The Paper Chase:
A Guide to Hot Issues & New Practice Guidelines and Policies for 2004
By Kelly M. Pyrek
January 2004 marks the kick-off of several new patient-safety mandates as well as represents numerous infection control-related issues being addressed by new and/or pending clinical practice and systems guidelines. While this section represents the most pertinent topics that impact infection control and public health, there are many more issues that remain open as various government and private-sector agencies and organizations endeavor to revise existing policies, procedures and recommended practices to better reflect current thought and research. Watch upcoming issues of ICT for policy updates.
State Requires Hospitals Infection Data
Hospitals across the country are watching Pennsylvania very carefully, as a state agency is forcing hospitals to disclose how many of their patients develop infections after they are hospitalized. Effective Jan. 1, 2004, the Pennsylvania Health Care Cost Containment Council is requiring 200-plus facilities to submit this data in an effort to compel hospitals to improve their healthcare delivery. In what could eventually become a model for the nation, the program endeavors to place nosocomial infections on healthcare consumers radar. The program proposal was passed by a 12-1 vote. The council wants hospitals to gather infection-rate data using the definitions established Centers for Disease Control and Prevention (CDC), and defines hospital-acquired infections as essentially infections not present when the patient was first hospitalized.
The following infections must be reported: urinary tract infection; surgical site infection; pneumonia; bloodstream infection; bone and joint infection; central nervous system infection; cardiovascular system infection; eye, ear, nose, throat or mouth infection; gastrointestinal system infection; lower respiratory tract infection other than pneumonia; reproductive tract infection; skin and soft tissue infection; systemic infection; and multiple-site infection. The council has given hospitals three months to prepare their data, and the first reports to the public are scheduled for March 2005.
New research in The Journal of the American Medical Association (JAMA) released Oct. 7, 2003 concluded that medical injuries in hospitals pose a significant threat to patients and incur substantial costs to society. Hospital-acquired infections top the list in both costs and additional days of hospitalization required. According to the JAMA article, which is based on data from 20 percent of U.S. hospitals:
- Infections acquired during surgery result in almost 11 additional days of hospital care at an extra cost of $57,727 as well as an increased risk of death of 22 percent.
- Patients who get an infection as a result of medical care in hospitals spend almost 10 more days in the hospital, incur $38,656 in excess charges and have an increased risk of dying of 4.3 percent.
Medical Errors Bill Circulates Through Congress
The Consumers Union, owner of the Web site www.stophospitalinfections.org and publisher of Consumer Reports magazine, is asking U.S. senators to halt the rapid advance of a bill that would make it nearly impossible for consumers to compare the quality of care provided by doctors and hospitals, as well as keep hospital infection rates from becoming public. Medical error legislation (formally called the Patient Safety and Quality Improvement Act), H.R. 663, passed the House by a vote of 418 to 6 on Oct. 13, 2003, and its Senate companion, S. 720, has cleared the Senate Committee on Health, Education, Labor and Pensions. As of press time the first week in December 2003, the Senate bill was scheduled to come to the Senate floor.
The Consumers Union says these bills could set back state disclosure laws by keeping all types of patient safety data hidden from public view. The group charges that the bills define patient safety data so broadly that the definition will cover hospital infection rates and outcome measures on specific medical procedures, and that this could undermine progress made in a number of states to make public hospital infection rates and other important quality-of-care data. On Aug. 20, 2003, Illinois signed into law a mandatory reporting bill called the Hospital Report Card Act, for hospital acquired infections, a law that would be preempted if Congress passes S. 720. The Consumers Union is asking Senate leadership to add a provision in S. 720 clarifying that the federal bill does not preempt state law requiring reporting of infection rates and other patient safety and quality information.
Hospitals should cure people, not make them sicker, said Lisa McGiffert, director of www.StopHospitalInfections.org. Making infection rates available to the public will motivate hospitals to improve conditions and guarantee patient safety. We must not destroy this important patient safety tool.
The Illinois law goes into effect Jan. 1, 2004 and the Illinois Department of Public Health will be making its final rules for compliance shortly. In Minnesota, lawmakers recently passed a bill requiring hospitals to report 27 never events such as wrong-site surgeries or deaths related to medical errors created by the National Quality Forum (see item that follows).
