Premier Safety Share

In this issue

Premier Safety Web site

June 2004

Dear Colleague:

DELETE THIS EMAIL. Yes, you read correctly. ALL issues of Safety Share are archived on our Web site by date and topic, and are searchable, when ever you need the information.

And, did you know? There are more than 20,000 pages of information on our Web site on many safety topics including: back injuries; reuse of SUDs; bar coding; sharps injury prevention; construction; and guidelines from AHRQ, NQF, CDC and APIC; and environmentally preferable purchasing, to name just a few.

Tell your colleagues about our safety resources.

Sincerely,
Gina Pugliese, editor
Vice President, Premier Safety Institute

News

Safety tools

 

First on-line sharps injury prevention course - Touro University

Touro University International (TUI) has a series of four on-line, distance learning courses, leading to a “Graduate Certificate in Sharps Injury Prevention,” that will be offered beginning in September 2004. The goal of the program is to provide healthcare and other professionals with advanced knowledge, skills and abilities to assist international efforts to eliminate the risk of needlestick and other sharps injuries and the subsequent risk to bloodborne infections (e.g., HIV, HBV, HCV). This certificate program in sharps injury prevention is partially funded through an unrestricted educational grant from the Safety Institute, Premier, Inc. The attached program brochure provides a description of the courses. For additional information about this course, Premier sponsored scholarship information and other sharps safety resources, visit the Safety Institute Web site.

Downloads and links

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Medicare payments linked to reporting hospital quality performance data

Hospitals must submit their quality performance data on 10 specific measures by July 1, 2004, to the Centers for Medicare and Medicaid Services (CMS) in order to receive the full Medicare payment. Endorsed by Congress, this is the first time that CMS has linked the quality reporting to higher Medicare payments. Hospitals that do not submit data will have their payment update reduced by 0.4 percentage points for fiscal year 2005-07. See fact sheets below.

The nearly 5,000 hospitals already voluntarily reporting these 10 performance measures as part of the National Hospital Voluntary Reporting Initiative (NHVRI) only need to notify CMS that they are reporting for their annual payment update. The NHVRI was launched in 2003 as a public-private collaboration among CMS, the American Hospital Association, the Federation of American Hospitals, and the Association of American Medical Colleges. Since October 2003, data from the 10 measures submitted voluntarily by hospitals has been reported on the CMS Web site. CMS plans to expand the initial "starter" set of 10 hospital quality measures at a later date.

Both the Hospital Quality Data Reporting for annual Medicare payment updates and the NVHRI are part of the broader CMS Hospital Quality Initiative. Two other projects that are part of the CMS initiative include a hospital patient survey and a demonstration project to financially reward top performing hospitals for quality with increased payment for Medicare patients.

Hospital Patient Survey - HCAHPS

The hospital patient survey, known as HCAHPS, is designed to develop a national standard for collecting information on patient perspectives of hospital care and is currently being piloted in Arizona, Maryland and New York.

The Premier Hospital Quality Incentive Demonstration Project

The Premier Hospital Quality Incentive Demonstration is a three-year project that will recognize and provide financial rewards to hospitals that demonstrate high-quality performance in a number of areas of acute care. CMS will identify hospitals in the demonstration with the highest clinical quality performance for each of the five clinical areas. Hospitals in the top 20 percent of quality for those clinical areas will be given an increased financial payment as a reward for the quality of their care. Specifically, those hospitals in the top decile of performance for a given diagnosis will be provided a 2 percent bonus of their Medicare payments for the measured condition, while hospitals in the second decile will be paid a 1 percent bonus. The cost of the bonuses to Medicare will be about $7 million a year, or $21 million over three years.

Financial incentives for health plans

A recent study published by Center for Studying Health System Change describes how health plans are increasingly offering incentive payments to reward both physicians and hospitals for quality improvement. The study of 12 U.S. communities suggests the quality indicators used most commonly include patient satisfaction and preventive care use, while use of more sophisticated outcome and process measures is less common. Incentive payments take a variety of forms, but typically involve a modest bonus. The study can be found at in the May 2004 Issue Brief published by The Center for Studying Health System Change.

