Update on the Maryland Patient Safety Program

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1 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 Fifth Annual Maryland Patient Safety Conference April 2, 2009 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

2 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

3 Mandatory Reporting of Adverse Events 1 Limited mandatory reporting Regulations effective 3/15/04 First Five Years 767 Level 1Adverse Events reported. Of the 1653 hospital complaints received from patients/families, only 18 duplicated any of the 767 Level 1 Adverse Events reported by hospitals. 2% of the Level 1 Adverse events were also reported to OHCQ as a complaint. 3

4 Which Hospitals Reported 62 of 69 hospitals (90 %) have reported at least one Level 1 adverse event since 3/15/2004. All hospitals with more than 100 beds have reported more than 1Level 1 Adverse Event. Acute care hospitals reported 701of the 767 Level 1 Adverse Events (91%). Special hospitals (chronic, children s, rehabilitation) reported 25 Level 1 events (3%). Psychiatric Hospitals reported 41 Level 1 adverse events ( 5%). Total Level 1 Adverse Event by Hospital Type Hospital Type Total No. of Hospitals No. of Hospitals Reporting No. of Level 1 Events Acute General (96%) 701 Special Hospital - Psychiatric Special Hospital Other (85%) (67%) 25 TOTALS (90%) 767 4

5 Level 1 Adverse Events 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 beds beds Less than 100 beds TOTAL Adverse Event Reports by Hospital Size and Type Acute Hospitals >300 beds Acute Hospitals beds Acute Hospitals Beds Acute Hospitals < 100 Beds No. of Hospitals No. of Adverse Events Median No. of Reports Psychiatric Hospitals Other Hospitals

6 Reporting 15 hospitals have each reported more than 20 Level 1 Adverse Events over the 5 years or more than 4 events a year. 11 acute care hospitals reported less than 10 events, less than 2 per year. There appears to be few differences in the number and types of reported events for acute care hospitals with greater than 250 beds. 6

7 Factors That Affect Reporting Commitment by the hospital leadership and the patient safety director clearly plays a role. Personnel changes appear to have an impact on reporting. Hospital s internal reporting systems appear to be more problematic than the fear of reporting. Patient /Family Notification Hospitals have improved in providing notice to patients and/or families o FY 05 37% o FY 06 89% o FY 07-94% o FY 08 91% We cannot comment on the quality of this notification to patients/families, but disclosure is mandatory. 7

8 Observations Few hospitals report events to The Joint Commission. Hospitals are more likely to report suicides to TJC than other events. A significant number of events occur during procedures considered routine or less risky laparoscopic cholecystectomies, D&C, colonoscopies, vaginal hysterectomies. Location of Adverse Events Location of Events Number of Events Medical Surgical Units 258 Surgical Suites 76 Emergency Departments 64 Psychiatric Units 54 Intensive Care Units 53 Labor & Delivery 37 Radiology (including interventional) 21 Rehabilitation 8 Pediatrics 6 8

9 Top 10 Reported Events Falls 281 Delay in treatment 76 Airway management 48 Suicide attempt/ suicide 40 Medication Error 38 Fetal Demise or Injury 27 Misdiagnosis 26 Unanticipated Complication 24 Other 20 Malfunctioning devices 19 Top 10 Reported Events-FY2008 Falls 82 Delay in Treatment 20 Suicide or Attempt 11 Fetal Injury or death 9 Medication Error 8 Airway management 7 Other 5 Death/Disability Related to Health Care Acquired Infection Surgical Procedure Not Consistent with Consent 4 Malfunctioning Devices 4 5 9

10 Adverse Event Outcomes: FY 06, FY 07 & FY 08 Death Loss of Function Loss of Limb/Organ Surgery Increased Rehab LOS Transfer to higher level of care Deaths Attributed to the Top Reported Events FY08 Adverse Event Category # of Deaths # of Events Falls Delay in Treatment Suicides and attempted suicides Fetal Injury or death 5 9 Medication Error 3 8 Airway management 3 7 HAI 4 5 Malfunctioning Devices 3 4 Wrong patient/ Wrong body part

11 FY Level 1 events reported. Falls continue to account for 45% of the reports 78 fatalities at time of report, or 43% Fewer incidents related to anti- coagulation Significant increase in suicides o FY 07 4 o FY Root Cause Analysis 11

12 Case No. 1 Elderly patient (>90) who had an outpatient lap cholecystectomy arrested in the parking lot upon discharge. Patient had had a severe hypotensive episode four days prior after an invasive diagnostic test done under GA and had the RRT called. RCA focused on RN s decision to discharge patient (patient technically met criteria even though he had had another hypotensive episode in the PACU) and on the staff functioning during the code. RCA did not address appropriateness of patient criteria for outpatient surgery. Also did not address who is in charge of patients in PACU the surgeon or the anesthesiologist. Case No. 2 A confused patient on the Telemetry unit was taken for an MRI. The EKG leads were left on. The patient was prone and the noise from the machine covered up his cries of pain. The tech repositioned the patient at one point due to his restlessness and did not notice the leads. The patient suffered 2 nd & 3 rd degree burns on his chest. RCA did not identify any root causes. Action items consisted of a plan to transfer all patients needing MRIs to another hospital for testing. RCA did not address the preparation of patients (that will continue to be a problem even if they go to another hospital), the violations of policy, or the fact that the MRI suite was not on the list for routine environmental safety rounds. 12

