Office of Health Care Quality Assessment · 3 This summary report presents the findings from serious preventable adverse events reported to the Department’s Office of Health Care

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Office of Health Care Quality AssessmentReport Preparation Team

Cynthia M. Kirchner, MPH, Director, Quality Improvement

Emmanuel Noggoh, Director, Health Care Quality Assessment

Mary Noble, MD, MPH, Clinical Director,

Patient Safety Reporting System

Sara Day, RN, BSN, CSM, Supervising Health Care Evaluator


Debra Virgilio, RN, MPH, Research Scientist

Health Care Quality Assessment

Debra Morgan, Software Development Specialist

Office of Information Technology

Abate Mammo, PhD, Program Manager

Health Care Quality Assessment

Adan Olmeda, Administrative Support


Jan Applebaum, Graphic Design

For further information contact:Patient Safety Reporting SystemOffice of Policy and Strategic PlanningHealth Care Quality AssessmentNew Jersey Department of HealthPO Box 360Trenton, NJ 08625-0360Phone: (800) 418-1397Fax: (609) 984-7707Website: www.NJ.gov/health/ps

2010 Summary Report

ii

iii

Lists of Tables and Figures ..............................iv

Executive Summary ..........................................1

I. Introduction..............................................3

II. Overall Reporting Patterns by Facility Type..............................................4

III. General Acute Care Hospitals ..................5

A. Reportable and Not Reportable Events by Year ...................................5

B. Reporting Patterns (2005-2010) ........7

C. Reportable Events and Associated Deaths by Event Category .................9

D. Event Types Associated with Highest Percent Deaths ...................121. Intraoperative or Postoperative

Coma, Death or Other Serious Preventable Adverse Event........13

2. Care Management “Other” Events ........................................13

3. Fall Events .................................144. Surgery “Other” Events.............165. Suicide/Attempted Suicide

Events ........................................16

E. Most Frequently Reported Event Types ................................................171. Pressure Ulcers..........................182. Retained Foreign Objects (RFOs)...19

F. Major Root Causes for All Events ..............................................20

G. Contributing Factors to All Events ........................................21

H. Impact of All Events on Patients .....22

IV. Overall Reporting Patterns for Specialty Hospitals: ...............................................23A. Comprehensive Rehabilitation

Hospitals ..........................................241. Root Causes for All Events........242. Contributing Factors to All

Events ........................................253. Impact of All Events ..................26

B. Psychiatric Hospitals........................271. Root Causes for All Events........272. Contributing Factors to All

Events ........................................283. Impact of All Events ..............….29

C. Special Hospitals .............................301. Root Causes for All Events........302. Contributing Factors to All

Events ........................................313. Impact of All Events ..................32

V. Ambulatory Surgery Centers..................33A. Root Causes for All Events ..............34B. Contributing Factors to All

Events ..............................................35C. Impact of All Events ........................35

VI. Division of Mental Health and Addiction Services ................................................36A. Implementation ................................36B. Overall Reporting Patterns...............36C. Focus on Specific Events .................36

Appendix 1: Classification of SeriousReportable Adverse Events ....................38

Appendix 2: Required Components of aRoot Cause Analysis...............................41

Patient Safety Reporting System (PSRS)Contact Information...............................42

* Most frequently reported events include falls, pressureulcers, retained foreign objects and care management“other” events. Falls and care management “other”events have been reviewed in the section “SpecificEvents with the Highest Number of Associated Deaths.”

Table of Contents

iv

List of Tables

Table 1: Reporting Pattern by FacilityType...................………………4

Table 2: General Acute Care Hospitals: Reportable and Not Reportable Events by Year ................................5

Table 3: General Acute Care Hospitals: Reporting Patterns (2005-2010) .....7

Table 4: General Acute Care Hospitals: Reports Based on Hospital Maintained Beds .............................8

Table 5: General Acute Care Hospitals: Reportable Events and Associated Deaths by Event Category .............9

Table 6: General Acute Care Hospitals: Event Types Associated with Highest Percent Deaths ................12

Table 7: General Acute Care Hospitals:Most Frequently Reported Event Types ............................................17

Table 8: General Acute Care Hospitals: Major Root Causes for All Events ...........................................20

Table 9: General Acute Care Hospitals: Contributing Factors to All Events ...........................................21

Table 10: General Acute Care Hospitals: Impact of All Events on Patients.........................................22

Table 11: Specialty Hospitals: Overall Reporting Pattern .........................23

Table 12: Comprehensive Rehabilitation Hospitals: Contributing Factors to All Events .................................25

Table 13: Psychiatric Hospitals: Contributing Factors to All Events ....................28

Table 14: Special Hospitals: Contributing Factors to All Events ....................31

Table 15: Ambulatory Surgery Centers:Reportable and Not Reportable Events by Year ..............................33

Table 16: Ambulatory Surgery Centers:Events Reported ...........................33

Table 17: Ambulatory Surgery Centers: Contributing Factors to All Events ...........................................35

List of Figures

Figure 1: General Acute Care Hospitals: Trends in Reportable and Not Reportable Events...........................6

Figure 2: General Acute Care Hospitals:Distribution of Surgery-Related Events ...........................................10

Figure 3: General Acute Care Hospitals:Location of Surgery-Related Events ...........................................11

Figure 4: General Acute Care Hospitals:Percent of Total Falls by Age Group............................................14

Figure 5: General Acute Care Hospitals:Percent of Total Falls by Location ........................................15

Figure 6: General Acute Care Hospitals:Pressure Ulcers by Age Group......18

Figure 7: General Acute Care Hospitals:Location of Pressure Ulcer Events ...........................................19

Figure 8: Comprehensive Rehabilitation Hospitals: Root Causes for All Events ...........................................24

Figure 9: Comprehensive Rehabilitation Hospitals: Impact of All Events ...........................................26

Figure 10: Psychiatric Hospitals: Root Causes for All Events ...................27

Figure 11: Psychiatric Hospitals: Impact of All Events .................................29

Figure 12: Special Hospitals: Root Causes for All Events................................30

Figure 13: Special Hospitals: Impact of All Events......................................32

Figure 14: Ambulatory Surgery Centers: Root Causes for All Events ...........................................34

Figure 15: Ambulatory Surgery Centers:Impact of All Events .....................35

Tables and Figures

1

The New Jersey Patient Safety Act(P.L.2004, c.9) requires all New Jerseylicensed health care facilities report

every serious preventable adverse event tothe Department of Health (DOH) for thepurpose of enhancing patient safety. Facilitiesmust perform a Root Cause Analysis (RCA) toidentify the systems issues which led to theevent and to implement strategies to preventfuture events.

