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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-safetymandates as well as represents numerous infection control-related issues beingaddressed by new and/or pending clinical practice and systems guidelines. Whilethis section represents the most pertinent topics that impact infection controland public health, there are many more issues that remain open as variousgovernment and private-sector agencies and organizations endeavor to reviseexisting policies, procedures and recommended practices to better reflectcurrent 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 astate agency is forcing hospitals to disclose how many of their patients developinfections after they are hospitalized. Effective Jan. 1, 2004, the PennsylvaniaHealth Care Cost Containment Council is requiring 200-plus facilities to submitthis 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 toplace nosocomial infections on healthcare consumers radar. The programproposal was passed by a 12-1 vote. The council wants hospitals to gatherinfection-rate data using the definitions established Centers for DiseaseControl and Prevention (CDC), and defines hospital-acquired infections asessentially 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 jointinfection; 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; systemicinfection; and multiple-site infection. The council has given hospitals three months toprepare their data, and the first reports to the public are scheduled for March2005.
New research in The Journal of the American Medical Association (JAMA)released Oct. 7, 2003 concluded that medical injuries in hospitals pose asignificant threat to patients and incur substantial costs to society.Hospital-acquired infections top the list in both costs and additional days ofhospitalization required. According to the JAMA article, which is basedon data from 20 percent of U.S. hospitals:
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 nearlyimpossible for consumers to compare the quality of care provided by doctors andhospitals, as well as keep hospital infection rates from becoming public.Medical error legislation (formally called the Patient Safety and QualityImprovement 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 onHealth, Education, Labor and Pensions. As of press time the first week inDecember 2003, the Senate bill was scheduled to come to the Senate floor.
The Consumers Union says these bills could set back state disclosure laws bykeeping all types of patient safety data hidden from public view. The groupcharges that the bills define patient safety data so broadly that the definitionwill cover hospital infection rates and outcome measures on specific medicalprocedures, and that this could undermine progress made in a number of states tomake public hospital infection rates and other important quality-of-care data.On Aug. 20, 2003, Illinois signed into law a mandatory reporting bill called theHospital Report Card Act, for hospital acquired infections, a law that would bepreempted if Congress passes S. 720. The Consumers Union is asking Senate leadership to add a provision in S. 720clarifying that the federal bill does not preempt state law requiring reportingof infection rates and other patient safety and quality information.
Hospitals should cure people, not make them sicker, said Lisa McGiffert, director ofwww.stophospitalinfections.org. Making infection rates available to thepublic will motivate hospitals to improve conditions and guarantee patientsafety. We must not destroy this important patient safety tool.
The Illinois law goes into effect Jan. 1, 2004 and the Illinois Department ofPublic Health will be making its final rules for compliance shortly. InMinnesota, lawmakers recently passed a bill requiring hospitals to report 27 neverevents 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 membershiporganization created to develop and implement a national strategy for healthcarequality measurement and reporting, has endeavored to improve U.S. healthcarethrough endorsement of consensus-based national standards for measurement andpublic reporting of healthcare performance data that provide meaningfulinformation 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 therising number of hospital-acquired infections and how to meet new patient-safetymandates for 2004 (see JCAHOs Patient Safety Goals).
The 30 practices were culled from more than 200 universal patient-safetyprinciples and are organized in five categories: creating a culture of safety;matching healthcare needs with service delivery capability; facilitatinginformation transfer and clear communication; adopting safe practices inspecific clinical care settings; and increasing safe medication use. The 30practices 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 forNursing-Sensitive Performance Measurement, a draft of 13 evidence-basednursing sensitive performance measures needed for quality improvement, publicaccountability and patient safety. In October 2003, a 30-day public comment period was opened and closed, and inNovember 2003, the recommendations were revised in response to the comments andthis revised document was forwarded to NQF members. The initial round of votingwas scheduled to commence in mid-December 2003. The final recommendations are expected to be released in 2004. The draftframework categories include patient-centered outcome measures (includingmeasures designed to address failure to rescue, as well as prevalence ofpressure ulcers, pneumonia, falls, UTIs, central line catheter-associatedinfections) 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 alarmabout hospital-acquired infections, the Joint Commission on the Accreditation ofHealthcare Organizations (JCAHO) is prepared to survey, effective Jan. 1, 2004,all JCAHO-accredited healthcare facilities for implementation of the agencys2004 National Patient Safety Goals (NPSG). The 2004 NPSG includes the six NPSGsand their requirements, as well as a new goal with two requirements that focuson reducing the risk of nosocomial infections. The 2003 goals are as follows:
JCAHOs Strengthened IC Standards
For 2004, JCAHO has approved revised standards to help prevent the occurrenceof 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 conceptsembodied in existing standards, but sharpen and raise expectations oforganization leadership and of the infection control program itself.
