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The long-awaited Centers for Disease Control and Prevention (CDC) Guidelines on Environmental Infection Control in Health Care were released on June 6, 2003, in the Morbidity and Mortality Weekly Report. The 50-page guideline contains the complete list of recommendations, rationale, ranking categories, references, and one appendix on water sampling for Legionella.
The guidelines include recommendations for reducing infection risk related to air and water environmental concerns, cleaning and disinfecting environmental surfaces, environmental culturing, laundry and bedding, managing regulated medical waste, construction and renovation, use of carpeting, pest control, animals in healthcare facilities and water quality in hemodialysis.
The complete 200-page guideline, including all the background information and full appendices should be published in the next two months on the CDC Web site.
The U.S. Occupational Safety & Health Administration (OSHA) announced in the May 27, 2003, Federal Register that it withdrew a proposed 1997 TB Rule because it did not meet the burden of risk to justify the enactment and publication of a final standard.
In 2002, OSHA reopened the comment period on the rule in light of an Institute of Medicine (IOM) report that found the standard could be inflexible. The proposed standard, published in October 1997, would have required employers to protect TB-exposed workers using infection control measures similar to procedures outlined by the Centers for Disease Control and Prevention (CDC) 1994 guidelines for preventing the transmission of M. tuberculosis. Many professional organizations, including the American Hospital Association (AHA) and the Association for Professionals in Infection Control and Epidemiology (APIC), noted in past letters to OSHA that hospitals have spent considerable time and resources developing TB control programs consistent with the CDC guidelines. AHA and APIC felt that OSHA’s proposed requirements go beyond those recommendations, placing an unnecessary burden on hospitals and staff.
This does not mean that regulations related to control and prevention of tuberculosis are suspended. A 1996 OSHA directive remains in effect, using OSHA’s “general duty” clause to enforce the 1994 CDC Guidelines for the Prevention of Transmission of M. tuberculosis. Administrative controls such as early identification of possible pulmonary tuberculosis (TB) cases, engineering controls such as airborne infection isolation rooms, personal protective equipment such as N95 respirators, and tuberculin skin testing are all elements addressed in the directive. Healthcare facilities using respirators for protection from M. tuberculosis continue referencing OSHA’s respiratory protection standard for TB.
Nearly 1000 hospitals have volunteered to collect and report quality performance data for three medical conditions -- acute myocardial infarction, heart failure and pneumonia -- to share with the public. This initiative, led by the American Hospital Association (AHA), the Association of American Medical Colleges (AAMC) and the Federation of American Healthcare Systems (FAHS) is supported by the Centers for Medicare & Medicaid Services (CMS), the Agency for Healthcare Research and Quality (AHRQ), National Quality Forum (NQF), the American Association of Retired Persons (AARP), and the AFL-CIO. California and Idaho hospital associations joined those in 14 other states and the District of Columbia in endorsing the voluntary, hospital-led initiative, according to the AHA.
In an advisory and call-for-action released on May 2, the AHA, AAMC and FAHS provided details of the effort, titled called the Quality Initiative: A Public Resource on Hospital Performance. Hospital leaders were asked to voluntarily permit patient care data, already being collected as part of a hospital's accreditation through the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), to be displayed with accompanying information on a public Web site. Data to be displayed in the first report includes results of their performance on 10 quality measures for three medical conditions -- acute myocardial infarction, heart failure and pneumonia. These 10 measures are common to JCAHO’s ORYX program and CMS’ 7th Scope of Work. They also have been endorsed by the NQF as national standards of hospital quality measurement.
Two data-collection pathways are available for hospitals to send information to CMS' Quality Improvement Organization (QIO) Data Warehouse: one through a JCAHO-approved ORYX vendor for accredited hospitals; the other, using CMS-developed CART software for submitting directly to the QIO data warehouse and the CMS Web-based reporting system called Q-Net.
Data will be reported initially on the CMS Web site with a July 2003 target date. By summer 2004, the data will be reported on the CMS Web site for Medicare beneficiaries and the general public.
The results of a CMS-led pilot study in Arizona, Maryland, and New York in 2003 on the initial 10 quality measures will be used to develop the Medicare beneficiary Web site. Later phases of the study will include testing a draft patient perception-of-care survey instrument, as well as additional quality measures.
The National Quality Forum (NQF), which represents 173 health care and consumer groups, has endorsed 30 patient safety practices that should be universally used in healthcare settings to reduce the risk of harm to patients resulting from processes, systems, or environments of care. Among the 30 patient safety practices in the new report, Safe Practices for Better Healthcare: A Consensus Report, are informing patients that they are likely to fare better if they have certain high-risk, elective surgeries at facilities that have demonstrated superior outcomes; specifying explicit protocols for hospitals and nursing homes to ensure adequate nurse staffing; hiring critical care medicine specialists to manage all patients in hospital intensive care units; ensuring that hospital pharmacists are more actively involved in the medication use process; and creating a culture of safety in all health care settings.
