FALL 2013 VOL. 7 NO. 1, pp. 114-123 Risk Assessment as Standard Work in Design Patricia W. Morrill, PMP, EDAC ABSTRACT OBJECTIVE: This case study article examines a formal risk assessment as part of the decision making process for design solutions in high risk areas. The overview of the Failure Modes and Effects Analysis (FMEA) tool with examples of its application in hospital building projects will demonstrate the benefit of those structured conversations. RESULTS: In both cases, participants uncovered key areas of risk enabling them to take the necessary next steps. While the focus of this article is not the actual design solution, it is apparent that the risk assessment brought clarity to the situations resulting in prompt decision making about facility solutions. BACKGROUND: This article illustrates how two hospitals used FMEA when integrating operational processes with building projects: (1) adjacency decision for Intensive Care Unit (ICU); and (2) distance concern for handling of specimens from Surgery to Lab. CONCLUSIONS: Hospitals are inherently risky environments; therefore, use of the formal risk assessment process, FMEA, is an opportunity for design professionals to apply more rigor to design decision making when facility solutions impact operations in high risk areas. METHODS: Both case studies involved interviews that exposed facility solution concerns. Just-in-time studies using the FMEA followed the same risk assessment process with the same workshop facilitator involving structured conversations in analyzing risks. KEYWORDS: Case study, decision making, hospital, infection control, strategy, work environment AUTHOR AFFILIATIONS: Patricia W. Morrill is the President of PM Healthcare Consulting, LLC, in Caledonia, Wisconsin. CORRESPONDING AUTHOR: Patricia W. Morrill, President of PM Healthcare Consulting, LLC, P.O. Box 287, Caledonia, WI 53108; pmorrill@ pmhcconsulting.com; (262) 639-6700. 114WWW.HERDJOURNAL.COM PREFERRED CITATION: Morrill, P. W. (2013). Risk assessment as standard work in design. Health Environments Research & Design Journal, 7(1), 114-123. 2013 VENDOME GROUP LLC RISK ASSESSMENT IN DESIGN CASE STUDY H ealthcare environments are ironically and yet inherently laden with risk. Staff must be diligent in disposing of needles, solutions and biohazardous waste in appropriate receptacles. The high rate of hospital-acquired infections (HAIs) has increased the exposure of patients and healthcare staff to noxious cleaning solutions and chemically treated surfaces. These are well-known, day-to-day potential hazards that patients and staff encounter. Healthcare facility designers must stay abreast of new products on the market to alleviate the spread of infection from surface materials. This article examines the benefits of addressing potential physical environment risks as standard work in design projects. Standard work is defined as a step-by-step description of the actions and tools needed to complete a task (Touissant & Gerard, 2010). For the purposes of this article, \"task\" involves the facility planning process. Standard work is established through analysis, observation, and employee involvement. Employees are involved because the people closest to By incorporating risk assessment as the work understand it best (Manos & Vincent, 2012). As we strive to improve healthcare delivery processes, we can simul- standard work, design professionals taneously seek better facility solutions that support safer envican increase rigor of informed ronments. By incorporating risk assessment as standard work, design and decision making. design professionals can increase rigor of informed design and decision making. Background This case study article describes two examples of how risk assessments have been used in hospital design projects. Hospital A is a replacement critical access hospital with a total capacity of 25 beds accommodating medical/surgical, critical care, and obstetric patients. Hospital B is a rural integrated hospital and clinic with a phased replacement project with 50 beds. In early 2000at the urging of The Joint Commissionhospitals started using the Failure Mode and Effects Analysis (FMEA) to analyze medication errors. FMEA is a model used to prioritize potential defects based on their severity, expected frequency, and likelihood of detection (MoreSteam.com, 2013), with broad potential for application, including in design. John Reiling, past CEO of St. Joseph's Hospital in West Bend, Wisconsin, that opened in 2005, authored several articles about the design process used to focus on safety. The use of