Are Amended Surgical Pathology Reports Getting to the Correct Responsible Care Provider?

Transcription

1 Are Amended Surgical Pathology Reports Getting to the Correct Responsible Care Provider? Vinita Parkash, MD, 1,4 Akosua Domfeh, MD, MPhil, 1,4 Paul Cohen, MD, 1,4 Neal Fischbach, MD, 2 Mary Pronovost, MD, 3 G. Kenneth Haines III, MD, 1 and Peter Gershkovich, MD, MHA 1 From the 1 Department of Pathology, Yale University School of Medicine, New Haven, CT; 2 Oncology Associates of Bridgeport, Bridgeport, CT; and 3 Norma F. Pfriem Breast Care Center and 4 Department of Pathology, Bridgeport Hospital, Bridgeport, CT. Key Words: Amended; Surgical pathology; Reports Am J Clin Pathol July 2014;142:58-63 ABSTRACT Objectives: Amended reports (AmRs) need to follow patients to treating physicians, to avoid erroneous management based on the original diagnosis. This study was undertaken to determine if AmRs followed the patient appropriately. Methods: AmRs with diagnostic changes and discrepancies between ordering and treating physicians were tracked. Chart reviews, electronic medical report (EMR) reviews, and interviews were conducted to establish receipt of the AmR by the correct physician. Results: Seven of 60 AmRs had discrepancies between the ordering and treating physicians, all with malignant diagnoses. The AmR was present in the treating physician s chart in only one case. Ordering physicians indicated that AmRs were not forwarded to treating physicians when corrected results arrived after patient referral, under the assumption that the new physician was automatically forwarded pathology updates. No harm was documented in any of our cases. In one case with a significant amendment, the correct information was entered in the patient chart based on a tumor board discussion. A review of two electronic health record systems uncovered significant shortcomings in each delivery system. Conclusions: AmRs fail to follow the patient s chain of referrals to the correct care provider, and EMR systems lack the functionality to address this failure and alert clinical teams of amendments. Upwards of 27 million surgical pathology reports communicate critical tissue evaluation results to treating physicians in the United States annually. 1 In a small number of cases, these reports have errors, and a corrected (amended) report is issued at a later date. 2 The amended report (AmR) needs to follow the patient through a potentially rapid chain of referrals to a physician actively caring for the patient, to avoid erroneous management based on the original report Figure 1. This is particularly challenging because the procedure report generation loop has closed and an erroneous report is in circulation. We conducted this study to determine how often AmRs did not reach the correct treating physician, and the role of the electronic medical record (EMR) in addressing this issue. Materials and Methods The Bridgeport (CT) Hospital Institutional Review Board assigned a quality assurance (QA) activity waiver to this study. All AmRs over an 18-month period with a change in the final diagnosis field of the report were tracked to determine if the active treating physician received a copy of the AmR. For the purposes of this study, the physicians listed in the original request for a pathologic consultation were designated as ordering physician (OP) and physicians currently caring for the patient were designated the current treating physician (CTP). CTPs were identified from a review of medical records or discussion with the OP. In cases in which the CTP was 58 Am J Clin Pathol 2014;142:58-63 Downloaded 58 from

2 not the OP, a chart review (to document receipt of the AmR) and an interview addressing the transmission of the AmR were conducted in both physician offices. The EMR system was reviewed to study delivery mechanisms for the AmR. At all sites the following were recorded: (1) the presence of the AmR in the record, (2) the removal/sequestration of the original (erroneous) report, (3) the method of notification of the physician to the arrival of an AmR, (4) the method for recording the receipt of the AmR, and (5) if the physician was not the CTP, the mechanism of forwarding the report to the CTP. The taxonomy proposed by Meier et al 2 was used to classify amendments. We evaluated the effectiveness of two hospital EMR systems (Cerner Millennium PowerChart [Cerner, North Kansas City, MO] and EpicCare EMR [Epic, Verona, WI]) in notifying the OP and CPT of the AmRs. Results Case Distribution Of a total of 20,065 surgical reports issued, 134 were amended (6.7 per 1,000 cases), of which 60 (2.9 per 1,000 cases) had changes in the final diagnosis field. Of these, 53 listed the CTP either as a primary or copy to physician in the pathology information system. Seven cases of malignancy of the breast (11.7% of final diagnosis field amendments; overall rate 0.34 per 1,000 cases) did not list the CTP. There were two primary level diagnostic errors. In one case, a microscopic focus of in situ carcinoma