The NQF consensus report is partly based on work by a team of researchers at AHRQ's Evidence-based Practice Center at Stanford University/University of California at San Francisco. The team identified the 30 voluntary consensus standards from a list of 220 candidate practices based on each practice's specificity, effectiveness, potential benefit, applicability , and readiness for implementation. This report also identified 27 practices that have great promise for reducing adverse events and should have high priority for further research. See the links below for information on ordering this report from NQF.
At Premier’s annual performance improvement conference, 16 hospitals and health systems were honored for establishing innovative strategies and programs that improve patient care and safety. This award, fully funded by Premier, is based on a peer-review process in which member facilities submit applications profiling their programs. Profiles and abstracts of the 2002 honorees are available for anyone to view online at Premier’s public Award for Quality Web site.
The 2002 Award winners and their programs include:
The U.S. Food and Drug Administration (FDA), in an April 30, 2003, Federal Register notice, announced its expanded requirements for 510(k) premarket notification and additional validation data to assure that reprocessed single-use devices (SUDS) are substantially equivalent to the original or "predicate" devices already FDA-approved. The FDA identified certain critical devices (those devices that contact normally sterile tissue) that were previously exempt from 510(k) premarket notification requirements, and now are no longer exempt and must have 520(k) approvals. These devices include for example, dental diamond coated burs, percutaneous biopsy needles, and gynecologic biopsy forceps. The 510(k) applications must be submitted by July 24, 2004, to qualify for reprocessing. The FDA is also requiring validation data to be submitted with the 510(k) pre-market notification requests for certain reprocessed SUDs. This requirement will hold reprocessed SUDs to a higher standard than the 510(k) approved "predicate" device because pre-market validation data has generally not been required for 510(k) submissions on the original device. This validation data must be submitted by January 30, 2004, if a 510(k) application has already been approved for a specific device and for all new 520 (k) applications.
These FDA actions were prompted by requirements in the Medical Device User Fee and Modernization Act (MDUFMA) of 2002, which specified the termination of 510(k) exemptions for certain critical devices and additional premarket validation data for all 510(k) applications. Other requirements of the MDUFMA include labeling reprocessed devices with the statement: "Reprocessed device for single use" and the "Reprocessed by [name of reprocessor]” and the revision of the mandatory and voluntary MedWatch forms to include boxes indicating if the device was a processed SUD and the name of the reprocessor. These additional requirements are intended to provide additional measures for monitoring and assuring the safety and efficacy of the reprocessed SUDs.
The Institute of Medicine’s (IOM) Committee on Smallpox Vaccination Program Implementation is advising the Centers for Disease Control and Prevention (CDC) to pause its smallpox vaccination program before offering the vaccine more widely
The CDC had asked the IOM to monitor its smallpox vaccination program before venturing into the massive project. In its latest report, the IOM panel recommends that CDC pause to evaluate the program's processes and outcomes to date to ensure the program continues to be as safe as possible for vaccinees and their contacts. The panel claims that a pause also would allow time for CDC and the states to modify vaccination plans, data systems and materials in response to changing circumstances, and to re-evaluate the program's role in overall smallpox preparedness. The agenda and PowerPoint presentations of the May meeting, as well as an audiotape of proceedings, are available from the IOM site.
Adverse drug events (ADEs) occurred in 25 percent of patients responding to a survey in four primary care practices in Boston, according to an article by Tejal Gandhi and colleagues in the April 17, 2003, issue of the New England Journal of Medicine. Twenty-eight percent of ADEs were ameliorable and 11 percent were preventable. Ameliorable ADEs were related to physicians’ failure to respond to medication-related symptoms (63 percent) and from patients’ failure to inform physician of symptoms (37 percent).
Prescriptions were computerized at two of the practices and handwritten at the other two. Preventable ADEs were due to prescriptions errors, one-third of which could have been prevented by the use of advanced computerized systems of prescribing medications, according to the article. The medication classes most frequently involved in ADEs were selective serotonin-reuptake inhibitors, beta-blockers, angiotensin-converting-enzyme inhibitors, and nonsteroidal anti-inflammatory agents.
Brigham and Women’s Hospital (BWH) study data resulted in strategies to help reduce the rate of outpatient adverse drug events, including better education about commonly prescribed medications, increased monitoring of side effects, and computerized checks for drug dosages and allergies. To help improve doctor-patient communication, BWH developed Patient Gateway, a personalized Web site for patients to check their medications, access medication information and e-mail clinicians.
