Premier Safety Share
In this issue
Premier Safety Web Site
April 2002
Welcome to Safety Share, the online newsletter from the Premier Safety Institute. We invite you to comment.
Also, visit our Safety Web site for more safety resources: disaster readiness, latex allergies, reuse of single-use devices, sharps injury prevention, evidence-based practices (new AHRQ report), environmentally preferable purchasing, and mercury pollution prevention.
News
- CDC reports 26 patient infections and one death from contaminated tissue transplants
- Inadequate response to bronchoscope recall possible cause of patient infections
- Patient deaths from medical gas mix-ups prompt FDA to issue advisory
- JCAHO places moratorium on sentinel event scoring and issues alert on ventilator-related deaths
- CMS and CDC launch national Surgical Infection Prevention Project
- American Institute of Architects answers hospital design and construction questions on Web site
- OSHA extends comment period for TB standard
CDC reports 26 patient infections and one death from contaminated tissue transplants
The Centers for Disease Control and Prevention (CDC) reported 26 cases of infection and one death associated with contaminated tissue transplants. Half of the patients were infected with the bacteria, Clostridium. These cases have prompted increased scrutiny by federal agencies and new recommendations from the CDC that include sterilization of these tissues.
Tissue allografts (transplants between two individuals) are commonly used in orthopedic surgical procedures. A rare but serious complication is bacterial infection. None of the tissue transplants in these 26 cases had undergone sterilization, a process that kills all the bacteria (download entire CDC report below). Most tissue transplants only undergo aseptic processing which does not render them sterile. One reason is that some sterilization technologies can weaken tissue. CDC also noted that the extended intervals between death and tissue harvesting from the donors likely contributed to the contamination.
In response to these investigations, the CDC provided additional guidance to tissue processing companies that includes 1) use of sterilization methods to process tissues when feasible; 2) enhanced processing and validation procedures to minimize potential for bacterial contamination; and 3) strict adherence to recommended time limits for tissue retrieval from donors. The FDA also updated its industry guidance procedures for processing tissue transplants (download FDA Guidance below).
- CDC report: Tissue allograft infections (42 KB)
- FDA: Validation procedures for tissue transplants (17 KB)
- Premier Safety Web resource on patient safety and medical errors
Inadequate response to bronchoscope recall probable cause of patient infections
Investigators at Johns Hopkins University notified the Centers for Disease Control and Prevention (CDC) of bacterial infections among patients that may be associated with defective bronchoscopes. The CDC noted that many facilities, including Johns Hopkins, may have missed the voluntary recall of the bronchoscopes by the manufacturer three months earlier.
Olympus America of Melville, NY initiated the recall on November 30, 2001. The company notified 2,361 hospitals and healthcare institutions it recorded as purchasers by certified letters marked: "URGENT: RECALL." Olympus has received written confirmation from more than 90 percent of those healthcare institutions and has followed up with those that did not respond. Despite its efforts, company officials reported that less than 40 percent of the recalled bronchoscopes were returned for repair.
A voluntary recall is prompted by a company and not the FDA; however, some facilities may have interpreted "voluntary" as optional. The recall involved the following model numbers: BF-40, BF-P40, BF-1T40, BF-3C40, BF-XP40, BF-XT40, BF-240, BF-P240, BF-1T240, BF-6C240, BF-160, BF-P160, BF-1T160, BF-3C160, BF-XT160.
From June 1, 2001 to February 4, 2002, 100 of the 410 patients who underwent bronchoscope procedures at Johns Hopkins tested positive for exposure to Pseudomonas aeruginosa, a rate two to three times higher than expected. This prompted an investigation that revealed contamination in several of the bronchoscopes, likely due to loose ports, which were the reason for the recall (download Summary of Johns Hopkins Investigation below). Johns Hopkins has initiated an aggressive campaign to contact all patients who were exposed to bacteria because of the defect.
The CDC initiated a rapid notification (download notification below) with a summary of the investigation by Johns Hopkins and a notice to readers in the Morbidity and Mortality Weekly Report to alert the healthcare community of the recall (download notice to readers below).
Hospitals and healthcare facilities that use Olympus America bronchoscopes should find out if they have returned the bronchoscopes to the company for repair. (See Olympus recall notice, below, for additional information.) If they have no record of receiving the manufacturer’s recall notice, they should also determine if suppliers are using incorrect addresses. For example, loading docks or purchasing departments (the address to which medical supplies and devices may be shipped) may be receiving communications intended for administrative offices or clinical departments where supplies and devices are used. Hospital officials may want to notify their suppliers of correct addresses or take other steps to ensure that safety-related communications are appropriately routed.
Additional information is available from Olympus at 800.848.9024 and from the Food and Drug Administration at 800.638.2041.
