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University of Michigan Health System Program and Operations Analysis

Analysis of the Clinical Engineer Workload in the

Biomedical Engineering Department

Final Report

To: Jeff Short, Manager, Biomedical Engineering Department

Tim Baron, Clinical Engineer

Salim Kai, Clinical Engineer

Ron McCarty, Clinical Engineer

Samuel Clark, Coordinator, Program and Operations Analysis

Professor Mark Van Oyen, IOE 481 Instructor

From: IOE 481 Project Team, Program and Operations Analysis

Ross Broms

Olivia Dunn

Prateek Harsh

Aaron Shaw

Date: April 20, 2010

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Table of Contents

Executive Summary ..............................................................................................4

Introduction ...........................................................................................................7

Background ...........................................................................................................7

Key Issues ........................................................................................................8

Project Scope ...................................................................................................9

Goals and Objectives ............................................................................................9

Project Approach and Methodology .....................................................................9

Phase I: Data Collection and Preliminary Findings.........................................9

Phase II: Data Analysis ................................................................................. 11

Key Findings Driving the Conclusions .............................................................. 12

Findings from Preliminary Research ............................................................ 12

Findings from the Work Distribution Study ................................................. 13

Conclusions ........................................................................................................ 17

Recommendations .............................................................................................. 18

Expected Impact ................................................................................................. 19

Acknowledgements of Support Provided by Operating Entities ....................... 19

Appendix A: Findings from Preliminary Research ......................................... A-1

Appendix B: Work Distribution Study Data Collection Sheets ...................... B-1

Appendix C: Breakdowns of Activity Frequency Under Each Category ........ C-1

Appendix D: Familiarity/Expertise Assessment for All Activities ................. D-1

Appendix E: FTE Calculations ......................................................................... E-1

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List of Tables and Figures

Figure 1: Percent of Total CE Time Spent on Each Category ..............................5

Figure 2: Actual and Projected Incident Reports per CE per Quarter ..................5

Table 1: Analysis of Hiring Options for the BME Department ...........................6

Figure 3: Actual and Projected Incident Reports per CE per Quarter ............... 13

Figure 4: Percent of Total CE Time Spent on Each Category ........................... 13

Figure 5: Work Distribution of CE 1 by Subcategory ....................................... 14

Figure 6: Work Distribution of CE 2 by Subcategory ....................................... 15

Figure 7: Work Distribution of CE 3 by Subcategory ....................................... 16

Figure 8: Percent of CE Time that Requires Familiarity with the Subject of the

Activity (excluding Other category) ................................................... 17

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Executive Summary The manager of the Biomedical Engineering (BME) department at the University of Michigan Hospital System (UMHS) believed that the three clinical engineers (CE’s) employed by the department are overworked. He believed that this is due to multiple factors, including a shift in the hospital’s philosophy to be one of the safest hospitals in the country and the resulting increase in workload for the CE’s. He also believed that some of the tasks the CE’s perform do not require their expertise and could be reallocated to an administrative employee. The department manager asked the team to identify the tasks performed by the CE’s, determine the proportion of time the CE’s spend on these tasks, and identify inefficiencies in their workload. The CE’s perform three main tasks at UMHS: 1) reviewing incident reports; 2) processing explants; and 3) approving Institutional Review Board (IRB) proposals. Currently, two CE’s work full-time on incident reports and explants. The third CE is also a full-time employee for the BME department but only a half-time CE, devoting his CE time to IRB proposals. The methods used for the project team’s analysis of the CE’s workload included preliminary research, interviews, observations, and a work distribution study: • Preliminary research allowed the team to gain a better understanding of the types of tasks

that require a CE’s expertise and knowledge. According to the American College of Clinical Engineering (ACCE), the traditional responsibilities of CE’s are proactive. In addition, the team analyzed data on the number of incident reports the BME department at UMHS received in the past three years, showing that there has been an increase of approximately 70 reports (on average) each year. The total number of incident reports per quarter increased almost 170% between Q1 2005 and Q1 2010. The manager of the BME department informed the team that the staffing level has remained constant since Q3 2005.

• Interviews with the CE’s were conducted by the project team to obtain information regarding the day-to-day activities of the CE’s at UMHS. The team identified three categories of tasks: reviewing incident reports, processing explants, and approving Institutional Review Board (IRB) proposals. A more detailed breakdown of each category was developed to construct an initial list of activities for the work distribution study.

• Observations were carried out to develop an exhaustive list of tasks performed by the CE’s. The team observed for a total of 13 hours. Upon completion of the observations, the team expanded the list to ensure it is exhaustive, clarify vague tasks, and identify an appropriate level of detail for the data collection sheets to be used in the work distribution study. The exhaustive list of tasks that the CE’s perform can be seen in Appendix B.

• A Work Distribution Study was carried out for two weeks to identify the proportion of time the CE’s spend on their day-to-day tasks. The three CE’s carried beepers and marked a tally on the list next to the task they were performing each time the beeper sounded.

With the data collected from the work distribution study, the team calculated the proportion of time that the CE’s spend on each task. As shown in Figure 1 below, the proportion of time that the CE’s spend on each category was found to be 46.08 percent Incident Reports, 22.09 percent approving IRB’s, 8.91 percent processing explants, and 22.92 percent on other activities (meetings, lunch breaks, etc).

