1 Report of Pre-analytical Processes at Toronto East General Hospital (Submission for CLMA Pre-analytical Excellence Award) Marilyn Spagnoli, MLT, ART, BTech, MHS Director, Laboratory Services Toronto East General Hospital February 27, 2012 2 INTRODUCTION Toronto East General Hospital (TEGH) is a 515-bed, urban, full service community teaching hospital comprised of acute care, rehabilitation, complex continuing care, and mental health beds, as well as ambulatory, emergency, diagnostic and laboratory services. On an annual basis, TEGH has over 60,000 emergency visits, over 20,000 acute care admissions, delivers approximately 3500 babies, and serves the needs of over 220,000 patients within its ambulatory care programs. The department of Laboratory Medicine embraces the hospital’s vision to be the leader in quality and value. A quality management system serves to articulate all policies/processes/procedures while maintaining records of quality activities. Our success in laboratory pre-analytical processes exemplifies our commitment to the hospital’s mission and deep-seated accountability framework and success factors: patient focus, ensure value, encourage people, collaborative spirit and inspire innovation. Laboratory processes (pre-analytical, analytical and post-analytical) are patient focused as we strive for safety, quality, and timeliness. The efficiencies created ensure value and appropriate use of resources. We appreciate our people and have made the investment in training, communication and healthy, safe workplace. Our excellence is a result of extensive collaboration within and between departments and with our vendor partners. Technology has enabled significant innovation; however, creativity, training and communication have a major role. This report presents an integrated approach, with a combination of preanalytical processes, to improve patient safety and ensure high quality laboratory results. 3 PRE-ANALYTICAL PROCESSES: Electronic Order Entry Laboratory orders are placed on the nursing units using the hospital information system (HIS). Specimen labels are generated via the laboratory information system (LIS) based on the orders placed in the HIS as translated to the LIS by an orders interface. The specimen tube types and volumes required are set in the LIS and the appropriate labels are then generated accordingly. Building the orders interface required extensive collaboration between laboratory staff, information technology services and patient care areas to ensure appropriate order entry processes were in place before processes were converted to electronic formats. The concept of order sets was created to provide an intuitive ease of ordering for the end user while managing utilization of laboratory tests. Electronic laboratory order entry has been in place for over a decade, where nursing or clerical staff would input physician’s orders. Such electronic order entry processes served to build a sound foundation for the computerized provider order entry (CPOE). In 2010, CPOE was implemented hospital wide. Laboratory resources were integrally involved in the planning and implementation of the project. Order sets were standardized in consultation with laboratory leaders to strengthen appropriate utilization. Planning and implementation of this project included physician participation, redundant/downtime plans, extensive training, extensive change management and physician adoption strategies. CPOE has improved clarity in physician’s orders, utilization and standardized care. Improved efficiencies have resulted in more appropriate use of resources and improved timeliness of laboratory results. This initiative is an enabler of patient safety, increasing the quality of patient care through standardized 4 order sets that support best practices. The system supports availability of active clinical decision support and reminders. Work flow is improved through streamlined care processes and reduced turnaround times for patient investigations and therapies. Improved communication between clinicians and the system strengthens training of locums or trainees for adoption of best practices. CPOE also provides the opportunity for remote access to order entry. Overall, CPOE supports data driven clinical and management decision making. Patient identification Patient identification mishaps are the greatest source of error for laboratories. At TEGH, patients are uniquely identified using a hospital identifier on an armband. The hospital has a policy that emphasizes positive patient identification using at least two client identifiers prior to the provision of any service or procedure. Patient identification is sought proactively versus retrospectively; wherever possible, the patient is involved in the identification process. For personal information such as the patient’s name or date of birth, the patient is asked to state the information in its entirety, rather than asking for a passive agreement. Acceptable patient identifiers include the patient’s name (first, middle and surname), date of birth, hospital number and/or the patient’s health card number. Positive patient identification protocols are imparted during clinical orientation sessions for new employees and are regularly communicated by nursing practice leaders to ensure adherence to the policy. Recent improvements in the health card validation process have also strengthened patient identification efforts. Staff are now able to validate the patient’s health card number through the HIS. If there are discrepancies between