was identified, and in the other, a micrometastasis was identified in deeper levels when sections were cut before being sent out for review at a secondary institution. Five secondary level Original treating physicians Timeline Specimen Surgeon/IR Report Pathologist Oncologist Postsignout review Current treating physicians Amendment Additional oncologist Error detected Specimen for pathologic consultation Pathology report Amended report Referral Figure 1 Chart showing the flow of information among the ordering physician, pathologist, and the current treating physician, in transforming a tissue specimen from a patient to an actionable surgical pathology report. IR, interventional radiologist; dotted line, optional referral. x defects were found. These included two cases with grade change, two cases with stage change, and one case with a change in histologic subtype of tumor. The differences between AmRs that did and did not reach the CTP are listed in Table 1. Of note, all seven AmRs not reaching the CTP carried a diagnosis of malignancy, were delayed AmR generations (issued >21 days after issue of original report), and documented communication of amendment to the OP but not the CTP. x Table 1 Characteristics of Cases With and Without Amended Reports in Treating Physician Files Parameter Type of error/defect Cases With Amended Reports Reaching CTP (n = 53) Admixture of error types; most commonly transcription errors Cases With Amended Reports Not Reaching CTP (n = 7) Diagnostic/misinterpretation errors (100%) Type of case Admixed; benign and malignant cases Malignant cases (100%) Method of detection of error Admixed; treating physician pickups (40%) Pathologist detected on secondary review (100%) External consultant detected error 0% 2/7 (29%) Time to detection of error Early (<21 days) 83% Late (>21 days; range days) 100% Documentation of communication of error to OP 40% 100% Documentation of communication of error to CTP (often same as OP) 40% 0% a CTP, current treating physician; OP, ordering physician. a None of the cases documented communication with OP, but communication likely occurred in a conference setting. Downloaded from Am J Clin Pathol 2014;142:

3 Parkash et al / Amended Surgical Pathology Reports Review of Records at the Physician s Office OP (Two Practices, Two Physicians) The original reports for all cases were filed, signed, and dated. The AmR was present in all five cases in one OP s office. The other OP had the AmR in 0 of 2 cases, both of which had secondary diagnostic errors. The reason for the absence of the AmR was unclear; staff suggested that this now-retired surgeon discarded AmRs if amendments were not significant. The OP indicated that AmRs were forwarded to the CTP if the AmR was received before referral. However, there was no mechanism in place to forward reports if the patient had already left the surgeon s care. OPs assumed, although unaware of the specifics, that a mechanism existed to ensure communication of the AmR to the CTP. Importantly, neither OP had a mechanism for following up on even significant AmRs if the patient chose a CTP other than the CTP recommended by the OP. CTP (One Oncology and One Radiation Oncology Practice, Four Physicians) Chart review at the CTPs offices revealed a copy of the original report in all nine instances (two patients had been referred to radiation oncologists), though in five cases these reports showed the altered formatting consistent with printing from the hospital EMR. A copy of the AmR was present in only one of nine instances. Harm was not documented in any case. Report defects did not influence management decisions in six cases; in the case with a change in nodal status the information was recorded based on a tumor board discussion. In this case, a consultant letter from the referral institution indicating the change was also present in the chart; however, neither the AmR nor the consultant pathology report was present in the file. No AmRs were found in the radiation oncologists office (pertinent to two cases). Both oncologists and radiation oncologists confirmed learning of amendments indirectly, predominantly from tumor board discussions. Differences in Records Between the Paper Medical Chart and the EMR The differences between the paper medical record and the EMR are summarized in Table 2, and are detailed below. Identification of Amendment and Timeline of Amendment The hospital paper chart was bulky and had multiple and haphazardly arranged copies of both the AmR and the original report; the AmR was missing in one instance. In both EMR systems, the AmR replaced the original report 100% of the time (a copy of the original is available elsewhere, but not readily accessible). The EMR display, however, raised some issues. None of the EMR systems displayed an amended alert on the primary screen Figure 2B, which was readily seen on the paper report Figure 2A. However, one system (Cerner) used a generic label of modified when viewing events in chronologic order. In both EMR systems, the