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Figure 1: Percent of Total CE Time Spent on Each Category

The number of incident reports received by the BME department has been approximately linearly increasing for the past three years with an average increase of 17 incident reports per quarter since the first quarter of 2005. The team used this linear model to approximate the projected number of incident reports per CE for two scenarios until Q4 2013: 2 CE’s processing incident reports and 3 CE’s processing incident reports. The raw data and projections are shown in Figure 2 below.

Figure 2: Actual and Projected Incident Reports per CE per Quarter

Incident Reports

46%

Other23%

IRB Proposals22%

Explants9%

March 15-26, 2010 - All 3 CE’s total workload with overall N = 842

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Then team then determined whether each activity, except those under the Other category, requires the familiarity or expertise of a CE. This list can be found in Appendix D. Aggregating the data revealed that about 78 percent of the workload requires the expertise of the CE’s. Additionally, from discussions with the BME department manager, the team anticipates that the number of incident reports will continue to rise because of possible under reporting that the hospital administration hopes to eliminate. Furthermore, the new Mott Children’s hospital will open soon, which will likely spark more equipment-related incidents that would require the time and expertise of the CE’s. Based on the team’s findings, to reduce the current workload, the team analyzed two options for staffing levels that would help optimize the CE’s time, decrease the inefficiencies, and consequently increase CE satisfaction.

Hiring Options Hire a part-time administrative assistant Hire an additional full-time clinical engineer to process incident reports and explants

Pros • Less costly than hiring a full-time clinical engineer for equal number of FTE’s

• Reallocation of the tasks that do not require the familiarity or expertise of the CE’s could improve CE satisfaction

• Reduced workload for CE’s could lead to increased CE satisfaction

• Relief for CE’s due to slower increase in number of incident reports per CE

Cons • Inefficiencies in communication between clinical engineers and the administrative assistant

• No relief for CE’s in the future due to continuing rise in incident reports

• Higher cost than an administrative employee

• Training takes three to four quarters

FTE Calculation Approximately 6 quarters after hiring, the number of incident reports per FTE will return to the current levels

Approximately 15 quarters after hiring, the number of incident reports per FTE will return to the current levels

Table 1: Analysis of Hiring Options for the BME Department Through identification of the tasks performed by the CE’s, the proportion of time spent on these tasks, and the inefficiencies in the CE’s workload, the project team recommends that UMHS should hire one additional CE in the BME department to process incident reports and explants. The expected outcomes of implementing this recommendation are:

• Increased CE time spent on proactive activities that could reduce the number of future incidents

• Increased CE satisfaction due to reduced workload – only 5.8 additional incident reports per CE each quarter compared to the current rate of 8.7

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Introduction The Biomedical Engineering (BME) department at the University of Michigan Hospital System (UMHS) currently employs three Clinical Engineers (CE’s). The department is responsible for all clinical equipment within the hospital, including the functional analysis, safety, and repairs of devices. These devices include any item that is exposed to a patient, which range from bandages to MRI machines. Traditionally, duties of CE’s include analyzing devices prior to purchase, training and supervising technicians, and serving as technology consultants for other hospital staff. The manager of the BME department believes that the CE’s are overworked, due in part to the engineers performing activities that could be completed by less specialized individuals. In addition, the CE’s have expressed dissatisfaction with their current workload, citing inefficiencies in their tasks as a key contributor. Currently, no documentation exists on the amount of time that the engineers spend on various jobs. Therefore, the manager would like to know how long the engineers spend on various tasks to determine if additional engineers are needed, or if some work could be reallocated to less specialized employees. The manager asked the team to identify the tasks performed by the CE’s, determine the proportion of time the CE’s spend on these tasks, and identify inefficiencies in their workload. After analyzing the data, the team has created recommendations for an optimal staffing level for the BME department, which addresses the manager’s concerns about the workload of the CE’s. This final report presents an overview of the project background, approach, findings, conclusions, and recommendations. Background According to the BME department manager, the workload for the BME department has increased significantly in the past five years, owing in large part to a shift in UMHS leadership’s philosophy to be one of the safest hospitals in the country. During those five years, however, staffing levels have remained constant. Traditionally, CE’s perform proactive tasks to ensure that accidents do not occur and that all machines and devices are safe for patient use. However, the CE’s at the UMHS feel that many of the tasks they perform fall outside of the traditional responsibilities of CE’s. Much of the work that the CE’s perform requires follow-up from parties involved in various hospital departments – such as cardiology when working with pacemakers – so e-mails and office visits to other staff members have become common tasks for the CE’s. The current tasks that the CE’s at UMHS perform can be divided into three categories:

1. Reviewing Incident Reports Any medical device that comes in contact with a patient and is considered ‘defective’ is sent to the BME department for follow-up. Defective devices include electronic bed adjusters that are not working properly and pacemakers that experience a premature end of life. Each device requires its own incident report, which is completed by any hospital staff member aware of the incident. According to the CE’s, each report takes about 15-20 minutes to complete. If the report is completed

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incorrectly or is incomplete, the CE’s may need to follow up with the staff member who filed the report, which can require several calls, e-mails, or personal visits.

