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Report of Root Cause Analysis Click here to view the Contributory Factor Tree for this Root Cause Analysis Administrative and Preliminary Data Note that the six process flow charts used in this root cause analysis have been omitted from this training report. RCA Code No: 056      RCA Event Name: Delayed Diagnosis of Hodgkin's Disease Description of Event under Analysis:      Twenty-year-old female had a six-month delay in diagnosis of Hodgkin's Disease. Location of Event: "X" Medical Center and remote clinic of that medical center RCA Start Date: 9 January 1999      RCA Completion Date: 11 February 1999 Date RCA Locally Approved: 23 February 1999      Date External Report Submitted: JCAHO Option 4 Organizational Entities Impacted by Event "X" Medical Center "Y" remote (satellite) clinic Radiology Department Laboratory Department Information Management Department Participant (name & position/discipline) Hours Participant (name & position/discipline) Hours Dr. Bryce(Team Leader) 16 D. Gallagher(Team Facilitator) 16 Dr. L. Callahan (senior clinic physician) 4 Dr. Gaithers (radiology) 3 J. Phillips (medical technician) 3 Dr. Weiss (risk mgmt advisory committee) 2 B. French (clinic X-ray Tech) 2 T. Byron (clinic administrator) 5 P. Klaman (process consultant) 2 R. Jessup (recorder) 6 K. Lainier (information management) 4 L. Samuelson (information management) 2.5 Information Needed Person(s) Responsible Medical Records Dr. Bryce Radiology Process data Dr. Gaithers Laboratory Process data Dr. Bryce Attributed RCA Cost Source Cost Personnel Salaries $ 3,540 Personnel Benefits 1,180 External Consultants 0 Materiel 0 Lost Revenue NA Other (describe): 0 Total $ 4,720 Immediate Corrective Action Taken All items entered here should also appear in the Root Contributory Factor & Action Plan grid. Comments Clinic created new PPD Convertor log Initial group session identified inadequacy of previous logs Clinic created new X-ray tracking log Literature Reviewed in Course of Root Cause Analysis JCAHO Sentinel Event Policy Kern, K. Medicolegal Analysis of the Delayed Diagnosis of Cancer in 338 Cases in the United States. Archives of Surgery. 1994;129:397-404. Berlin, L. Communication of the Significant but not Urgent Finding. American Journal of Radiology. 1997; 168:329-331. Fischer, G. et. al. Adverse Events in Primary Care Identified from a Risk-Management Database. The Journal of Family Practice. 1997;45:40-46. Grams, R. and Moyer E. The Search for the Elusive Electronic Medical Record System -- Medical Liability, the Missing Factor. Journal of Medical Systems. 1997;21:1-10. Incidental Findings (Findings not directly contributing to the event or condition under analysis, but which represent opportunities for improvement) Comments Clinic's lack of special handling procedure for wet read requests New policy for handling wet-read requests also tracked by new X-ray log Clinic's X-ray log does not include results Addressed by a revised X-ray log Unclear chain of custody for clinic's X-rays to medical center Computer system does not record the time/date that a lab result is acknowledged by a provider, or that provider's name Recommend medical center executive staff for refer issue to information management oversight committee Patient's PPD result not entered in PPD log Inattention to detail & inadequate supervision of log entries Clinic's PPD flow chart has no decision point for PPD reactors Referred to Clinic for procedural clarification Clinic without written documentation of training on PPD reading Required by medical center policy, but policy has insufficient compliance and monitoring. Referred to Clinic for corrective action. Poorly documented notification of provider on X-ray report Action Items #5 and #6 Initial Possible Contributors (factors suggested by cursory examination)           Physician error: clinical judgement           Physician error: negligence High Visibility, Non-Contributory Factors Explanation for Concluding that Factor is Non-Contributory None Not Applicable Sequence of Events Six process flowcharts were used to help identify processes, and elaborate this sequence of events. When included, this sequence of events is extremely detailed, as it must be in order to be effective. They are excluded from this sample report for the sake of brevity, but would be included in a full report of root cause analysis. Date Time Event 12 May Medical Record and PPD log entry that PPD had been placed 14-15 May PPD read (unidentified provider) as 17mm induration, entered in Medical Record 18 May Blood drawn at clinic for Liver Function Tests (LFT) and blood sample transported by courier to medical center laboratory per clinic's SOP 18 May 1616 LFT order from handwritten order form, with senior clinic physician listed as ordering provider, entered into computer system by medical center laboratory technician unknown Senior clinic physician reviews LFT results, electronically signs and puts in new results "saved" list 19 May Chest X-ray taken at clinic 19 May Clinic physician reviews film and notes "?wide mediastinum, no parenchymal disease" on handwritten note 19 May X-ray transported to medical center with many other films from clinic 01 Jun Clinic medical technician duties turned over to replacement, due to incumbent being temporarily assigned to other duties outside clinic. 19 Jun X-ray noted to have returned from medical center without being interpreted. 19 Jun X-ray returned to medical center per entry in clinic X-ray log 22 Jun Chest X-ray 2-view (read only) order entered into computer system from technician's hand written note, with clinic senior physician as ordering provider. 23 Jun Chest X-ray read at medical center Radiology by resident with staff supervision 23 Jun 1520 Specific comment on X-ray report states "physician was informed of these findings 23 June 1998 at 1520." No other evidence of the abnormal report being communicated to the "ordering" provider 24 Jun 1005 Chest X-ray report transcribed into computer system, available for review, and should be on clinic physician's "new results" menu. 1 Jul 1420 Chest X-ray transcription approval signed by radiology resident 17 Jul 1300 Chest X-ray supervision signed by radiology staff 06 Nov Patient seen at clinic and referred to ENT for evaluation of "neck mass r/o malignancy" 12 Nov Fine needle biopsy consistent with Hodgkin's Disease   Barrier Identification This section is not usually included as part of the RCA report,   but is included here to better illustrate this portion of the RCA methodology. Barrier Worked? Remarks / Comments Health Maintenance PPD Program Yes Program identified PPD conversion Annual Health Record Review Yes Health maintenance