13 Case No. 3 A 44 y/o male patient drove to the ED & got out of his car screaming that he was in pain. He was very agitated in the waiting room-refusing triage & registration- just wanted to see a MD. The RN was able to get his VS which were within normal limits except a higher than normal heart rate. He struck the RN. Security came & he was taken for an EKG in the treatment area but he continued to act out. Security told him to calm down or leave. The police were there on another matter & got involved taking him out. The next day EMS came in with another patient & informed staff that the man had been found dead the previous evening. He stabbed himself in the chest. It turned out he had an idiosyncratic response to an antibiotic prescribed in the community. RCA focused on the EMTALA aspects of this case, which was appropriate, but missed the opportunity to train staff in managing disruptive & violent behavior in the ED. No outcomes were listed. Case No. 4 Male smoker with CHF & obesity came to ED with a hernia. The surgical PA decided to manually reduce hernia under moderate sedation. Didn t clear it with delegating surgeon or with ED attending. Also, did not tell patient's RN & did not stay with patient after procedure. Wasn t privileged to use mod sedation. The patient was given 2 mg Dilaudid & 2 mg Versed IV. Patient did not wake up well and was very diaphoretic with high B/P within 15 minutes of end of procedure. Denied chest pain but EKG showed AMI. Taken to cath lab, but continued to deteriorate & could not be resuscitated. RCA did not explore why PA went so far beyond his practice agreement, why so many policies were not followed, why communication between the nurses was so poor, or whether the apparent lack of supervision had any bearing on the outcome of this case. Hospital planned to privilege all of the PAs to perform conscious sedation. Will this action really prevent a similar occurrence? 13

14 Case No. 5 Elderly female patient with complex CV history, admitted for stenting of descending thoracic aortic aneurysm. Spent overnight in ICU, then transferred to MS floor. The patient had several episodes of hypotension and was in a lot of pain. PA and staff thought she was hypotensive from antihypertensives. No neurovascular assessment was done. Patient managed by PAs overnight, no MD was notified about the change in condition. By the next morning, the patient was a paraplegic. RCA focused narrowly on vascular patients without addressing the larger issues of PA supervision and back-up, chain of command, authority gradients, threshold for calling RRT and nursing supervision. Only proximate causes were identified. Special Mention OHCQ has received 3 reports of vascular damage leading to amputation associated with the use of IV promethazine (Phenergan) Promethazine is formulated in phenol and has an acidic ph of 4 to 5.5. Very caustic to vascular intima and surrounding tissues. No effective reversal or treatment for extravasation. ISMP recommends eliminating IV route. Safer administration includes diluting and slow infusion through large vein, never in hand or forearm veins. Immediately stop infusion if patient complains of any pain or burning. See Clinical Alerts at: regulated_programs/h_alerts.htm?id=1 14

15 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 outcomes of implemented action items. 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. Failure to get administrative or executive-level buy-in on corrective actions. Action Items and Outcomes Still the worst part of RCAs. Frequently superficial and of limited scope. Training and policy revision remain very popular despite limited effectiveness. Action items may need to be developed by a group other than the RCA team. Any action item can be made stronger with frequent random monitoring. For outcomes: Determine what you hope to accomplish with the action item and how to get there. What specific staff behaviors do you expect? How will you monitor for compliance? Have you done any long-term analysis of past RCAs to determine percentage of action items implemented and the success or failure of those interventions? 15

16 RCA Better Practices Every hour rounding on patients with RNs on even hours and CNAs on odd hours. Pop-up message in E-MAR that prompts nurse to implement fall precautions when a sleeping pill is given. Changed diuretic administration schedule from 9-9 to 9-5. Automatic post-op x-ray ordered when lap procedure converted to open. Removing all paralytics from Pyxis or floor stock. Only made available in separate emergency intubation box. Are Maryland Hospitals Safer? Maybe Yes Maybe No 10/15 fatal surgical events in 2008, 4/11 so far in FY09 3/4 fatal events associated with anticoagulation in 2008, zero so far in /7 fatal HAIs in 2008, 3/5 in FY09 6/9 fatal med errors reported in 2007, 3/8 in 2008, and 1/1 so far in /22 fatal delays in treatment in in 2007, 17/20 in 2008, and 6/10 so far in FY09 7/9 maternal/child deaths associated with the birth process in 2008, 4/4 so far in FY09 4/5 successful suicides in 2007, 10/11 in 2008, and 7/7 so in FY09 16

17 What we have learned Underreported events (based on other state s experience) o Level 3 /4 Hospital Acquired Pressure Sores o HAI o Medication Errors o Falls Future Plans More onsite patient safety reviews Data collection/review Follow up on certain adverse event reports Hospital specific reviews More Clinical Alerts and information sharing. Work with the Maryland Patient Safety Center to develop collaboratives and best practices. 17

18 Future Plans Hospitals that submit RCAs that do not comply with may be cited with deficiencies. Hospitals may receive deficiencies or fines for having an ineffective patient safety program. (Department may fine up to $500/day for failure to report). Contact Information Hospitals/ Patient Safety: (410) Website: Wendy Kronmiller Renee Webster Anne Jones 18

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