Safety Standards and Implications for the Use of Contrast Media

By Judith M. Atkins, RN, MSN
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Judith M. Atkins, RN, MSN is the founder of McKenna & Associates Healthcare Consultants,Charleston, WV.

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) guidelines 1 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 mistakes.

Patient safety initiatives

JCAHO has identified 14 systems 1 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 critical.

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 security 1 of all medications, including contrast media.

OSHA is concerned with worker safety, and sharp injuries remain the leading occupational hazard for healthcare workers. 2 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 protocols.

The second major JCAHO theme is the maintenance of a uniform patient care processes. 1 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. 1

Medication management

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. 3,4 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. 5 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.

Infection control

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 6 (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 5 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 nursing unit.

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.

Conclusion

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.

REFERENCES

  1. 2006 Comprehensive Accreditation Manual for Hospitals: The Official Handbook. Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations; 2006.
  2. The Bloodborne Pathogens Standard from OSHA (2001) codified at 29 CFR §1910.1030[c][1][ic][b] and 29 CFR §1910.1030[c][1][v]).
  3. Joint Commission Perspectives, August 2006, Volume 25, Issue 8; Copyright 2006; Joint Commission on Accreditation of Healthcare Organizations.
  4. Joint Commission Perspectives, June 2005, Volume 25, Issue 6; Copyright 2005; Joint Commission on Accreditation of Healthcare Organizations.
  5. National Patient Safety Goals. Joint Commission on Accreditation of Healthcare Organizations. Available online at: www.jointcommission.org.
  6. Joint Commission on Accreditation of Healthcare Organizations. Preventing needlestick and sharps injuries. Sentinal Event Alert. Issue 22. August 1, 2001.
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Safety Standards and Implications for the Use of Contrast Media.  Appl Radiol. 

January 05, 2007
Categories:  Contrast Agents|Section



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