institute prepares guidance ECRI Institute prepared a Special Report, "FDA Orders Recall of Baxter COLLEAGUE Infusion Pumps: Hospitals May Continue to Use for Now," that is publicly available. According to Eric Sacks, director of Healthcare Product Alerts at ECRI Institute, "Hospitals are in an awkward situation having been notified that the pumps will be recalled related to safety problems, but not having the details or remedial options available yet." The recent recall order does not stem from any newly identified design or safety risk, but rather, as FDA explained in its press release, because of concerns regarding the time frame in which Baxter could adequately address previously identified safety issues. "It is important that everyone understand that FDA has stated that at this time users can continue to use COLLEAGUE pumps," added Sacks. "The best way to respond for now is to organize your team and be prepared to take action when the actual recall is announced." In preparation, hospitals should identify internal stakeholders, notify them of the latest announcement, and ask them to help identify key institutional factors related to future replacement of the pumps across the enterprise.

Baxter to offer replacement of COLLEAGUE pumps What is known at this time is that FDA's action will require Baxter to compensate users of the COLLEAGUE in some way. In its May 3, 2010, press release, Baxter said it anticipates that, among alternatives to be provided to customers, the company will offer to exchange Baxter's Sigma SPECTRUM infusion pumps for COLLEAGUE infusion pumps without charge to customers. For those who choose not to adopt the SPECTRUM, Baxter will be required to offer some form of monetary compensation. The company is currently negotiating a value for COLLEAGUE pumps with the FDA. Baxter also has indicated that facilities that lease the pumps may be entitled to terminate leases without penalty.

Meanwhile, ECRI Institute has reminded hospitals that "transitioning to new infusion pumps is no easy task" and should not be done in haste. For example, regardless of which replacement pump is selected, facilities using COLLEAGUE will need to develop a new drug library - a collaboration between pharmacy, nursing, and medical staff that typically takes three to six months.

Resources for users More details, including ECRI Institute's Special Report, the FDA press release, and Baxter's press release, are available on the ECRI Institute website. The FDA also has issued a "Questions and Answer" and feedback form on its website. Current users are urged to use the feedback form to communicate any concerns to the FDA regarding this action, including suggesting an adequate timeline to permit planning and a safe transition to an alternative infusion pump.

FDA announces a new initiative to address infusion pump safety Infusion pumps have been the source of persistent safety problems and not confined to one manufacturer or type of device, according to the FDA. In the past five years, the FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps. Those events include serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address safety concerns, according to FDA data. In April, FDA announced a new initiative to address safety problems and will be establishing additional premarket requirements that will include static testing in FDA's facilities before device submissions. More on FDA's initiative:

More on FDA's initiative:

 

 

Methods to detect adverse events are unreliable; hospital incident reports miss 93 percent: OIG study

Shortcomings in current screening methods for adverse events have implications for Medicare payments and federal initiatives to monitor them, according to a study by the Office of Inspector General (OIG); the study found that present on admission codes and incident reporting systems are missing the majority of events.

Methodology Five methods of identifying adverse events (AE) in hospitalized Medicare patients were examined by the OIG in its report to Congress titled, "Adverse Events in Hospitals: Methods for Identifying Events."

A sample of 278 Medicare beneficiary hospitalizations from acute care hospitals were screened using five methods:

  • Nurse review of medical records (IHI global trigger tool);
  • Interviews of Medicare beneficiaries;
  • Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicators (PSI);
  • Hospital billing data - Present on admission (POA) diagnosis codes; and
  • Review of internal hospital incident reports.

Overall, 63 percent of the possible events identified by these five screening methods were not associated with actual events.

POA codes and hospital incident reports found to be unreliable Patient diagnosis codes for POA were inaccurate or absent for seven of the 11 Medicare hospital-acquired conditions (HACs) identified by the physician reviewers. This inaccuracy would prevent Medicare's automated payment software from identifying the HACs, resulting in both overpayments and limiting use of billing data to monitor quality of care in hospitals.

Hospital incident reports were not generated for 93 percent of the events identified, including some of the most serious events. This lack of complete reporting prevents hospitals from tracking and reporting AEs as required by regulation. It also suggests that hospital reporting systems may be unreliable as a source of information for patient safety organizations (PSO), entities that aggregate and analyze information about AE voluntarily reported by hospitals.

