Plugging the Dike: Capturing and Reporting Clinical Test Results: An Enterprise Risk Management Approach Susan Penney, JD Director of Risk Management UCSF Medical Center June 14, 2012
Overview What is the Problem? Scenarios Failure Mode Effect & Criticality Analysis (FMECA) What are the Legal Issues? Solutions in Place Relay Center for communication of test results IDX Revisions Revised Requisition Forms e-discharge Summary Relay Center Ongoing Issues 2
Why Are We Here? Cases in Bay Area $1.4 Million settlement in failure to diagnose lung cancer: Failure to report results of Chest CT to attending Failure to include CT results and needed follow up in discharge summary Failure to communicate test results or discharge summary to primary care physician Lawsuit: Failure to report 2003 surgery pathology findings to patient, resulting in 6 year delay in treatment of papillary thyroid carcinoma System for communicating test results relied on patient making a post-op appointment No tickler system for pathology results Pathology would not have called MD with results No documentation of review process of path reports within the clinic reports are filed in the chart
Why Are We Here? Test Pending at Discharge Test for Hep B & C ordered 9/05, unavailable at discharge Test result not communicated to patient found out he was Hep C positive in November 2007 Diagnosed with liver cancer Patient died January 2008 System for reporting test results Residents would not see results until entered in the chart Results would be sent to the team of residents involved in the care and not to a particular resident
Why Are We Here? Late Diagnosis of Cancer Patient/Family dissatisfaction for failure to report results of CT Scan taken in ED and delay in diagnosis of renal cancer Patient Complaint: Failure to advise patient or family of finding of lung cancer on CT Scan ordered in ED in January 2010. (Radiology note that result called to ED) Patient underwent surgery for AAA and prolonged course prior to expiration in late April Family upset because results not communicated and would have moved to palliative care earlier
Why Are We Here? Renal Transplant 66 y.o. female s/p renal transplant 2001 hospitalized in September 2011 for Urosepsis at hospital 1 Follow-up plan after discharge included periodic blood and urine testing. November 9, 2011, patient presented to hospital 2 for the testing Urinalysis results indicated UTI Test results reported to hospital 1 via fax, but not acted upon Patient admitted to hospital 2 for uro-sepsis on 11-14
Why Are We Here? Renal Transplant Current Process for management of test results in Renal Transplant at Hospital 1 Renal Transplant patients often have f/u labs drawn at outside labs Patients are given a fax/requisition to give to outside lab personnel Outside lab sends results to hospital 1 via fax Upon receipt of the fax, an administrative assistant will enter the blood results into a transplant specific software Urine results are not entered into the system but are instead handed to the provider for review. Patient has made a complaint and wants to know system solution Suggestions?
Why Are We Here? Radiology/ED- Patient presented to ED June 19, 2010 (prior to Relay Center) for abdominal pain suspicious for gallbladder Abdominal CT Scan done showing an incidental 1.7 cm suspicious lung nodule: report says: Correlation with lung cancer risk factors and clinical symptoms recommended. Dedicated chest CT or follow-up in 3 months recommended ED Note: regarding LLL nodule, patient has no concerning sx at this point for malignancy that would warrant further work of lung nodule. Given size, should have repeat imaging in 6 months via Chest CT ED note: Patient informed that will need PCP and to obtain repeat CT Patient did not want a referral to PCP and said she would select on her own
Why Are We Here? Radiology/ED- Patient did not get second CT until December 15, 2011 appears to be advanced lung cancer GOOD NEWS: Our providers documented the patient discussion about needed follow-up BAD NEWS: The Relay Center was not available to report this test result to her PCP GOOD NEWS: Our Relay Center would now capture this test result and report it directly to PCP, if identity known.
Where does the buck stop? The Ordering Physician? The Performer of the Test? The Primary Care Physician? The ED provider?