failure mode and effects analysis, patient focus groups, mock-ups with employee evaluation, and checklist safety design principles (latent conditions and active failures) helped St. Joseph's create the safest room they could envision (Reiling, Hughes & Murphy, 2008). Begun in the 1940s by the U.S. military, FMEA was further refined by the aerospace and automotive industries. The purpose of the FMEA is to take actions to eliminate or reduce failures (American Society for Quality, 2013a). Failures in healthcare have become increasingly transparent via website reporting of infections and satisfaction comparison ratings. Healthcare reform has exposed the high incidence and unacceptable cost of preventable infections and injuries. Six 2013 VENDOME GROUP LLC HEALTH ENVIRONMENTS RESEARCH & DESIGN JOURNAL 115 CASE STUDY FALL 2013 VOL. 7 NO. 1, pp. 114-123 Sigma training includes FMEA as part of the \"Define\" and \"Improve\" phases (MoreSteam.com, 2013) of the DMAIC methodology: Define a problem or improvement opportunity; Measure process performance; Analyze the process to determine the root causes of poor performance; Improve the process by attacking root causes; and Control the improved process to hold the gains (American Society for Quality, 2013b). With the continued high rate of harm in hospitals, design professionals must be alert to assessing risk potential in their design projects. The case studies presented here offer two examples of two questions raised: one during design, and one during occupancy planning, which should have been addressed during design. This article does not advocate one solution for each question, but rather promotes the risk assessment process to expose the best design decision for high risk areas. Method For Hospital A, the author conducted a current state workflow assessment at the start of pre-design that involved individual interviews and observation. Opportunities for improvement were documented and prioritized based on workflow issues with a space impact. The location of the intensive care unit was identified as a top priority. With differing opinions about the location of this high risk patient care area, the author recommended the FMEA process. For Hospital B, during the occupancy planning phase, the author conducted Lean A3 problem solving training, then individual interviews with hospital leadership to assess their problem-solving process. The lab leadership interviews identified a workflow challenge created by design decisions that needed resolution prior to occupancy. The problem concerned the high risk handling of frozen specimens and the author recommended the FMEA process. The FMEA process was recommended in both cases because of the time constraints related to the building projects. The intent of the just-in-time study with the FMEA tool was to influence decision making; the research involved the investigation of whether the FMEA process did benefit facility decisions. The process involved the following steps in a workshop setting facilitated by the author, a trained quality professional in Lean and Six Sigma, serving in a consultant role: 1. An interdisciplinary team was assembled, representing content expertise, executive leadership for prompt decision making, and at least one individual not familiar with the process who could ask probing questions. 2. The team was provided with just-in-time training about the FMEA tool with a healthcare example. 3. A high-level flow diagram of the process being analyzed was developed. 4. From the flow diagram, a process step was selected as a priority for the risk assessment. 116WWW.HERDJOURNAL.COM 2013 VENDOME GROUP LLC RISK ASSESSMENT IN DESIGN CASE STUDY 5. Using the FMEA tool, the team: Discussed potential failures involved in the process step. Identified the effects of each failure. Scored the level of severity (on a scale of 1-10 with a definition of each level). Identified the potential causes of the failure. Scored the likelihood that each cause might occur (1-10). Identified the controls in place for the failure. Scored the probability that the controls would detect each cause (1-10). Multiplied each of the scores for the risk priority number (RPN), therefore: severity occurrence detection = RPN. Finally, documented the recommended actions. Hospital ACritical Access Hospital Design question: Should the two-bed intensive care unit (ICU) be located adjacent to the emergency department (ED) or the medical/surgical (med/surg) inpatient unit? This question often arises in small hospitals that need to crosstrain nursing staff to flex between units