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
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
- Improve the safety of using high-alert medications
- Eliminate wrong-site, wrong-patient, wrong-procedure
- 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
- 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
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
- 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
- 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
- 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
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
- 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:
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
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
Knowing HIV status is a powerful motivator for behavior change, said
Gerberding. When people know their status, they take steps to protect their partners.
- Use of trade names and commercial sources is for
identification only and does not imply endorsement by the U.S. Department of
Health and Human Services or the Centers for Disease Control and Prevention.
CDC protects peoples health and safety by preventing and controlling
diseases and injuries; enhances health decisions by providing credible
information on critical health issues; and promotes healthy living through
strong partnerships with local, national, and international organizations.