2. Processing Explants

Medical devices removed from patients (such as a pacemaker at the end of its lifespan), called “explants,” are sent to the CE’s. The Food and Drug Administration (FDA) classifies medical devices as either trackable or non-trackable. All trackable devices must be returned to the manufacturer when they are explanted from a patient. Depending on the type of device and whether the patient was harmed, non-trackable devices can either be sequestered indefinitely or discarded. Incident reports are filed for all devices explanted before their expected end-of-life.

3. Approving Institutional Review Board (IRB) Proposals

When a medical researcher at UMHS wants to use a medical device in a manner other than its approved use, the researcher must submit a proposal for the alternative use of the device. A designated CE investigates and makes recommendations to the IRB on the risk associated with each device’s proposed use.

Some tasks within the categories above require specific knowledge of the equipment, particularly in cases of defective or misused equipment. However, the CE’s and their manager feel that some tasks are more clerical in nature and could be handled by less specialized employees. The team quantified the workload distribution of the CE’s to determine which tasks could be reallocated to other employees, thus increasing satisfaction by allowing the CE’s time to perform tasks that require their technical expertise. The student team examined the activities of the three clinical engineers in the Biomedical Engineering department. Of these three, two CE’s are working full-time processing incident reports and explants. The third CE is also a full-time employee for the BME department but only a half time CE, devoting his CE time to IRB proposals. The primary parties involved in this project included the clinical engineers and the BME department manager. The secondary parties included persons with whom the clinical engineers interact during their tasks such as physicians, nurses, the Risk Management department, and BME department technicians. Key Issues The following key issues influenced the need for this project:

• Incident reports have more than doubled in the past 3.5 years • The clinical engineers are frustrated with their current workload because no additional

CE’s have been hired during the same 3.5-year span • Clinical engineers and management believe some tasks performed by the CE’s can be

given to less specialized employees • The CE’s would prefer more time to perform tasks that better fit their job description

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Project Scope This project included a study of the clinical engineers’ workload in the Biomedical Engineering department at UMHS. The workload is comprised of the tasks that the clinical engineers perform in their day-to-day work. Time spent in a meeting was recorded but not analyzed in detail. Any task not connected to the clinical engineers was not included in this project. Specifically, the team did not study tasks or activities conducted by the biomedical engineering department administrators. Goals and Objectives To identify the tasks performed by the CE’s, determine the proportion of time spent on these tasks, and identify inefficiencies in the CE’s workload, the student team completed the following tasks:

• Interviewed the CE’s to create an initial activity list for a work distribution study • Observed the CE’s during their working hours to refine the initial activity list • Conducted a work distribution study to determine the proportion of time CE’s spend on

various tasks • Identified inefficiencies in the CE’s workload

With this information, the team developed recommendations to:

• Reallocate tasks to match employee skill sets to appropriate activities, including hiring additional personnel if needed

• Increase CE satisfaction by reducing workload and/or reallocating tasks Project Approach and Methodology The project methodology followed a two-phased approach: data collection and data analysis. Phase I: Data Collection and Preliminary Findings The team collected data using four methods: preliminary research, interviews, observations, and work distribution study. After each of these steps, the team gained additional insight that aided the completion of the subsequent step. These methods and corresponding findings are described below. 1. Preliminary Research The team’s preliminary research consisted of investigating the roles of clinical engineers in a hospital environment. This research allowed the team to better understand the types of tasks that require a CE’s expertise and knowledge. Briefly, a CE’s responsibilities include the following1

• Assessing and procuring new technology :

• Assuring regulatory compliance in the medical technology management 1 "Clinical Engineer (defined)." American College of Clinical Engineering. Web. 25 Jan. 2010.

<http://www.accenet.org/default.asp?page=about&section=definition>.

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• Training and educating technical and medical personnel in the use of medical equipment • Investigating incidents that affect patient safety

Although the duties listed above are the traditional responsibilities of CE’s as established by the American College of Clinical Engineering (ACCE), the CE’s at UMHS do not have the opportunity to pursue the proactive responsibilities, such as assessing and procuring new technology and training medical personnel. At UMHS, the BME administrators establish the role of the CE’s. Due to the high workload volume, the CE’s responsibilities at UMHS are narrower in scope than those defined by the ACCE. The team based its recommendations on the responsibilities established by the ACCE. The team also obtained historical data from the BME department manager. This data consists of the number of incident reports received by the department each quarter between 2005 and the first quarter of 2010. The raw data is attached in Appendix A-1. From this data, the team found that between 2006 and 2008, the average quarterly number of incident reports doubled. The team fit a linear regression to the quarterly data and found the following regression equation: y = 17.414x+128.01 (1) where x is the number of quarters since the beginning of 2005 and 128.01 is the (approximate) initial number of incident reports at the beginning of 2005. The linear regression is confirmed by the R2 statistic, which measures the accuracy of the regression equation on a scale of 0 (not accurate) to 1 (perfectly accurate). With a score of 0.87874, Equation 1 has a very high correspondence to the actual data. The verification of the model allowed the team to use it to predict future incident report volumes for the BME department. 2. Interviews Next, the team interviewed each CE to understand the tasks CE’s perform on a daily basis. The primary goal was to develop an initial list of activities for the work distribution study. As often as possible, open-ended questions were asked to allow the CE’s to give detailed answers. Examples of questions include:

• What is the typical process, start to finish, for processing an explant? An IRB? • How are incident reports received? What are the first steps you take in responding to

incident reports? • What tasks do you do when you first arrive to work?