the information provided by 5 the Ministry of Health and information in the HIS, a window appears displaying both sets of information. Staff reviews both lists to identify the mismatch and then copy the Ministry information into the HIS. Information compared includes: patient name(s), gender and date of birth. Specimen Collection In order to achieve the highest quality of laboratory results, specimens must be submitted correctly. Specimen rejections are often due to inappropriate submission or incorrect specimens. The hospital employs a dedicated phlebotomy team collection model for routine in-patient and out-patients. However, a nurse collection model exists in Emergency and in critical care areas. Education on specimen collection and general laboratory information is provided to clinical staff as part of orientation and on an ongoing basis to reinforce compliance. An on-line specimen collection manual and specimen dictionary is readily available through the hospital intranet. These documents reflect the most current versions as they are directly linked to the laboratory’s quality management document control system. Labels for specimen collection indicate the required specimen tube type for the requested test and the multiple tube/containers required. Barcode technology is used on the label to enable a fully automated laboratory system. Recently, a Lab Roadshow was used to demonstrate the specimen collection containers and their appropriate application (see Appendix A). The ‘Lab Roadshow’ visited all nursing areas to make for a short presentation. Additional sessions were available on request and targeted sessions were also arranged for areas that were trending 6 higher numbers of specimen rejections. Laminated posters were also created to depict appropriate specimen collection containers which were posted in clean utility rooms for ongoing reference. A reduction in the number of specimen rejection was observed following these interventions (see Appendix B). When specimen submissions are incorrect, an electronic incident reporting system facilitates easily accessible reporting. The hospital supports a ‘just culture’ of patient safety and encourages reporting of all incident and adverse events. Incident reporting pertaining to laboratory testing is categorized as pre-analytical, analytical and post- analytical. Incident reports are referred to risk management and back to the departments involved to identify root causes, trends, patterns and corrective action plans where required. Transport The importance of timely transport to the laboratory cannot be understated. A pneumatic tube system links several key areas such as Emergency, critical care areas and oncology, with the receiving area of the laboratory. The tube system is maintained and monitored regularly to ensure specimen integrity. A portering system is used for other areas and for those specimens not able to be transported by the tube. An electronic tele- tracking system is used to ensure appropriate prioritization and accountability for transport. Technology: Preanalytical Laboratory Automation In 2011, the Roche Modular Pre-analytical Automation (MPA) was fully implemented to receive, centrifuge, aliquot and sort all laboratory specimens. Despite only the chemistry analyzers being fully integrated, all core lab blood work is received 7 and processed using the automation. Specimens are sorted by a technician on designated racks and then directly loaded onto the instrument. The technology is fully interfaced with the HIS, LIS and the connected analyzers. Specimen receipt in the lab is acknowledged in the patient record via the interface. Decapping, centrifuging, and aliquotting are automated, on-line as defined in the interface according to test requirements. A laboratory technician is responsible for overseeing the pre-analytical technology and addressing any errors/alarms as they occur. The automation requires minimal maintenance; however, a certain comfort level is required for acceptance. Extensive training and support for all staff was provided by the vendor prior to implementation. Training included both didactic and hands-on education. The uptake by the lab technician group was exceptional as this group had limited exposure and experience with such advanced technology. The MPA has allowed continuous processing, eliminating the need for interrupted loading of stat specimens. It has also limited the use of batch testing thus reducing manual intervention of storage and retrieval. The automation has significantly increased the speed at which patient samples are processed in the sample receiving area. Diminished reliance on technical staff for manual tasks has allowed technologists to concentrate on more specialized tasks. This fully automated platform has allowed the laboratory to absorb increased volumes without increasing staff. It is ergonomically sound, thus eliminating many of the staff health and safety risks associated with manual sample handling. The system also keeps the primary tubes “pristine” to ensure that samples are not contaminated, thereby reducing potential sampling errors. In addition to 8 the pre-analytical advantages, the system automatically archives samples for ease of retrieval. EVIDENCE Traditionally, turnaround times for laboratory results have served as the principle performance indicator. In looking for other meaningful measures we adopted a strategy- in-a-page process. Multiple stakeholders worked collectively through the process to reach the ultimate goal of consistently providing