The Never Events
The National Quality Forum (NQF), a private, not-for-profit membership organization created to develop and implement a national strategy for healthcare quality measurement and reporting, has endeavored to improve U.S. healthcare through endorsement of consensus-based national standards for measurement and public reporting of healthcare performance data that provide meaningful information about whether care is safe, timely, beneficial, patient-centered, equitable and efficient. The NQFs recommended 30 healthcare safe practices (or never events) are being adopted by an increasing number of states that are concerned about the rising number of hospital-acquired infections and how to meet new patient-safety mandates for 2004 (see JCAHOs Patient Safety Goals).
The 30 practices were culled from more than 200 universal patient-safety principles and are organized in five categories: creating a culture of safety; matching healthcare needs with service delivery capability; facilitating information transfer and clear communication; adopting safe practices in specific clinical care settings; and increasing safe medication use. The 30 practices can be found in a report, Safe Practices for Better Healthcare, in the report archives at www.qualityforum.org.
Nursing-Sensitive Performance Measurement
The NQF also is crafting its National Voluntary Consensus Standards for Nursing-Sensitive Performance Measurement, a draft of 13 evidence-based nursing sensitive performance measures needed for quality improvement, public accountability and patient safety. In October 2003, a 30-day public comment period was opened and closed, and in November 2003, the recommendations were revised in response to the comments and this revised document was forwarded to NQF members. The initial round of voting was scheduled to commence in mid-December 2003. The final recommendations are expected to be released in 2004. The draft framework categories include patient-centered outcome measures (including measures designed to address failure to rescue, as well as prevalence of pressure ulcers, pneumonia, falls, UTIs, central line catheter-associated infections) nursing centered intervention measures and system- centered measures (including skill mix and nursing-care hours per patient day). For more details, go to the report archives at www.qualityforum.org.
JCAHOs Patient Safety Goals
As healthcare continues to capitulate to the newest swell of public alarm about hospital-acquired infections, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) is prepared to survey, effective Jan. 1, 2004, all JCAHO-accredited healthcare facilities for implementation of the agencys 2004 National Patient Safety Goals (NPSG). The 2004 NPSG includes the six NPSGs and their requirements, as well as a new goal with two requirements that focus on reducing the risk of nosocomial infections. The 2003 goals are as follows:
- Improve the accuracy of patient identification
- Improve the effectiveness of communication among caregivers
- Improve the safety of using high-alert medications
- Eliminate wrong-site, wrong-patient, wrong-procedure surgery
- Improve the safety of using infusion pumps
- Improve the effectiveness of clinical alarm systems
- Reduce the risk of healthcare-acquired infections (see the item that follows)
JCAHOs Strengthened IC Standards
For 2004, JCAHO has approved revised standards to help prevent the occurrence of healthcare-associated infections. (Watch for a Q&A with Robert Wise, MD, vice president of standards for JCAHO, in the February 2004 issue of ICT.) The standards, which take effect in January 2005, retain many of the concepts embodied in existing standards, but sharpen and raise expectations of organization leadership and of the infection control program itself.
The revised standards are the result of the work of an expert group of infection control practitioners, hospital epidemiologists, physicians, nurses, risk managers and other healthcare professionals, along with significant input from accredited organizations participating in a field review. Since the work of these groups began, two new issues emerging antimicrobial resistance and the management of epidemics and emerging pathogens have been identified.
The revised standards are designed to raise awareness that healthcare- associated infections are a national concern that can be acquired within any care, treatment or service setting, and transferred between settings, or brought in from the community. Therefore, prevention represents one of the major safety initiatives that a healthcare organization can undertake. The revised standards focus on the development and implementation of plans to prevent and control infections, with organizations expected to:
- Incorporate an infection control program as a major component of safety and performance improvement programs
- Perform an ongoing assessment to identify its risks for the acquisition and transmission of infectious agents
- Effectively use an epidemiological approach which includes conducting surveillance, collecting data, and interpreting the data
- Effectively implement infection prevention and control processes
- Educate and collaborate with leaders across the organization to effectively participate in the design and implementation of the infection control program
The Joint Commission also made the CDCs updated hand-washing guidelines a 2004 National Patient Safety Goal for all accredited organizations in an effort to bring further attention to infection control issues.
Furthermore, JCAHO has advised accredited organizations that healthcare- associated infections resulting in death or serious injury should also be voluntarily reported to the Sentinel Event database. The 2004 National Patient Safety Goals require organizations to manage as sentinel events all healthcare-associated infections that result in death or major permanent loss of function. For more details, visit www.jcaho.org.
