Safety Share

November 2004

Dear colleague:

Save time and adapt tools that others have developed. Visit our Safety Tools archive with:

  • On-line list - linking to each tool, or
  • Download complete list of tools
See Safety Tools below.

Gina Pugliese, editor
Vice President, Premier Safety Institute


Safety tools

Studies show reducing interns' work hours can reduce serious medical errors

Two recent studies at Brigham and Women's Hospital confirmed that reducing the number of consecutive hours and the total hours per week worked by interns in the intensive care unit cuts down on attention failures and serious medical errors.

In the first study, led by Lockley, interns were studied during two different three-week rotation schedules in the ICU: a traditional rotation that included extended work shifts, and an interventional rotation that limited scheduled work to 16 or fewer consecutive hours. After review of daily sleep and work logs, and continuous polysomnography, the interns in the traditional schedule worked more than 80 hours per week, compared to interns in the interventional schedule, who worked fewer than 80 hours per week. Compared to interns on the traditional schedule, those interns on the interventional rotation worked 19.5 fewer hours per week, slept 5.8 hours more per week, slept more in the 24 hours preceding each working hour, and had less than half the rate of attention failures while working during on-call nights. (Attention failures were defined by continuous electrooculography (EOG) as intrusion of slow-rolling eye movements into wakefulness during working hours.)

In the second study, led by Landrigan, researchers compared the rates of serious medical errors made by interns in the intensive care unit while working a traditional schedule - with extended (24 hours or more) work shifts every other shift - with an interventional schedule that eliminated extended work shifts and reduced the number of hours worked per week. Compared to interns on the interventional schedule, those interns on the traditional schedule made 36 percent more serious medical errors, (including 56 percent more non-intercepted serious errors), 5.6 times as many serious diagnostic errors and 20 percent more serious medication errors, despite the use of computerized provider order entry (CPOE) in the ICU. Also, the total rate of serious errors in the critical care units was 22 percent higher during the traditional schedule than during the interventional schedule.

The researchers noted that more than 100,000 physicians are currently in training in the United States and that most of these residents are regularly scheduled to work 30-hour shifts. Extended work shifts and long workweeks continue to be permitted, even under the scheduling reforms instituted last year by the Accreditation Council for Graduate Medical Education. Further, these findings may not only apply to residents and interns, but other staff such as attending physicians and nurses.

Downloads and links

Abstract - Lockley (26 KB) (.doc)

Abstract - Landrigan (32 KB) (.doc)

Back to News


As the number of workers per manager increases, employee engagement decreases

The reduction of management positions, a common cost containment strategy, can negatively impact employee engagement. A recent study at Fairview University Medical Center, Minneapolis, found that as the number of people reporting to a single manager (span of control) increased, employee engagement scores decreased.

The span of control ranged from fewer than five direct reports to up to 100 reports. Almost 13 percent of the managers studied had more than 40 direct reports, with 86 percent of these being nurse managers in patient care areas. The employee-engagement survey results indicated that as span of control increased, the engagement scores decreased, independent of other variables such as tenure, work status (full or part-time), and contract status (union or non-union).

Factors that differentiate. Of the 12 factors reviewed for engagement among work groups of more than 15 employees, the two that most differentiated managers' engagement were 1) whether employees felt their opinions counted [for groups of 15 or fewer] and 2) whether there was someone at work who encouraged their development.

Additional management positions increase scores. In order to achieve a 30-80 percent reduction in the span of control, management positions were then added to four patient care areas where managers had more than 80 direct reports. One year after the positions were added, the employee engagement scores increased in these patient care areas.