policy encourages annual review of medical record, with examination as deemed appropriate. Review appropriately conducted. Clinic's SOP Yes Call for immunizations to be administered during the annual verification process. Patient responded and was administered a PPD test Initial Physician's Evaluation No No record of evaluation or any progress note indicating PPD conversion Blood Draw for LFT Yes As per health maintenance procedure Abnormal LFT result report from No Computer system recorded the LFT results as "reviewed by ordering physician." "Ordering physician" signifies here that the clinic's medical technician surrogates the order for the physician, per SOP. Thus, the physician may or may not be aware of the order in his or her name. In this case, the computer records that the physician electronically signed acknowledgment of results and put it in the new results "saved" list. The system does not account for the time and date of this electronic acknowledgement. A clinic provider must dial into computer using a modem, which can be both difficult and time consuming. Chest X-ray No Performed at clinic in accordance with policy Preliminary Clinic Physician's X-ray Interpretation No Required per clinic's SOP: film read as "?wide mediastinum" - film sent to medical center Radiology for interpretation but no follow-up on suspected abnormality Clinic's X-ray Log No Logged as performed, but the log was not used to record results, track provider notification, or track any action required Clinic's PPD Log No Logged as placed, but no result was recorded in the log Computerized Electronic Logs No No data could be retrieved; no long term backup felt to be required. Clinic was using the computerized PPD Converter Log per SOP, but these records could not be found for this period of time. It appears that the providers relied on the clinic procedures to act as a tickler for both chest X-ray and LFT results. Medical Center X-ray Abnormal Result Reporting No Computer records read "Senior clinic physician was informed of these findings 23 June 1998 at 1520." No specific method of communication was noted and the physician does not recall this communication. A Radiology memo outlining policy for the direct communication of significant abnormal findings by the radiologist to the requesting provider conflicts with a departmental SOP, "Exams with Significant Findings." The memo does not address notification to clinic providers. Medical Center Wet Reading Log No Medical Center Radiology SOP calls for log which no longer is used, SOP not updated. With a computer system crash, there would no record of communicated results reporting. The current SOP appears to delegate the tasks of reporting notification to non-radiologist providers. Medical Center Radiology SOP "Clinic Exam" and "Hanging Exam" No The process for interpreting and returning results for radiographic exams "should under normal circumstances, be returned with 24 hours but no more than 48 hours." This x-ray film was returned to clinic unread after approximately 30 days, which required the clinic to return the film to the medical center for interpretation. Medical Record No The patient's immunization record has the PPD interpretation recorded. There is no progress note entry that documents patient education or diagnostic findings.   Root Contributory Factors and Action Plan Contributory Factor Corrective Action Measurement Strategy Person(s) Responsible Action Due Date Person(s) Responsible Follow-up Date 1 Physician not following up on abnormal radiologic studies Refer this to privileging authority for review and appropriate action Chair, Credentials Committee, May 1999 To be determined by privileging authority TBD 2 Physician not following up on abnormal laboratory studies 3 Undue Clinic reliance on computer system for results reporting and tracking: no log for satellite clinic labs and x-rays run at Medical Center Create log for all diagnostic studies drawn or performed on Clinic and institute process for regular supervision of log entries. Clinic Administrator, June 1999 Verify log implementation and institution of a mechanism for regular supervision of log entries Clinic Director, July 1999 4 No requirement for medical technician turnover Develop position-specific turnover guide and implement in all satellite clinics Clinic Administrators, June 1999 Medical Center chief administrative office will designate responsible office for oversight & review Chief Administrative Officer, July 1999 5 Contradictory Medical Center Radiology policy for reporting significant abnormal results Revise departmental policy and SOP's to provide consistency. Reemphasize the responsibility of the Radiologist to directly contact the ordering provider for urgent or significant findings. Create Radiology logbook for noting all communication with Clinic providers. Train all personnel (providers and support) on new procedures. Chief, Radiology, May 1999 Track on a monthly basis the number of Clinic X-ray results requiring assistance with direct communication of results. (Also see #7 below). Chief, Radiology , July 1999 6 Incomplete policy for handling Clinic X-rays at Medical Center 7 Direct communication between Radiologist and Clinic provider is difficult due to insufficient number of phone lines Information Management to submit communication plan and monitoring plan Head, Information Management, May 1999 To be determined be Executive Committee action on proposed communication plan Head, Information Management, June 1999 8 Low quality telephone lines 9 Modem settings incorrect Rectified Head, Information Management, completed Feb 1999 Tested & Passed Head, Information Management, completed Feb 1999 10 Computer system software "bug" not corrected due to decision by chief financial officer of Medical Center Medical Center priorities to be examined and modified and appropriate CEO and Executive Committee, May1999 To be determined based upon re-prioritization results CEO and Executive Committee, June 1999 11 Training deficit in orientation of new medical records clerk Establish and implement training program for new records personnel which includes integration of records from satellite clinics Medical Records Administrator, April 1999 Compare appointment schedule at satellite clinics with completed records in records archive: audit for record completness Medical Records Administrator, August 1999 Root Cause Analyst SoftwareTM | FAQs on the Issues | Root Cause Analysis Training Cost-Effective Root Cause Analysis | Root Cause Analysis Software - Article Resource Links | Guestbook | About MRMA | Email MRMA  Root Cause AnalystTM is developed in partnership with Accurate Assessments. 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