JCAHO Requires Universal Protocol Compliance
All JCAHO-accredited organizations that provide surgical services will be expected to be in compliance with the Universal Protocol for preventing wrong-site, wrong-procedure and wrong-person surgery beginning on July 1, 2004. The Universal Protocol expands existing requirements under the 2003 and 2004 National Patient Safety Goals and will be applicable to all operative and other invasive procedures. Essential components of the protocol include: the pre-operative verification process; marking of the operative site; taking a time out immediately before starting the procedure; and adaptation of the requirements to non-operating room settings, including bedside procedures.
The Universal Protocol is the consensus product of a national Summit on Wrong Site Surgery convened last spring by JCAHO, the American Medical Association, the American Hospital Association, the American College of Physicians, the American College of Surgeons, the American Dental Association and the American Academy of Orthopedic Surgeons. Summit participants concluded that wrong-site, wrong-procedure and wrong-person surgery can be prevented and that a Universal Protocol is needed to help accomplish this goal.
This protocol asks healthcare organizations to set a goal of zero-tolerance for surgeries on the wrong site or on the wrong person, or the performance of the wrong surgical procedure, says Dennis S. OLeary, MD, president of JCAHO. These are occurrences which simply should never happen.
A three-week public comment period in July 2003 generated more than 3,000 responses from surgeons, nurses and other healthcare professionals who were overwhelmingly in support of the protocol. The comments also provided the basis for a number of refinements to the protocol. For more details, visit www.jcaho.org.
New Environmental Services Guidelines
Late last year the Centers for Disease Control and Prevention (CDC) and its Healthcare Infection Control Practices Advisory Committee (HICPAC) released Guidelines for Environmental Infection Control in Healthcare Facilities. The guidelines authors acknowledge that while the healthcare facility environment is rarely implicated in disease transmission, except among patients who are immunocompromised, inadvertent exposures to environmental pathogens can result in adverse patient outcomes and cause illness among healthcare workers. Environmental infection control strategies can effectively prevent these infections.
This report reviews a number of previous guidelines and recommendations and also does the following:
- Revises multiple sections, including cleaning and disinfection of environmental surfaces; environmental sampling; laundry and bedding; and regulated medical waste, from previous editions of the CDCs Guideline for Handwashing and Hospital Infection Control
- Incorporates discussions of air and water environmental concerns from the CDCs Guideline for Prevention of Nosocomial Pneumonia
- Consolidates relevant environmental infection control measures from other CDC guidelines ¡ Includes two new topics: infection control concerns related to animals in healthcare facilities and water quality in hemodialysis settings
Key recommendations include:
- Establishment of a multidisciplinary team to conduct infection control risk assessment
- Use of dust-control procedures and barriers during construction, repair, renovation or demolition
- Use of special infection control measures for high-risk patients
- Use of airborne-particle sampling to monitor the effectiveness of air filtration and dust-control measures
- Use of procedures to prevent airborne contamination in ORs when infectious tuberculosis patients need surgery
- Performance of routine culturing of water as part of a control program for legionellae
- Use of strategies for environmental surface cleaning and disinfection strategies with respect to antibiotic-resistant microorganisms
- Use of proper infection control practices related to healthcare laundry handling
For the full report, see the June 6, 2003 edition of the Morbidity and Mortality Weekly Report (Vol. 52, No. RR-10).
CDCs Draft SARS Plan
The CDCs draft SARS plan, Public Health Guidance for Community-Level Preparedness and Response to SARS, is a working document outlining the strategies that would guide the U.S. response in the event of a SARS outbreak, as well as describing activities at the federal, state and local levels to prepare for and respond to a reemergence of SARS. The plan integrates and builds on other preparedness and response plans for SARS and for other public health emergencies, such pandemic influenza and bio-terrorism. The plan emphasizes, The basic strategy that controlled SARS outbreaks worldwide was rapid and decisive surveillance and containment. The keys to successful implementation of such a strategy are up-to-date information on local, national and global SARS activity; rapid and effective institution of control measures; and the resources, organizational and decision-making structure, and trained staff vital to rapid and decisive implementation.
The draft guidelines address command and control; surveillance of cases and contacts; preparedness and response in healthcare facilities; community containment measures; management of international travel related risks; laboratory diagnostics; communication; and information technology. For details, visit http://www.cdc.gov/ncidod/sars. State and local health departments, hospitals and other public health providers will be able to comment on the draft by sending an email to [email protected].