Downloads and links

Journal Nursing Administration abstract by Cathcart (26 KB) (.doc)

Back to News


CMS SIP project expands into SCIP to include other surgical complications

The Surgical Care Improvement Project (SCIP) is a national partnership of organizations committed to improving the safety of surgical care through the reduction of post-operative complications. The goal (expanded from the prior Surgical Infection Prevention project or SIP) is to reduce surgical complications nationally by 25 percent by the year 2010 in four target areas: surgical site infections and cardiac, respiratory, and venous thromboembolic complications. A SCIP steering committee has been working together since 2003 to develop a quality improvement framework to improve both patient safety and the quality of care for surgical services nationwide. In preparation for an official launch in summer 2005, several developmental activities are currently under way, including completion of a three-state demonstration pilot, the formation of four technical expert panels to provide specialized guidance for improving each of the four target areas, and development of information, materials and evidence-based strategies to help hospitals and their professional staffs participate - and succeed - in this national effort.

In addition to the proper use of antibiotics to prevent surgical site infections, examples of additional measures being evaluated include prevention of hypothermia during the procedure, maintaining high levels of inspired oxygen, controlling serum glucose within certain limits, and avoiding shaving of the operative site.

The SCIP steering committee consists of 10 public and private organizations, including: the Agency for Healthcare Research and Quality; American College of Surgeons; American Hospital Association; American Society of Anesthesiologists; Association of periOperative Nurses; Centers for Medicare & Medicaid Services; Centers for Disease Control and Prevention; Department of Veterans Affairs; Institute for Healthcare Improvement; and the Joint Commission on Accreditation of Healthcare Organizations. Premier, Inc, a participating member of the SIP project, continues to contribute to the SCIP expert panel on surgical site infections.

Downloads and links

For more information on SCIP, go to:

Back to News


Medication errors with pain pumps more harmful: USP, CAPS alert

The Center for the Advancement of Patient Safety (CAPS) issued an alert in the September issue of U.S. Pharmacopeia (USP) based on its finding that drug errors with patient-controlled analgesia (PCA) pumps are 3.5 times more likely to be harmful than drug errors in general.

The most common types of errors with PCA pumps were improper dose/quantity (38.9 per cent), unauthorized drug (18.4 percent), and omission error (17.6 percent). PCA pumps have several safety features designed to prevent the administration of excessive amounts of analgesic medication. For example, PCAs have a "lockout interval" that specifies the minimum amount of time between each dose and an established maximum allowable amount of drug during a predefined time period. In a review of medication errors submitted to its MEDMARX™ and USP Medication Errors Reporting (MER) Program from September 1, 1998, through August 31, 2003, however, USP observed medication errors involving PCA pumps actually increasing the chance of harming a patient.

Recommendations for preventing such errors include conducting a Failure Modes and Effects Analysis (FMEA) on existing and new pumps, utilizing available bar codes on all PCA medications, and reviewing policies for patients' own pumps brought into the facility. Additional recommendations require proper staff training and demonstration of competency, and written instructions for family members not to touch the PCA pump.

Downloads and links

The complete set of recommendations can be reviewed at:

The entire report can be viewed at:

Back to News


JCAHO issues anesthesia awareness alert

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) recently urged hospitals and healthcare professionals to take steps to prevent "anesthesia awareness." In its recent Alert, the JCAHO notes instances in which patients wake up during surgery and feel excruciating pain without being able to cry out. Anesthesia awareness occurs especially during a cardiac, obstetric or major trauma surgery in which general anesthetics are provided in smaller doses because of potential stress on the heart or the unborn baby. As many as 40,000 patients wake up during general anesthesia each year and about one-quarter of these patients report feeling pain. This number represents only one to two cases in every 1,000 general anesthetics administered, but the experience is traumatic for those patients who experience such an event.

The Alert is intended to provide a better understanding of this frightening phenomenon among healthcare professionals, as well as dispense practical advice to help prevent or manage anesthesia awareness. Certain medications, such as immobilizing drugs, are often administered and patients usually cannot signal that they see, hear or feel during general anesthesia. To help prevent such occurrences and their impact on patients, some specific recommendations include:

  • Educate clinical staff about anesthesia awareness and how to manage patients who have experienced it;
  • Inform patients who are at higher risk of anesthesia awareness before they undergo surgery;
  • Use effective anesthesia monitoring techniques;
  • Conduct post-operative follow-up of all general anesthesia patients;
  • Provide access to counseling and other supports for patients who experience awareness;
  • Develop and implement an anesthesia awareness policy.

