Developed from a round table discussion sponsored by GE Healthcare through an unrestricted educational grant.
Judith M. Atkins, RN, MSN
is the founder of McKenna & Associates Healthcare
Many requirements of the Federal Occupational Safety and Health
Administration (OSHA) and the Joint Commission on Accreditation of
Healthcare Organizations (JCAHO) apply to imaging departments and
cardiac catheterization laboratories (cath labs), especially with
regard to the storage and administration of contrast media. Both of
these organizations continue to strengthen their standards with
regard to employee and patient safety and reducing risks of
injuries. To better improve safety in the healthcare environment,
it is important to move from a localized (or departmental) approach
to risk management to a system approach. In the past, individual
departments would analyze their own patterns and trends of injuries
or incidents and would then base their procedural changes on that
analysis. However, now both OSHA and JCAHO expect all healthcare
facilities to look beyond individual departments and to learn from
the experiences of departments across the nation. The goal is to
mitigate the effects of mistakes by designing systems to anticipate
human errors and prevent adverse events.
One way to do this is to take advantage of commercially
available safety products and equipment. The JCAHO's Environment of
Care (EOC) Standards and the National Patient Safety Goals (NPSG)
can be specifically applied to contrast packaging. Like other
medical products and devices, contrast bottles that used to always
be glass are now available in a polymer bottle. This is an example
of how departments can anticipate the dangers of glass breakage or
other means of injury and create systems to mitigate those dangers.
The reasons are simple: no matter how many checks and balances are
in place to prevent adverse patient or employee events, there are
still going to be errors. If a product's packaging is designed to
prevent those errors, then this product has a built-in fail-safe
against those injuries. By anticipating the nature of potential
mistakes, medical products can be designed to prevent those very
Patient safety initiatives
JCAHO has identified 14 systems
that cause the greatest harm in our hospitals in the event of their
failure (Table 1). Using the tracer methodology, JCAHO has found a
good way to measure the quality of our systems by looking at
healthcare through the eyes of the patient. This says, in essence,
that a facility's focus must not be about preparing for the next
JCAHO survey, it must be about preparing for the next patient. If
there are known risks (such as medication risks or risks of sharps
injuries), then departments should take advantage of what expert
consensus has told us about those risks.
In radiology departments, communication is certainly one of the
most important of these critical systems. JCAHO has found that in
65% of cases, communication was the root cause of a sentinel event
that cost a patient his or her life. This is why many of the NPSGs
revolve around communication, including the use of two patient
identifiers. Just as with any other medication, if contrast media
is transferred from its original packaging to any other container
or syringe, proper labeling and communication of that transfer is
Both information management and medication management are
obviously aspects of communication, but so is a facility's
organizational structure. Policies and procedures must be
consistent throughout an entire healthcare organization. For
instance, if staff members in both the radiology department and the
cath lab administer contrast media to patients, the standards must
be the same. There must be standardization across the board in
material handling and safety protocols.
The second leading cause of adverse events across our nation is
a lack of employee orientation and training. It is imperative that
all department staff members know how to use the safety devices
that are already available, are conversant with labeling standards
and requirements, and are aware of EOC and NPSG regulations.
Standards impacting contrast media
The standards that most directly impact the management of
contrast media are OSHA and JCAHO. In 2004, the Center for Medicare
Services (CMS) changed the definitions for the security of
medications. Because JCAHO surveys healthcare facilities on behalf
of the Medicare program, they had to tighten the procedures for the
of all medications, including contrast media.
OSHA is concerned with worker safety, and sharp injuries remain
the leading occupational hazard for healthcare workers.
If safety devices are available that can help to prevent sharps
injuries (eg, retractable scalpels or polymer packaging), they
should be evaluated and used if possible. Another important aspect
of OSHA regulations in the healthcare setting is their priority to
reduce worker exposure to occupational hazards, including bodily
fluids, radioactive materials, and contrast media.
JCAHO, on the other hand, is concerned with functional
standards, and they focus on two major themes. First, departments
must utilize the JCAHO accreditation process to ensure proactive
risk reduction. This means that a facility, as well as each
department, must adopt a proactive approach to reducing risks to
employees and patients. These requirements apply to all
organizations, even those that have not experienced a sentinel
event. So facilities must not only take advantage of available
safety devices, but must also continually educate the staff about
these standards and safety protocols. When the radiology and cath
lab staff understand the NPSGs and proactive risk reduction issues
as well as the rationale behind them, they will follow the
protocols more consistently. Using adhesive labels and
double-checking patient identifiers is not simply a matter of
satisfying arcane JCAHO standards. These are simple steps that will
make a true difference in patient care. Once the staff understand
that, they are more conscientious about following the
The second major JCAHO theme is the maintenance of a uniform
patient care processes.
This can be particularly challenging in more complex organizations
and systems, but it is important. Whether contrast is handled and
administered by cath lab nurses, by radiology or CT techs, or by
any staff in another department, it must be handled the same way.
Consistent standards and safety procedures must be maintained
across the entire organization.