The following types of facilities currentlyreport to the Patient Safety ReportingSystem:v General acute care hospitals beganreporting February 1, 2005;

v Comprehensive rehabilitation hospitalsbegan reporting April 1, 2008;

v Psychiatric hospitals began reportingApril 1, 2008;

v Special Hospitals began reporting April 1,2008;

v Licensed ambulatory surgery centersbegan reporting October 1, 2008.

The following facility type reports to theDepartment of Human Services, Division ofMental Health and Addiction Services:v State psychiatric hospitals beganreporting August 2008.

Summary of reported adverse eventsfor all facility types in 2010:v 797 events were reported to the PatientSafety Reporting System by all facilitytypes;

v 694 events were determined to bereportable adverse events;

v 103 deaths were associated with theadverse events.

General Acute Care Hospitals:v Submitted 562 reportable adverse eventsin 2010 which was a 23.5 percent increasein the number of reports compared to2009;

v The average number of reportable eventsper reporting hospital was 7.9; theaverage number of reportable eventstended to increase with hospital size;

v There were 85 deaths associated with theadverse events; specific events with thehighest percent of associated deaths wereintraoperative or Postoperative coma,death, or other serious preventableadverse events, care management “other”events, fall events and surgery “other”events;

v The most frequently reported events werefalls, pressure ulcers, retained foreignobjects, and care management “other”events;

v Adverse events were most often causedby care planning process, communicationamong staff and/or with thepatient/family, orientation and training ofstaff and supervision, and physicalassessment process; 62 RCAs did notidentify a systems root cause for theevent;

v The most frequent consequences of theevents were additional laboratory testingor diagnostic imaging, additional patientmonitoring in current location, surgery,and increased length of stay.

Comprehensive RehabilitationHospitals:v There were 38 reportable events and 8deaths associated with care management“other” events, falls, and one medicationerror;

v The most frequently reported root causeswere communication among staff and/orwith the patient/family and care planningprocess;

Executive Summary

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v Approximately 50 percent of patients hada visit to an emergency department, wereadmitted to the hospital, and /ortransferred to a more intensive level ofcare.

Psychiatric Hospitals:v There were 14 reportable events and 2deaths associated with care management“other” events;

v The most frequently reported root causewas communication among staff and/orwith the patient/family;

v Eight patients had a visit to anemergency department and/or weretransferred to a more intensive level ofcare.

Special Hospitals:v Six reportable events were submittedwith no associated deaths;

v The most frequently reported root causeswere communication among staff and/orwith the patient/family, care planningprocess and availability of information;

v Impact of the events included additionalpatient monitoring in current location,additional laboratory testing or diagnosticimaging, visit to an emergencydepartment, and disability-physical ormental impairment.

Ambulatory Surgery Centers:v Submitted 74 reportable events with 8deaths associated with intraoperative orPostoperative coma, death or otherserious preventable events and surgery“other” events;

v The most frequent root causes were careplanning process, physical assessmentprocess, and communication among staffand/or with the patient/family;

v Of the 74 reported events, approximately67 percent of the patients were admittedto hospitals; other frequently reportedimpacts were additional laboratory testingor diagnostic imaging and visit to anemergency department.

Division of Mental Health andAddiction Services:v Overall there were 14 reportable eventscomprising seven falls, six attemptedsuicides and one medication error;

v There were no associated deaths resultingfrom these events.

Executive Summary

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This summary report presents thefindings from serious preventableadverse events reported to the

Department’s Office of Health Care QualityAssessment (HCQA), Patient Safety ReportingSystem (PSRS). PSRS staff reviewed andanalyzed the data from event and Root CauseAnalysis (RCA) reports submitted fromJanuary 1, 2010 through December 31, 2010.

This report also includes the findings ofreportable events from the Division of MentalHealth and Addiction Services (DMHAS)which is separately reported in section VI ofthis document.

Health care facilities are required to reportserious preventable adverse events andperform a root cause analysis (RCA) for eachreportable event. The classification anddefinitions of serious preventable events can befound in Appendix I.

The RCA process requires the facility toprovide a description of the event; determinethe causes; write a corrective plan; andmonitor the corrective plan of action. SeeAppendix 2 for the complete requiredcomponents of an RCA.

Each RCA is reviewed by PSRS or DMHASprofessional clinical staff to ensure that thefacility performed a thorough and crediblereview of the adverse event. PSRS andDMHAS staff work with facilities to improvetheir analysis and the corrective actionsdesigned to minimize the recurrence of events.

This report is one component of theDepartment’s commitment to supportingquality through collecting and analyzinginformation on health care and making thisinformation available for consumers andhealth care providers.

I. Introduction

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This annual report summarizes the 2010Patient Safety Reporting System(PSRS) reportable events and RCAs

with a focus on events with a high percentageof associated deaths and the most frequentlyreported events. The report covers events andRCAs submitted by general acute carehospitals, specialty hospitals (comprehensiverehabilitation, psychiatric and specialhospitals), and ambulatory surgery centers. Italso provides an overview of all the years thePSRS has been in operation.

The number of reportable and not reportableevents submitted to the Patient SafetyReporting System for 2010 from all facilitieswas 797. The number of deaths was 103 or14.8 percent of the 694 reportable eventssubmitted.

Table 1 below shows the distribution of eventsreported to the New Jersey Department ofHealth, Patient Safety Reporting System byfacility types during 2010.

II. Overall Reporting Patterns by Facility Type

Table 1: Reporting Pattern by Facility Type

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A. Reportable and Not ReportableEvents by Year

Table 2 and Figure 1 demonstrate therelationship between reportable events andnot reportable events over the past six years.Not reportable events do not meet thestatutory definition of a serious preventableadverse event. These include events whichresult in less serious injury such as smallsuperficial lacerations and single rib fractureswith no significant impact on the patient.

With the exception of 2009 and 2010, notreportable events represent less than 10percent of the total events collected. Therewas a slight increase of not reportable eventsin 2009, to 12 percent of the total events, andto 11 percent in 2010. One of the reasons forthe increase in the absolute number of notreportable events is related to a change in the

process of event determination. Previously,any injury still present after seven days or atdischarge resulting from a fall was acceptedas a reportable event.

Beginning in 2009, consistent with theNational Quality Forum (NQF) and otherstates’ patient safety programs, only fallsresulting in serious injury and with asignificant impact on the patient are acceptedas reportable events. These may include, butare not limited to, death, long bone fractures,hip fractures, intracranial hemorrhage orinjuries that severely limit basic lifefunctions. Consistent with this change, lessserious injuries were determined to be notreportable. The change was initiated to focusroot cause analysis on events that have themost severe impact on patients. Table 2 andFigure 1 show the trend over the past sixyears.