Downloads and links

JCAHO Anesthesia Alert (46 KB) (.doc)

For more information on anesthesia awareness, visit:

Read the JCAHO Alert at:

Back to News


AIA seeks comments on minimum requirements of single rooms for proposed construction guideline

On November 1, the American Institute of Architects (AIA) opened the public comment period on the proposed 2006 edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities. One of the most significant proposed changes would make single-bed private rooms the minimum standard for new hospital construction. The proposal most likely to generate the most comments is section 7.2.A1, which calls for single-bed patient rooms (unless the functional program demonstrates the value of a multi-bed arrangement). The guidelines revision committee performed extensive research prior to proposing a minimum standard of single-bed patient rooms, looking at issues such as costs, infection control, patient falls, and therapeutic impact. For an overview of these issues and access to the single versus multiple occupancy patient room study commissioned by the Facilities Guidelines Institute, go to Construction, single room study-AIA.

Other guideline changes include a new section on intermediate care units, a new section on gastrointestinal endoscopy facilities, a new chapter on primary care hospitals (small and rural community facilities), psychiatric outpatient centers, assisted living facilities and hospice care facilities, and a new appendix on green architecture.

The guidelines describe minimum program, space, and equipment needs for all clinical support areas of hospitals, nursing homes, freestanding psychiatric facilities, outpatient and rehabilitation facilities, and long-term care facilities. They also include the minimum engineering design criteria for plumbing, medical gas, electrical, heating, ventilating, and air conditioning systems. Comments must be submitted before January 31, 2005, from the AIA Web site and may only address the recommended changes in the draft text, new sections of the document, or deletions from the 2001 edition. The final guideline is expected to be published in early 2006.

Downloads and links

Single-room study files from Premier's Safety Institute Construction module at:

To view the new draft and submit comments, go to:

Back to News


FDA updates data on previously approved 510(k) reprocessed single-use devices

Per requirements of the federal Medical Device User Fee and Modernization Act of 2002, the FDA published a list of reprocessed SUDs that had already received 510(k) approval/clearance and that required supplemental data on functionality, cleaning, and sterility. The FDA has completed its review of the supplemental validation submissions (SVS) data for more than 1,800 device models to determine if these devices remained substantially equivalent to legally marketed predicate devices after reprocessing.

Some previously approved SUDs can no longer be reprocessed. Based on its review of the SVS, the FDA has provided detailed information on its Web site on the status of devices that were reviewed. The information includes the name of the reprocessing company, the specific SUD with model number, and device type/category. Although the majority of 1,800 device models were approved for continued reprocessing, some were not. The FDA provides three online lists:

  • No longer legally marketed devices;
  • Legally available devices; and
  • Complete list. (Devices that require supplemental validation submission data, including model, size, length, color and other details on the vendor and SUD.)

Lists status. These FDA product lists are vendor- and product-specific (e.g., a specific product/device may no longer be legally marketed for one company but that same device may remain legally available for another company.) The FDA will update these lists as new information becomes available, and it recommends periodic checking of the status of reprocessed devices currently being purchased. FDA maintains a database of all reprocessed devices that require FDA review and are cleared for marketing. Some device types, whether or not they are reprocessed, do NOT require premarket review and clearance by the FDA. For questions about whether a specific device type requires FDA review and clearance, facilities should contact the reprocessing company or the FDA Premarket Review Staff (510(k)) at 301.594.1190.