based on census. A pre-design workflow and facility assessment of the existing hospital condition identified risks with the isolated location of ICU being staffed with only one or two nurses who needed to focus on patient care while also needing to retrieve supplies and equipment stored away from the ICU rooms. To provide a safer environment, hospital officials wanted ICU to be immediately adjacent to either the emergency department or the med/surg unit for improved access to other nursing staff, supplies, and equipment. ResultsHospital A Design question: Should the After identifying the various support needs of ICU during the two-bed intensive care unit high-level flow discussion in the FMEA workshop (see Figure 1), participants agreed that the lack of proximity of supplies, be located adjacent to the equipment, and medications to nurses was the risk to analyze. emergency department or the The discussion identified the potentially serious implications of distant supplies, equipment, and medications as documentmedical/surgical inpatient unit? ed in the FMEA tool (see Table 1). Given the unacceptable cost of duplicating equipment, the adjacencies to ICU were essential in reducing risk. From this analysis, the decision was made to locate the ICU adjacent to Med/ Surg based on (1) more similar care; (2) hospitalist overlap; (3) ICU nursing's ability to provide expertise to Med/Surg; (4) shared supplies; (5) shared meds; and (6) shared technology. The FMEA benefit realized in this case was the clear depiction of commonalities between ICU and med/surg, leaving no doubt in decision making. This hospital is under construction at the time of this writing. 2013 VENDOME GROUP LLC HEALTH ENVIRONMENTS RESEARCH & DESIGN JOURNAL 117 118WWW.HERDJOURNAL.COM Pastoral Care Case Management Family Family Lab Admitting Pre-Admit Open Unit Charts, phones Nurse Runner to get equipment, such as BIPAP, vents, IVs, commodes Equipment Off the Unit Med/Surg Surgery Med/Surg Access to: Toilet Break room Equipment on Unit and Nearby Responsibilities Clerk Med/Surg Runner to get supplies, such as dressings Supplies Central Supply Materials Mgmt Med/Surg Logistics: not enough staffing to leave Unit Hospitalist MD in Office Risk: Availability of service Diagnostic Imaging, CT Nuclear Medicine Risk: Code on elevator during transport Figure 1. Hospital AICU primary support needs in consideration of best adjacency. Supervisor I/T ICU Nurse runs ventilator Cardiopulmonary for EKGs Risk: Availability M-F / On-call Housekeeping Runner for Pyxis (Supervisor, Nurse) Pharmacy Med/Surg Identifies key commonalities with Med/Surg Med/Surg Dietary CASE STUDY FALL 2013 VOL. 7 NO. 1, pp. 114-123 2013 VENDOME GROUP LLC RISK ASSESSMENT IN DESIGN CASE STUDY Hospital BRural Integrated Hospital and Clinic Occupancy Planning Question: How can frozen specimens be transported safely and quickly from operating rooms (ORs) in a new building to the lab remaining in an attached facility? (See Figure 2.) During Lean A3 Problem Solving training sessions, this question was raised and the lab leadership agreed to hold an FMEA workshop because of the risks involved in handling frozen specimens. This question, as is the one for Hospital A, is frequently discussed during design when faced with the options of a STAT lab near surgery or a distance dilemma when timing is of the essence, as in this case, with a patient remaining in the operating room until pathology results are known. For this particular hospital project, it was decided late in design to remove the STAT lab (due to staffing and cost issues), though the operational impact was not addressed until occupancy planning was underway. ResultsHospital B The FMEA workshop participants discussed the risks involved when pathology is not alerted to a STAT specimen from the OR, whether the specimen transport occurs via pneumatic tube or walked by courier as documented in the FMEA tool (see Table 2). The pneumatic tube usage for specimens from the OR was a new process for this hospital to plan for with Occupancy planning question: How can frozen specimens be transported safely and quickly from operating rooms in a new building to the lab remaining in an attached facility? Figure 2. Hospital BDistance concern for specimen transport from surgery to lab. Surgery NEW HOSPITAL Phase 1 Replacement Campus CLINIC Lab VACATED HOSPITAL Offices and Support Functions Only 2013 VENDOME GROUP LLC HEALTH ENVIRONMENTS RESEARCH & DESIGN JOURNAL 119 CASE STUDY FALL 2013 VOL. 7 NO. 1, pp. 114-123 Table 1. Failure Modes and Effects Analysis (FMEA). ITEM: LEAD: CORE