amended alert was visualized only on the secondary screen or in a split screen set up if the specific report was selected Figure 2C and Figure 2D, and was relatively inconspicuous because the formatting was altered to fit the screen. None of the EMR systems displayed the date of issue of the AmR on the primary screen; cases were logged only by date of service (Figures 2B, 2C, and 2D). In the EpicCare EMR, the field for the date of result duplicated the date of service. Even on the secondary screen, the timeline for the amendment was not readily accessible, because much of this information was moved to the bottom of the report (which in many cases spanned seven to eight pages). Likewise, Table 2 Differences Between Paper Medical Charts and EMR Systems in the Delivery and Display of AmRs Paper Medical Record Cerner Millennium PowerChart EpicCare Original report Easily accessed with risk for confusion with AmR Replaced by AmR; no risk for confusion Replaced by AmR; no risk for confusion AmR Absent in one case Present in all cases Present in all cases Record of receipt of AmR Present; signed and dated by clinician Present, but not displayed Present, but not displayed Arrangement of events Chronologic by date of receipt of report Chronologic by date of service Chronologic by date of service Flag for AmR in primary field (Figure 1) On front page; easily identified Not identified/ modified label available in some fields Not identified Ease of identification of amendment (Figure 1) Relatively easy; depicted in a QA field immediately following final diagnosis field Difficult; QA field present at end of report Difficult; need to open PDF report AmR, amended report; EMR, electronic medical report; PDF, portable document format; QA, quality assurance. 60 Am J Clin Pathol 2014;142:58-63 Downloaded 60 from

4 the QA field explaining the reason for the amendment, readily seen on the paper report (Figure 2A), was moved to the bottom of the report in the electronic charts, making identification of the amendment difficult. In addition, some required reporting elements were missing on the secondary screen in both EMR systems reviewed. These elements pertained not just to the AmRs, but also to all surgical pathology reports. This included laboratory identifiers such as Clinical Laboratory Improvement Amendments number, laboratory name (our health system has three laboratories in two cities), and technical information such as slide labeling and special studies details). In the EpicCare EMR, one could access this information by viewing the surgical pathology report in a portable document format (PDF), but it was unclear if clinicians knew of this capability or how often they used it. Printing and transmission of a non-pdf report resulted in reports with missing information and improper display of information. A B C D Figure 2 Comparative analysis of the first page (or equivalent) of amended reports. A, Paper record. B, C, D, Screen shots displaying the view in Cerner Millennium PowerChart (B, C, Cerner, North Kansas City, MO) and EpicCare systems (D, Epic, Verona, WI). In the paper record (A) the amended flag (red box) is seen on the first page and the timeline for the case is evident (blue arrow). In addition, laboratory identifiers are also displayed (logo, Clinical Laboratory Improvement Amendments number). The primary screen in the electronic medical record displays only the date of service (Cerner Millennium PowerChart), and an amendment flag is not visible. Selecting the specific record for the appropriate date of service displays the amended flag (red box) in both the Cerner and the EpicCare Systems (C, D); however neither the timeline nor the Quality Assurance field is placed in a location that would bring attention to the alteration in the report. Indeed in the Epic system (D), both the date of service and date of report are identical, giving an incorrect impression about the status and timeline for the report. Downloaded from Am J Clin Pathol 2014;142:

5 Parkash et al / Amended Surgical Pathology Reports Issues of Notification and Acknowledgment None of the systems (paper or electronic) reviewed had a mechanism to alert a clinician to the specific arrival of an amendment. In both EMR systems, reports arrived in the physician s queue with a generic surgical pathology label and the clinician had to acknowledge a report to remove the case from their queue. Opening of the reports from the mail queue did not provide the PDF report with all of the attendant issues highlighted before. An amendment alert, timeline details, record of last review of report, and action details at prior review (eg, forwarding of the report to a CTP) were not readily accessible; therefore, it was possible for the clinician to mistakenly assume that he or she had received a duplicate copy of the original report and miss the amendment. The EpicCare system did offer to forward the report electronically to another care provider, but it required that the OP know who the CTP was. Discussion A tissue evaluation remains the primary mechanism of making a definitive diagnosis of malignancy; hence, surgical pathologists examine most tissues removed during surgery to exclude, confirm, or detail the diagnosis of malignancy. These results are embodied in the surgical pathology report. A minor percentage of these reports will be discovered to have errors on secondary review (tumor board conferences, QA activities, or referral reviews) and an AmR will issue to communicate corrections to treating physicians. 