III. General Acute Care Hospitals

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Table 2: General Acute Care Hospitals: Reportable and Not Reportable Events by Year

a: Represents 11 months of data since the program started on February 1, 2005

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Figure 1: General Acute Care Hospitals: Trends in Reportable and Not Reportable Events

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B. Reporting Patterns (2005-2010)

Since reporting began in February 2005, 2,832reportable adverse events have been submittedby New Jersey general acute care hospitals tothe Patient Safety Reporting System (PSRS) asof end of year 2010. In 2010, the sixth year ofreporting, 562 reportable events from generalacute care hospitals were submitted. Thefollowing describes the serious preventable

adverse events that occurred in general acutecare hospitals.

There was a 23.5 percent increase in thenumber of reports in 2010 compared with 2009(Table 3). In 2010, 71 of the 72 (98.6 %) generalacute care hospitals in New Jersey submittedreportable events. The average number ofreports per reporting hospital was 7.9 percent.This average does not take into accounthospital size and bed capacity.

Table 3: General Acute Care Hospitals: Reporting Patterns (2005-2010)

a: Represents 11 months of data since the program started on February 1, 2005


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Table 4: General Acute Care Hospitals:Reports Based on Hospital Maintained Beds

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Number of Hospitals Reporting

Number of Reports

Percent of Reports

Average Reported Per Bed

Size <=100 4 8 1.4 2.0 101-200 17 69 12.3 4.1 201-300 24 170 30.3 7.1 301-400 9 55 9.8 6.1 401-500 10 153 27.2 15.3 501+ 7 107 19.0 15.3 Total 72 562 100.0 7.9

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A review of reportable events by maintainedbed size groupings shows that one third ofNew Jersey’s general acute care hospitals arewithin the 201-300 range. The hospitals inthis bed size range accounted for 30.3 percentof all events reported in 2010. This group wasfollowed by the 10 hospitals in the 401-500 bedsize group which reported 153 events,

representing 27.2 percent of the totalreportable events in 2010. There were fivehospitals with less than 100 maintained bedseach but only four reported at least one event.As a group, these hospitals reported thefewest number of adverse events—8 in total or1.4 percent. The average number of reportableevents tends to increase with hospital size asshown in Table 4.


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Table 5: General Acute Care Hospitals: Reportable Events and Associated Deaths by Event Category

Event Category Total

Events

Percent of Total

Events

Total Death Events

Deaths per 100 Events

A: Care Management 156 27.8 28 17.9

B: Environmental 173 30.8 13 7.5

C: Product or Device 49 8.7 1 2.0

D: Surgery-Related 147 26.2 38 25.9

E: Patient Protection 37 6.6 5 13.5

Total 562 100.0 85 15.1

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C. Reportable Events and Associated Deaths by Event Category

As indicated earlier in the report, there were562 adverse events reported by New Jerseygeneral acute care hospitals in 2010 andaccepted by the PSRS. There were 85 deathsassociated with these adverse events. Theevents reported are classified into five eventcategories as follows:

v Care Managementv Environmentalv Product or Device-Relatedv Surgery-Relatedv Patient Protection

Environmental events were the mostfrequently reported events, such as falls.(Detailed analysis follows later in this report.)As a category, environmental eventsaccounted for 30.8 percent of total events and7.5 percent of the total deaths in 2010. Caremanagement events, such as medicationerrors, pressure ulcer events and caremanagement “other” events, accounted for27.8 percent of reportable events and 17.9percent of all deaths resulting from patientadverse events. The third highest category ofevents reported was surgery-related. As acategory, it accounted for 26.2 percent ofreportable events and 25.9 percent of alldeaths reported in 2010. Table 5 provides anoverview of reportable events in the eventcategories with associated deaths.


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Figure 2: General Acute Care Hospitals: Distribution of Surgery-Related Events

As Table 5 demonstrates, the surgery-relatedevent category had the highest number ofassociated deaths (38) and deaths per 100events (25.9).

In 2010, general acute care hospitals reported147 surgery-related events, which accountedfor 26.2 percent of total events reported (Table5). Retention of foreign object, intraoperativeor Postoperative coma, death or other seriouspreventable adverse events and surgery“other” events were the most frequentlyreported surgical events. These three eventtypes accounted for 23 percent of allreportable events submitted by general acute

care hospitals. There were 37 deathsassociated with the three event types,representing over 42 percent of all reportabledeaths across all facility types in 2010.

There were 39 intraoperative or Postoperativeevents with 25 associated deaths. Of the 20reported surgery “other” events, 11 resulted indeath (55%). There were 12 wrong body partevents reported in 2010, which resulted in fourdeaths. This represents a decrease of over 27percent of reported wrong body part eventscompared to 2009. Additionally, there were fourevents reported for wrong surgical procedureswith no associated deaths. There were no wrongpatient events reported in 2010.


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As would be expected, most of these surgery-related adverse events occurred in theoperating room. The remainder of the

surgery-related events occurred in theradiology department, emergencydepartment, or other location (Figure 3).

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Figure 3: General Acute Care Hospitals: Location of Surgery-Related Events


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D. Events Types Associated with Highest Percent Deaths

The table below shows the event types withthe highest percent of deaths. As shownbelow, the highest percent of deaths wasassociated with intraoperative orPostoperative coma, death or other seriouspreventable adverse events. Of the 39patients in this event type, 25 died, whichaccounted for 64.1 percent of the events in

this event type. The second highest eventtype was surgery “other” with 20 events and11 deaths (55%). Care management “other”was the third highest in terms of percent ofdeaths. There were 46 reportable events and21 deaths, representing 45.7 percent of thepatients in the care management “other”event type. Patient or resident suicide orattempted suicide accounted for 37 events and5 deaths. The percent of deaths in this eventtype was 13.5.

Table 6: General Acute Care Hospitals: Event Types Associated with Highest Percent Deaths

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Event Type

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Number of Deaths

Percent Deaths to Events

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20 11 55.0 Suicide/Attempted Suicide 37 5 13.5 All Other Event Types 254 11 4.3 Total 562 85 15.1


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1. Intraoperative or PostoperativeComa, Death or Other SeriousPreventable Adverse Event

Reports of intraoperative or postoperative(that is, within 24 hours) coma, death or otherserious preventable adverse event in anypatient of an ambulatory surgery facility, inany hospital same day surgery patient, or inany American Society of Anesthesiologists(ASA) Class I hospital patient were high in2010 compared to the previous years. Therewere 39 events from general acute carehospitals accepted by the PSRS in 2010,which accounted for 6.9 percent of totalevents. In 2009, there were 23 eventscompared to 11 events in 2008.