- CDC's
rapid notification - Summary of Johns Hopkins Investigation
(25 KB) - CDC's
notice to readers - Morbidity and Mortality Weekly Report
(19 KB) - Olympus America Inc. recall letter (28 KB)
Patient deaths from medical gas mix-ups prompt FDA to issue advisory
In the past four years, the Food and Drug Administration (FDA) has received reports of seven deaths and 15 injuries to patients who were supposed to receive oxygen, but received a different gas instead, such as nitrogen. These events prompted the FDA to issue a public health advisory to hospitals, nursing homes, and other healthcare facilities on avoiding medical gas mix-ups.
Two of the seven deaths occurred in December 2000 in a nursing home that had received a shipment of medical grade oxygen that inadvertently included a vessel of industrial grade nitrogen. An employee selected the nitrogen vessel instead of oxygen but was unable to connect it to the oxygen system (as a safeguard, the connectors for oxygen vessels are specially fitted so that they are compatible only with oxygen delivery systems). To connect the nitrogen, he removed a fitting from an empty oxygen vessel and installed it on the nitrogen vessel. A total of four patients died.
The FDA health advisory (download advisory below) provides recommendations to prevent these mix-ups, including separate storage areas for medical grade and industrial grade products, 360 degree wraparound vessel labels, training personnel that they should never change fittings, and double checking oxygen systems after new vessels are connected.
In a related incident in a hospital in New Haven, CT, two patients died after they were mistakenly given an anesthetic instead of oxygen because a meter that controlled the flow of oxygen was mistakenly plugged into an adjacent receptacle for nitrous oxide. The oxygen meter was equipped with safety prongs to prevent the mix-up, but one of the prongs was broken off. Checking and double checking oxygen systems and connections before use on patients are one example of a systems change that might reduce this risk.
JCAHO places moratorium on sentinel event scoring and issues alert on ventilator-related deaths
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) announced that it is placing a moratorium on using a healthcare organization's response to sentinel event alert recommendations as the basis for scoring standards.
The current requirements call for organizations to review all alert recommendations, determine their applicability, and implement the appropriate ones or reasonable alternatives within 90 days of publication of the alert. Despite the moratorium on scoring, the JCAHO has announced that surveyors will assess, for consultative purpose, an organization's knowledge of alert recommendations and its implementation plans.
The JCAHO is seeking the assistance of the Accreditation Process Improvement Task Force (composed of representatives of state hospital associations) to develop a revised approach to the publication and use of sentinel event alert recommendations. The revisions will not be in place until 2003. Experts agree that the alerts have provided important information for healthcare facilities to prevent medical errors. However, there has been concern that the alerts were being used for scoring healthcare facilities on safety in the absence of an established process for field review, consensus, and cost-effectiveness.
The JCAHO will also use the alerts to develop an annual set of National Patient Safety Goals. An advisory board will assess the appropriateness of the goals based on existing evidence and/or expert consensus and cost-effectiveness. Beginning in July 2002, JCAHO plans to release six goals with no more than two recommendations for each annually. Healthcare facilities will be surveyed for compliance beginning in January 2003. Although aggregate data will be available to the public, individual organizational data will not be disclosed until 2004 at the earliest.
The most recent alert from the JCAHO, Preventing ventilator-associated deaths and injuries, has come under close scrutiny by safety experts (download Alert below). It cites JCAHO receipt of 23 reports of events related to long-term ventilation with 19 resulting in death. The root cause analysis of the 23 cases revealed that 87 percent were related to inadequate orientation and training. Safety experts have voiced concern that this alert may prompt hospitals to place too much emphasis on individual staff training without an equal emphasis on systems redesign, including new alarm response procedures; new processes for alarm testing and verification of settings; upgrading alarms and monitoring systems; and training for staff caring for ventilator patients.
- JCAHO Sentinel Event Alert: Preventing ventilator-related deaths and injuries (31 KB)
- Premier Safety Web resource on patient safety and medical errors
CMS and CDC launch national Surgical Infection Prevention Project
The Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) are collaborating on a national initiative, the CMS/CDC Surgical Infection Prevention (SIP) Project. The goal is to improve the selection and timing of the administration of prophylactic antibiotics, both factors proven to reduce the risk of surgical infections. The state Quality Improvement Organizations (QIOs) will oversee the project that will be phased in over three years, with one-third of states joining in August 2002.
Post-operative infection is a major cause of patient injury, mortality, and healthcare cost. Approximately 2.6 percent of nearly 30 million operations are complicated by surgical site infections each year. Infection rates of up to 11 percent are reported for certain types of operations. Each infection is estimated to increase a hospital stay by an average of seven days and add more than $3,000 in charges. Appropriate pre-operative administration of antibiotics is an effective way to prevent many of these infections.