From the interviews, the team found that no two days are the same for the CE’s. Each day’s activities depend almost wholly on the incident reports that arrive to the CE’s the day before. Since such a broad range of devices exist for which the engineers are responsible, it is difficult to know what activities (tests or otherwise) the CE’s will have to perform on a given day. However, the team was able to discern three main categories of tasks: reviewing incident reports (“Incident Reports” on the data collection sheet), processing explants (“Explants”), and approving IRB proposals (“IRB Proposals”). To validate and refine the initial list of activities, the team observed the CE’s during their normal working hours.

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3. Observations The team observed the CE’s during the work day for a total of 13 hours over one week. These observations served as a follow-up to the interviews and allowed the team to create an exhaustive list of tasks performed by the CE’s. During the observations, team members followed the engineers during their normal work hours, making notes and asking questions for clarification. After the observations, the team met with each other to clarify and refine vague tasks from the initial activity list, as well as to add to the list tasks that were not mentioned during the interviews.

The team found that certain activities performed by the CE’s are completed in sequence, and therefore could be aggregated on the activity list. For example, when processing a trackable explant, a CE verifies the model and serial numbers, photographs the device, and packages the device to be shipped. Therefore, these tasks were grouped under the common subcategory “Process trackable explants” on the final activity list.

Another change from the initial activity list was finding an appropriate level of detail for the activities. For example, the initial list included separate activities for walking to a destination and walking back from a destination. The group consolidated these activities into one task labeled “Travel” to make the activity list easier to navigate for the CE’s. 4. Work Distribution Study As the last step in the data collection phase, the team used the exhaustive list of activities, which is attached in Appendix B, to perform a two-week work distribution study. The team briefed the engineers about their role and responsibilities in the study prior to data collection. During their working hours, each CE carried a beeper that was programmed to sound an alarm at exponentially distributed intervals with a mean of four times per hour. Each time the beeper sounded, the CE’s were to mark a tally on the data collection sheet next to the task they were performing. After the first day of data collection, a team member reviewed the data collection sheets with each of the CE’s. The team member verified that an accurate number of marks were made during each time interval on the data collection sheet. For example, were beepers are programmed to sound an average of four times per hour. Thus, the team expected approximately 2 x 4 = 8 marks per two-hour time interval, plus or minus four (because the exponential distribution is random). At the end of the first day, the team found that all of the CE’s collected the data correctly. Over two weeks, the data collection sheets were collected and reviewed with the CE’s twice more. Phase II: Data Analysis While the CE’s were collecting data during the work distribution study, the team designed and created a Microsoft Access database to analyze the data. When the first set of data collection sheets were gathered, the team began to enter the data into the database. After data entry, the team ran queries in Access to determine relevant statistics, such as the proportion of time CE’s spend on activities:

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• Under each category (Explants, etc.) • That require their expertise

The proportions generated by the queries provided insight into which tasks the CE’s spend the most time doing. This allowed the team to make conclusions on, and thus recommendations for, the BME department staffing level. Key Findings Driving the Conclusions The key findings for this project fall into two main categories: the findings from the preliminary research and the findings from the work distribution study. Findings from Preliminary Research After obtaining the historical incident report data from the BME department manager, the team found a linear trendline for the number of incident reports per quarter, as discussed in the Project Approach and Methodology section. Using the projected number of incident reports, the team compared the increase of incident reports per CE per quarter for the current situation to a situation with an additional CE. Since only two CE’s currently work on incident reports, the projections for two CE’s and three CE’s were compared. Model of incident report volume for 2 CE’s The team found that for two CE’s working with incident reports, the number of reports is expected increase by approximately 8.71 incident reports per CE per quarter. (The team assumes that the CE’s split the work of the incident reports equally.) That means that if each CE received 50 incident reports in a given quarter, the team would expect that each CE would receive approximately 58.7, or simply 59 incident reports the subsequent quarter. The trendline for this data follows the equation

y = 8.7071x+64.007 (2) where x is the number of quarters since the beginning of 2005 and 64.007 is the approximate number of incident reports per CE in the first quarter of 2005. The R2 value for this equation was approximately 0.8787, so the equation fits the current data well. Model of incident report volume for 3 CE’s If the BME department hires an additional CE to work on incident reports, the expected increase in workload would be approximately 5.80 incident reports per CE per quarter. The equation for this projected data follows the equation

y = 5.8048x+42.671 (3) where this equation has the same format as Equation 2. No R2 value exists for this equation because it is based completely on projected data.

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The actual and projected equations are shown in Figure 3.

Figure 3: Actual and Projected Incident Reports per CE per Quarter

Findings from the Work Distribution Study The team collected a total of 842 data points from the 3 CE’s over the 10 days of data collection. The team performed a top-down analysis of the CE workload, starting with high-level analysis of the four main categories and subsequently breaking down the data into finer levels of detail. Overall CE workload breakdown by category First, the team split the data up by category (Incident Reports, Explants, IRB Proposals, and Other), and found that the CE’s spend about 46 percent of their time working with incident reports. Figure 4 below shows the breakdown of CE time by category.