A major factor contributing to the increasednumber of reported events in 2010 relates to amore consistent classification of events in thiscategory. Part of the language in the abovenoted definition includes: ‘…intraoperativeor postoperative coma, death or other seriouspreventable adverse event…’ Additionaleducation was provided to facilities regardingthe need for consistency to include otherserious events in this event type in addition todeath and coma.

Of the 39 reportable intraoperative orpostoperative coma, deaths or other events in2010, there were 25 deaths, which represents29.4 percent of total deaths (85) in all eventtypes in 2010.

2. Care Management “Other” Events

Among care management events, the secondhighest number of reported event types wascare management “other.” Care management“other” events include care managementrelated events which do not meet thedefinition of the specific care managementevent types, such as medication errors andpressure ulcers. Events must meet thestatutory definition of a serious preventableadverse event.

Care management “other” events include, butare not limited to, delays in medical care,such as failure to order appropriate diagnosticstudies, failure to follow-up with the results ofthe studies, failure to communicate theresults, and failure to implement appropriatetreatment.

In addition, care management “other” eventsinclude failure to perform any of the abovetasks in a timely manner. For example, anelderly patient fell and hit her head. Theorder for the CT scan of the head was enteredinto the computer as a routine order and itwas scheduled for the following day. In theevening on the day of the fall, the patientbecame unresponsive. Following successfulresuscitation, a CT scan demonstrated a largeacute subdural hematoma. This would beconsidered a care management “other” event.

There were 46 care management “other”events reported out of a total of 156 in thecare management category. This represents29.5 percent. Twenty-one deaths wereassociated with the care management “other”event type, representing 24.7 percent of alldeaths in 2010.


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3. Fall Events

Falls continue to be the most frequentlyreported event submitted to the PatientSafety Reporting System. In 2010 there were166 fall events resulting in 12 deaths. Fallsaccounted for 29.5 percent of total eventsreported. Falls represented 96.0 percent of theenvironmental events (173).

Falls are more common in older patients,especially over age 60. A review of thereportable fall events resulting in seriousinjury submitted by general acute care

hospitals showed that 62 percent of thepatients were in the age group between 71and 90 years old. Specifically, 30.3 percent ofthe patients were in the 71-80 age groupswhile 32.1 percent were aged between 81 and90 years (Figure 4).

The overall death rate for falls was 14.1percent. As one might expect, fall relateddeaths appear to be associated with increasingage. Falls have a significant risk of death andfall prevention should be a high priority forgeneral acute care hospitals.

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Figure 4: General Acute Care Hospitals: Percent of Total Falls by Age Group


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Of the 166 reportable falls, the majorityoccurred in the patient’s room (76.5%), usuallywhen the patient was attempting to go to thebathroom (Figure 5). Other locations forpatient falls, although to a lesser extent, werehallways or other common areas (7.2%),

emergency departments (5.4 %) andICU/CCU/TCU (4.2%). The adverse eventusually occurred within the first 7 daysfollowing admission.

Figure 5: General Acute Care Hospitals: Percent of Total Falls by Location

Patient/Resident Room refers to nursing units not otherwise specified.

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4. Surgery “Other” Events

There were 147 surgery-related eventsreported in 2010. Of this total, there were 20events categorized as surgery “other.”Surgery “other” events include surgery-related events which do not meet thedefinition of the specific surgery event types,such as intraoperative or postoperative eventsand wrong body part events. As an example,surgical site infections which manifestthemselves more than 24 hours post-op andmeet the statutory definition of a seriouspreventable adverse event would fit into thisevent type. Also included would be seriouspost-op bleeding requiring intervention whichoccurs more than 24 hours following surgery.

This event type is the fourth most frequentlyreported event and represents 13.6 percent ofthe events in the surgery-related category.Eleven of the 20 events resulted in death(55%). These deaths represent 13 percent of alldeaths in 2010.

5. Suicide/Attempted Suicide Events

There were 37 reportable adverse events forthis event type and these represent 100% ofall Patient Protection events and 3.6 percentof all reportable events. There were 5completed suicides, which is 13.5 percent ofdeaths in all categories. Four of the deathsoccurred in the patients’ rooms. The otherdeath occurred offsite when the patient wasgranted a one day pass. The facility failed toprovide for appropriate oversight of thepatient during the offsite visit.


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E. Most Frequently ReportedEvent Types

Upon review of the specific event typessubmitted in 2010, falls, pressure ulcers,retained foreign objects, and caremanagement “other” events represent the

four most frequently reported event types inorder of frequency. Fall events and caremanagement “other” events have beendiscussed in detail in the “Specific Eventswith Highest Number of Associated Deaths”section.

Table 7: General Acute Care Hospitals: Most Frequently Reported Event Types

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Fall events

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Event Type

Number of Reported Events

Percent of Total Events

Falls 166 29.5 Pressure Ulcers 92 16.4 Retained Foreign Objects 72 12.8 Care Management Other 46 8.2 Intraoperative or Post-operative Coma, Death or Other Adverse Events

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Suicide/Attempted Suicide 37 6.6


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1. Pressure Ulcers

In 2010, there were 92 Stage III and IVpressure ulcers accepted as reportable by thePatient Safety Reporting System. Thisnumber represents 59 percent of all reportableevents in the category of care managementand accounted for 16.4 percent of totalreportable events submitted by New Jersey

general acute care hospitals. There were nodeaths attributable to pressure ulcer events.

As the chart below shows, most of the patientswho developed pressure ulcers were theelderly, between the ages of 61-90 years. Inaggregate, this age group accounted for 64cases and 70.0 percent of the total pressureulcer events (Figure 6).

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Figure 6: General Acute Care Hospitals: Pressure Ulcers by Age Group


19

2. Retained Foreign Objects (RFOs)

Retention of a foreign object in a patient aftersurgery was the third most frequentlyreported event type in 2010. There were 72reportable RFO events, representing 12.8percent of all general acute care hospitalevents. This is an increase from 2009 whenRFOs represented five percent of total events.

Examples of RFOs include sponges (includingvaginal sponges), instruments, needles, guidewires, and catheters. There was oneassociated death. This event type excludesobjects intentionally implanted as part of aplanned intervention, objects present prior tosurgery that were intentionally retained, andretained broken microneedles.

Figure 7: General Acute Care Hospitals: Location of Pressure Ulcer Events*

* Event locations are based on event reporting forms in use in 2010• Patient Resident/Room refers to nursing units not otherwise specified.

Most of the patients who developed pressureulcers while hospitalized were located in apatient/resident room (58 or 64%). Of the total

92 pressure ulcer events, 29 occurred inICU/CCU/TCU units. This represents 31.5percent of pressure ulcer events.