Downloads and links

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No evidence that vaccines linked to autism, IOM reports

Based on a thorough review of clinical and epidemiological studies, neither the mercury-based vaccine preservative thimerosal nor the measles-mumps-rubella (MMR) vaccine is associated with autism, according to a new Institute of Medicine (IOM) report. Hypotheses regarding how the MMR vaccine and thimerosal could trigger autism lack supporting evidence, and are theoretical only. The IOM concludes that future research to find the cause of autism should be directed toward other hypotheses that are supported by current knowledge and evidence and offer more promise for providing an answer.

The new IOM report updates two earlier reports, published in 2001, on possible links between autism and the MMR vaccine and thimerosal. At that time, the committee determined that the evidence did not show an association between the MMR vaccine and autism, but there was insufficient evidence to determine whether thimerosal was associated with neurodevelopmental disorders such as autism.

Prenatal exposures to another form of mercury have been shown to adversely affect early childhood development and mercury is known to have a toxic effect on the nervous system. In the 2001, report the committee concluded that it was possible to hypothesize that thimerosal might trigger neurodevelopmental problems. It was recommended that infants receive vaccines without mercury preservatives and by 2002, most childhood vaccines contained no traces of mercury. The committee revisited these issues because several studies exploring the epidemiology and biological mechanisms of possible links between vaccines and autism have been undertaken during the past three years.

Autism is not a single condition, but rather a complex set of severe developmental disorders characterized by sustained impairments in social interaction and communication abilities, as well as restricted or repetitive patterns of behaviors and interests. It is unknown how many cases of autism there are, but two reviews of published studies put the prevalence at one case for every 1,000 children. While some information suggests that autism rates may be rising, it is not clear whether the observed increase is real or due to factors such as heightened awareness of the disorder or the use of a broader diagnostic definition.

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All hospitals must now comply with OSHA’s bloodborne pathogen rule

The July 1, 2004, deadline is approaching for all Medicare hospitals to be in compliance with the Occupational Safety and Health Administration's (OSHA) Bloodborne Pathogens (BBP) standards. The Centers for Medicare & Medicaid Services (CMS) sent a letter to hospital administrators informing them that the proposed inpatient prospective payment system rule for fiscal year 2005 contains a provision implementing an important Medicare Modernization Act requirement. That requirement calls for all Medicare participating hospitals to comply with OSHA's Bloodborne Pathogens (BBP) standards as part of their Medicare provider agreement. Most hospitals already are subject to the OSHA BBP standards because their state has a plan or other BBP standards that meet the OSHA standards. Any hospital that was not previously covered by a plan in compliance with OSHA's standards will be covered by the CMS rule. This includes non-federal, government-owned hospitals in 26 states, the District of Columbia, the Virgin Islands and Guam that did not have their own BBP standards.

Downloads and links

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Premier releases results of survey on disclosure practices

Survey points to promising trends in medical error disclosure
The majority of hospitals responding to a Premier survey have formal, board approved policies to disclose medical errors to patients, according to a survey conducted by Premier, Inc. More than 200 respondents participated in the informal, anonymous survey on disclosure practices in hospitals, conducted among visitors to the 6th Annual National Patient Safety Foundation (NPSF) Congress held in Boston May 3-6, 2004.

The survey on disclosure practices defined disclosure as "honestly telling patients or their families about unexpected harm that occurs as a result of treatment or care not directly because of a patient's illness or underlying condition." The survey was modeled after other recently published surveys and was intended to determine if responses would be similar when provided by a completely random representation of healthcare professionals. The survey uncovered some promising trends in medical error disclosure practices.

Those studies, as well as the Premier survey, indicate that while hospitals and doctors continue to be haunted by medical errors, they are becoming more receptive to revealing such mistakes and discussing them with affected patients.