Figure 4: Percent of Total CE Time Spent on Each Category

Incident Reports

46%

Other23%

IRB Proposals22%

Explants9%

March 15-26, 2010 - All 3 CE’s total workload with overall N = 842

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Main category breakdown by activity Next, the team found the proportion of each activity within each category. About 32 percent of the CE’s time spent on incident reports (not the total time) was spent updating the incident reports, with about 9 percent spent on packaging devices associated with incident reports. Nearly half of the time designated under the ‘Other’ category was devoted to meetings, with about 16 percent devoted to lunch and other breaks. For the IRB proposals, about 20 percent of the time was spent reading e-mail requests, about 18 percent reviewing research projects, and about 16 percent creating a document with the research information. About 36 percent of the time spent on explants was packaging explants to be shipped, with another 17 percent spent on creating a monthly trackable explant report. Detailed breakdowns of the activities within each of these main categories are located in Appendix C. Work distribution by CE by subcategory Additionally, the team examined the proportion of time spent by each CE by subcategory. The subcategory was chosen because it provided an appropriate level of detail; at the category level, the chart would be too broad to provide any real insight, while at the activity level, the chart would be too hectic. As reflected by Figures 5, 6, and 7 below, CE’s 1 and 2 processed incident reports and explants while CE 3 processed IRB proposals. As shown in Figure 5 below, CE 1 spent 20 percent of his time processing devices for incident reports, 14 percent picking up medical devices, 14 percent updating incident reports, 13 percent processing non-trackable explants, and 9 percent documenting explants. Another 12 percent of CE 1’s time was spent in meetings. As predicted, the aforementioned subcategories combined comprise more than 80 percent of CE 1’s time are the typical duties of a CE.

Figure 5: Work Distribution of CE 1 by Subcategory

Process device20%

Pick up medical device14%

Update incident report14%

Process non-trackable explants

13%

Meeting12%

Document explants

9%

Preliminary investigation

6%

Personal5%

Process trackable explants

4%

Assorted activities(<2% each) 3%

March 15-26 2010, N =155

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As illustrated in Figure 6 below, CE 2’s work distribution has similar subcategories, though the subcategories are weighted differently. CE 2 spent 27 percent of his time updating incident reports, 25 percent processing devices for incident reports, 15 percent communicating about the devices, and 10 percent picking up medical devices. Another 8 percent of CE 2’s time was spent in meetings.

Figure 6: Work Distribution of CE 2 by Subcategory

Depicted in Figure 7 below is CE 3’s work distribution. As mentioned earlier, CE 3 is a full-time employee, but only part-time CE (.5 FTE). This is reflected by the fact that the investigate device and preliminary investigation subcategories, which fall under the IRB category, represent almost 50 percent of CE 3’s workload. The remaining 50 percent of the workload includes the technical, meeting, and personal subcategories, which respectively employ 18, 14, and 11 percent of CE 3’s workload. These 3 subcategories are mostly related to non-CE responsibilities.

Update incident report27%

Process device25%

Communications15%

Pick up medical device10%

Meeting8%

Preliminary investigation

7%

Process trackable explants

5%

Assorted activites (<2%

each)3%

March 15-26, 2010, N =371

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Figure 7: Work Distribution of CE 3 by Subcategory

Determination of inefficiencies by activity Prior to the work distribution study, the team identified a binary designation loosely defined as whether or not each activity required the expertise of the CE. After discussions within the group and with the BME department manager, the team broadened this definition to whether or not the activity requires a CE to be familiar with the subject of the activity (incident report, explant, IRB proposal, etc.) to complete the activity. For example, updating an incident report may not require the background and experience of a trained CE, but could not be easily completed by someone without a familiarity of the specific incident report. Thus, that particular activity was given a ‘Yes’ for this binary designation. On the contrary, traveling to pick up explants, which is done at roughly regular intervals by the CE’s and does not require familiarity with the explants themselves, was given a ‘No’ for this binary designation. In this report, the terms ‘familiarity’ and ‘expertise’ are used interchangeably. The team further investigated the top ten tasks by time spent in each category and determined whether or not they require the familiarity of a CE. This helped identify categories that contain many tasks that can be reallocated. The tables containing these tasks are found in Appendix D. After separating all of the activities based on this designation, the team removed all activities under the Other category. Meetings, breaks, and other such activities are insignificant for this particular analysis, since an employee in any role – CE, administrative, or otherwise – would likely have these same activities. Separating the remaining activities by the previously mentioned binary designation, which is seen in Appendix D, the team found that approximately 78 percent of the CE’s time is spent on activities that require the CE’s familiarity with the subject of the activity, as reflected in Figure 8 below.