timely high-quality lab results. The primary gap was consistency and predictability in our turnaround time. Contributing factors were identified under three categories: equipment/technology, people, and processes. Tactics for improvement included: improved communication, expanding use of the MPA, training, and minimizing downtimes. Metrics for the tactics were identified and captured as lead metrics. Lead metrics, associated more closely with inputs, measure the tactics used to achieve our goal. Lag metrics measure the end result or outputs, which we determined to be the test result turnaround times (see Appendix C). Average turnaround times and predictability generally exceed benchmarks. Upon further investigation for continuous improvement, delays were found to be predominantly due to instrument downtimes, barcode reader malfunctions and/or staffing transition times. Metrics are reported daily at the departmental huddle each morning. Huddles provide an effective venue for communicating issues and problems as well as positive corroboration for successes. Continuous improvement is the main goal. Metrics are reviewed on a regular basis and changed as goals are achieved and other opportunities for improvement are identified. The laboratory huddle is well attended by staff and with exceptional enthusiasm. Ideas are solicited and welcomed for additional process 9 improvements. Such departmental huddles are held throughout the hospital and staff are encouraged to visit other unit’s huddles to engage in system wide collaboration. Members from the hospital executive team regularly visit the laboratory huddle imparting acknowledgment and support. Improvement plans are prepared collectively and shared with all staff to empower and engage staff in their respective areas. Laboratory staff feel valued when they understand the organization’s commitment to improving pre-analytical processes. Laboratory accomplishments are clearly demonstrated by the metrics and staff feels a sense of pride. Laboratory technicians are empowered to function at a higher level while within their scope of practice. In a recent staff satisfaction survey, results indicated a high level of employee commitment and overall satisfaction. Effective change management, communication and training for implementing significant technology changes have all contributed to these results. CONCLUSION Understanding the importance of pre-analytical processes and collaboration across the organization has led to ongoing improvements. The organization continues to adopt a comprehensive approach to ensure the highest quality laboratory results with the implementation of best practices and technology. Future work is planned to use barcode technology for positive patient identification and specimen collection to further enhance patient safety. The organizational culture of continuous improvement enables patient safety and quality improvement initiatives. Support from senior management has allowed the laboratory to excel and raise its profile as an essential contributor to patient care and safety. 10 APPENDIX A- ‘LAB ROAD SHOW’ The “Lab Road Show” cart is used to provide ‘show and tell’ about specimen collection. The cart displays an assortment of specimen containers and is used to communicate specimen collection information. The communication was conducted initially by a laboratory manager together with a lab technician and later only by lab technicians. The cart was also used to distribute laminated posters of the collection which were posted in clean utility rooms for ongoing reference. 11 APPENDIX B- SPECIMEN REJECTIONS Specimen rejections have decreased. Initiatives such as the ‘Lab Road Show’ and other targeted education sessions have contributed. Ongoing communication and education is required to sustain and further reduce rejections. *Data does not include rejections for Pathology, Blood Bank and Coagulation Labs. 12 APPENDIX C – TURNAROUND TIME METRICS Figure 1. Average turnaround time for complete blood cell counts (CBC) for 2011 (time of receipt in lab to time verified) The target for predictability is that 85% of stat CBC tests are verified within the target average TAT (45 min form Jan –Apr; 30 min. from May-Dec). Commencing March 2011, CBC tests were received using the MPA and manually transferred to CBC analyzer. Based on successes, the target was reduced from 45 min. to 30 min. in May. Figure 2. Predictability of turnaround time for CBCs for 2011 (time of receipt to time verified) The target for predictability is 85% of stat CBC tests are verified within the target average TAT (45 min form Jan –Apr; 30 min. from May-Dec). The predictability dropped slightly when the target was reduced to 30 min. in May. 13 Figure 3. Average turnaround time for Electrolytes (Na, K, Cl, CO2) for 2011 (time of receipt to time verified) The target for average TAT of electrolytes is 45 min. Routine chemistry testing was integrated on the MPA in Nov 2010. Average TAT was consistently at or below the 45 minute target. The average TAT dropped further once all core lab specimen were received using the MPA due to standardized processing. Figure 4. Predictability of turnaround time for Electrolytes (Na, K, Cl, CO2) for 2011 (time of receipt to time verified) The target for predictability is 75% of stat electrolytes tests are verified within the target average TAT of 45 min. Predictability was trending close to target and exceeded the target once standardized processing came in effect.
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