Preparing for the Next SARS Outbreak
Draft recommendations from the CDC say that healthcare workers with pneumonia may be the harbinger of a new outbreak of severe acute respiratory syndrome. It is recommended that amidst widespread cases of influenza this winter, hospitals should be on the lookout for clusters of two or more healthcare workers involved in direct patient care who have pneumonia that was confirmed through chest X-rays by local or state health departments. Until there is a reliable laboratory test to detect SARS, much of SARS surveillance will depend on careful observance of epidemiological patterns. SARS was contracted by more than 1,700 healthcare workers in six countries; the U.S. reported eight labconfirmed cases.
Early detection, protection (better engagement of contact precautions) and sound infection control practices are essential for SARS prevention in healthcare facilities, as is consistent monitoring of employee health. The CDC recommends hospitals:
- Incorporate SARS preparedness into existing preparedness plans for smallpox or pandemic flu
- Coordinate with public health departments to facilitate SARS preparedness
- Plan ahead for potential SARS scenarios ¡ Assess staffs ability to contend with SARS cases
- Have a plan for screening patients, visitors and healthcare workers for SARS
CDCs Interim Rule on Monkeypox
To prevent the transmission of the viral disease monkeypox, the FDA and the CDC have issued an interim final rule to establish new restrictions and modify existing restrictions on the import, capture, transport, sale, barter, exchange, distribution and release of African rodents, North American prairie dogs and certain other animals in the United States. In 2003, an outbreak of monkeypox linked to exotic animals caused 37 confirmed, 12 probable, and 22 suspect cases in the United States.
Emerging infectious diseases which originate in animals such as monkeypox, plague and West Nile virus continue to pose a significant threat to public health here in the United States, says Julie Gerberding, MD, director of the CDC. Sound public health calls for us to take action to protect the public from diseases that can be spread by exotic animals.
This interim rule is an increased measure by both agencies to prevent the possible transmission of monkeypox from imported animals and from those currently in the U.S. that may have become infected. As outlined in the rule, the CDC will restrict the importation of these animals, and the FDA will restrict domestic interstate and intrastate movement of these animals, with exemption procedures to accommodate special circumstances. For more details, visit www.cdc.gov.
JCAHOs Unannounced Surveys Get Underway
Operating in a constant state of readiness will be the norm in 2004 for healthcare facilities seeking accreditation by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO). Not only will surveyors look for this readiness, they also want to see a true culture change that fully embraces in-depth, long-term changes of systems and processes especially when it comes to meeting JCAHOs 2004 National Patient Safety Goals and other requirements (see page 35). In order to successfully meet JCAHOs unannounced surveys, healthcare facilities should heed this advice:
- Provide attainable, measurable quality-improvement goals for staff members to meet
- Allocate the proper resources that facilitate more-effective systems
- Ensure collaboration among staff members and various departments in order to assure a global approach to survey preparedness
- Make regular rounds to mimic the survey process
- Ensure that real-world clinical practices resonate with the facilitys policies and procedures
- Increase staff presence in patient-care units to determine what quality-improvement measures need to be implemented
For more information, visit www.jcaho.org.
AORNs Proposed Practices for Hand Scrubs
The window of opportunity for comment on the Association of periOperative Registered Nurses (AORN)s Proposed Recommended Practices for Surgical Hand Antisepsis/Hand Scrubs closed Nov. 21, 2003, and work on the final recommendation is underway by members of the AORN Recommended Practices Committee. Championing hand hygiene and looking to the CDCs revised hand hygiene guidelines, the draft recommendations include:
- Recommended Practice I: All personnel should follow basic handhygiene practices.
- Recommended Practice II: An FDA-cleared, surgical hand-antiseptic agent approved by the facilitys infection control personnel should be used for all surgical hand antisepsis/scrub.
- Recommended Practice III: Surgical hand antisepsis/scrub should be performed before donning sterile gloves for surgical or other invasive procedures. Use of either an FDA-cleared, antimicrobial surgical scrub agent intended for surgical hand antisepsis or an FDAcleared, alcohol-based hand-antiseptic agent which has been approved for surgical hand antisepsis with documented persistent activity is acceptable.
- Recommended Practice IV: Surgical hand antisepsis scrub using an FDA-cleared, antimicrobial scrub agent should include a standardized hand scrub procedure which follows manufacturers written guidelines and is approved by the healthcare facility.
- Recommended Practice V: Surgical hand antisepsis/hand scrub with an FDA-cleared, surgical antisepsis handrub product should follow a standardized application according to manufacturers written guidelines.