20

F. Major Root Causes for AllEvents

In 2010, the most frequent root causes ofadverse events reported to PSRS were careplanning process (46.4%), communicationamong staff and/or with the patient/family(44.8%), orientation and training of staff andsupervision of staff (31.9%) and physicalassessment process of the patient (26.5%).(Table 8)

In sixty-two RCAs, “Other” was identified as theroot cause. This option is available when thefacility does not identify one of the specific rootcauses (such as care planning process or patientobservation procedures). In effect, thisdesignation indicates that the facility identifiedno systems cause of the event. This represents8.2 percent of all general acute care hospital

reportable events. Forty-two events that had aroot cause of “other” were associated withdeath. This represents 67.7% of all events with aroot cause “other” and 49.4% of all deaths.

The 62 root cause “other” RCAs were submittedby 30 hospitals. One hospital submitted 7 RCAswith a root cause of “other” which included 5deaths. Ten hospitals each submitted 2 RCAswith the root cause “other.”

In a few of these RCAs, facilities furtherdefined the root cause of “other” as hand-offprocedures, availability of equipment, andmedication ordering. These root causes couldhave been classified as one or more of thespecific root causes, such as care planningprocess. Some RCAs identified the patient andthe patient’s clinical condition as the root causeof the event.

Table 8: General Acute Care Hospitals: Major Root Causes for All Eventsa

Root Cause Number of Events Percent of Events

Care Planning Process 261 46.4 Communication among Staff and/or Patient/ Family 252 44.8 Orientation and Training of Staff and Supervision of Staff 179 31.9

Physical Assessment Process 149 26.5

Patient Observation Procedures 108 19.2

Equipment Maintenance/Management 77 13.7

Availability of Information 59 10.5

Other 46 8.2

Data drawn from 562 RCAs submitted for 2010 events. Percent does not total 100% since events g

The third most frequent c

a: Data drawn from 562 RCAs submitted for 2010 events. Percent does not total 100% since eventsgenerally have more than one root cause.


21

G. Contributing Factors to All Events

Patient characteristics were the mostfrequently reported contributing factor to theevents (56.6%). This category can include thepatient’s confusion, co-morbidities and thepatient’s choice to refuse care. Task factors(tasks performed or omitted by any member

of the care team that contribute to the event)were contributing factors in approximatelyone third of events (32.2%). The third mostfrequent contributor to events was teamfactors (29%); this includes failure of the careteam to work together and to communicateappropriately (Table 9).

Table 9: General Acute Care Hospitals: Contributing Factors to All Eventsa

a: Data drawn from 562 RCAs submitted for 2010 events. Percent does not total 100% since eventsgenerally have more than one contributing factor.

Contributing Factors

Number of Events

Percent of Events

Patient Characteristics 318 56.6 Task Factors 181 32.2 Team Factors 163 29.0 Procedures 152 27.0 Patient Records Documentation 100 17.8 Equipment 89 15.8


About a third

o


22

Table 10: General Acute Care Hospitals: Impact of All Events on Patientsa

a: Data drawn from 562 RCAs submitted for 2010 events. Percent does not total 100% since eventsgenerally have more than one outcome.

Impact/Outcome Number of Patients

Percent of Patientsc

Additional Lab Testing or Diagnostic Imaging 256 45.6 Additional Patient Monitoring in Current Location 253 45.0 Surgery Major and Minor 240 42.7 Increased Length of Stay 206 36.7 Disability-Physical or Mental Impairment 186 33.1 Death 85 15.1 Loss of Bodily Function 16 2.8 Loss of Sensory Function 7 1.2 Loss of Body Parts 3 0.5

Data drawn from 562 RCAs submitted for 2010 events. Percent does not total 100% since events

g

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This report is the second

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Psychiatric hospitals

s

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H. Impact of All Events onPatients

A review of the 562 events and correspondingRoot Cause Analysis (RCA) reports for 2010revealed that similar to 2009, the mostfrequent consequences of serious preventableadverse events on patients includedadditional laboratory testing or diagnosticimaging (45.6%) and additional patient

monitoring in current location (45.0%). Over40 percent of the patients (42.7%) receivedeither major or minor surgery. About a thirdof the patients also experienced physicaldisability or mental impairment (33.1%) or anincrease in their length of stay (36.7%) asshown in Table 10. There were 85 deathsreported, which accounted for 15.1 percent ofall affected patients.


23

Mandatory adverse event reporting forthe comprehensive rehabilitation,psychiatric and special hospitals

began April 1, 2008. This report is the secondfull year of reporting for these hospitals.

There were 58 reportable events submittedfrom specialty hospitals in 2010.Comprehensive rehabilitation hospitalssubmitted 38 reportable events, averaging

about three event reports per month.Psychiatric hospitals submitted 14 reportableevents while special hospitals submitted 6(Table 11).

Special hospitals were the lowest reportersamong the specialty hospitals, consistent withprior years. Variation in reporting may relateto the size and patient population of thefacility.

IV. Overall Reporting Patterns for Specialty Hospitals: Comprehensive Rehabilitation, Psychiatric and Special Hospitals

Table 11: Specialty Hospitals: Overall Reporting Pattern

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Figure 8: Comprehensive Rehabilitation Hospitals: Root Causes for All Eventsa

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A. Comprehensive Rehabilitation Hospitals

Of the 15 comprehensive rehabilitationhospitals in the state, 13 (86.7%) reported atleast one event in 2010. As noted earlier,there were 38 reportable events from thesehospitals. There were 29 fall events,representing 76.3 percent of the totalreportable events submitted bycomprehensive rehabilitation hospitals. Caremanagement “other” events were the secondhighest number of reportable events (7 eventsor 18.4% of the total). There was onereportable medication error and onereportable pressure ulcer event submitted.

There were eight (8) reportable deathssubmitted by comprehensive rehabilitationhospitals. One-half (4) were associated withcare management “other” events and threewere related to falls. The remaining onedeath was attributed to a medication error.

1. Root Causes for All Events

Most of the 38 events (22 or 57.9%) submittedhad a root cause related to communicationamong staff and/or with patient/family. Thiswas followed by care planning process, patientobservation procedures and orientation andtraining of staff (Figure 8).


25

Table 12: Comprehensive Rehabilitation Hospitals: Contributing Factors to All Eventsa


Patient Factors Number of Events

Percent of Events

Patient Characteristics 24 63.2

Task Factors 10 26.3

Team Factors 9 23.7

Equipment 8 21.1

Patient Record Documentation 8 21.1

Procedures 6 15.8

Data drawn from 562 RCAs submitted for 2010 events. Percent does not total 100% since events

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2. Contributing Factors to All Events

The most frequently reported contributingfactors were patient characteristics (63.2%),

task factors (26.3%) and team factors (23.7%).Additional factors reported were procedures,equipment and patient record documentation(Table 12).