TEAM: Location of an Intensive Care Unit (ICU) in a Critical Access Hospital Lean Six Sigma Consultant Team: Administration, Nursing, Facilities, Architect Process Step: Identify systems and functions Potential Failure Mode: What are the potential failure modes that could occur in this function? Potential Effect(s) of Failure: What are potential effects of each failure mode? Severity: Severity of effects Potential Cause(s) / Mechanism(s) of Failure: What are the potential causes of the failure mode? Occurrence: Likelihood of each cause Current Controls: List controls for each failure mode Detection: Probability of detecting each cause with controls R. P. N.: Risk Priority Number S x O x D Process Step: Bringing resources to the ICU, especially supplies, equipment, medications. of Failure\tSeverity Potential Effect(s) Potential Cause(s) / Mechanism(s) of Failure\tOccurrence\tCurrent Controls\tDetection\tR. P. N. Potential Failure Mode: IVs not on site Life/death: med, 10 supply, equipment Space 10 constraints Par levels, centralized stock 1 Hospital formulary for each Pyxis 6 Supervisors 4 100 \u0007No one available Quality of care 9 Financial constraints\t10 to help be a runner (duplication of equipment, par levels) \u0007 on't have D what's needed Delay in care 8 \u0007Insufficient Staff satisfaction 6 Asset management 9 storage \u0007 on't want to D duplicate Patient/family 6 satisfaction (staff running around) I\u0007n use elsewhere (not enough due to cost) Information management 9 Labor 9 \u0007 an't locate C what's needed P\u0007 ar level out so no one to restock \u0007 eds not on M premises \u0007No bariatric furniture RECOMMENDED ACTION(S):\u0007ICU adjacency to med/surg based on (1) more similar care; (2) hospitalist overlap; (3) ICU can provide expertise to med/surg; (4) shared supplies; (5) shared meds; (6) shared technology. 120WWW.HERDJOURNAL.COM 2013 VENDOME GROUP LLC RISK ASSESSMENT IN DESIGN CASE STUDY the surgery department opening in a more distant location. The group realized they needed (1) more information from the pneumatic tube vendor about STAT alerts, and (2) to work with OR staff about calling to notify pathology of the OR specimen. This FMEA workshop occurred 5 months prior to occupancy. The Lab Director of Hospital B (who had participated in the FMEA workshop) was interviewed 1 year post-occupancy and shared that: All frozens are successfully tubed from the OR. It was a \"change\" that the surgeons had to get comfortable with and have confidence in the pneumatic tube. Initially, some continued to walk the specimens over, but that ended very quickly. The team took each type of specimen, met with the areas that would be sending that type of specimen, determined the best flow, and created a chart as a guide for how to package and how to transport. It is attached to the pneumatic tube policy. Table 2. Hospital BFailure Modes and Effects Analysis (FMEA). ITEM: LEAD: CORE TEAM: Frozen Specimen from Surgery to Lab in a Rural Hospital Distance Created with Design of Replacement Campus, Phase 1 Lean Six Sigma Consultant Administration, Lab, Process Improvement, Quality Process Step: Identify systems and functions Potential Failure Mode: What are the potential failure modes that could occur in this function? Potential Effect(s) of Failure: What are potential effects of each failure mode? Severity: Severity of effects Potential Cause(s) / Mechanism(s) of Failure: What are the potential causes of the failure mode? Occurrence: Likelihood of each cause Current Controls: List controls for each failure mode. Detection: Probability of detecting each cause with controls R. P. N.: Risk Priority Number S x O x D Process Step: Lab specimen processing courier Potential Failure Mode: Potential Effect(s) of Failure\tSeverity Specimen not Delay in reporting 7 marked STAT Delay in courier 7 to pathology \u0007Delay in OR (Note: Not the right attendees to address delay in OR) Potential Cause(s) / Mechanism(s) of Failure\tOccurrence\tCurrent Controls\tDetection\tR. P. N. Human error 7 Pneumatic tube 3 does not alert (design failure from vendor) Call from OR 2 98 Green form with specimen 2 42 RECOMMENDED ACTION(S): (1) Do an FMEA on the current control identified: call from OR; (2) consult with vendor regarding pneumatic tube alert. 