2 Erroneous management of a case based on the original (incorrect) interpretation can have devastating consequences for the patient. Patients have undergone unnecessary double mastectomies and thyroidectomies because AmRs that changed the diagnosis from malignant to suspicious were not communicated to the correct and active treating physician. 3,4 Our study suggests that institutions do not have adequate safeguards in place to ensure delivery of the AmR to the responsible care provider in the age of sub- and superspecialization and rapid referrals. Our study also identifies additional challenges in the EMR with respect to communication of the AmR to the CTP. Our study shows that AmRs are not delivered to the responsible care provider in a subset of cases in which the stakes are high. Failure of delivery was documented in 11.7% of amended cases with final diagnosis field error, all of which had a diagnosis of malignancy. Failure occurred in cases with delayed amendments (>21 days after the release of original report) and in spite of documented communication with a physician. The first two associations for this failure are readily explained. It stands to reason that a change in physician is more likely in cases requiring adjuvant therapy, which is more likely in cases of malignancy. That all seven cases pertained to a diagnosis of breast malignancy is likely a reflection of the case mix at our institution. It is the predominant malignant specimen seen at our institution, where surgery and chemotherapeutic interventions are provided by separate clinicians. It also stands to reason that a change in physician is directly related to the time elapsed between issue of the original report and the AmR. However, failure of report delivery to the CTP in spite of verbal communication with a physician is alarming. The most likely explanation for this failure is that communication occurred with the incorrect care provider. The communication occurred not with the current and active CTP, but with the original OP. This is similar to the problem reported by Roy et al 5 for postdischarge pending test results. Roy et al 5 found that primary care physicians failed to respond appropriately to alert value laboratory results ordered by hospitalists at the time of discharge. In both scenarios, this is because the physician who needs to respond to the test is different from the physician ordering the test. In the setting of the postdischarge pending test, the OP is the hospitalist and the CTP is the primary care provider; while in the setting of the AmR the OP is the surgeon or interventional radiologist, whereas the CTP is the oncologist or a radiation oncologist. The AmR presents the additional complication that a prior incorrect result is in circulation. Indeed, this communication gap in which a communication is sent to the OP rather than the current responsible care provider may explain the lack of follow-up on alert values reported by authors even when notification for the alert value was acknowledged for urgent clinical laboratory test results. 6 Notification was likely acknowledged by the physician ordering the test, but action was not instituted, because this physician was no longer actively caring for the patient. This is similar to our cases in which communication between the OP and the pathologist was documented, but the results do not appear to have been communicated to the active CTP (as evidenced by the absence of the report in the CTP office). Pathology departments and health care systems need to institute specific mechanisms that will allow them to identify the correct active CTP at the time results are issued. There are several possible mechanisms to identify the responsible CTP for surgical pathology cases. In larger institutions with unified medical records, it may be possible to identify the CTP by checking the medical record to determine whom the patient is scheduled to see in a subsequent visit. Alternatively, this information can be sought from the OP. We follow both of these procedures and document these on an amendment worksheet. We have instituted another method, because we are a hospital-based service with only two oncology practice affiliates. Every week we acquire the list of new patients scheduled to be seen by the oncologists, cross-check these in the pathology system, and append the name of the oncologist as a copy-to physician to all pertinent pathology results. 62 Am J Clin Pathol 2014;142:58-63 Downloaded 62 from