Recommendations The OIG recommended that CMS and AHRQ explore ways to identify AEs when conducting medical record reviews for other purposes, e.g., during hospital CMS compliance surveys, possibly requiring new interpretative guidelines for tracking AEs, which currently do not exist. The OIG stated that CMS needs to verify that claims are coded accurately and completely to ensure identification of Medicare HACs, and AHRQ should inform PSOs that internal hospital incident-reporting systems may provide insufficient information about AE.  

Related study The discrepancies found are consistent with another study conducted at the Mayo Clinic (Premier Safety Share Sept 09 Mayo clinic), which also found major variations in identifying AEs, depending on the methods used. This study similarly used external (AHRQ PSI) and internal (incident-reporting system) indicators, plus a subset sample using the IHI global trigger tool. It found inconsistencies in the definitions and detection methods. Based on their findings, these authors suggested that measuring AE requires a multifaceted approach, cautioning against use of any one indicator for public reporting and performance comparisons.

 

 

Lab errors - Call for more automation to prevent mislabeling, misidentification and related harm to patients

Mislabeling of clinical laboratory and pathology specimens results in repeat diagnostic procedures and delayed or unnecessary surgical procedure. Use of electronic patient identifiers is one key prevention strategy.

Analysis More than 200 root cause analyses (RCA) over an eight-year period in the VA system identified system vulnerabilities in specimen collection, processing, analysis, and reporting associated with patient misidentification involving the clinical laboratory, anatomic pathology, and blood transfusion services. Data were categorized by three stages of the laboratory test cycle. Patient misidentification accounted for nearly three quarters of 253 adverse events, and occurred in all three stages of the test cycle: pre-, analysis, and post-analysis. Examples follow:

  • Pre-analysis The largest percentage (73 percent of the 182 misidentification errors) occurred during collection at admission such as wrist bands mislabeled or orders for the wrong patient due to similar names and Social Security numbers (SSN). This included two-source patient identification for clinical laboratory specimens and failure of two-person verification of patient identity for blood bank specimens. 
  • Analysis 20 percent of errors included relabeling, as well as misidentified microscopic slides due to a failure of two-pathologist verification for cancer diagnosis as well as wrong patient transfusion due to mislabeled blood products or failure of two-person verification for blood products before release by the blood bank.
  • Post-analytic phase The smallest number (7 percent) included results being reported into the wrong patient medical record or incompatible blood transfusions associated with failed two-person verification of blood products.

Findings Patient misidentification figured greatly in patient errors, whether in the clinical laboratory, anatomic pathology, or blood transfusion processes. Errors were analyzed with data mining software, and determined that the pace of reporting increased in 2007. Authors speculated that beginning in 2006, the VA expansion of the use of wireless bar-coding alerted the system to the problems of mislabeling and may have led to increased awareness and reporting due to mislabeling during specimen collection. Another important issue emerged causing misidentification - that is, patients with similar names, birthdays, and the last four digits of their Social Security number.

Solutions As a result of meticulous analysis and identification of the root causes, the authors provide a valuable table which identifies an intervention for each type of error, along with the positive effect in reducing errors. For example, one change includes: 1) the use of the full SSN and 2) use of electronic means for at least two of three patient identifiers (name, birth date, or SSN). The overall theme identified to reduce error is increased automation for as many processes as possible, with an expectation that such a focus will lead to systemic mitigation and prevention strategies.

More resources: Premier Safety Institute UDI and Bar-coding
 

 

CDC updates H1N1 infection control guidance and reports flu vaccination rate the highest this season

The Centers for Disease Control and Prevention (CDC) is updating the "Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel," noting the availability of an effective vaccine and experience with the virus. In a separate report, the CDC reported higher flu vaccination rates this season among healthcare workers than ever before

In a May 3, 2010, posting on the "Question and Answer" section of CDC's H1N1 Flu website, the question of how infection control measures may be revised for the upcoming season was addressed. The posting explains the revision will take into consideration the availability of a safe and effective vaccine and new information about the health impact of the novel H1N1 influenza strain - both of which will significantly change the circumstances and offer guidance on how best to control this infection. The response describes the process of how this guidance is being updated to reflect these changes.

Highest reported influenza vaccination rates among healthcare workers On a related note, the CDC's April 2, 2010, "Morbidity and Mortality Weekly Report," notes that since 1989, overall influenza vaccination coverage among healthcare personnel has never exceeded 49 percent in any season. However, the results of a population-based survey during January 2010 estimated vaccination coverage among healthcare workers was 37.1 percent for 2009 pandemic influenza A (H1N1) and 61.9 percent for seasonal influenza. Overall, 64.3 percent received either of these influenza vaccines, higher coverage than any previous season.