2013 VENDOME GROUP LLC HEALTH ENVIRONMENTS RESEARCH & DESIGN JOURNAL 121 CASE STUDY FALL 2013 VOL. 7 NO. 1, pp. 114-123 When asked about the follow-up needed and identified in the FMEA process, the Lab Director responded that: The OR calls the pathology department when they are sending a frozen. This alert is working consistently and we have not had any delays. We are at 100% compliance for our turnaround goal of 20 minutes for frozen sections. The formal FMEA risk assessment process helped the participants focus their discussion and prioritize next steps resulting in successful decision making and outcomes. Conclusion and Recommendation These two cases demonstrate the FMEA process informing facility decisions. For Hospital A, it resulted in locating the ICU adjacent to the medical/surgical unit and not the emergency department. For Hospital B, it resulted in transporting specimens from the operating room to pathology via pneumatic tube instead of physically walking the long distance. Both hospitals were faced with decisions that involved potential delays in patient care and the FMEA structured conversations generated solutions focused on safely integrating operations and the physical environment. The FMEA process brought clarity in situations in which the solutions were not obvious and there were differing opinions. As referenced on The Joint Commission website, the physical environment is a cause of sentinel events (i.e., unexpected death or serious injury or the risk of these types of death or injury). There were a total of 901 sentinel events reported to The Joint Commission in 2012. The 10 most common root causes of these events are: 1. Human factors 2.\tLeadership 3.\tCommunication 4.\tAssessment 5. Information management 6. Physical environment 7. Continuum of care 8. Operative care 9. Medication use 10.\tCare planning (Rodak, 2013) Many of these categories can be influenced by healthcare design professionals who can explore with hospital leadership a broader role for risk assessment during the design process. 122WWW.HERDJOURNAL.COM 2013 VENDOME GROUP LLC RISK ASSESSMENT IN DESIGN CASE STUDY The evidence provided in this study suggests a compelling opportunity to increase rigor in making design decisions that have an impact on operations. Given the inherent risk in healthcare environments and the demonstrated benefit of the FMEA process for decision making, it is recommended that design professionals include risk assessment as standard work within the \"task\" of facility planning. Implications for Practice Healthcare design teams are urged to include risk assessments as a routine and essential part of the facility planning process. As the pressure intensifies for hospitals to improve quality while reducing cost, facility planners need to understand the importance of risk analysis in decision making for design solutions. During pre-design, facility planners should bring forth the discussion with hospital leadership about who can fill the role as facilitator of risk assessment workshops as needed for design decision making. Structured conversations about potential risk add rigor to decision making about design solutions. Failure Modes and Effects Analysis (FMEA) is a proactive risk assessment process that can be included in a professional development training program. References American Society for Quality. (2013a). Failure mode effects analysis (FMEA). Retrieved from www.asq.org/learn-about-quality/process-analysis-tools/overview/fmea.html American Society for Quality. (2013b). Define measure analyze improve control (DMAIC). Retrieved from http://asq.org/learn-about-quality/six-sigma/overview/dmaic.html Manos, S., & Vincent, C., (Eds.). (2012). The Lean handbook: A guide to the bronze certification body of knowledge. Milwaukee, WI: ASQ Quality Press. MoreSteam.com. (2013). Failure modes & effects analysis (FMEA). Retrieved from www.moresteam.com/toolbox/fmea.cfm? Reiling, J., Hughes, R. G., & Murphy, M. R. (2008). The impact of facility design on patient safety. In R.G. Hughes, (Ed.), Patient safety and quality: An evidence-based handbook for nurses (Chapter 28). AHRQ Publication No. 08-0043. Rockville, MD: Agency for Healthcare Research and Quality. Retrieved from http://www.ahrq.gov/legacy/qual/nurseshdbk/docs/ ReilingJ_BEPD.pdf Rodak, S. (2013, February). Top 10 root causes of sentinel events. Becker's ASC Review. Retrieved from http://www.beckersasc.com/asc-quality-infection-control/top-10-root-causes-of-sentinel-events.html Touissant, J., & Gerard, R. (2010). On the mend: Revolutionizing healthcare to save lives and transform the industry. Cambridge, MA: Lean Enterprise Institute. 2013 VENDOME GROUP LLC HEALTH ENVIRONMENTS RESEARCH & DESIGN JOURNAL 123 Copyright of Health Environments Research & Design Journal (HERD) is the property of Vendome Group LLC and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use