Update on the Maryland Patient Safety Program Department of Heath and Mental Hygiene Wendy Kronmiller, Director Renee Webster, Assistant Director Anne Jones RN, Nurse Surveyor Third Annual Maryland Patient Safety Conference March 23, 2007 Mission of (OHCQ) Protect Maryland s Citizens through Regulation and Enforcement Develop Standards for Providers Educate Providers and Consumers Respond to the Public Improve Quality 1
What OHCQ Does The OHCQ is the agency within the Department of Health and Mental Hygiene charged with monitoring the quality of care in Maryland s 8,000 health care and community residential programs. The OHCQ licenses and certifies the state s health care facilities. The OHCQ uses state and federal regulations, which set forth minimum standards for provision of care and conducts surveys to determine compliance. The OHCQ also educates providers, consumers, and other stakeholders through written materials, presentations, its Web site and at conferences and seminars. Reporting Requirements Office of Health Care Quality Mandatory Level 1 Adverse Events Events that caused death or serious disability (lasting >7days or present at discharge) MD. Patient Safety Center Voluntary Any and all events including near misses 2
Mandatory Reporting of Adverse Events 1 1 No mandatory reporting 2 2 Limited mandatory reporting Regulations effective 3/1/04 From March 1, 2004 to March 1, 2007 48 Adverse Events reported. After further review, 413 were determined to be Level 1 Adverse Events Of the 991 hospital complaints received from patients/families, only duplicated Level 1 Adverse Events reported by hospitals. Additional events were also identified through complaint investigation and survey activities conducted by OHCQ 3
Which Hospitals Reported in FY 2006 47 of 69 hospitals have reported a Level 1 event. (A total of 6 hospitals have reported) 28 of the 29 hospitals with >200 beds. Acute care hospitals reported 133 adverse events (90%). Special hospitals (chronic, children s, rehabilitation, psychiatric) reported 1 Level 1 events (10%). Special Hospitals are usually smaller & perform fewer invasive procedures. Total Level 1 Adverse Event by Hospital Type Hospital Type Total Number of Hospitals Number of Hospitals Reporting Number of Level 1 Events Acute General 47 38 133 Special Hospital - Psychiatric 13 8 Special Hospital Other 9 4 7 TOTALS 69 47 148 4
Total Level 1 Based on Hospital Capacity Hospital Size Number of Licensed Beds Number of Hospitals Number of Hospitals Reporting Number of Level 1 Adverse Events 300 or more beds 12 12 47 200 300 beds 17 16 6 100 200 beds 19 14 36 Less than 100 beds 21 9 TOTAL 69 47 148 Observations Hospital staff are becoming more comfortable determining what is reportable. Reporting rates continue to increase. o FY 2006 - Reporting has increased 16%, with 68% of hospitals reporting at least 1 event. Hospitals have improved significantly in providing notice to patients and/or families o FY 200 37% o FY 2006 89%
Observations (Continued) While inter-hospital comparability is difficult, licensed bed capacity increases frequency of reported events. Patients in acute care hospitals are more likely to incur Level 1 adverse events than patients in specialty hospitals, but the events are just as likely to be fatal in either setting. A significant number of events occur during procedures considered routine or less risky. Top 9 Location of Adverse Events Location of Events Medical Surgical Units Emergency Departments Operating Rooms Intensive Care Units Psychiatric Units Labor & Delivery Radiology (including interventional) Pediatrics Outpatient Number of Events 4 19 18 13 10 9 7 3 2 6
Top 10 Reported Events Falls Delay in treatment Airway management Medication Error Misdiagnosis Suicide attempt/ suicide Unanticipated complication Vascular Access Device Unanticipated Intra-op or post- op death Fetal Demise or Injury 126 46 40 33 28 26 22 17 16 14 Top 10 Reported Events-FY2006 Falls Airway management Suicide/Attempted Suicide Unanticipated complication of treatment Delay in Treatment Medication Error Other Fetal Injury or death Intra op or Immediately Post Op Death Misdiagnosis 46 18 11 9 8 8 7 6 7
Adverse Event Outcomes: FY 200 & FY 2006 Cumulative Death Attributed to the Top Reported Events FY2006 Adverse Event Category Falls Airway management Suicide/Attempted Suicide Unanticipated Complication of Tx Delay in Treatment Medication Error Fetal Injury or death Intra op/immediately Post Op Death Misdiagnosis # of Deaths 11 16 7 6 9 6 2 # of Events 46 18 11 9 9 8 6 8
How Does OHCQ Review RCAs Nurse surveyor uses OHCQ evaluation tool to review the event. Patient Safety team (Medical Director, chief nurse, nurse surveyor, Assistant Director) meet to review RCAs. Based on review, team/nurse will identify additional information or clarification needed to complete the review. Conference calls, meetings, telephone calls and letters. Problems with RCAs Failure to identify root causes. Failure to develop action plans to correct human factors and other system problems. Failure to develop quantifiable measures to monitor implementation of the action plans. Failure to establish reasonable times frames to correct systems problems. Failure to measure outcomes rather than processes. Failure to move beyond a Blame & Shame mentality. 9