6 Any subsequent modification to the reports will transmit automatically to both the OP as well as the CTP. Our sister institution faxes AmRs to a central cancer center site, where the staff directs the AmR to the appropriate CTP. However, these processes are tedious, not fail-safe, and may not be viable in large-volume practices. An information system based solution is preferable. Copying the pathology information system with referral requests could allow for updated clinician information. This would not address the scenario of a patient choosing a CTP outside the health care system. Therefore, institutions need to consider directly alerting patients to a change in their report, and getting information about the CTP from the patients themselves when such information cannot be obtained from within the system. Still, identification of the correct active care provider for the pathologist (and indeed other diagnostic specialties such as radiology) will continue to be a challenge and innovative solutions are needed to address this problem. Additional challenges in the communication of the AmR were identified, which were specific to the EMR. However, the EMR was superior to the paper record in ensuring that the AmR overwrote the original, and sequestered the original in a way that avoided confusion. The delivery and display of the AmR did not sufficiently highlight the report as being revised and corrected. The AmR was completely obscured on the primary screen because of the loss of the amendment alert and reporting timeline, and this was exacerbated by the date of service only display, which buried more recently issued AmRs under reports with a later date of service. Even the secondary screen made it difficult to identify amendment specifics because of reformatting. Insufficient highlighting of the AmR in the EMR is particularly problematic because the EMR allows rapid dissemination of information, including erroneous information, across multiple physician offices and institutions. The ability to cut and paste entire pathologic diagnoses into discharge summaries enables and even encourages subsequent clinicians to avoid visiting the pathology chart section. Alerts for additional and altered information and timeline displays for surgical pathology reports are therefore essential to avoid errors related to AmRs. Another possibility, drawn from social media sites, is to devise a system that displays significant recent events in sidebars that require acknowledgment and have forwarding capabilities. An additional issue that we uncovered in the EMR during this study applies not just to AmRs but globally to all pathology reports. The report display in the default format did not meet the reporting guidelines set forth by the College of American Pathologists. 7 Although this issue was overcome by using a PDF report (offered in the EpicCare system), the fact that this was not a default mechanism means that one could print a pathology report without the appropriate identifying information and with altered formatting with attendant issues. Therefore, EMR systems need to have better and possibly unique displays with additional functionality for surgical pathology reports. AmR is but one reporting feature that is unique to surgical pathology. Other features that are (almost) exclusive to surgical pathology include synoptic reporting, unusually long reports (sometimes as long as 8-10 pages), and frequent alteration of original reports by the results of new tests. Modified radiology and clinical laboratory result display formats do not take into account the unique workflow of surgical pathology reports; thus, they can cause problems in the communication of surgical pathology results. These concerns need to be taken into account when devising an EMR that addresses the needs of the various departments and units in a health care system. Address reprint requests to Dr Parkash: Dept of Pathology, Bridgeport Hospital, 267 Grant St, Bridgeport, CT References 1. Valenstein PN. Formatting pathology reports: applying four design principles to improve communication and patient safety. Arch Pathol Lab Med. 2008;132: Meier FA, Varney RC, Zarbo RJ. Study of amended reports to evaluate and improve surgical pathology processes. Adv Anat Pathol. 2011;18: Diagnosis disaster: who s to blame or did everyone contribute? The Medical Insurance Group. MIGA Bulletin. Accessed May 20, Do doctors make the worst patients? MDA National Group. MDA National: Defence Update. Winter mdanational.com.au/media/18497/du_winter_08_web.pdf. Accessed May 20, Roy CL, Poon EG, Karson AS, et al. Patient safety concerns arising from test results that return after hospital discharge. Ann Intern Med. 2005;143: Singh H, Thomas EJ, Sittig DF, et al. Notification of abnormal lab test results in an electronic medical record: do any safety concerns remain? Am J Med. 2010;123: Goldsmith JD, Siegal GP, Suster S, et al. Reporting guidelines for clinical laboratory reports in surgical pathology. Arch Pathol Lab Med. 2008;132: Downloaded from Am J Clin Pathol 2014;142: