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Special Reports |
1 From the Department of Radiology, Beth Israel Deaconess Medical Center, Harvard Medical School, 1 Deaconess Rd, Boston, MA 02215. From the 2005 RSNA Annual Meeting. Received August 29, 2005; revision requested October 13; revision received December 5; accepted January 6, 2006; final version accepted January 9. Address correspondence to J.B.K. (e-mail: jkruskal{at}bidmc.harvard.edu).
| ABSTRACT |
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Materials and Methods: This HIPAA-compliant study had institutional review board approval; informed consent was not required. Using repeated plan-do-study-act cycles, a radiology quality management team applied a 10-step process to implement an online reporting system. The system permits remote submission of cases by staff members. The number of weekly submissions to the system over a 9-month period was evaluated and compared with that for the preceding 6 months by using the Mann-Whitney test. Sources and nature of data, actions initiated, and final outcomes were also analyzed. Recorded data included forum of discussion, dimension of care, action items, monitoring of follow-up and compliance, and notification status.
Results: During the first 9 months of implementation, 605 cases were submitted (mean, 21.4 cases per week), a significant increase (P < .005) compared with the preceding 6 months (mean, 3.2 cases per week). Cases, which were submitted by residents (121 cases [20.0%]), fellows (94 cases [15.5%]), faculty members (319 cases [52.7%]), or technologists (54 cases [8.9%]), reported technical (33.1%) or administrative (8.0%) issues. The 329 clinical cases (54.4%) included 60 errors in communication (18.2%), 67 errors in interpretation (20.4%), 78 diagnostic delays (23.7%), 99 missed diagnoses (30.1%), and 54 procedural complications (16.4%); some cases were in more than one category. Twenty-three cases (3.8%) resulted in submission-related QA projects, and 69 cases (11.4%) resulted in individuals or sections of the hospital undergoing additional training.
Conclusion: A secure online QA reporting system promotes reporting of QA events and serves as a database for identifying and managing trends, initiating performance improvement projects, and providing feedback to staff members who submit cases.
© RSNA, 2006
| INTRODUCTION |
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For identification of barriers to improving the quality of radiology services, system rather than individual factors are likely to be the root cause of most problems (1114). To our knowledge, root cause analyses of radiologic quality initiatives have not been widely employed or described. As Thrall (1) has highlighted, these barriers include poor or nonexistent medical information and management systemsbarriers that are further compounded by the underreporting of adverse events.
The Joint Commission on Accreditation of Healthcare Organizations requires that all hospitals develop systems for the ongoing monitoring of clinical and technical performance. This is especially challenging for the field of radiology, where limited outcome data exist. To develop such systems, it is first necessary to establish a simple means for confidential reporting of quality-related matters. This reporting system should be searchable, provide ongoing data for trend identification and analysis, and encourage all staff membersbe they technical, administrative, or clinicalto submit events in a manner that results in constructive feedback, is of educational benefit, and encourages identification of improvement priorities.
Physicians may be reluctant to report adverse clinical events, especially if this event represents self reporting or self incrimination or may have punitive consequences. Deitch et al (15) have shown that radiologists remain skeptical about the usefulness of continuous quality improvement. To encourage submission of all data necessary to improve the quality of care, not only must the system be simple, peer reviewed, nonpunitive, and fair, but there also must be some recognizable positive feedback and benefit to staff members for submitting such data. We hypothesized that a simple online reporting system, with which staff membersincluding radiologists, technologists, managers, and administratorswere regularly made aware of trending data and of quality improvement initiatives resulting from their submissions, would further encourage ongoing submission of data. Thus, the purpose of our study was to evaluate an online system we have developed and implemented for reporting and managing quality assurance (QA) events occurring in a radiology department.
| MATERIALS AND METHODS |
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Using repeated plan-do-study-act cycles, we subscribed to a 10-step process for implementation of an online QA reporting system for performance improvement (Table 1). A radiology quality management team (RQMT) was established and met weekly from April 2004 to June 2004 to analyze and identify ways of improving reporting of QA data. We also aimed to improve clinical and technical performance in our academic hospitalbased Department of Radiology, in which approximately 400 000 studies are performed annually. Members of the team included the physician director of radiology QA (J.B.K.), the radiology nurse manager (Y.J.M.), and the radiology director of operations (D.T.H.). Support staff members included a software engineer (C.S.Y.), who performed rapid online integration of all changes as the reporting process was developed, and two radiologists (J.S. and H.Y.K.) with 3 and 4 years of involvement with QA programs, respectively.