26

Figure 9: Comprehensive Rehabilitation Hospitals: Impact of All Eventsa


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3. Impact of All Events

Due to the adverse event, about 50 percent ofthe patients had a visit to an emergencydepartment, were admitted to the hospital, ortransferred to a more intensive level of care.

Other major impacts included disability-physical or mental impairment. Additionallaboratory testing or diagnostic imaging andsurgery were also observed as impacts forthese patients (Figure 9).


27

Figure 10: Psychiatric Hospitals: Root Causes for All Eventsa


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B. Psychiatric Hospitals

Eight out of the 10 psychiatric Hospitalsreported at least one event during 2010(80.0%). A total of 14 reportable events weresubmitted to the Patient Safety ReportingSystem. Of the 14 events, eight (57.1%) werefalls, three were care management otherevents (21.4%) and three were patient orresident suicide or attempted suicide (21.4%).

There were a total of two deaths which wereassociated with care management “other”events.


Communication among staff and/or withpatient/family, and care planning process werethe major causes of adverse events withinpsychiatric hospitals. Others root causesincluded physical assessment process andpatient observation procedures (Figure 10).


28


Procedures (50%) and patient characteristics(42.9%) were the most frequently reportedcontributing factors to events occurring inpsychiatric hospitals. The next most

frequently reported contributing factor wasstaff factors (35.7%). Team factors, taskfactors, and other factors each represented 21percent of the total contributing factors(Figure 13).

Table 13: Psychiatric Hospitals: Contributing Factors to All Eventsa


Patient Factors

Number of Events

Percent of Events

Procedures 7 50.0 Patient Characteristics 6 42.9 Staff Factors 5 35.7 Team Factors 3 21.4 Task Factors 3 21.4 Other Factors 3 21.4


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29

Figure 11: Psychiatric Hospitals: Impact of All Eventsa


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Eight of the 14 events (57.1%) resulted in thepatient being sent to the emergencydepartment or transferred to a more intensivelevel of care. Additional patient monitoring,

surgery and disability-physical or mentalimpairment were also reported.

As noted earlier, there were two deaths reportedand both deaths were associated with caremanagement “other” events (Figure 11).


30

Figure 12: Special Hospitals: Root Causes for All Eventsa


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C. Special Hospitals

Eight of the 13 (61.5%) special hospitalsreported at least one event in 2010. This isconsistent with prior years. Six reportableevents were submitted to the PSRS in 2010and seven reportable events were submittedin 2009. Variation in reporting may relate tothe size and patient population of the facility.Five of the events were from the caremanagement category: pressure ulcers (2) andcare management “other” events (3). There

was one event reported as a fall. None of theevents reported by special hospitals resultedin death.


The primary root causes were communicationamong staff and/or with patient/family. Thesewere followed by care planning process andavailability of information (Figure 12).


31


The most frequently reported contributingfactor was patient characteristics (83.3%),followed by team factors and patient record

documentation (33.3% each). Additionalreported factors included task factors,procedures, equipment, and staff factors(Table 14).

Table 14: Special Hospitals: Contributing Factors to All Eventsa

a: Data drawn from 6 RCAs submitted for 2010 events. Percent does not total 100% since events generallyhave more than one contributing factor.

Patient Factors

Number of Events

Percent of Events

Patient Characteristics 5 83.3 Team Factors 2 33.3 Patient Record Documentation 2 33.3 Task Factors 1 16.7 Procedures 1 16.7 Equipment 1 16.7 Staff Factors 1 16.7


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32

Figure 13: Special Hospitals: Impact of All Eventsa


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The impacts from the reportable adverseevents were additional laboratory testing or

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33

New Jersey licensed ambulatory surgerycenters (ASCs) began reporting seriouspreventable adverse events to PSRS as

of October 1, 2008. Therefore, 2010 was the

second full year of reporting. Since October 1, 2008a total of 135 reportable and 21 not reportableevents have been submitted (Table 15).

V. Ambulatory Surgery Centers

Table 15: Ambulatory Surgery Centers: Reportable and Not Reportable Events by Year

a: Represents 3 months of data since reporting started on October 1, 2008

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In 2010 there were 74 reportable adverseevents submitted by 41 of 119 licensed ASCs(34.5%). The number of reportable eventsincreased by 54.2 percent compared to 2009.

A majority of the cases were surgery-related,and these accounted for 68 cases or 91.9percent of the total. Intraoperative orpostoperative coma, death or other seriouspreventable adverse events accounted for 43events or 58.1 percent of ASC adverse events,

while surgery “other” events numbered 20,which is 27.0 percent of the total reportedevents. Fifty out of the 74 patients (67.6%)were admitted to hospitals.

There were eight deaths reported: six fromintraoperative or postoperative coma, death orother serious preventable adverse events(75.0%) and two due to surgery “other” events(25.0%) (Table 16).

Table 16: Ambulatory Surgery Centers: Events Reported

Event Category Number of Events

Percent of

Events

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to Hospital

Number

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Intraoperative or Post-Operative Coma, Death or Other Serious Preventable Adverse Event 43 58.1

37

6 20 27.0 10 2

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1 1.3 0 0 Total 74 100.0 50 8

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34

A. Root Causes for All Events

The 74 RCA reports showed that the mostfrequent causes of all the events reported byambulatory surgery centers were careplanning process, physical assessment

process, and communication among staffand/or with patient/family. Availability ofinformation, orientation and training of staff,and patient observation procedures were alsoidentified as root causes (Figure 14).

Figure 14: Ambulatory Surgery Centers: Root Causes for All Eventsa


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35

B. Contributing Factors to All Events

The most frequently reported contributing factorswere patient characteristics (52.7%), procedures

(47.3% of events), and other (25.7%). Taskfactors, staff factors and team factors were alsoidentified as contributing factors (Table 17).

Table 17: Ambulatory Surgery Centers: Contributing Factors to All Eventsa

a: Data drawn from 74 RCAs submitted for 2010 events. Percent does not total100% since events generally have more than one contributing factor.

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C. Impact of All Events Seventy-four reportable events were submitted. Ofthese events, 67.6% were hospitalized. Additional

laboratory testing/diagnostic imaging was providedto 63.5% and 56.8% visited the ED. Patients alsohad an increased length of stay and about 30%required additional surgery (Figure 15).