Revisions to the scoring of the 2003 JCAHO National Patient Safety Goal regarding marking the correct surgical site have been made as a result of consensus reached at the May 9, 2003 Wrong Site Surgery Summit. The Summit was sponsored by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), its corporate members, and the American Academy of Orthopaedic Surgeons. Effective immediately, the Joint Commission has modified how it scores JCAHO National Patient Safety Goal #4, which requires organizations to "Eliminate wrong-site, wrong-patient, wrong-procedure surgery." Specifically, the change affects the scoring of the second recommendation under this goal (4.b.), which states that organizations must “implement a process to mark the surgical site, and involve the patient in the marking process.”
Organizations will still be required to mark the surgical site in cases involving right/left distinction, multiple structures (such as fingers or toes), or levels (such as the spine). This requirement will continue to be scored. However, JCAHO is no longer requiring that the site be marked for other types of procedures, including mid-line sternotomies for open-heart surgery, Cesarean sections, laparotomy and laparoscopy, and interventional procedures for which the site of insertion is not predetermined, such as cardiac catheterization procedures. Organizations not marking the site in these cases will not be scored noncompliant for recommendation “b” of Goal #4 as long as they are consistently marking the sites involving right/left distinction, multiple structures, or levels.
In addition, JCAHO has instituted a change regarding marking teeth prior to extraction surgery. JCAHO is supporting the position of the American Dental Association (ADA) on this issue, exempting dental procedures from the site-marking requirement. The ADA acknowledges, and JCAHO supports, that there is not a reliable method to directly mark teeth intended for extraction. This change was also made as a result of discussion at the summit.
To guide healthcare providers through the evolving disclosure process, the American Society for Healthcare Risk Management (ASHRM) has developed a monograph, Disclosure of Unanticipated Events: The Next Step in Better Communication with Patients, which builds upon the previous paper, ASHRM Perspective on Disclosure of Unanticipated Outcome Information.
This latest paper, the first in a three-part series, will focus on three aspects of the disclosure process:
The Occupational Safety and Health Administration (OSHA) has released an online tool to help employers with emergency planning. The Evacuation Planning Matrix, available at http://www.osha.gov/dep/evacmatrix/index.html, includes a checklist for evaluating existing plans and to help develop new plans, a color-coded zone pyramid to help employers evaluate a facility's risk of experiencing a terrorist incident.
A new federal guidance is now available to help facility specialists in business and government strategically select and use air-filtration and air-cleaning systems for protecting occupants in buildings from chemical, biological, or radiological attacks. Offered by the U.S. Department of Health and Human Services (HHS), the guidance document was jointly developed with the Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health (NIOSH). Titled, “Guidance for Protecting Building Environments from Airborne Chemical, Biological, or Radiological Attacks,” the document covers key steps for selection of appropriate filtration systems.
For example, the first step is to identify the types of systems most effective against various agents and then determine which type would be the most logical to install in a particular location. Environmental health, safety, and security managers can also use these guidelines as an emergency preparedness tool and to improve indoor air quality and reduce occupational respiratory illness. The document recognizes the many complicated issues involved in choosing an appropriate filtration and cleaning system. Decisions appropriate for one building may not be appropriate for all buildings. Building engineers and managers need to assess different factors that will help them make the best decisions for particular situations. These factors include the intended use of the system, prevention of "filter bypass" or leakage around filters, lifecycle costs for the system and the potential for air leakage through the walls of the building.
AHRQ and the National Council on Patient Information and Education (NCPIE) released a new resource called, “Your Medicine: Play It Safe” to help consumers use prescription medicines safely. The 12-page brochure, available in English and Spanish, includes a detachable, pocket-sized medicine record form that can be personalized.
More than 35,000 people from 105 countries have visited QualityHealthCare.org, IHI’s global online improvement resource, the site, in the two months since its launch. More than 7,400 have registered on the site. IHI recently announced that QualityHealthCare.org has been expanded to include a new section on improving access in the office practice, complementing the existing patient safety section. To learn more about how to use QualityHealthCare.org, a guided tour of the site via Web conferencing technology (details below) will be available on June 12 at 10 am (EST).
An Influenza Vaccine Summit in mid-May co-sponsored by the Centers for Disease Control and Prevention (CDC) and the American Medical Association (AMA) was a collaborative effort to improve influenza vaccination rates for the coming season. The link provided has valuable information that may be shared freely with all interested parties; it also links to other valuable information such as Summit PowerPoint presentations, “Standing Orders,” by Dale Bratzler, MD, Quality Improvement Officer, Oklahoma.
In addition, a CD with many resources, including an 18-minute video on “Standing Orders,” has been produced by Centers for Medicare and Medicaid (CMS) and the Oklahoma Quality Improvement Organizations (QIO) and distributed to all state QIOs. More information is available from:
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.