Some state laws now require patients to be informed about "unanticipated outcomes" in their care. Patient safety standards from the Joint Commission on Accreditation of Healthcare Organizations have required hospitals to disclose to patients all unexpected outcomes of care since July 2001.

More hospitals appear to be adopting formal disclosure policies. For example, the vast majority of respondents (75 percent) said their facilities had established formal, board-approved disclosure policies. Only about 12 percent said no such policies are yet in place.

In an early 2002 survey of risk managers at a nationally representative sample of 500 U.S. hospitals, only one-third of hospitals reported having board-approved policies in place.

Serious errors are being disclosed more frequently
None of the respondents in the 2004 Premier survey indicated that disclosures of serious or short-term harm were never given. A majority (57 percent) said serious or short-term harm are frequently disclosed to patients or families, while a smaller percentage (37 percent) said such disclosures are always made.

In contrast, a 1991 study reported on in the Journal of the American Medical Association revealed that as many as 76 percent of hospital risk officers had not disclosed a serious error to a patient.

While hospitals are more likely to disclose errors that result in short-term harm, more are disclosing errors that result in serious illness or death. In the Premier survey, 55 percent of respondents said death or serious illnesses are always routinely disclosed to patients or families. Another 45 percent said such notifications were frequently or sometimes given. Only 7 percent indicated such notices were infrequently given.

Nearly all respondents to the Premier survey (99 percent) said disclosure of a medical error resulting in harm is always accompanied by some kind of explanation. In nearly just as many instances (90 percent), such disclosure also includes an apology. Fewer hospitals and doctors, meanwhile, are likely to go beyond explanations and apologies. For example, about 70 percent of respondents to the Premier survey said such disclosures resulted in formal investigations; an even smaller percentage (60 percent) indicated that such disclosures were accompanied by an acknowledgement of harm or a promise to share the results of their investigation (about 50 percent) said their facilities offered such information).

Malpractice claims burden is biggest obstacle to disclosure
The financial burden and public stigma of malpractice claims continue to be the biggest barrier to more open communication about medical errors. Malpractice was named by 72 percent of respondents in the Premier survey as a disclosure barrier; other barriers included staff opposition to disclosure (35 percent) followed by fears of disturbing or frightening patients (30 percent), multiple malpractice insurers among the facility and its medical staff (17 percent) and cost concerns (15 percent).

In the conclusion of a three-part series of articles on disclosure of unanticipated outcomes in healthcare, (published between May 2003 and February 2004), the American Society for Healthcare Risk Management of the American Hospital Association (ASHRM) stated that, "If our health care system can succeed in making effective communication the norm, we will advance light years in our effort to reduce errors and change the punitive nature of malpractice judgments. Safe and trusted health care can only be achieved one organization, one provider and one patient at a time."

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FDA issues additional industry guidance for reuse of single-use devices

The U.S. Food and Drug Administration (FDA) recently released revised guidance covering the procedures and time frames for reviewing the validation data submitted to the agency for certain reprocessed single-use devices (SUDs). The new document, entitled "Guidance for Industry and FDA Staff; Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices," supersedes a guidance of the same title issued last year.

The previous guidance, from July 8, 2003, described the types of validation data that FDA recommends be submitted on cleaning, sterilization and functional performance of certain reprocessed single-use devices to ensure that they are substantially equivalent to the original products. That document also provided guidance on how the FDA intends to implement these validation data requirements.

The main changes in the revised guidance describe in more detail the time frame for FDA's reviews of these validation data submissions, and what actions it will take if a reprocessed single-use device is found not to be substantially equivalent (NSE) to the original SUD. The new guidance clarifies that following its review of the supplemental validation submission, the FDA intends to issue either a letter finding the reprocessed SUD to be substantially equivalent (SE) to the original device, or a letter requesting additional information. The manufacturer that receives the request for additional information will have 30 days to respond, and then FDA intends to make a final decision on substantial equivalence within 60 days.