- Recommended Practice VI: Policies and procedures for surgical hand antisepsis should be developed, reviewed periodically, and be readily available in the practice setting.
For more details, visit: http://www.aorn.org/proposed/handscrub.htm.
IDSAs New Guidelines for Community-Acquired Pneumonia
In December 2003, the Infectious Diseases Society of America (IDSA) released new guidelines intended to help physicians manage the treatment of patients with lung disease. The updated Practice Guidelines for the Management of Community-Acquired Pneumonia in Immunocompetent Adults appeared in the Dec. 1, 2003 issue of Clinical Infectious Diseases.
The current guidelines, an update of earlier versions published in 1998 and 2000, improve upon many of the key areas and introduces new diagnostic and management strategies, including suggestions for initial empiric therapy for community-acquired pneumonia (CAP).
Because the cause of pneumonia is often difficult to determine, initial treatment is usually initiated with antibiotics, which cover a broad range of bacterial pathogens. Previous versions of the guidelines listed numerous drug options for treatment of CAP, including fluoroquinolones, which have become widely used to treat pneumonia.
One of the most significant changes in comparison to the previous guidelines is that there are more specific recommendations about individualizing antimicrobial therapy based on stratification of the patient by two factor prior use of antibiotics and presence of comorbid conditions, says Thomas M. File Jr., MD, of Summa Health System in Akron, Ohio, one of the guidelines authors.
The committee that was charged with updating the guidelines became concerned about misuse and overuse of fluoroquinolones, which could lead to the demise of fluoroquinolones as useful antibiotics within the next 5 to 10 years. Since publication of the 2000 guidelines, several compounds have been withdrawn because of serious safety concerns, and resistance to this class of drugs has been increasing. Rather than relying so heavily on fluoroquinolones, the new guidelines recommend that, for those patients who have previously been healthy and who have not been treated with antibiotics for any reason within the preceding three months, a macrolide alone is adequate in the management of CAP. Macrolides are one of the most popular and long-standing classes of antibiotics. To help physicians select the best drug for other types of patients, the guidelines include an easy-to-read table that lists the preferred treatment options given specific patient variables.
The guidelines also provide detailed management strategies on new topics such as CAP in the elderly and severe acute respiratory syndrome (SARS). Healthcare workers must be vigilant in recognizing SARS because of important epidemiologic implications, which include the potential for rapid spread to close contacts, including health care workers and household contacts. Preventive efforts include proper precautions in patients with suspected or established SARS, including standard precautions (hand hygiene), contact precautions (use of gowns, goggles, and gloves), and airborne precautions (use of negative-pressure rooms and fit-tested N95 respirators).
Because lung infections have been identified as potential bioterrorism agents, the guidelines include a discussion on a number of microbes that can be disseminated by aerosol as biological weapons, potentially afflicting thousands of people. The agents most likely to cause severe pulmonary infection are Bacillus anthracis, Franciscella tularensis and Yersinia pestis.
Other important recommendations include the following:
- Vaccination against influenza and pneumococcus infection is the mainstay of prevention against pneumonia for older adults.
- For outpatients, antibiotic therapy should be initiated within 4 hours, rather than the previously suggested 8 hours, after registration for hospitalized patients with CAP.
- Early treatment (within 48 hours after onset of symptoms) is effective in the treatment of influenza.
For more details, visit www.idsociety.org.
HHS New HIV Prevention Initiative
The U.S. Department of Health and Human Services (HHS) new Advancing HIV Prevention Initiative emphasizes HIV testing as a routine part of care, greater access to HIV testing, increased attention to prevention among HIV-positive persons, and reduced mother-to-child transmission. CDC research demonstrates that rapid HIV testing, a cornerstone of the new initiative, can provide accurate results in just over an hour for women whose HIV status is unknown at labor. The CDC also has announced a new national system for measuring the rate of HIV infections in the U.S. Using the Serologic Testing Algorithm for Recent HIV Seconversion (STARHS) technology, 35 U.S. locations will be able to more accurately monitor the number of new HIV infections that occur each year and target prevention resources to the populations most in need. On July 18, 2003, the CDC released new guidelines for medical professionals on integrating HIV prevention into the regular medical care of people living with HIV; get the details at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5212a1.htm.
Knowing HIV status is a powerful motivator for behavior change, said Gerberding. When people know their status, they take steps to protect their partners.
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