System Review: A Method for Investigating Medical Errors in Health Care Settings

Additional Statement, Submitted by Gregory L. Alexander, M.H.A., B.S.N., R.N., Freeman Health System; and Tamara T. Stone, Ph.D., M.B.A., Department of Health Management and Informatics, University of Missouri-Columbia

Abstract

System analysis is a process of evaluating objectives, resources, structure, and design of businesses. System analysis can be used by leaders to collaboratively identify breakthrough opportunities to improve system processes. In health care systems, system analysis can be used to review medical errors (system occurrences) that may place patients at risk for injury, disability, and/or death. This study utilizes a case management approach to identify medical errors. Utilizing an interdisciplinary approach a System Review Team was developed to identify trends in system occurrences, facilitate communication, and enhance the quality of patient care by reducing medical errors.

A System Analysis Approach

Sarah is a 73-year-old patient who has been admitted to the critical care unit (CCU) for Myocardial Infarction. She is in stable condition. The physician has ordered medication that is depleting excess fluid in her cardiovascular system. The medication has a negative side effect that causes depletion of potassium circulating in the blood. The physician has ordered supplemental Potassium Chloride by IV to replenish Sarah's supply of potassium. Potassium Chloride is purchased by the pharmacy and is stored in a clear plastic container. The potassium solution is clear. The pharmacy also purchases saline solution used to flush intravenous catheters. Saline is contained in a clear plastic container. Each of the plastic containers has white labels with green stripes. They are the same size containers both have gray rubber ports through which to draw the injectate. Sarah's nurse administers a bolus of Potassium Chloride for Sarah and prepares to flush the IV line with the saline. She reaches for the saline and draws up 10cc of clear fluid. She injects the medication into the IV and then suddenly realizes that she has picked up the wrong medication and injected a 10cc bolus of Potassium Chloride directly into the vein of Sarah. Sarah experienced a sudden onset of hyperkalemia. Over the next several hours, Sarah's condition becomes increasingly unstable with episodes of bradycardia, nausea, muscle irritability, and weakness.

These types of occurrences in the delivery of healthcare are preventable and should be scrutinized to determine the cause of the occurrence. One approach to determine cause of variation is a system analysis approach. System analysis enables individuals to identify breakthrough opportunities to improve organizational performance by modifying the system or by modifying behavior of individuals in the system. System analysis has successfully been applied to manufacturing, banking, home building, etc. for many years.¹ More recently, system analysis tools have been developed for nursing and allied health care and are being utilized to measure care quality through identification of cause and effect relationships among systems problems.^{2, 3}

W. Edwards Deming and Joseph Juran were pioneers in the development of system analysis methods. Deming emphasized statistical quality control while Juran emphasized the advantages of good group process in getting quality improvement suggestions from employees.⁴ Deming created 14 Points for Management, which serve as a basis for the transformation theory of the American industry. Deming emphasized that organizations and leaders which intend to stay in business and which wish to protect investors and jobs must adopt and take action on the 14 points. Joseph Juran developed a Trilogy Theory for quality management and a theoretical "Breakthrough Sequence" which he states is a new approach which starts with the proposition that all managerial activity is directed either at:

• breaking through into new levels of performance, i.e., Breakthrough, alias creation of change, or alternately,
• holding the resulting gains, i.e., Control, alias prevention of change.⁵
Deming's 14 points and Juran's Breakthrough Sequence are applicable to large or small organizations and to manufacturing or service organizations including health care systems. The theories these men developed were used as a foundation for the system analysis research described in this discussion.

Gaps and Significance

Specific aims of this research were 1) to incorporate key quality indicators that can be measured, benchmarked, or trended, 2) to utilize research to identify breakthrough opportunities to improve organizational performance, 3) to improve and facilitate interdisciplinary communication and care planning, and 4) to enhance the quality of patient care through a concurrent utilization review function which will provide early detection and prevention of system occurrences.