If the agency reviews the validation data and determines that the reprocessed SUD is not substantially equivalent (NSE) to the original device, it will issue a NSE letter and the device may no longer be legally marketed. The manufacturer may submit a new premarket notification [510(k)] with the validation data required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) at a later date. The MDUFMA requirements apply to critical reprocessed SUDs, which contact normally sterile tissue or body space, and to semi-critical SUDs, which contact intact mucous membranes without penetrating normally sterile areas of the body. Two years ago, a FDA survey found that more than 45 percent of all hospitals with more than 250 beds reuse SUDs ranging from compression device sleeves to endoscopic/laparoscopic instruments and electrophysiology catheters. The recommendations are effective immediately. Comments may be submitted to the FDA at http://www.fda.gov/dockets/ecomments.

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CMS Surgical Infection Prevention Project issues antimicrobial prophylaxis advisory

CMS' National Surgical Infection Prevention Project (SIPP) recently published a joint advisory statement on "Antimicrobial Prophylaxis for Surgery: An Advisory Statement from the National Surgical Infection Prevention Project," in the June 15 issue of Clinical Infectious Diseases. Premier, Inc. joins numerous other national healthcare and professional organizations in officially endorsing these guidelines; organizations include the American College of Surgeons, the American Academy of Orthopaedic Surgeons, and the Society of Thoracic Surgeons.

The quality improvement project is co-sponsored by the Centers for Medicare & Medicaid Services and the Centers for Disease Control and Prevention (CDC) and is conducted through the CMS Health Care Quality Improvement Program. Its goal is to reduce the occurrence of post-operative infection by improving the selection and timing of preventative antibiotic administration.

When the National Surgical Infection Prevention Project was launched in 2002, clinical experts identified areas of inconsistency among the existing surgical infection prevention practice guidelines, as well as issues that were not addressed in any of the guidelines. Areas of focus included selection of antibiotics for patients with certain antibiotic allergies, and the duration of antibiotic therapy after completion of the operation.

Project leaders hosted a forum of national medical organizations in January 2003. The two-day meeting led to initial consensus concerning antibiotic selection, timing, and duration for select types of surgery. The resulting advisory statement was subsequently accepted by all of the participating organizations, as well as additional national medical organizations. Its most important features were recommendations that antibiotics used to prevent surgical infection should be given during the hour before surgery and that they should not be used for more than 24 hours after the end of the operation. Timely administration results in more effective infection prevention, while short duration is less likely to produce antibiotic-resistant bacteria.

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JCAHO assesses compliance with USP guidelines on compounding sterile preparations

Beginning July 1, 2004, the JCAHO will begin surveying compliance with a new chapter in the 2004 United States Pharmacopoeia-National Formulary (USP-NF) entitled "USP Tests and Assays Chapter 797, Pharmaceutical Compounding, Sterile Preparations." This new chapter deals with new requirements for the compounding, preparation, and labeling of sterile drug preparations and applies to healthcare institutions, pharmacies, physician practices, and other facilities that prepare or compound sterile preparations (for example, intravenous solutions, eye drops).

The JCAHO's June issue of Perspectives states: "The Joint Commission will expect compliance with all its standards where the current requirements are already identical to USP-NF 797." JCAHO expects organizations to assess any significant risks by July 1 and implement the more basic elements of the plan. It also states that "facility-based requirements of the USP-NF 797 only need to be planned for future implementation."

JCAHO recommends that to comply with these requirements, organizations should immediately evaluate their current practices in the light of the new USP-NF chapter and make appropriate changes. Organizations should work with their pharmacies to determine:

  • If they are preparing or compounding sterile preparations and if so, determine the USP risk level;
  • Review the built environmental requirements.