Investigate device25%

Preliminary investigation

23%Technical18%

Meeting14%

Personal11%

Mott construction

5%

Other4%

March 15-26, 2010, N =316

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Figure 8: Percent of CE Time that Requires Familiarity with the Subject of the Activity

(excluding Other category) Conclusions Based on the findings, the team concludes that the workforce level in the BME department has not matched the increase in the workload for the CE’s. This increased workload has caused the CE’s to be overworked leading to CE dissatisfaction. The increased workload is due in large part to the rise in number of incident reports, which has been driven by a change in UMHS leadership’s philosophy to be the safest hospital in America. The team anticipates that the number of incident reports will continue to rise because of possible under reporting that the hospital administration hopes to eliminate. Additionally, the new Mott Children’s hospital will open soon, which will likely spark more equipment-related incidents that would require the time and expertise of the CE’s. The team identified the tasks performed by the CE’s and determined the proportion of time the CE’s spent on these tasks. Approximately half of the current CE workload is on incident reports. With the increasing number of incident reports, the project team concludes that time spent doing other, perhaps more desirable or proactive tasks is lost. The majority of the work performed in the incident report category is spent updating incident reports, which the team has identified as an activity that requires the familiarity or expertise of a CE. With a detailed look of the CE’s non-Other category workload, 22 percent of the tasks currently performed by the CE’s were identified as inefficient, meaning these tasks do not require the familiarity/expertise of a CE. To reduce the current workload, the team analyzed two options for staffing levels that would help optimize the CE’s time, decrease the inefficiencies, and consequently increase CE satisfaction. An analysis including the pros and cons of both options is below. In addition, the team performed an FTE calculation for each option to find the number of quarters until the incident report workload for each CE returns to current levels. These calculations, which are

Requiresfamiliarity

78%

Does NOT require

familiarity22%

March 15-26, 2010 - All 3 CE’s total workload with overall N = 652

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shown in Appendix E, helped the team to understand the quantitative implications and effectiveness that each hiring option would provide. Option 1: Hire a part-time administrative assistant The first option is to hire a part-time administrative assistant to perform the activities that do not require the expertise or familiarity of the CE’s including packaging, traveling, or picking up explants. Pros:

• Less costly than hiring a full-time clinical engineer for equal number of FTE’s • Reallocation of the tasks that do not require the familiarity or expertise of the CE’s could

improve CE satisfaction Cons:

• Inefficiencies in communication between clinical engineers and the administrative assistant

• No relief for CE’s in the future due to continuing rise in incident reports FTE Calculation:

• Approximately 6 quarters after hiring, the number of incident reports per FTE will return to the current levels

Option 2: Hire an additional full-time clinical engineer to process incident reports and explants The second option is to hire an additional full-time clinical engineer to process incident reports and explants, which will help alleviate some time spent on activities that make up most of the CE’s workload and free up time for CE’s to work on more proactive tasks. Pros:

• Reduced workload for CE’s could lead to increased CE satisfaction • Relief for CE’s due to slower increase in number of incident reports per CE

Cons:

• Higher cost than an administrative employee • Training takes three to four quarters

FTE Calculation:

• Approximately 15 quarters after hiring, the number of incident reports per FTE will return to the current levels

Recommendations Through identification of the tasks performed by the CE’s, the proportion of time spent on these tasks, and the inefficiencies in the CE’s workload, the project team recommends that UMHS should hire one additional CE in the BME department to process incident reports and

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explants. This recommendation is supported by the team’s findings and conclusions, specifically that:

• Approximately 78% of the current workload requires CE familiarity and/or expertise • CE incident report workload has steadily increased in the past 5 years and will likely

continue to increase in the future • CE incident report workload is not projected to return to current levels for almost 15

quarters if an additional CE is hired to process incident reports and explants Expected Outcome Implementation of the team’s recommendations will lead to:

• Increased CE time spent on proactive activities that could reduce the number of future incidents

• Increased CE satisfaction due to reduced workload – only 5.8 additional incident reports per CE each quarter compared to the current rate of 8.7

Acknowledgements of Support Provided by Operating Entities The Department Manager of BME supported the team through continuous communication. He provided information necessary to complete the project. Additionally, he provided updates, regarding changes in the requirements and expectations of the project. The client also communicated the importance of this project to the CE’s to encourage support from them. The three clinical engineers in the BME department provided support for the project through their participation in interviews, observations, and the work distribution study, which required them to record the activity they were performing each time that their beepers sound. The CE’s shared any concerns with the project team, which helped to produce accurate and measurable results. The project coordinator mentored the project team by communicating with the team each week and offering guidance. The project coordinator provided beepers for the work distribution study and colored cardstock for the data collection sheets. The coordinator gave feedback to the project team members to help develop their industrial engineering skills.

A-1

APPENDIX A: Findings from Preliminary Research

Source: BME department manager Jeff Short; received via e-mail March 30, 2010

B-1

Name: _________________________ Start Time: ________ am/pm Date: 03/___ /10 End Time: ________ am/pm Day of Week: M Tu W Th F Part of Shift Incident Reports 0-2 hours 2-4 hours 4-6 hours 6-8 hours 8+ hours Download/read incident reports Use Maximo database Update incident report Pick up medical device

Travel Talk to party involved

Process device Match new device to incident report Open/File work order Take device to shop Check MAUDE for similar incidents Test device Take and upload photos Look up product info online Call manufacturer for product information Download or examine history log

Communications Send/read e-mail regarding incident report On phone regarding incident report Go to incident site, talk to person(s) involved

Other: ____________________________ Part of Shift Explants 0-2 hours 2-4 hours 4-6 hours 6-8 hours 8+ hours Create monthly trackable explant report Update incident report with explant date Pick up explants