Figure 15: Ambulatory Surgery Centers: Impact of All Eventsa

a: Data drawn from 74 RCAs submitted for 2010 events. Percent does not total100% since events generally have more than one outcome.

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36

A. Implementation

The process for each hospital’s riskmanagement department codingapplicable incidents as patient safety

act events continued this year. To ensureadherence, members of the Division of MentalHealth and Addiction Services’ Patient SafetyAct Event Oversight Committee monitorsincident reports from all five state psychiatrichospitals to ascertain if an incident enteredinto the Unusual Incident ReportingManagement System (UIRMS) should havebeen categorized as a Patient Safety ActEvent and tracks to ensure that a root causeanalysis is conducted.

This committee is tasked with assessing theroot cause analysis for thoroughness andcredibility using the Joint Commissioncriteria as well as the requirements of thePatient Safety Act. Inquiries are made toobtain clarification or more information andrecommendations are sent back to thefacilities with regards to systems and processissues. There continued to be emphasis on re-education of Risk Managers, Directors ofQuality Management, and Medical Directorsregarding processes. This committeecontinued to seek clarification regardingreportability on some fall events from theDepartment of Health.

This committee also evaluates system-wide orhospital-specific patient safety issues andmakes additional recommendations to reducethe risk to patient. Tracking these tocompletion was, and continues to be, achallenge. A log is maintained and timelinessof completion and review of the causeanalysis is tracked.

The plan is to continue with training in 2012.

B. Overall Reporting Patterns

From January 1, 2010, through December 31,2010, fourteen (14) events meeting the definitionof Patient Safety Act event were reported by the5 State Hospitals. The majority of these events(Seven out of fourteen, 50%) were falls withmajor injury. Suicide attempts, (6 out of 14, 42%)and one medication error (8%) accounted for therest.

C. Focus on Specific Events

1. Falls (7)Of the seven falls, three of the patientswere male and four were female. All wereover the age of 60 with the average age of70. Five of the seven events were hipfractures, two were other extremities. Sixof the seven patients had a history offalls. Six of the seven patients hadmultiple psychotropic medicationsordered.

Root Causes:v The fall risk assessment and

reassessment process was notsystematically implemented andpersons using the tool were not usingit correctly resulting in a lower score.

v Physical Therapy assessment andfollow-up was problematic.

v In two cases equipment to mitigatethe risk of harm to patients was notordered or not checked to see iffunctioning.

v Polypharmacy and use ofantipsychotic medications in theelderly was felt to be a contributingfactor.

v Hand-off communication among careproviders in relation to falls risk.

VI. Division of Mental Health and Addiction Services

37

Prevention Strategies:v Multi-factorial causes and one of the

two major interventions implementedhave resulted in a major impact inreducing falls or reducing impact. Itwas decided that an ad hoc groupneeded to review best practices andevidenced based practices for reducingfall risks.

v Preventative routine environmentalrounds to ensure the properfunctioning of falls preventativedevices were instituted.

v Continued emphasis was placed on theneed to decrease polypharmacy,especially in the elderly. Thecommittee planned for a 2011 webinar,with the New Jersey HospitalAssociation, on Aging, Mental Illnessand Antipsychotics with Dr. StephenM. Scheinthal, Board CertifiedGeriatric Psychiatrist, AssociateDirector and Chief of GeriatricBehavioral Health, AssociateProfessor, Psychiatry at UMDNJ-SOMInstitute for Successful Aging inStratford, N.J.

2. Attempted Suicide (6)The second leading event reported byDivision hospitals was attemptedsuicide. Of the 6 reported events inthe patient protection category, all sixevents were by females with twofemales making two attempts eachduring the reporting period. Two ofthe females were 27 and 28 years old,the remaining females were both 55years old at the time of the event.

A review of the Root Cause AnalysisReports show that some of therecurrent root causes continued to bethe areas of behavioral assessment/reassessment, patient observationprocedures and communicationamong staff.

Root Causes:v Assessment and Reassessment processv Care Plan

Prevention Strategies:v Have at least one ‘safer’ bedroom perunit near nurses’ station

v Massive training held in the fall of 2010with Dr. Shawn Christopher Shea onInterviewing Techniques for AssessingSuicide Risk

v Continue assessing for suicide risk inthe environment

c. Medication Error (1)

There was one medication errorreported of a patient receiving thewrong medication which resulted in acritical analysis of the medicationadministration process.

Root Causes:v The medication administration processfor morning medications was assigned tonight shift and day shift nurses whichresulted in a patient receiving the wrongmedication.

Prevention Strategies:v Reassign the administration of morningmedications to day shift nurses.

Report Preparation Team

Rosita M. Cornejo, MPH, RD, CPRPDirector of Quality Management

Robert Eilers, M.D.Medical Director

Lisel Hutchins, MPA, BSN, RNQuality Assurance CoordinatorOffice of Quality Management

Alberto RegaladoQuality Assurance CoordinatorOffice of State Hospital Management

VI. Division of Mental Health and Addiction Services

38

The definitions below indicate the general classification and type ofserious preventable adverse event.

A. Care management-related events include, but are not limited to:

1. Patient/resident death, loss of body part, disability, or loss of bodily function lasting morethan seven days or still present at discharge, associated with a medication error (e.g., errorsinvolving the wrong drug, wrong dose, wrong patient/resident, wrong time, wrong rate,wrong preparation, wrong route of administration, etc.).

2. Patient/resident death, loss of body part, disability, or loss of bodily function lasting morethan seven days or still present at discharge, associated with a hemolytic reaction due to theadministration of ABO-incompatible blood or blood products.

3. Maternal death, loss of body part, disability, or loss of bodily function lasting more thanseven days or still present at discharge associated with labor or delivery in a low-riskpregnancy while in a health care facility.

4. Patient/resident death, loss of body part, disability, or loss of bodily function lasting morethan seven days or still present at discharge associated with hypoglycemia, the onset ofwhich occurs while the patient is being cared for in the health care facility.

5. Death or kernicterus associated with failure to identify and treat hyperbilirubinemia in aneonate while the neonate is a patient in a health care facility.

6. Stage III or IV pressure ulcers acquired after admission of the patient/resident to a healthcare facility. This does not include skin ulcers that develop as a result of an underlyingvascular etiology, including arterial insufficiency, venous insufficiency and/or venoushypertension; or develop as a result of an underlying neuropathy, such as a diabeticneuropathy. Also excludes progression from Stage II to Stage III, if Stage II was recognizedand documented upon admission.

7. Patient death, loss of body part, disability, or loss of bodily function lasting more than sevendays or still present at discharge, associated with spinal manipulative therapy provided in ahealth care facility.