Plans of Action Identified in Root Cause Analysis Proposed Action Change In P/P Formal education Disciplinary actions Process Improvement Equipment Modifications Environmental Changes Workload/Staff Changes Data Tracking/Trending Peer Review 3/1/04 to 6/30/0 79% 79% 4% 10% 31% 11% 18% 36% 12% FY 2006 71% 70% 2% 42% 27% 9% 31% 42% 14% Onsite Patient Safety Program Reviews Problems noted in each survey. Unreported Level 1 Adverse Events have been noted on most of the surveys Deficiencies were cited and the hospitals submitted Plans of Corrections. Surveys have provided an opportunity for hospitals to work with OHCQ staff to resolve compliance problems. 10
Patient Safety Aids Short RCA form for investigating Falls. Elective form can be used for falls in lieu of convening a full RCA team. Change In Classification form. Standardized questions OHCQ staff would like answered when a facility has found that previously reported event is not a Level 1 Adverse Event. Patient Event Decision Tree Are Md Hospitals Safer? Maybe Yes 4 falls with 3 deaths in 2006, 39 falls with 13 deaths in 200 1 maternal death in 200, 1 maternal injury in 2006 4 fetal/neonatal deaths in 200 with 2 injuries, 2 deaths and 1 injury in 2006 8 suicides and 3 serious injuries in 200, 7 suicides in 2006 1 airway deaths in 200, 11 in 2006 Maybe No 1 death associated with alarms in 200; 8 in 2006 2 deaths with vascular access in 200, 4 in 2006 1 death associated with failure to act in 200, in 2006 1 wrong site/wrong patient surgery in 200, in 2006 3 retained foreign bodies in 200, 4 in 2006 11
Nosocomial Infections Two patients developed necrotizing fasciitis following planned C-sections. One patient developed sepsis when tube feeding was given through abdominal drain instead of G-tube. Three other patients became septic after PEG tubes were replaced and tube feedings started but placement had not been verified with contrast x-ray. Death or serious disability related to a nosocomial infection will be added to the event classification for 2007. Alarms OHCQ released an e-mail blast about alarm events. A patient arrested and the RN did not hear the alarm because she was in the med room. Other deaf spots on the unit were found. Patient taken off tele for radiology. When he was brought back to room, transporter did not put patient back on tele or tell anyone patient was in room. The SpO2 alarm indicated SpO2 was zero. Four staff evaluated patient. Three of them thought they felt a pulse. No one called 911 or got the AED for more than 1 minutes. A RN turned off the dysrthymia alarm on a patient who had a pacemaker, not realizing that this action turned off all the alarms. Patient went from V-tach to V-fib to asystole without any one noticing. A patient with an AICD arrested and died. His AICD continued to fire at 60 BPM so the asystole alarm did not sound. 12
Maternal/Child 39 week, Spanish-speaking patient arrived for scheduled induction for protienuria. Despite pleas from husband, no one assessed her for hours to determine that she was actually in labor. FHR was 70. Had emergency C-section, infant with poor Apgars and prolonged NICU stay. Another Spanish-speaking patient who was pregnant went to her OB-GYN for vaginal bleeding. She was prescribed an abortifacient suppository for some reason. She then went to the ED, because she was concerned and did not want to abort. After confirming the pregnancy with U/S, the ED MD at the hospital told her to go ahead and take the drug. Other Patient on telemetry unit arrested and died in a locked bathroom because no one knew where the key was located. Five cases of wrong site/wrong patient surgeries reported in 2006. Four cases of retained foreign body. Cardiac surgeon wanted to take patient to cath lab on a Friday evening, even though anesthesia was not available and patient was known to have a difficult airway. Procedure required more sedation than anticipated. Patient had respiratory distress, could not be intubated, and died. RN transported patient from ED to ICU with Levophed and Dopamine off pump. Patient arrested on arrival to ICU. 13
Lesson Shared Abdominal feeding tubes: Do not rely on auscultation to verify placement. The standard of practice is to do an x-ray with contrast. Do your bathroom doors lock? If so, are the keys readily identifiable and accessible? Falls: Giving diuretics and laxatives in the evening increases the chances of a fall in the middle of the night. Do ancillary departments understand fall precautions? Alarms: Make sure staff are aware of all features of the monitor and know which alarms are safe to silence. Consider having your engineering people disable some features. Ensure alarm volumes are loud enough to hear. What we have learned In FY 2006, of 7 Level 1 Adverse Events classified as Other were determined to be hospital acquired infections (HAI). In FY 2007, HAI will be added to the Level 1 Adverse Event Classifications compiled by OHCQ. Underreported events (based on other state s experience) o Level 3 /4 Hospital Acquired Pressure Sores o HAI o Medication Errors o Falls 14
Continued Challenges Faced By OHCQ Patient Safety Program Continuing to refine the system and timeliness of Event and RCA review. Data Collection/Review. Staffing Future Plans More Onsite surveys of Patient Safety Programs. When appropriate, hospitals that submit RCAs that do not comply with 10.07.06 may be cited with deficiencies. Hospitals may receive deficiencies or fines for failing to report a Level 1 Adverse Event. (Department may fine up to $00/day for failure to report). 1
Future Plans Analysis of data for repeated similar events. More Clinical Alerts and information sharing. Interface Patient Safety Program with other DHMH Public Health Programs. 16
Contact Information Hospitals/ Patient Safety: (410)402-8016 Website: www.dhmh.state.md.us/ohcq/ Email: Wendy Kronmiller wendykronmiller@dhmh.state.md.us Renee Webster rwebster@dhmh.state.md.us Anne Jones ajones@dhmh.state.md.us 17