Therefore the built-in environment requirements should be reviewed and assessed in accordance with USP defined risk levels. Each organization should perform an assessment of their current practices and environment to determine where they do not meet the USP 797 requirements, and then develop a detailed action plan to bring practice into alignment with the requirements over a reasonable time frame. Longer-term issues are best addressed during remodeling and renovation with a potential five-year or greater implementation time frame. Copies of the USP 797 requirements are available at the USP Web site, http://www.usp.org. Professional organizations such as the American Society of Healthcare Pharmacists (ASHP) and the American Society of Healthcare Engineering (ASHE) are providing assistance with interpretation. See the ASHP USP guide below.

Additional background on USP 797: This chapter, "Pharmaceutical compounding-Sterile Preparations," describes three risk levels for preventing contamination of products compounded by pharmacies. The levels determine the status of the area where the compounding occurs. Factors considered include type of product, policies/procedure required, personnel education, training and evaluation, storage and handling, facilities and equipment. The type of product is the determinant of the required risk level. A brief description of the risk levels and an example of product requiring that level of cleanliness are provided.

  • Low level: The controlled area requires an ISO class 5 or "class 100" environment-horizontal or vertical laminar airflow (LAF) workbench or barrier isolator located in an ISO Class 8 ("class 100,000") buffer room or cleanroom with ante area. That is, the ante area need not be separated from the controlled area with a physical wall. Examples of sterile products preparation requiring this level include transferring a sterile drug product from a vial into an IV bag and compounding total parenteral nutrients (TPN) solutions.
     
  • Medium level: The controlled area is the same as the low level, requiring an ISO class 5 or "class 100" environment-horizontal or vertical laminar airflow (LAF) workbench or barrier isolator located in an ISO Class 8 ("class 100,000") buffer room with an ante area that is not separated with a physical wall. An example of processes needing this level is preparation of portable pump reservoirs for multi-day administration or compounding TPN solutions with an automated compounding device.
     
  • Highest level: The controlled area requires an ISO class 5 or ("class 100") environment-horizontal or vertical laminar airflow (LAF) workbench or barrier isolator located in an ISO Class 8 ("class 100,000") but the ante area should be a separate room. Examples of processes needing the highest level of protection include preparation of TPN solutions made from dry amino acids; preparation of morphine sulfate 50/mg/ml injections.

Definitions of cleanroom standards for airborne particulate cleanliness classes based on Federal Standard (FS) 209 are available from several sources. Although the USP 797 is a guideline, state boards of pharmacies can enforce it if they so stipulate in their regulations. Once state boards incorporate USP 797, the JCAHO will survey for compliance. The FDA can also enforce this chapter.

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Safety tools

 

ICU toolkit - improve safety and quality of care

A toolkit designed to help hospitals improve safety and quality of care in their intensive care units is now available on the Michigan Health and Safety Coalition Web site, http://www.mihealthandsafety.org/icu_toolkit.html. The MHA toolkit (.pdf) (177 KB) is a series of recommendations based on current research and best practices. It was developed by a nine-member volunteer workgroup of health professionals experienced in leading ICUs and improving patient safety and quality of care. The toolkit will help hospitals:

  • Evaluate their ability to provide ICU care;
  • Identify activities and resources needed to provide optimal care;
  • Strengthen ongoing patient safety improvement activities and implement new ones;
  • Measure improvements in patient and hospital care; and
  • Adopt a model of care that reflects evidence-based best practices.

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Webcast- Designing the 21st century hospital

A Webcast, "Designing the 21st Century Hospital: Serving Patients and Staff," is available from the Robert Wood Johnson Foundation (RWJF). The webcast features researchers, design professionals, and hospital leaders presenting and discussing how hospitals of the future should be built, organized, and managed to maximize patient safety and outcomes and improve staff performance and satisfaction. Featured are up-to-the-minute evidence-based design concepts for healthcare buildings. With an anticipated $20 billion in new hospital construction and major renovations projected annually for the next decade, the central question of the conference was how hospitals' physical design, operating systems, and "corporate culture" affect patients, staff, and hospitals' bottom line. Speaker bios, conference discussion and written highlights will be available at:

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AHRQ, AHA, AMA poster – Five steps to patient safety for consumers

A new poster available from the Agency for Healthcare Research and Quality (AHRQ) and supported by the American Hospital Association and the American Medical Association titled "Five Steps to Safer Care" is now available in both English and Spanish (.pdf) (360 KB). The poster succinctly describes the five steps patients can take to ensure safer care.