8. Other patient/resident care management-related adverse preventable event resulting inpatient death, loss of a body part, disability, or loss of bodily function lasting more thanseven days or still present at the time of discharge not included within the definitions above.

B. Environmental events include, but are not limited to:

1. Patient/resident death, loss of body part, disability, or loss of bodily function lasting morethan seven days or still present at discharge, associated with any shock while being cared forin a health care facility. Excludes events involving planned treatments, such as electriccounter shock (heart stimulation).

Appendix I: Classification of Serious Reportable Adverse Events1

1 Adapted from National Quality Forum. Serious Reportable Events in Healthcare: A Consensus Report. Washington,DC: National Quality Forum; 2002.

39

2. Any incident in which a line designated for oxygen or other gas to be delivered to apatient/resident contains the wrong gas or is contaminated by toxic substances and results inpatient/resident death, loss of body part, disability or loss of bodily function lasting morethan seven days or still present at discharge.

3. Patient/resident death, loss of body part, disability, or loss of bodily function lasting morethan seven days or still present at discharge, associated with a burn incurred from anysource while in a health care facility.

4. Patient/resident death, loss of body part, disability, or loss of bodily function lasting morethan seven days or still present at discharge, associated with a fall while in a health carefacility.

5. Patient/resident death, loss of body part, disability, or loss of bodily function lasting morethan seven days or still present at discharge, associated with the use of restraints or bedrailswhile in a health care facility.

6. Other environmentally-related adverse preventable events resulting in patient/residentdeath, loss of a body part, disability, or loss of bodily function lasting more than seven daysor still present at the time of discharge not included within the definitions above.

C. Product or device-related events include, but are not limited to:

1. Patient/resident death, loss of body part, disability, or loss of bodily function lasting morethan seven days or still present at discharge, associated with use of generally detectablecontaminated drugs, devices, or biologics provided by the health care facility, regardless ofthe source of contamination and/or product.

2. Patient/resident death, loss of body part, disability, or loss of bodily function lasting morethan seven days or still present at discharge, associated with use or function of a device inpatient/resident care in which the device is used or functions other than as intended,including but not limited to catheters, drains, and other specialized tubes, infusion pumps,and ventilators.

3. Intravascular air embolism that occurs while the patient/resident is in the facility. However,this does not include deaths or disability associated with neurosurgical procedures known topresent a high risk of intravascular air embolism.

4. Patient/resident death, loss of body part, disability, or loss of bodily function lasting morethan seven days or still present at discharge associated with use of a new single-use device ora reprocessed single-use device in which the device is used or functions other than asintended. All events related to single-use devices should be reported in this category.Indicate whether the device was new or had been reprocessed.

5. Other product or device-related adverse preventable event resulting in patient death, loss ofa body part, disability, or loss of bodily function lasting more than seven days or still presentat the time of discharge not included within the definitions above.


40

D. Surgery-related events (i.e., any invasive manual or operative methods including endoscopies, colonoscopies, cardiac catheterizations, and other invasive procedures) include but are not limited to:

1. Surgery initiated (whether or not completed) on the wrong body part.2. A surgical procedure (whether or not completed) intended for a different patient of the

facility.3. A wrong surgical procedure initiated (whether or not completed) on a patient.4. Retention of a foreign object in a patient after surgery, excluding objects intentionally

implanted as part of a planned intervention and objects present prior to surgery that wereintentionally retained.

5. Intraoperative or postoperative (i.e., within twenty-four hours) coma, death or other seriouspreventable adverse event for an ASA Class I inpatient or for any ASA Class same daysurgery patient or outpatient. Includes all patient deaths, comas or other seriouspreventable adverse events in situations where anesthesia was administered; the plannedsurgical procedure may or may not have been carried out.

6. Other surgery-related adverse preventable event resulting in patient death, loss of a bodypart, disability, or loss of bodily function lasting more than seven days or still present at thetime of discharge not included within the definitions above.

E. Patient/resident protection-related events include, but are not limited to:

1. Discharge of an infant to the wrong person, excluding patient/resident abductions.2. Any patient/resident death, loss of body part, disability, or loss of bodily function lasting

more than seven days associated with patient/resident elopement.3. Patient/resident suicide or attempted suicide while in a health care facility. However, this

does not include deaths or disability resulting from self-inflicted injuries that were thereason for admission to the health care facility.

4. Other patient/resident protection-related adverse preventable event resulting in patientdeath, loss of a body part, disability, or loss of bodily function lasting more than seven daysor still present at the time of discharge not included within the definitions above.


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N.J.A.C. 8:43E-10.6(l)

The root cause analysis performed by a facility in response to a report of an occurrence of a seriouspreventable adverse event may vary in substance and complexity, depending on the nature of thefacility and the event involved, but shall include the following general components:

1. A description of the event, including when, where and how the event occurred and theadverse outcome for the patient or resident;

2. An analysis of why the event happened that includes an analysis not only of the directcause(s) of the event, but also potential underlying causes related to the design or operationof facility systems;

3. The corrective action(s) taken for those patients or residents affected by the event;

4. The method for identifying other patients or residents or settings having the potential to beaffected by the same event and the corrective action(s) to be taken;

5. The measures to be put into place or systematic changes needed to reduce the likelihood ofsimilar events in the future; and

6. How the corrective action(s) will be monitored to assess their impact.

New Jersey Department of Health Review of Root Cause Analyses

N.J.A.C. 8:43E-10.6(m)

The Department shall:

1. Review an RCA to determine whether it satisfies the criteria in (l) above; and

2. Return an RCA that does not meet the criteria in (l) above to the facility for revision andshall not consider the RCA complete until the Department determines that the RCA meetsthe criteria in (l) above.

Appendix II: Required Components of a Root Cause Analysis

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PSRS Telephone: 609-633-7759PSRS Website http://nj.gov/health/ps

PSRS Staff:Mary Noble, MD, MPH, Clinical Director

[email protected]

Sara Day, RN, BSN, CSM, Supervising Health Care Evaluator

[email protected]

Laurel Holder-Noel, RN, CHC, MSJ, Health Science Specialist

[email protected]

Adan Olmeda, Administrative Support

[email protected]

Patient Safety Reporting System (PSRS) Contact Information

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Limited copies are available by writing to the New Jersey Department ofHealth, Office of Health Care Quality Assessment, P.O. Box 360, Trenton, NJ08625, by calling (800) 418-1397, by e-mailing [email protected] or by faxat (609) 984-7735. The report is also posted on our website atwww.nj.gov/health/ps.

Documents

Office of Health Care Quality Assessment · 3 This summary report presents the findings from serious preventable adverse events reported to the Department’s Office of Health Care