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Preimplementation Planning
Prior to the development and launching of the online system on October 1, 2004, we analyzed the existing preimplementation process of QA reporting, with reference to any procedural steps likely to prevent or limit submission of QA data. We also analyzed the number, origin, and type of submissions over the preceding 6-month period (from April 1, 2004, to September 30, 2004). Data from this analysis were then used to facilitate the design of the online system.
Online Radiology QA Reporting System
The system comprises (a) a screen for data input and submission, (b) a Web-based mechanism for routing each submission for peer review, (c) a screen for documenting findings or actions resulting from this review, and (d) a screen for recording that the final review has taken place by the RQMT, which submits the completed case for data analysis and trending. The workflow of the system is illustrated in Figures 1 and 2.
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The system is fully compliant with Health Insurance Portability and Accountability Act regulations, and only staff members who had taken and passed an online Health Insurance Portability and Accountability Act compliance course and examination were allowed access.
Additional data recorded include patient medical record number or case-specific accession number; these numbers allow us to directly import finalized reports from our radiology information system. It is also possible to submit non-patient topics; indeed, this section of the site encourages staff members to submit such topics for investigation or response. The site thus serves as a comprehensive and interactive performance improvement repository because each of the submitted topics receives a response generated by the RQMT.
The input sheet then asks for a summary of pertinent issues and asks whether the submission relates to clinical or technical matters or both and whether it is in response to a section or modality review session or follows a review by another department or hospital. Using a series of check boxes, the submitter then classifies a submission according to whether it is equipment, technologist, or staff related. For procedures, the submitter also classifies whether there was a major or minor complication, whether errors in communication or interpretation occurred, and whether diagnosis was delayed or states that the submission is simply for purposes of data collection or trending. Causes of error are classified according to a modification of the system proposed by Renfrew et al (16) into errors of complacency, faulty reasoning, lack of knowledge, "underreading," and poor communication. More than one category could be chosen. In addition, we also documented how each case was brought to the submitter's attention, with options that included self report, report from nonradiologist physician, report from another member of our department, report from a patient (or patient family member); and report from another department, another hospital, or our own Healthcare Quality or Risk Management Divisions.
Data Review
Through frequent Web-based monitoring of the site (at least daily, including weekends), all members of the RQMT were able to assign cases submitted for review to modality managers, section chiefs, section QA officers, or other individuals as appropriate. With this system, cases are automatically assigned by e-mailing a unique and secure link to each case through a series of drop-down menus. When this link is accessed, a new online data sheet appears that includes all of the originally submitted data and provides options for documenting findings and outcomes from the case review. Specific boxes are also available to record such data as whether the case was discussed at section or other QA meetings (and when such meetings were held). For analysis purposes, a dimension-of-care category (safety, efficiency, effectiveness, patient centered, or timeliness) is included, and action items (including disciplinary action items) are also requested. Should follow-up be deemed necessary, the name of the person assigned to follow up the case can be inserted, as well as a date for anticipated resolution. This allows the RQMT to be notified when follow-up has not occurred, and an e-mail is automatically generated to remind the assigned person that a response is outstanding. In addition, when a submission is assigned, the date is recorded and that individual is automatically reminded with an e-mail message if the review has not been returned within 14 days.
Additional information that can be recorded after review includes notification status and final outcome. Notification status options include no notification required or notification of one or more of the following individuals or groups: our chairman, section chiefs or managers, modality chiefs or managers, program directors, the Graduate Medical Education Office, hospital compliance officers, patient care representatives, the Department of Risk Management, and the Department of Health Care Quality. Final outcome is categorized according to whether these data should be kept for trending analysis alone, another department or physician should be notified, or this case should be submitted to other hospital committees for discussion. Once these data are inserted, the reviewer submits the case by clicking a button and it is reflected as reviewed (with a submission date) on the online Web site (Fig 3). The case is then ready for review by the RQMT.
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Postimplementation Period
Prior to being launched, the system was demonstrated to all Department of Radiology modality managers, nurses, residents, fellows, and attending staff members at staff meetings, at department QA meetings, and through a series of small group and personal educational seminars. Staff members were encouraged to provide feedback and suggestions for improvement. All feedback was collected and discussed at RQMT debriefing sessions, and changes were implemented when they were considered to improve the system. The system was officially launched on October 1, 2004, and the designated departmental QA director (J.B.K.) reviewed the entered data on a daily basis. The RQMT met monthly to review all entered data and responses to the submissions once they were assigned for action and to close out cases. Summaries of these data were submitted to the departmental executive committee for review on a monthly basis. Two authors (J.B.K. and J.S.) evaluated the number of submissions into the system plotted against time (in a 9-month period) and in consensus analyzed sources of data, actions initiated, and final outcomes from October 1, 2004, to June 30, 2005. An e-mail questionnaire was sent to radiologists and residents who did not submit cases during the initial 3 months of deployment. Radiologists were given a series of options as to why they had not used the system.
Statistical Analysis
When applicable, descriptive statistics were employed, and data are presented as means ± standard errors of the mean. Differences in mean group data were considered significant at P < .05. Differences between the medians of the two unpaired groups (ie, the number of cases submitted per month prior to implementation and the number of cases submitted after implementation) were compared by using the Mann-Whitney test. Analyses were performed by using software (JMP IN 5.1; SAS Institute, Cary, NC).
| RESULTS |
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Most clinical submissions were from the abdominal imaging section (34.4%, n = 208), followed by angiographyinterventional radiology (54 cases) and ultrasonography (US) (30 cases). Most technical submissions involved the CT and magnetic resonance (MR) imaging divisions (CT, 60 cases [30.0%]; MR imaging, 42 cases [21.0%]). During the time of data acquisition, the fewest clinical submissions were received from our mammography (five cases), nuclear medicine (four cases), and neuroradiology sections (one case). Reasons why some members had not used the system varied (Table 2).
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Actions, Outcomes, and Categories
Of the initial 605 submissions, 149 (24.6%) were submitted for data collection, analysis, and trending, and in 106 (17.5%) of these cases, no specific or additional follow-up was considered necessary at the time of review. Of all cases submitted, 23 (3.8%) resulted in new QA and/or quality improvement projects being initiated (examples of which are provided in Table 3), and 69 (11.4%) cases resulted in individuals or entire sections undergoing additional training relating to online submission.
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Twelve submissions were not related to specific cases but instead were related to quality improvement issues that were identified during study interpretation (eg, how to increase the speed of sending large files to PACS), to quality- or performance-related matters that were specific to our work (eg, the optimal Doppler US technique for evaluating transplanted liver), or to issues that arose during performance of a procedure (eg, limiting radiation exposure during CT-guided procedures).
Red Flag Data
Analysis of the red flag data revealed that 18 ED cases were uploaded after not being approved in 24 hours. After notification, 16 of these were approved within 2 hours. The 23 online ED preliminary report changes are currently being analyzed by members of both the radiology department and the ED specifically to look at the effect on patient care, the importance of the changed report, the experience of the resident reader, and to identify resident teaching opportunities arising from these errors.
Because deployment of the reporting system was a quality initiative involving the use of ongoing plan-do-study-act cycles, each addition or modification to the system was monitored and recorded (Figure 5).
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| DISCUSSION |
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Participation and Compliance with System
The process of implementation has not been universally well received by all of our radiologists. Not all clinical sections have fully complied with submission of clinical data. There are many possible reasons why sections or individuals might be reluctant to report errors, and we are addressing means of encouraging such data entry. One of our priorities is to facilitate data entry and workflow.
An extensive recent physician survey (18) revealed that 80% of physicians did not trust their employing hospital to run an error-reporting system. The entire issue of self reporting is controversial, but, in that survey, ensuring that submitted data were confidential and not retrievable did not satisfy those physicians who were reluctant to participate. As policies are introduced in which radiologists are expected to communicate adverse events or major errors to patients, we anticipate a further challenge to clinician participation with a reporting system such as ours.
FitzGerald (19) believes that the current culture of blame in the health care industry inhibits reporting of error and near misses. Sixteen of 56 attending radiologists (28%) and six of 36 residents (17%) in our department did not use the system during its first 4 months of being active. In response to an e-mail questionnaire attempting to analyze causes for this, 11 physicians stated that they had no reason to submit cases or that they did not know how to access the system (n = 7); others feared misuse of data or reprisal and questioned confidentiality and the possibility of discovery and protection. Many physicians believe that such systems are bureaucratic, time consuming, costly, unnecessary, and an infringement on their independence (17). Through department chiefs, our institution monitors physician performance for credentialing purposes. Only 40% of hospitals in the United States use such data for determining clinical privileges (15). Indeed, Deitch et al (15) have suggested that proper use of data for credentialing purposes requires computerized databases and commented that these did not exist in 1994. Our system has been developed in part in anticipation of future requirements.
The system currently records the name of the person submitting each case. This allows us to monitor participation and to automatically e-mail the submitter when the case is reviewed and closed. We chose to avoid establishing an anonymous reporting system to avoid the possibility of personal vendettas, realizing that this might limit reporting of clinical missed diagnoses. To further improve participation, we are considering allowing limited anonymous submissions for specific scenarios, each instance of which will be dealt with by the RQMT.
We have received few self reports of clinical errors by attending staff members. We believe that this may be due in part to most of these cases being submitted by the resident reading the case at the request of the attending physician involved in the case. Indeed, on the basis of our experience, we now encourage residents and fellows to submit cases at the time an error is identified to eliminate the possibility that attending staff members may avoid self reporting.
Benefits of Online Reporting System
Prior to the launch of this online site, each section within the Department of Radiology collected its own QA data and presented them for discussion at section QA meetings. The radiology QA director reviewed a summary of these discussions and minutes. Having all of these data presented on a screen now permits comparison of data between sections and easy identification of trends. Of the cases submitted, 11.4% have resulted in additional training of individuals, and 3.8% have resulted in initiation of specific performance improvement projects. By applying "dimensions of care" to each submission, unexpected opportunities have been identified. As an example, when a resident submitted a report describing management of a contrast material reaction, review of the case identified an opportunity for standardizing medications in our crash carts, for reevaluating and aligning our treatment of severe contrast material reactions with methods used by our cardiologists, for creating cards to be carried by all physicians describing guidelines for management of contrast material reactions, and for updating and re-presenting our annual "Management of Contrast Reactions" talk.
Educational Benefits
The Joint Commission on Accreditation of Healthcare Organizations mandates that quality improvement be included in our training curricula and that trainees participate in QA projects. Our online system facilitates identification of potential performance improvement projects for residents during their quality improvement electives. A recent example resulted from a radiology resident submission questioning appropriate utilization of CT studies by ED residents. This allowed us to assign the case as a resident elective project and has resulted in an educational process teaching ED residents how to order the most appropriate imaging studies. Because a feedback loop is included in the submission process, all participants receive feedback on the outcome of each of their submissions once it has been reviewed and closed. In this way, an educational component is included in which members of the department actually get to see exactly how their quality concerns can be translated directly into improved performance in their workplace.
An example submitted to us illustrates the positive educational and clinical benefits of the system. An abdominal imaging fellow reported a lack of consistency when US technologists scanned the livers of patients after transplantation. Our response was first to review the protocol to measure how compliant our sonographers were with departmental scanning guidelines and the protocol for patients with liver transplants. A prospective 3-month survey was performed and revealed that certain US technologists required additional training to improve their compliance with the protocols. This also resulted in an opportunity to upgrade the scanning protocols, along with a seminar on Doppler US for liver transplantation. The system has thus provided unexpected educational benefits, and more and more technologists and residents are realizing that reporting of seemingly minor problems may have a positive educational benefit for them and their colleagues. We believe that this is one reason the number of submitted cases continues to grow on a weekly basis.