Travel Talk to someone at department

Process non-trackable explants Identify batch/product/lot number Investigate cause of harm or failure Tag & sequester device Dispose of non-trackable device Package explants to be shipped Take and edit photos

Process trackable explants Verify model/serial number of explant on report Investigate causes of harm or failure Tag and sequester trackable devices Package explants to be shipped Take and edit photos

Communications Send/read e-mail regarding explants On phone regarding explants On phone regarding shipping/packaging logistics

Other: ____________________________

APPENDIX B: Work Distribution Study Data Collection Sheets

B-2

Part of Shift Other 0-2 hours 2-4 hours 4-6 hours 6-8 hours 8+ hours Respond to pager Meeting Training Repair device Consult with technician Install new equipment Organize files/desk Check status of preventive maintenance program Personal

Wash hands Use restroom Lunch/other breaks

Other: ____________________________ Other: ____________________________

B-3

Name: _________________________ Start Time: ________ am/pm Date: 03/___ /10 End Time: ________ am/pm Day of Week: M Tu W Th F Part of Shift IRB Proposals 0-2 hours 2-4 hours 4-6 hours 6-8 hours 8+ hours Read e-mail requests Review research project on eResearch Investigate device

Use Internet to review proposed use Assess risk of device on FDA site Search for FDA 510K for device Check MAUDE database for reported failures Search MAXIMO database Create document with research information Contact proposee regarding proposal Schedule an appointment to test device Visit worksite to test device

Provide advice to IRB Send e-mail with findings/recommendations of

risk On phone regarding recommendation

Other: ____________________________ Other: ____________________________ Part of Shift Other 0-2 hours 2-4 hours 4-6 hours 6-8 hours 8+ hours Respond to pager Meeting Training Repair device Consult with technician Install new equipment Organize files/desk Check status of preventive maintenance program Personal

Wash hands Use restroom Lunch/other breaks

Other: ____________________________ Other: ____________________________

C-1

APPENDIX C: Breakdowns of activity frequency under each category

47.67

16.0613.47

8.8113.99

0

10

20

30

40

50

60

% o

f Tim

e Sp

ent

% of Total 'Other' Time Spent on Each ActivityMarch 15-26, 2010 - All 3 CE’s total workload with overall N = 190

C-2

20.4317.74

16.13

8.6

5.38 4.84 4.3 3.76 3.23 2.69 2.69 2.15 1.61 1.61

4.86

0

5

10

15

20

25

% o

f Tim

e Sp

ent

% of Total 'IRB Proposals' Time Spent on Each ActivityMarch 15-26, 2010 - 1 CE’s total workload with overall N = 189

36

17.33

12

6.67 6.67 6.67 5.33 4 5.33

0

5

10

15

20

25

30

35

40

% o

f Tim

e Sp

ent

% of Total 'Explants' Time Spent on Each ActivityMarch 15-26, 2010 - 2 CE’s total workload with overall N = 75

D-1

Requires expertise Does not require expertise Activity Category Download/read incident reports Incident Reports Use Maximo database Incident Reports Update incident report Incident Reports Travel Incident Reports Talk to party involved Incident Reports Match new device to incident report Incident Reports Open/File work order Incident Reports Take device to shop Incident Reports Check MAUDE for similar incidents Incident Reports Test device Incident Reports Take and upload photos Incident Reports Look up product info online Incident Reports Call manufacturer for product information Incident Reports Download or examine history log Incident Reports Send/read e-mail regarding incident report Incident Reports On phone regarding incident report Incident Reports Go to incident site, talk to person(s) involved Incident Reports PACKAGE DEVICE Incident Reports ASSIST LOCATE DEVICE Incident Reports JHW DEFECTIVE DEVICE Incident Reports Create monthly trackable explant report Explants Update incident report with explant date Explants Travel Explants Talk to someone at department Explants Identify batch/product/lot number Explants Investigate cause of harm or failure Explants Tag & sequester device Explants Dispose of non-trackable device Explants Package explants to be shipped Explants Take and edit photos Explants Verify model/serial number of explant on report Explants Investigate causes of harm or failure Explants Tag and sequester trackable devices Explants Package explants to be shipped Explants Take and edit photos Explants Send/read e-mail regarding explants Explants On phone regarding explants Explants On phone regarding shipping/packaging logistics Explants Read e-mail requests IRB Proposals Review research project on eResearch IRB Proposals Investigate device IRB Proposals Use Internet to review proposed use IRB Proposals Assess risk of device on FDA site IRB Proposals Search for FDA 510K for device IRB Proposals Check MAUDE database for reported failures IRB Proposals Search MAXIMO database IRB Proposals Create document with research information IRB Proposals Contact proposee regarding proposal IRB Proposals

APPENDIX D: Familiarity/Expertise Assessment for All Activities

D-2

Schedule an appointment to test device IRB Proposals Visit worksite to test device IRB Proposals Provide advice to IRB IRB Proposals Send e-mail with findings/recommendations of risk IRB Proposals On phone regarding recommendation IRB Proposals CALL IRB MED IRB Proposals MAXIMO MAINTENANCE IRB Proposals LOG INTO COMPUTER IRB Proposals FAX TIME SHEET IRB Proposals CONSTRUCTION PROJECT OVERVIEW IRB Proposals SETUP PM SCH IN MAXIMO IRB Proposals REVIEW CALENDAR IRB Proposals PROJECT WORK 6E MOTT IRB Proposals COVERING CALLS IRB Proposals FILL COFFEE MUG IRB Proposals REVIEW PREVIOUS STUDY IRB Proposals WORKING WITH ENGINEERING STUDENT IRB Proposals