JCAHO 2005-2006 standards
The latest JCAHO standards are divided into two sections:
patient-focused standards and organizational functions standards
(Table 2). While all patient-focused standards impact each
department, the requirements for medication management (MM) and
infection control (IC) are particularly important in any department
that handles or administers contrast media. The IC standards also
address worker safety, particularly in relation to proper sharps
management and prevention of employee injuries. The organizational
functions standards are geared toward improving organizational
performance. The primary way to do this is to move from reactive
risk reduction to proactive risk reduction. Of particular
importance are the standards related to the management of the EOC.
One of the key JCAHO requirements that apply to imaging
departments and cath labs is that contrast media is a medication.
In this regard, there are a number of JCAHO regulations that relate
to the handling of contrast media (Table 3). Given this
characterization of contrast under JCAHO guidelines, medication
management requirements apply to the use of contrast media.
Relevant to the packaging of contrast media, medications must be
properly and safely stored (MM 2.20).
According to MM 3.20, all medication orders (including those for
contrast) must be written clearly and transcribed accurately. The
need for an order to administer contrast can be problematic for
departments that use imaging protocols as standing contrast orders.
In such cases, the departments must make sure that these standing
orders have been through the appropriate medical staff approval
process, and that they are being used appropriately. In fact, all
prescription or medication orders must be reviewed for
appropriateness (MM 4.10). Of particular importance to contrast
administration is whether the contrast media was appropriate for an
individual patient, especially for a pediatric patient or a patient
with renal insufficiency. This requires a review of the
prescription by the pharmacy or under the direct control of a
Licensed Independent Practitioner.
Like all other medications, contrast must be prepared safely (MM
4.20) staff must use safety materials and equipment while preparing
hazardous medications. Departments must make sure of any available
supplies and equipment that make this preparation safer. To ensure
patient safety, all medications must be labeled (MM 4.30) and must
have standardized labeling.
No matter where the contrast is, whether it is in a cath lab or the
CT suite, the contrast label must be the same. If the label was
prepared ahead of time, staff must ensure that it is then placed on
the proper injector, bottle, or syringe, and then must also verify
it against the patient.
Based on risks, a hospital must establish priorities and set
goals for preventing the spread of healthcare-associated infections
(IC 3.10). Such procedures designed to reduce the risk of such
infections must address the safety of both patients and employees.
Healthcare employees must minimize the risk of transmitting
infections associated with the performance of procedures and the
use of medical equipment and medical devices
(IC 3.10). In order to minimize these risks, each facility and/or
each department must carefully analyze the potential risks and then
must address how to reduce them. Any time skin is broken (on a
patient or a healthcare worker), there is a greater risk for
infection. Along with the more common sharps injuries, such as an
accidental puncture by a syringe, healthcare workers can also be
injured by a metal crimp or broken glass associated with a glass
contrast media bottle.
2006 National Patient Safety Goals
As with the other requirements, a number of the NPSGs
apply to procedures in imaging departments and cath labs, as well
as other departments (Table 4). The top-priority NPSG is accurate
patient identification. There must be two declared patient
identifiers. Most facilities use patient name and date of birth.
However, the most common identification mistake is in the failure
to verify that name and date against something else, whether it is
the medication order, the protocol, or a requisition from the
The second NPSG goal is improved communication effectiveness.
This means implementing a standardized approach to "hand off"
communication between healthcare staff. As cited earlier, 65% of
the sentinel events that cost patients their lives are related to a
lack of communication among healthcare providers. Whenever a
patient is "handed off" to a medical, surgical, cath lab,
radiology, or ICU unit, staff must communicate that patient's
medications and other key information.
Finally, all healthcare facilities must improve the safety of
using medications. This includes many different elements, such as
appropriate drug concentrations, accurate identification of
look-alike and sound-alike drugs, and thorough medication labeling
(including on back tables or in sterile fields). These requirements
are not just applicable to pharmacies or medical units. One of the
big challenges with contrast safety is in choosing a contrast
medium and limiting it to one or two products. With fewer
concentrations, fewer products are used, thereby reducing the
chance of a mistake in contrast administration.
Both JCAHO Standards and OSHA direct us to proactively reduce
risk. The JCAHO and OSHA both measure your ability to apply
strategies that reduce risk. Reduction of potential for sharps is
the priority from OSHA. The priority for JCAHO is to reduce the
risk of errors related to medications.
2006 Comprehensive Accreditation Manual for Hospitals: The
Oakbrook Terrace, IL: Joint Commission on Accreditation of
Healthcare Organizations; 2006.
- The Bloodborne Pathogens Standard from OSHA (2001) codified
at 29 CFR §1910.1030[c][ic][b] and 29 CFR
Joint Commission Perspectives,
August 2006, Volume 25, Issue 8; Copyright 2006; Joint Commission
on Accreditation of Healthcare Organizations.
Joint Commission Perspectives,
June 2005, Volume 25, Issue 6; Copyright 2005; Joint Commission
on Accreditation of Healthcare Organizations.
National Patient Safety Goals.
Joint Commission on Accreditation of Healthcare Organizations.
Available online at: www.jointcommission.org.
- Joint Commission on Accreditation of Healthcare
Organizations. Preventing needlestick and sharps injuries.
Sentinal Event Alert.
Issue 22. August 1, 2001.