Performance Improvement
The system facilitates identification of opportunities for improvement. Residents in our hospital are offered quality improvement electives. Having reviewed examples of cases submitted to our online system, one resident chose to study ways of reducing errors in communication between radiology and other hospital departments. A review of the database and a search of the "communication error" data section revealed that errors were occurring owing to vaguely defined criteria and mechanisms for communication of critical radiology test results. This resident chose to focus on these areas, and, together with the RQMT and with input from the Massachusetts Coalition of Hospital Safety, the resident defined a set of clinical criteria and findings, such as unexpected pneumothorax, that required urgent communication with the ordering physician, along with a set of conditions that required less urgent (<3 days) direct communication. Together with these clinical conditions, a new policy for communication of critical radiologic findings was written and approved for our department and now serves to guide our interpretation and communication of abnormal results.
Enhanced Function of Reporting System
In response to user feedback, new changes have been implemented and many improvements have been made to the system since it was initially deployed. As an example, we have added a search engine not only for data analysis but also for selection of data that are transmitted to section chiefs and modality managers. Prior to section- or department-wide QA meetings, specific data can be extracted for analysis and presentation. The best example has been an accreditation site visit requiring specific US QA data to be made available to the investigator. A rapid extraction of all technical and clinical US quality cases provided useful data for presentation. A second improvement has been the incorporation of an automatic e-mail system for reminding reviewers that their cases are due for response (when no response has occurred after 2 weeks). This automatic e-mail function also notifies members of the RQMT that red flag cases have been received.
Limitations
We identified several limitations to this system, and have attempted to minimize these. Limitations were continuously sought as part of a plan-do-study-act feedback cycle. First, staff resistance to participation was due in part to concern for data security and privacy and risks associated with external review or discovery. We were assured through our Risk Management Department that all data were secure and protected, and we communicated this fact to all staff. In addition, in response to a submitted noncase-related question and request, this topic was covered at a department-wide QA meeting. A more challenging limitation to data submission is self implication and prevention of personal blame. The site certainly permits cases to be submitted that may appear to target specific members of the department or sections, but, in our experience, this issue was easily dealt with through rational peer review discussion. Other limitations we identified included lack of repeat submissions when staff members perceived that their prior submissions did not effect any meaningful results. For this reason, once a case is closed, an e-mail is now sent to the submitter inviting him or her to review the findings and outcome of the submission. Also, the time and thus (indirectly) the money required for data management and analysis should not be underestimated. Effective management of such a system requires a dedicated, interested, and enthusiastic team of qualified members.
When analyzing and presenting accumulated clinical data, it is important to compare the number of submissions with work volume. As an example, procedural complications reported must be related to the overall number of procedures performed and to case complexity. Similarly, missed CT diagnoses must ultimately be compared with a denominator of total interpreted cases over time. In this way, presented data would reflect performance more accurately.
Future Plans
In an ongoing effort to facilitate and encourage data entry, we have recently started developing a personal digital assistant (PDA) version of the online reporting system. This will allow staff members to input data directly from their PDAs. In addition, we have recently provided access to QA directors from other departments in our hospital. This will allow them to directly input data into the system and allow them to track action items and resolution of all submitted cases. It is our hope that this will permit us to submit similar QA issues to non-radiology departments. As an extension of this plan, the software has been specifically written so as to be easily modified and thus usable by other departments. The long-term plan is that this online QA reporting system will be deployed on a hospital-wide basis, and work toward achieving this goal has begun. We have already included all off-campus radiology outpatient offices and affiliated community hospitals and anticipate no difficulties with additional sites or departments using this system.
In summary, in response to the need for improved QA reporting, we have implemented an on-line radiology QA reporting system in our department. A secure online QA reporting system encourages ongoing submission of quality data, serves as a database for identifying and managing trends, and can be utilized for educational, maintenance, and clinical decision making.
| ADVANCES IN KNOWLEDGE |
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| FOOTNOTES |
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Abbreviations: ED = emergency department PACS = picture archiving and communication system QA = quality assurance RQMT = radiology quality management team
Authors stated no financial relationship to disclose.
Author contributions: Guarantor of integrity of entire study, J.B.K.; study concepts/study design or data acquisition or data analysis/interpretation, all authors; manuscript drafting or manuscript revision for important intellectual content, all authors; approval of final version of submitted manuscript, all authors; literature research, J.B.K., C.S.Y.; clinical studies, J.B.K., C.S.Y., J.S., D.T.H., Y.J.M.; experimental studies, J.B.K., C.S.Y., H.Y.K.; statistical analysis, J.B.K., C.S.Y.; and manuscript editing, all authors
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