In order to control variation in health care all disciplines involved in the delivery of care must begin to break down the organizational and disciplinary forms that health care has inherited and to build new forms that better meet the needs of those we serve.⁶ Quality teams have typically been guided to focus on improving product quality. These teams have typically not been empowered to make recommendations for improving operational efficiency or for improving the quality of work life in a specific area.⁴

There is little information on the usefulness of data recovered from investigation of the incidence of system occurrences in health care. Some of the adverse occurrence data that is available in the research focuses on errors in medicine, recognition of variation, and adverse occurrences as a measure of nursing quality.^{2, 7, 8} To impact methods of health care delivery, surveillance data on system occurrences must be gathered, analyzed, and discussed by all members of the health care team to define the problem, identify causes, test theories, and monitor responses to problem-solving strategies.⁹

The purpose of this research is too:

• describe a concurrent utilization review method used to identify system occurrences.
• define a multidisciplinary team approach implemented to discuss system occurrences and make recommendations for system changes.
• provide information on the quality indicators for process failures identified.
• provide evidence that the process of health care delivery is being communicated and improved upon based on recommendations of the multidisciplinary system review team.

The Diagnostic Arm: The Formation of a Concurrent Diagnostic Utilization Review Team

In January 1997 the hospital under review began an organizational restructuring within its administrative support team to develop a case management team. The working definition of the case management team for the health system is "a service function directed at coordinating care (organization and sequencing of services and resources) with payers and providers to ensure appropriate care for patients in the most effective and efficient manner. Initial goals for the case management team were to maintain a utilization review function, incorporate focused quality monitors which can be measured, benchmarked, and trended, incorporate a coding function, and improve and facilitate interdisciplinary communication and care planning.

The first phase of development was to develop the team. Leadership was chosen from within the organization to guide the team based upon experience and knowledge of organizational design. Registered Nurses who were identified as Patient Care Coordinators (PCC) and Physicians (Medical Director and Chief Operating Officer) worked together to implement the initial design of the utilization review network. Initially, eight PCC nurses were selected to assist in the development of the network and to participate in the case management process. Each of the nurses selected had completed a Bachelor of Nursing degree or had an advanced nursing certification in their area of practice.

The second phase of development took place over 4-8 weeks. This phase was used to determine key quality indicators, provide cross training for the investigation team, and to develop an initial set of functions. During this phase of development PCC nurses were assigned to a patient care area based upon their professional experience, certification's, etc.

During the third phase of development PCC nurses began performing concurrent reviews of patient care in their assigned area. PCC nurses were responsible for introducing themselves to each patient, for assisting in the planning of the patient's care throughout their length of stay, and assisting in implementing patient care as needed. PCC nurses reviewed the patient's plan of care including physician orders, lab reports, progress notes, documentation, nursing care plan, etc. Reporting mechanisms were established so that data could be collected and reported in a systematic way.

The Development of System Occurrence Indicators

Data Collection Process. System occurrences began being submitted in May 1997. Reporting mechanisms included identification of any unusual or adverse occurrences in the patient care area. This report was completed using a system occurrence form created to record the patient information sticker, department and location in which the system occurrence occurred, date of the occurrence, person responsible, narrative description of the event, and identification of the PCC completing the review. In July 1998, system occurrences identified by the PCC nurses were integrated into health system's quality assurance activities.

Coding the Data. The process of coding data began by sorting system occurrences by date of occurrence and each occurrence was given a case number to identify them individually. Second, in order to develop categorical quality indicators Grounded Theory and a qualitative process of open coding was used to determine categories for the system occurrences.^{10, 11} As mentioned previously, the PCC nurses utilized narrative data to describe system occurrences. Narrative data consisted of objective and subjective information about adverse events that occurred during the care of patients. All system occurrences reported between May 1997 and December 1998 were utilized to determine categories for quality indicators. Key descriptive words used in the PCC description were matched, highlighted, and trended to create the classification scheme for indicator/occurrence types. A severity scale was adapted from the physician peer review forms that identified severity based upon deviation from standards of care and/or patient response to system occurrences. A level 1-severity rating was determined by the system review team to be appropriate care management. No action was required on a Level 1 rating. A level 2-severity rating was any occurrence that was considered acceptable patient care management, however opinions may vary among practitioners. A level 3-severity rating was any Marginal Deviation in Standard of Care defined as any deviation that was barely within a lower standard or limit of quality or below standard. Marginal Deviation occurred when an event occurred that had no effects on the patient. A level 4-severity rating was a Significant Deviation in Standard of Care. It is defined as any occurrence that is below standard of care and causes a notable effect on the patient. The type and severity of the event was eventually used to categorize the information. Finally, a literature search was conducted to find information on identification and categorization of system problems. An article called, Systems vs. Performance Problems: A Peer Review Organization's Perspective from the May 1992 Quality Review Bulletin¹² proved to be very beneficial in the development of the system quality indicators.