Safety of devices with previous 510k clearance for reprocessing. "Any reference to the specific devices that can no longer be legally marketed as being dangerous or unsafe is incorrect," said Larry Spears, the FDA's deputy director of regulatory affairs, in response to concerns raised about the safety of the devices that had previous FDA 510K clearance and are now are in the "no longer legally marketed category." Spears' remarks were published in the November 9 e-newsletter, HPN Online.

Hospitals advised to work closely with reprocessing companies. Third-party reprocessing companies are contacting customers with information about the status of specific devices, voluntary withdrawal of products and follow-up actions (e.g., returns, credits). The FDA has said that it won't necessarily require a recall but will work with each company on a case-by-case basis to determine its plans for voluntary retrieval or withdrawal of the products.

Downloads and links

FDA site for online lists and FAQs:

FDA summary and information received from third-party reprocessing companies are available on the Premier Safety Institute Web site at:

Back to News | Back to top


Safety tools

Safety Share toolkit - Guide to all archived tools

One of the special resources developed from past issues of Safety Share is an archive of all safety tools published in the monthly newsletter. The resources are organized in an ExcelŽ spreadsheet, with descriptions of each tool and where they can be accessed. The spreadsheet is categorized by topic and includes many tools that are available from the Institute for Healthcare Improvement. These are listed separately as well as included under each pertinent topic. Access or download the spreadsheet at:
(258 KB) (.xls)

Back to Safety tools


Free publications - Diabetes educational tools

The National Diabetes Education Program (NDEP) has two new evidence-based publications for healthcare providers and patients. The first, "Guiding Principles for Diabetes Care," (352 KB) (.pdf) helps providers identify people with pre-diabetes and undiagnosed diabetes, and provide patient-centered care. The second booklet, "4 Steps to Control Your Diabetes for Life," (126 KB) (.pdf) complements the first and is for people with diabetes. It helps healthcare providers educate patients about self-care principles and how to be active partners in their own care. More than 18 million Americans have diabetes and about 40 percent of adults aged 40-74 have pre-diabetes, placing them at increased risk for diabetes and cardiovascular disease. Free copies can also be ordered at the NDEP Web site at or by calling the NDEP at 800.438.5383.

Back to Safety tools


New CDC list - Summary of resources to prevent spread of flu in the workplace

This latest tool (71 KB) (.pdf) from the CDC provides various resources, including important telephone numbers, Web pages, and poster/flyer links. Additional influenza resources can be found at:

Back to Safety tools


New AHRQ tool - Hospital Survey on Patient Safety Culture

On November 10, 2004, the Agency for Healthcare Research and Quality (AHRQ) in partnership with Premier, Inc., the Department of Defense and the American Hospital Association announced a new tool to assess the safety culture of a hospital as a whole, or in specific units within hospitals, as well as to track changes in patient safety over time and evaluate the impact of patient safety interventions. Premier's Safety Institute is providing the complete tool kit, which includes the survey, detailed user's guide for administration of paper or web-based methods, data collection and analysis, customizable templates for reporting results, references, and results of the pilot study. All components may be downloaded at

Back to Safety tools | Back to top


Editorial team

  • Gina Pugliese, RN, MS editor
  • Judene Bartley, MS, MPH, CIC, associate editor
  • John Hall, BSJ, contributor
  • Judith Luca, RN, BSN, contributor
  • John Deem, managing editor
  • Derek Kleckner, BA, Web master

About Premier

Premier, Inc. is a healthcare alliance entirely owned by 200 of the nations leading not-for-profit hospital and healthcare systems. These systems operate or are affiliated with 1,500 hospital facilities and hundreds of other healthcare sites. Premier provides an array of resources supporting health services delivery, including clinical and operational comparative data applications for quality/safety performance improvement, group purchasing and supply chain services, and insurance programs. The Centers for Medicare and Medicaid Services (CMS) has recently partnered with Premier for a three-year quality incentive demonstration project. Participating hospitals using Premier’s Perspective Online ™ database can receive recognition and additional Medicare payment when they meet or exceed specific quality measures.