Task Force on Test Results Task Force Members: Co-Chairs: Lab Chair and Director of Risk Members: Nursing Medicine Primary Care and inpatient medicine and surgery ED physicians and nurses IT from many places EHR planning group Outpatient Administration Lab, Pathology, Radiology Chief Medical Officer Admitting Operations Staff 11
Failure Mode Effects & Criticality Analysis Ordering, tracking and communicating laboratory, pathology and radiology test result process underwent a comprehensive, multidisciplinary review to: analyze systems detect possible failures identify methodologies to enhance and strengthen these systems (including review of best practices) develop implementation plans The top three vulnerabilities identified in the FMEA were: inconsistencies in entering appropriate information on the patient s requisition related to the name(s) of the appropriate physician(s), the porous process for physician notification of test results, and an inconsistent process for notifying patients of any test results that may require further follow-up 12
FMECA (con t) In order to improve the process for the management of test results the following actions have been taken or are in progress: IDX Improvements (provider identification) Requisition Forms Improvement (provider identification) Technology Solutions (e-discharge, Radiology Results Routing and Follow Up, Electronic Test Result Routing Demonstration Project -R.Cucina) Home Care Specific Improvements (communication and hand offs of test results) Relay Center (tracking, communicating and reporting subcritical results) 13
IDX: Provider Identification IDX= our Central Nervous System IDX Provider Fields have been reduced and clarified: Staff Training: requisite online staff educational module released System Change: revised provider fields now live IDX/APeX provider field congruency: in progress Quality Assurance: quality metric exploration Identifying Primary Care Provider (PCP): Admitting patient interview script revised to capture PCP information Admitting verification of UCSF PCP with UCSF PCP/patient search tool Identifying Attending of Record: Protocol and policy in place for Attending of Record identification at point of entry (Admitting) and updates during hospitalization (unit-level) Staff education and awareness completed Acknowledgements: Julie Cantu, Cindi Drew, Adrienne Green, Charles Green, Traci Hoiting, Brigid Ide, Randy Jones, Julie Koppel, Joyce Larson, Jeff Love, Melanie Mata, Rita Mistry, Miguel Rodriguez, Diane Sliwka, Ning Tang, Miriam Gonzalez-White
Requisition Forms: Provider Identification Lab, Radiology and Pathology Requisition Forms revised and in use: All 3 forms request same information: Ordering provider & status Attending MD Copy to: with provider # Notification of forms change and requirements provided to all staff Training for clinic staff utilization of new forms and requirements Monitoring intake sites (Laboratory, Radiology, Pathology) re: compliance with properly completing forms
e-discharge Summary e-discharge goals: Reliable identification of all tests pending at discharge Identification of studies that require further action after discharge Triage of these tests & studies to the appropriate providers using the electronic d/c summary as well as other more broadly applicable communication methods e-discharge Rollout Progress by Service Service Progress Roll Out Date Medicine (Parnassus, teaching & nonteaching) October 1, 2010 Medicine (MZ, non-teaching) November 15, 2010 Cardiology by March 2011 CHF by March 2011 Acknowledgements: Michelle Mourad, MD and Russ Cucina, MD
Relay Center The Joint Commission (TJC) Best Practice: concept of a centralized Medical Center Relay Center has been identified as a best practice by TJC. It empowers a Medical Center to serve as a centralized recipient of certain test values/ interpretations that require reliable and accelerated notification systems. The Relay Center will have responsibility for relaying of defined sub-critical test results/interpretations to providers and/or patients. These results would include those tests that are pending at discharge and sub-critical test results as identified by the electronic routing system. The Relay Center will not have responsibility for communication of Critical results; responsibility for communication of critical results will remain with the testing location. A centralized Relay Center has been developed (opened March 2011) for tracking and communicating test results for inpatients, Emergency Department patients and outpatients. It has been staffed with 2 FTE s
Relay Center (TJC Best Practice)
Relay Center Overview Presented to Task Force on Test Results September 1, 2011 to November 30, 2011
Total Subcriticals
Ordering, Primary & Ordering Contacted, No Primary Contacted *Note: Ten patients deceased.
No Primary Contacted
Call Turnover
Outpatient v. Inpatient at Date of Service
UCSF PCP vs. Non-UCSF PCP 1200 1000 1159 800 600 400 413 746 Total PCP Contacted UCSF PCP Non-UCSF PCP 200 0
Services w/ Greatest Number of Subcritical Results: General Internal Medicine Gastroenterology Medical Oncology Thoracic Surgery Spine Orthopaedic Surgery Kidney/Liver Transplant Positive Care Center/Infectious Disease Urology/Urologic Oncology Emergency Department
Next Steps: Relay Center Continuing refining scope Reporting system demonstration project Reporting on Metrics Relay Center and APeX
Moving Forward In-Basket Policy For Test Results Will create: Clarity for test result routing, communication and follow up. Options for work flow (limited number of options), but consistency of process within a particular clinical setting will be required Clarity as to accountability for test results Clarity on resident vs. attending vs. staff management of test results Expectations for frequency of reviewing in-basket and outside limit of when patients should be informed NOTE: In-Basket Policy development Will be monitored by Task Force and Ambulatory Operations Group
EHR In-Basket Policy UCSF implemented Epic in outpatient and inpatient setting Policy provides guidelines for management of In-Basket the location to which ordered test results will be sent Basic rules Providers must check in-basket each business day Owner is ultimately responsible for responding to messages Messages may be managed by pools Administrative staff will track compliance It is a work-in-progress 29
Moving Forward Monitor Electronic Health Record for how the in-basket works Monitor Relay Center activity for redundancy