In January 1999, the coding process was completed and the quality indicators for the system occurrences had been identified. The system occurrence reporting form was restructured to reflect the new categories and severity scale (select to access Appendix A [PDF file, 6 KB; Text Version]). A review of existing peer review forms (i.e. medical peer review, surgery peer review, etc.) obtained from the Quality Management department was completed to assist in the development of the system occurrence report form. The system occurrence form was restructured to mimic other peer review committee forms utilized in the system. The familiarization of forms would create less confusion and would facilitate communication and coordination between isolated peer review committees.

The system occurrence report form was restructured to include three sections. The first included a list and description of the indicator/occurrence, the department where the occurrence was identified, and the responsible department if different from where the occurrence was identified and the staff member involved in the system occurrence. The indicator list was determined from the coded system occurrence data. A comment section followed the indicators. When the PCC nurses identified a system occurrence they completed the top section of the form and identified an indicator. Then the PCC nurses would provide a brief description of the event in the comment section. The second section contains the severity scale utilized by the system review team to rate the occurrences. This scale was developed to stratify the occurrences according to deviations from standards of care and/or potential or actual effects that occurred to patients as a result of system occurrences. The third section includes the action section. This section was utilized to indicate actions taken on system occurrences that required action (i.e. level 3 and level 4 system occurrences). A comment section followed the third section to write any brief comments or recommendations made by the system review committee regarding the action plan.

The Steering Arm: Development of an Interdisciplinary System Review Team to Analyze System Occurrences and make Recommendations

In January 1999 administration gave approval to move forward with the development of a multidisciplinary system review team which would review system occurrences reported by the PCC nurses and would make recommendations based upon further findings. The system review team would be an informal group composed of selected individuals who were working in staff positions or charge positions within the health system. One administrator and the Medical Director would also be members of the committee. Selected individuals were identified to serve on the System Review Team including the following:

Select for Text Version

The initial meeting of the System Review Team included a welcome and statement of support by the COO, an orientation to the system review process, an inservice on peer review law and confidentiality by the Director of Quality Management, and first assignments to be reviewed.

System review assignments were made on a monthly basis for the system review team members. Assignments were made based upon each member's expertise and the event type that was identified via the system occurrence form. Every attempt was made to have assignments made within two weeks of each system review meeting to allow enough time for the system reviewer to obtain the chart, talk to personnel involved in the system occurrence, and to develop preliminary recommendations. Each reviewer was instructed to provide a brief description of the system occurrence to include the following:

• Name of Patient, age, and admitting diagnosis
• Location or department where event occurred
• List any staff members involved
• Indicator/Occurrence as classified by the PCC nurse
• Description of the event
• List any preliminary recommendations

Following the brief synopsis an informal roundtable discussion and brainstorming session of the system occurrence was conducted. During this time many things were discussed including processes, procedures, sequencing of events, etc. The peer review team decided upon a determination of the severity rating and plan of action during this time. Any system occurrence that was determined to be a Marginal or Significant Deviation from the Standard of Care required a recommended plan of action and follow up by the system review committee and the department manager responsible for the care of the patient.

Communication is the Key

Following the system review team meeting all system occurrences that were completely reviewed during the meeting were compiled. Each of the system reviews were entered into an excel spreadsheet which identified the following characteristics of each system occurrence:

Select for Text Version

Letters were generated on all system occurrences that measured a level 3 or level 4 on the severity scale. Letters were sent to the department heads and were copied to the administrative officers. The letters included a brief description of the events surrounding the system occurrence, the name of patient and account number, findings from the system occurrence team, and recommendations from the system review team. Follow up was requested on all letters sent.

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