The revised standards are the result of the work of an expert group ofinfection control practitioners, hospital epidemiologists, physicians, nurses,risk managers and other healthcare professionals, along with significant inputfrom accredited organizations participating in a field review. Since the work ofthese groups began, two new issues emerging antimicrobial resistance and themanagement 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 anycare, treatment or service setting, and transferred between settings, or broughtin from the community. Therefore, prevention represents one of the major safetyinitiatives that a healthcare organization can undertake. The revised standardsfocus on the development and implementation of plans to prevent and controlinfections, with organizations expected to:
The Joint Commission also made the CDCs updated hand-washing guidelines a 2004National Patient Safety Goal for all accredited organizations in an effort tobring further attention to infection control issues.
Furthermore, JCAHO has advised accredited organizations that healthcare-associated infections resulting in death or serious injury should also bevoluntarily reported to the Sentinel Event database. The 2004 National PatientSafety Goals require organizations to manage as sentinel events allhealthcare-associated infections that result in death or major permanent loss offunction. 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 requirementsunder the 2003 and 2004 National Patient Safety Goals and will be applicable toall operative and other invasive procedures. Essential components of theprotocol include: the pre-operative verification process; marking of theoperative site; taking a time out immediately before starting theprocedure; 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 WrongSite Surgery convened last spring by JCAHO, the American Medical Association,the American Hospital Association, the American College of Physicians, theAmerican College of Surgeons, the American Dental Association and the AmericanAcademy of Orthopedic Surgeons. Summit participants concluded that wrong-site,wrong-procedure and wrong-person surgery can be prevented and that a UniversalProtocol is needed to help accomplish this goal.
This protocol asks healthcare organizations to set a goal ofzero-tolerance for surgeries on the wrong site or on the wrong person, or theperformance 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 3,000responses from surgeons, nurses and other healthcare professionals who wereoverwhelmingly in support of the protocol. The comments also provided the basis for a number of refinements to theprotocol. For more details, visit www.jcaho.org.
New Environmental Services Guidelines
Late last year the Centers for Disease Control and Prevention (CDC) and itsHealthcare Infection Control Practices Advisory Committee (HICPAC) released Guidelinesfor Environmental Infection Control in Healthcare Facilities. The guidelinesauthors acknowledge that while the healthcare facility environment is rarelyimplicated in disease transmission, except among patients who areimmunocompromised, inadvertent exposures to environmental pathogens can resultin adverse patient outcomes and cause illness among healthcare workers.Environmental infection control strategies can effectively prevent theseinfections.
This report reviews a number of previous guidelines and recommendations andalso does the following:
Key recommendations include:
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-LevelPreparedness and Response to SARS, is a working document outlining thestrategies 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 toprepare for and respond to a reemergence of SARS. The plan integrates and buildson other preparedness and response plans for SARS and for other public healthemergencies, such pandemic influenza and bio-terrorism. The plan emphasizes, Thebasic strategy that controlled SARS outbreaks worldwide was rapid and decisivesurveillance and containment. The keys to successful implementation of such astrategy 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 rapidand decisive implementation.
The draft guidelines address command and control; surveillance of cases andcontacts; preparedness and response in healthcare facilities; community containment measures; management of international travel relatedrisks; laboratory diagnostics; communication; and information technology. Fordetails, visit http://www.cdc.gov/ncidod/sars. State and local healthdepartments, hospitals and other public health providers will be able to commenton the draft by sending an email to email@example.com.
Preparing for the Next SARS Outbreak
Draft recommendations from the CDC say that healthcare workers with pneumoniamay be the harbinger of a new outbreak of severe acute respiratory syndrome. Itis recommended that amidst widespread cases of influenza this winter, hospitalsshould be on the lookout for clusters of two or more healthcare workers involvedin direct patient care who have pneumonia that was confirmed through chestX-rays by local or state health departments. Until there is a reliablelaboratory test to detect SARS, much of SARS surveillance will depend on carefulobservance of epidemiological patterns. SARS was contracted by more than 1,700healthcare workers in six countries; the U.S. reported eight labconfirmed cases.
Early detection, protection (better engagement of contact precautions) andsound infection control practices are essential for SARS prevention inhealthcare facilities, as is consistent monitoring of employee health. The CDCrecommends hospitals:
CDCs Interim Rule on Monkeypox
To prevent the transmission of the viral disease monkeypox, the FDA and theCDC have issued an interim final rule to establish new restrictions and modifyexisting restrictions on the import, capture, transport, sale, barter, exchange,distribution and release of African rodents, North American prairie dogs andcertain other animals in the United States. In 2003, an outbreak of monkeypoxlinked to exotic animals caused 37 confirmed, 12 probable, and 22 suspect casesin the United States.