D-3

Familiarity/Expertise Assessment by Category

Requires familiarity Does NOT require familiarity

Incident Reports - Top Ten Activities

by % of Total Time Spent excluding “Other” category # Task % 1 Update incident report 19.11 2 PACKAGE DEVICE 5.55 3 Send/read e-mail regarding incident report 4.47 4 Talk to party involved 3.54 5 Download/read incident reports 3.39 6 Test device 3.39 7 Travel 3.24 8 Download or examine history log 2.77 9 Go to incident site, talk to person(s) involved 2.47 10 On phone regarding incident report 2.00

Explants - Top Ten Activities

by % of Total Time Spent excluding “Other” category # Task % 1 Package explants to be shipped 4.16 2 Create monthly trackable explant report 2.00 3 Travel 1.39 4 Investigate causes of harm or failure 0.77 5 Verify model/serial number of explant on report 0.77 6 Update incident report with explant date 0.77 7 Talk to party involved 0.62 8 Tag and sequester trackable devices 0.46 9 Take and upload photos 0.31 10 Investigate cause of harm or failure 0.15

IRB Proposals - Top Ten Activities by % of Total Time Spent excluding “Other” category

# Task % 1 Read e-mail requests 5.86 2 Review research project on eResearch 5.08 3 Create document with research information 4.62 4 Visit worksite to test device 2.47 5 CONSTRUCTION PROJECT REVIEW 1.54 6 LOG INTO COMPUTER 1.39 7 Contact proposee regarding proposal 1.23 8 Check MAUDE database for reported failures 1.08 9 Use Internet to review proposed use 0.92 10 PROJECT WORK AT 6E MOTT 0.77

E-1

Appendix E: FTE Calculations

FTE Calculations Based on the team’s findings, the two hiring options are to 1) hire a part-time administrative employee or 2) hire a full-time CE to process incident reports and explants. To understand the effectiveness of each hiring option, the team performed FTE calculations to find the number of quarters until the incident report workload for each CE returns to current levels. The calculations were based on the following assumptions: • The proportion of work that does not require familiarity for incident reports is 22%, which

was found from the team’s work distribution study • The current incident report workload is being addressed by the current staff on time (i.e. all

incident reports received are processed) • The linear regression is an effective representation of the rate of increase in the number of

incident reports for the near future • Any new employee will begin work in Q3 2010 • The necessary communication between the CE’s and an administrative assistant will result

in an estimated 30% loss of efficiency First, the team estimated the number of incident reports completed per FTE using Equation 4 by dividing the number of incident reports completed by the available number of FTE’s. The number of incident reports, 511, is the total projected by the team’s model (Equation 1) for Q2 2010, the current quarter. The proportion of work CE’s accomplish that requires familiarity and/or expertise is 78%. Therefore, the number FTE’s available for incident reports, which do require familiarity, is 2 FTE’s times 78%. 511 incident reports / (2 FTE’s * 78% of work requiring familiarity) = 327.56 incident reports completed per FTE available (4) Option 1: Hire a part-time administrative employee To begin comparing the two options, the team found the additional number of FTE’s provided to the current CE’s by reallocating tasks that do not require CE familiarity to a part-time administrative employee. This number was found by multiplying the number of FTE’s working on incident reports, 2, with the current inefficient time, 22%, and the efficiency factor. This factor is 100% minus the 30% efficiency loss due to communication with the administrative employee, 100% - 30% = 70%. 2 FTE’s * 22% of work not requiring familiarity * 70% efficiency factor = .308 FTE’s additionally available from hiring an administrative employee (5) Next, the team found how many additional incident reports could be completed during the additional FTE’s available after reallocating the inefficient workload. The number of additional incident reports was calculated by multiplying the number of incident reports completed per FTE, 327.56 (from Equation 4) times the number of additional FTE’s available, .308 (from Equation 5). The team then found the number of quarters before each CE’s workload returned to

E-2

current levels. This calculation takes the value obtained in Equation 6 and divides the value by the rate of additional incident reports filed per quarter, 17.4, which is the slope of the linear regression model (from Equation 1). This calculation is shown in Equation 7. 327.56 incident reports/FTE * .308 FTE’s = 100.9 incident reports (6) 100.9 incident reports / 17.4 incident reports per quarter = 5.8 quarters until the workload returns to the current level (7) Option 2: Hire a full-time CE to process incident reports and explants To find the number of quarters until the incident report workload returns to the current level for option 2, the team first found the additional number of FTE’s available from adding a third full-time CE. This number was calculated as the additional FTE times the proportion of efficient work, 1 FTE * 78% = .78 FTE’s. Similar to the calculations performed for Option 1, the team found the number of quarters until the workload returns to the current level, as shown in Equations 8 and 9 below. 327.56 incident reports/FTE * .78 FTE’s= 255.5 incident reports (8) 255.5 incident reports/ 17.4 incident reports per quarter = 14.7 quarters until the workload returns to the current level (9)