 

Tools

 

Premier - Safe injection practices survey

The Premier Safety Institute invites you and your colleagues to take a short survey to identify current practices of healthcare professionals who prepare and administer parenteral and injectable medications. All data are anonymous and aggregated results will be summarized on the Safety Institute website. The information will also be shared with professional associations, the Centers for Disease Control and Prevention, the Food and Drug Administration and other groups, to guide research and education related to reducing risks to patients. You are also invited to forward this invitation to staff who may prepare and administer parenteral and injectable medications in your organization and any affiliated locations, such as clinics, surgicenters and urgent care. Staff may include pharmacists, anesthetists, physicians, nurses, respiratory therapists and techs, for example. To invite others to participate, please forward this link www.premierinc.com/injectionpractices where the survey is located. To go directly to the survey go to: https://www.surveymonkey.com/s/SafeInjectionPractices-Web

 

HRET/AHA - Guide to address avoidable readmissions

A free guide to help hospital leaders address avoidable hospital readmissions, the "Health Care Leader Action Guide to Reduce Avoidable Readmissions," is a quick, simple resource that outlines four steps to avoid readmission:

  1. Examine your hospital's current state of readmissions;
  2. Assess and prioritize your improvement opportunities;
  3. Develop an action plan of strategies to implement; and
  4. Monitor your hospital's progress.

The guide was funded and produced by the Commonwealth Fund, the John A. Hartford Foundation, and the Health Research & Educational Trust (HRET) of the American Hospital Association.

 

AHRQ - 2010 patient safety culture survey data report

The Hospital Survey on Patient Safety Culture 2010 Comparative Database Report" is an update of the 2009 report that provides results from 885 hospitals and 338,607 hospital staff respondents using the safety survey tool. The 2010 report also includes a chapter on trending that presents results showing change over time for 321 hospitals that administered the survey and submitted data more than once. It can be used for comparisons with other hospitals using the survey, for internal assessment and learning, to identify strengths and areas for potential improvements, and to assess changes in patient safety culture over time. Hospitals seeking to submit data for inclusion in the comparative database can do so each year between May 1 and June 30.

 

FGI - 2010 design/construction guidelines

The 2010 Facility Guidelines Institute (FGI)'s "Guidelines for Design and Construction of Health Care Facilities" provides guidance on minimum program, space, and design guidelines for clinical and support areas of hospitals, outpatient facilities, long-term care, residential care facilities and mobile units. The Joint Commission, many federal agencies, and authorities in at least 42 states use the guidelines either as a code or a reference standard when reviewing, approving, and financing plans; surveying, licensing, certifying, or accrediting newly constructed facilities; or developing their own codes. Prominently featured are terms, requirements and best practices with infection prevention implications. The guidelines may be purchased at the American Society for Healthcare Engineering (ASHE) website or at the FGI website. For more information, see Premier's Green, Safer Building Design website.

 

HHS - Data transparency initiative "CMS Dashboard"

The Department of Health and Human Services (HHS) has launched a tool for viewing national, state, hospital and DRG claims payment and volume data from Medicare's inpatient prospective payment system. The CMS Dashboard tool is part of the Obama administration's new "open government" initiative. The CMS Dashboard BETA is a beta release and offers statistical views of the Inpatient Prospective Payment System (IPPS) data as it relates to claims payment and volume as collected by CMS. The data contained in this version is current as of April 2010 for inpatient discharges from January 2006 to March 2010. Future releases may contain additional CMS program data.

 

AHRQ - Nursing handbook on patient safety and quality

Nurses play a vital role in improving the safety and quality of patient care, not only in the hospital or ambulatory treatment facility, but also with community-based care and the care performed by family members. Nurses need to know what proven techniques and interventions they can use to enhance patient outcomes. To address this need, the Agency for Healthcare Research and Quality (AHRQ) has prepared a comprehensive handbook: "Patient Safety and Quality: An Evidence-Based Handbook for Nurses."

 

Michigan's MARR - Antimicrobial resistance prevention toolkit for LTC

The Michigan Antibiotic Resistance Reduction (MARR) Coalition's "Long Term Care Toolkit" is designed to help long-term care facilities implement the "12 Steps to Prevent Antimicrobial Resistance Among Long-Term Care Residents," a set of recommendations developed by the CDC as part of its campaign to prevent antimicrobial resistance in healthcare settings.

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