Emerging infectious diseases which originate in animals such asmonkeypox, plague and West Nile virus continue to pose a significant threatto public health here in the United States, says Julie Gerberding, MD,director of the CDC. Sound public health calls for us to take action toprotect the public from diseases that can be spread by exotic animals.
This interim rule is an increased measure by both agencies to prevent thepossible transmission of monkeypox from imported animals and from thosecurrently 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 willrestrict domestic interstate and intrastate movement of these animals, withexemption 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 forhealthcare facilities seeking accreditation by the Joint Commission on theAccreditation of Healthcare Organizations (JCAHO). Not only will surveyors lookfor this readiness, they also want to see a true culture change that fullyembraces in-depth, long-term changes of systems and processes especiallywhen it comes to meeting JCAHOs 2004 National Patient Safety Goals and otherrequirements (see page 35). In order to successfully meet JCAHOs unannouncedsurveys, healthcare facilities should heed this advice:
For more information, visit www.jcaho.org.
AORNs Proposed Practices for Hand Scrubs
The window of opportunity for comment on the Association of periOperativeRegistered Nurses (AORN)s Proposed Recommended Practices for Surgical HandAntisepsis/Hand Scrubs closed Nov. 21, 2003, and work on the finalrecommendation is underway by members of the AORN Recommended PracticesCommittee. Championing hand hygiene and looking to the CDCs revised handhygiene guidelines, the draft recommendations include:
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) releasednew guidelines intended to help physicians manage the treatment of patients withlung disease. The updated Practice Guidelines for the Management ofCommunity-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 and2000, improve upon many of the key areas and introduces new diagnostic andmanagement strategies, including suggestions for initial empiric therapy forcommunity-acquired pneumonia (CAP).
Because the cause of pneumonia is often difficult to determine, initialtreatment is usually initiated with antibiotics, which cover a broad range ofbacterial pathogens. Previous versions of the guidelines listed numerous drugoptions for treatment of CAP, including fluoroquinolones, which have becomewidely used to treat pneumonia.
One of the most significant changes in comparison to the previousguidelines is that there are more specific recommendations about individualizingantimicrobial 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 guidelinesauthors.
The committee that was charged with updating the guidelines became concernedabout misuse and overuse of fluoroquinolones, which could lead to the demise offluoroquinolones as useful antibiotics within the next 5 to 10 years. Sincepublication of the 2000 guidelines, several compounds have been withdrawnbecause of serious safety concerns, and resistance to this class of drugs hasbeen increasing. Rather than relying so heavily on fluoroquinolones, the newguidelines recommend that, for those patients who have previously been healthyand who have not been treated with antibiotics for any reason within thepreceding 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, theguidelines include an easy-to-read table that lists the preferred treatmentoptions given specific patient variables.
The guidelines also provide detailed management strategies on new topics suchas CAP in the elderly and severe acute respiratory syndrome (SARS). Healthcareworkers must be vigilant in recognizing SARS because of important epidemiologic implications, which include the potential forrapid spread to close contacts, including health care workers and householdcontacts. Preventive efforts include proper precautions in patients withsuspected or established SARS, including standard precautions (hand hygiene),contact precautions (use of gowns, goggles, and gloves), and airborneprecautions (use of negative-pressure rooms and fit-tested N95 respirators).
Because lung infections have been identified as potential bioterrorismagents, the guidelines include a discussion on a number of microbes that can bedisseminated by aerosol as biological weapons, potentially afflicting thousandsof people. The agents most likely to cause severe pulmonary infection areBacillus anthracis, Franciscella tularensis and Yersinia pestis.
Other important recommendations include the following:
For more details, visit www.idsociety.org.
HHS New HIV Prevention Initiative
The U.S. Department of Health and Human Services (HHS) new Advancing HIVPrevention Initiative emphasizes HIV testing as a routine part of care, greateraccess to HIV testing, increased attention to prevention among HIV-positivepersons, and reduced mother-to-child transmission. CDC research demonstrates that rapid HIV testing, a cornerstone of the newinitiative, can provide accurate results in just over an hour for women whoseHIV status is unknown at labor. The CDC also has announced a new national systemfor measuring the rate of HIV infections in the U.S. Using the Serologic TestingAlgorithm for Recent HIV Seconversion (STARHS) technology, 35 U.S. locationswill be able to more accurately monitor the number of new HIV infections thatoccur each year and target prevention resources to the populations most in need.On July 18, 2003, the CDC released new guidelines for medical professionals onintegrating HIV prevention into the regular medical care of people living withHIV; get the details at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5212a1.htm.
Knowing HIV status is a powerful motivator for behavior change, saidGerberding. When people know their status, they take steps to protect their partners.
CDC protects peoples health and safety by preventing and controllingdiseases and injuries; enhances health decisions by providing credibleinformation on critical health issues; and promotes healthy living throughstrong partnerships with local, national, and international organizations.