The three-year project builds on the experience of the CDC National Nosocomial Infections Surveillance (NNIS) System and previous CMS projects administered through its Health Care Quality Improvement Program. Surgical procedures to be studied in this project include coronary artery bypass graft (CABG); cardiac, colon, hip and knee arthroplasty; abdominal and vaginal hysterectomy; and selected vascular procedures. Quality indicators will include the proportion of patients 1) who receive antibiotics within one hour before surgical incision; 2) those who receive prophylactic antibiotics consistent with current recommendations; and 3) those whose prophylactic antibiotics were discontinued within 24 hours of surgery end time. One-third of the states will begin the project in each of the three phases beginning August 1, 2002; November 1, 2002; and February 1, 2003 (download phase in schedule by state below).
For more information go to the Surgical Infection Prevention (SIP) Project Web site or download press release below.
The state QIOs work in partnership throughout the healthcare system with physicians, hospitals, outpatient facilities and nursing homes on community-based quality improvement activities that help ensure the routine delivery of high quality medical care.
- Surgical Infection Prevention (SIP) phase in schedule by state (19 KB)
- SIP Project Web site (www.surgicalinfectionprevention.org)
- SIP press release (131 KB)
- Premier Safety Web resource on patient safety and medical errors
American Institute of Architects answers hospital design and construction questions on Web site
The Guidelines for Design and Construction of Hospital and Health Care Facilities, 2001, published by the American Institute of Architects (AIA), is considered the industry standard. It establishes minimum space, equipment, and engineering design criteria for construction and major renovation in healthcare facilities including a new requirement for an infection control risk assessment or ICRA (download sample form below). More than 40 states and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) reference the Guidelines for licensing or accreditation of healthcare facilities. Formal interpretations of the guidelines are now available online.
Sample question: Can walls be removed from toilet rooms in single patient med-surg rooms? In lieu of walls, can a curtain be used? Answer: No, the guidelines require a physical room for a patient toilet area (click here for full answer).
The AIA provides answers to these types of questions, as well as other formal interpretations (download additional formal AIA interpretations below). Its Web site includes monthly updates and procedures for requesting interpretations. The Facility Guidelines Institute (FGI) handles the process. Decisions are made by a six-person panel of members of the Health Guidelines Revision Committee (HGRC). Panel decisions are considered formal interpretations, but the ultimate interpretation of the guidelines is the responsibility of the state or federal authority with jurisdiction. To order the AIA guidelines or to request a formal interpretation, go to the AIA Web site.
- Answer to question: Do toilet rooms need walls? (23 KB)
- AIA Formal Interpretations of Guidelines (45 KB)
- AIA Web site interpretation page
- Construction Matrix (59 KB)
- ICRA sample tool (59 KB)
OSHA extends comment period for TB standard
The Occupational Safety and Health Administration (OSHA) has extended the comment period for its proposed occupational tuberculosis standard. This marks the second time in 2002 that OSHA has asked for comments on it. The comment period was reopened in January 2002 and originally was scheduled to end March 25, 2002
OSHA announced that the new deadline is May 24, 2002 (download OSHA notice below). It is specifically requesting input on the final draft of its risk assessment and the report requested by Congress, Tuberculosis in the Workplace, developed by the Institute of Medicine (IOM), the policy arm of the National Academy of Science (download summary of report below). The IOM committee preparing this report gathered research from numerous groups, including the Premier Safety Institute. The Safety Institute presented the IOM with the results of a national survey, conducted by Premier with assistance from the CDC, to assess the status of TB control programs in US hospitals. (Download abstract of Premier-CDC TB study below).
- OSHA Federal Register notice: March 5, 2002 (36 KB)
- IOM Report: TB in Workplace (26 KB)
- Premier-CDC study (23 KB)
- Premier Safety Web resource on occupational TB risks
Other features
The Premier Safety Web offers in-depth information on many key safety issues including:
- Disaster readiness
- Latex allergies
- Reuse of single-use devices
- Sharps injury prevention
- Evidence-based practices
- Environmentally preferable purchasing
- Mercury pollution prevention
Editorial team
Gina Pugliese, RN, MS editor
Judene Bartley, MS, MPH, associate editor
Donna Bernstein, MPH, marketing coordinator
Derek Kleckner, BA, Web master
About Premier
Premier, Inc. is a national strategic alliance of leading hospitals and healthcare systems representing more than 200 not-for-profit owners that own, operate, or are affiliated with approximately 1,600 facilities. Premier members have access to a wealth of resources that support them as they evolve into integrated delivery systems and improve community health across the continuum of care. Premier maintains corporate offices in San Diego, CA; Charlotte, NC; Chicago, IL; and Washington, DC. For information, visit www.premierinc.com.