Patient Safety Organizations and Accreditation

The ACR Department of Quality and Safety examines the pros and cons of becoming a PSO.patient safety organizations

On November 21, 2008, CMS published its final rule on the Medicare physician fee schedule, implementing the Patient and Quality Improvement Act of 2005.

As stated in the Federal Register, "The final rule establishes a framework by which hospitals, doctors, and other health-care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for the aggregation and analysis of patient safety events." In other words, for the first time, health-care providers could share information about patient safety events — incidents or accidents involving patients — with the intent of improving patient safety and quality nationally without fear of liability. It was announced that the PSOs could begin receiving information effective January 19, 2009.

The goal of this final rule seems compatible with the activities of the College's Department of Quality and Safety. The department already collects a great deal of information through the various ACR registries with the specific purpose of improving quality in imaging and patient safety. The department publishes more than 170 practice guidelines and technical standards in radiology and, utilizing the ACR Appropriateness Criteria®, provides referring physicians with a clinical tool to select the most appropriate imaging study for patients. It also publishes such references as the Manual on Contrast Media, version 8, and the ACR Guidance Document on MR Safe Practices: 2013.

The ACR has really made its mark in improving quality and patient safety through its accreditation programs. The College currently operates 10 accreditation programs, all of which are widely respected for their impact on quality and patient safety. For example, the Veterans Administration selected the ACR as its sole source for accreditation of its radiation oncology practices, and in 1992 the ACR was selected as the only national accrediting body in mammography under the Mammography Quality Standards Act. More recently, CMS named the ACR a national accrediting body under the Medicare Improvements for Patients and Providers Act. In each instance, the ACR was selected because the health-care community recognized the value of accreditation in creating a positive environment for patient safety and quality.

Perfect for PSO?

Based on these accolades, it would seem logical that the ACR would be the perfect candidate to serve as PSO under the Patient Safety Act. Unfortunately, the final rule specifically excludes "an entity that accredits or licenses health-care providers" from serving as a PSO. The justification for the prohibition is that accreditation organizations would have the ability to impose penalties or punishments on their accredited entities. Whether or not the justification is accurate, the perception alone that accrediting bodies would impose penalties could result in a chilling effect that would cause providers to hesitate before sending information to an accrediting body of that PSO.

In addition to this exclusion, many health-care organizations interested in becoming PSOs do not meet the rule's restrictive requirement that quality improvement and patient safety be the organization's "primary" stated activities. As a result, the law created an exception that would allow for wider participation. Interested entities can create a "component organization" with the sole function of improving quality and patient safety. The component organization may be a division of a separate legal entity or it may be a completely separate legal entity that is owned, managed, or controlled by a parent organization. In order for the ACR to participate in a PSO, creating a component organization is the only avenue available.

In order to serve as a PSO, organizations must meet 15 general requirements. A component PSO has even more requirements. These requirements include certification by the parent organization that written policies and procedures are in place to perform eight patient safety activities required by law, appropriate policies and procedures regarding confidentiality and security of patient safety work product, and an appropriately trained and qualified workforce. Work product is any data, reports, records, memoranda, analyses, or written or oral statements that could improve patient safety or health-care outcomes and are assembled by a provider for reporting to a PSO.

It would seem logical that the various ACR registries would provide the appropriate means by which to collect, analyze, and review patient safety information and provide reports back to the providers.

Additionally, within 24 months of its initial listing as a PSO, an organization must have at least two contracts with providers for the purpose of receiving and reviewing patient safety work product. Moreover, all patient safety work product must be collected in a standardized manner using published common formats and definitions. Alternately, the PSO must certify it is using approved formats and definitions that permit valid comparisons among similar cases and providers. IF the PSO collects data that do not fit neatly into one of these two options, then it must provide an explanation to the secretary of health and human services.

Utilizing the ACR's Registries

It would seem logical that the various ACR registries would provide the appropriate means by which to collect, analyze, and review patient safety information and provide reports back to the providers. This is similar to what the registries do now anyway. The issues, however, are the type of data the registries collect, compliance with the common format requirements currently in use, and the manner in which the data are ultimately used by the ACR. As a PSO, the ACR could only use the data to perform the functions of a PSO and not for other independent purposes. As a result, the ACR would not be able to use the data collected by the registries in other research. Therefore, data collected by the registries would require segregation from data collected for other purposes.

Accreditation Revisited

Assuming that the College was able to overcome the limitations on using its registries to collect PSO-related data, the accreditation issue would still pose a major hurdle. Under the final rule, the ACR could only participate if it created a component organization to serve as the PSO. Even then, the component organization would be required to function under very severe restrictions. All staff working for the PSO would be prohibited from performing any work functions for any other component of the ACR. That means all IT support to the registries would have to fully be dedicated to the PSO. The data collected by the PSO would have to be segregated from any other data collected by the ACR and protected by a firewall to prevent access by any other ACR staff not associated with the PSO. In essence, the ACR would have to create and operate a completely separate organization.

In addition to the other pitfalls, there is also financial risk related to becoming a PSO. Currently, there is no government funding for PSOs and no guarantee that establishing a PSO will generate revenue. After weighing the benefits and detriments of becoming a PSO, the ACR has deemed it cost prohibitive. The more prudent course of action at this time is to not pursue the creation of a PSO within the ACR. The quality and safety team will continue to monitor emerging regulations, and perhaps the future will present a better opportunity for the ACR to participate in this activity.


By Leonard Lucey

Leonard Lucey (This email address is being protected from spambots. You need JavaScript enabled to view it.) is legal counsel and senior director in the ACR Quality and Safety Department.

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