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Medication safety tool – 2004 ISMP self-assessment

The Institute for Safe Medication Practices (ISMP), in partnership with the Health Research and Educational Trust (HRET) of the American Hospital Association (AHA), has launched the 2004 ISMP Medication Safety Self Assessment for hospitals. The assessment is being distributed to hospitals across the country. ISMP estimates that the preliminary aggregate national data will be released in late 2004. The self-assessment tool was funded by the Commonwealth Fund and is available for download at:

Premier, Inc. joins a number of other healthcare organizations endorsing this survey, including the AHA and HRET, the American Medical Association, the National Patient Safety Foundation, the Joint Commission on Accreditation of Healthcare Organizations. The project will allow ISMP, AHA, HRET, and others to use the information to identify common medication system weaknesses, identify new areas of focus, and offer practical system enhancements, including those that are thought to provide the highest leverage for overall error reduction activities. Educational efforts and programs can be designed to help hospitals implement high leverage strategies that can positively impact patient safety. Results of the 2000 Self Assessment have lead to the development of the Pathways for Medication Safety ® educational tools, available at:

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NPSF brochure and video - patient safety

The National Patient Safety Foundation (NPSF) has a brochure and companion video entitled "Patient Safety: Your Role in Making Healthcare Safer." It was created to help patients become more involved in their healthcare safety. The companion video will help supplement and reinforce the safety message with patients. The brochure and video are part of the National Patient Safety Foundation's Stand up for Patient Safety campaign, which is designed to help patients learn practical ways to help ensure their safety in both inpatient and outpatient settings. The brochure is $45 and the companion video is $70. More purchase information is available from:

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ARHQ tools – training, evaluating disasters

A free tool from the Agency for Healthcare Research and Quality (AHRQ) helps hospitals evaluate their disaster training drills. The tool, developed by the Evidence-based Practice Center at the Johns Hopkins University, helps hospitals identify their strengths and weaknesses during a disaster drill and improve their ability to meet required emergency management plans. Areas assessed include pre-drill planning, incident command, decontamination, triage and treatment. The tool also includes checklists to help hospitals tailor drills to specific health threats, such as a biological or radiation incidents, and a spreadsheet to track and compare drill performance among hospital units or hospitals. Titled "Evaluation of Hospital Disaster Drills: A Module-Based Approach," the tool is available from the AHRQ as a notebook with accompanying CD-ROM by calling 800.358.9295 and referencing AHRQ Publication No. 04-0032. It also can be downloaded at http://www.ahrq.gov/research/hospdrills/hospdrill.htm.

AHRQ also published an Evidence Report (.pdf) (155 KB) titled "Training of Hospital Staff To Respond to a Mass Casualty Incident." This evidence report updates the evidence report "Training of Clinicians for Public Health Events Relevant to Bioterrorism Preparedness" and focuses on the effectiveness of hospital disaster drills, computer simulations, and tabletop or other exercises used in training hospital staff to respond to a mass casualty incident. Some key questions include:

  • What is the effectiveness of hospital disaster drills? computer simulations? tabletop or other exercises?
  • What methods or tools have been used to evaluate the effectiveness of hospital disaster drills, computer simulations, and tabletop exercises or other exercises?

The full report, Evidence Report/Technology Assessment No. 95, Training of Hospital Staff to Respond to a Mass Casualty Incident, may be obtained free from the AHRQ Publications Clearinghouse by calling 800.358.9295.

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Editorial team

Gina Pugliese, RN, MS editor
Judene Bartley, MS, MPH, CIC, associate editor
Donna Bernstein, MPH, marketing consultant
John Hall, BSJ, contributor
Derek Kleckner, BA, Web master
Judith Luca, RN, BSN, contributor

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.

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