Healthcare Barcoding and Safety Beyond Medication Ross Morrisson

Healthcare, Barcoding and Safety – Beyond Medication Ross Morrisson 1, Lauren Knish 1, Stuart Reasons 1 Advisors: Paul King, Ph. D. 1, Patrick Harris 2, David Roth 2 1 Design Goals Department of Biomedical Engineering, Vanderbilt University, Nashville, TN 2 Pharma. Sys Hospital Solutions, Cary, NC Software Design Problem Statement According to a study conducted by the Institute of Medicine, medical errors affect an estimated 1. 5 million people, killing several thousand in the United States each year and cost an estimated $1. 5 billion annually. As part of a wideranging effort to improve patient safety, on Feb. 25, 2004, the Food and Drug Administration (FDA) finalized a rule requiring bar codes on the labels of thousands of human drugs and biological products. The FDA estimates that the rule will help prevent nearly 500, 000 adverse events and transfusion errors while saving $93 billion in health costs over 20 years. Last year a group with Pharma. Sys completed software for medication verification. To meet FDA regulations, barcodes are also required on container labels of blood and blood components intended for transfusion. This year our group must expand the bar-coding software to include blood transfusion and specimen collection verification. Product Description (e. Meds) Software Development Guidelines Pharma. Sys Screen Shots SQAP – Software Quality Assurance (plan) • Planned systematic patterns of activities performed to assure the procedures, tools and techniques used during software development are adequate to provide the desired level of confidence in the final product. SRS – Software Requirements Specification • A specification for a particular software product, program or set of programs that perform certain functions. Use Cases Use Case - an SRS A Use Case describes how the system reacts to a user’s input actions. Possible Software Modifications Working with Pharma. Sys Hospital solutions we have expanded the e. Meds system. The e. Meds system is a point-of-care bedside product used by nurses to verify that patients are receiving the right medication as well as blood transfusions. If a conflict occurs during the administration the nurse will be notified. Our work included expanding the system both for blood transfusion as well as specimen collection. The benefits of the system are vast and include both patient safety as well as cost savings for the hospital and a reduction in paperwork. Furthermore the system ensures the patients “five rights “ before medication or transfusion administration. These rights are “right patient, right drug, right time, right dose, right administration route”. This wireless, mobile technology also allows nursing personnel to document information about the transfusion, including start and stop time and vital signs. The system also ensures that the operations of the pharmacy, physician, nurses and administration are all connected. The specimen collection system assists laboratory technicians in improving safety by providing positive patient identification for the patient and the lab test and ensuring that specimens are correctly bar-coded and labeled. Conclusions • • Conclusions and Future Directions Also includes: • Alternative Actions (optional note attachment) • Exceptions (something doesn’t check on the blood sample) • A Use Case has also been created dealing with Specimen Collection Our team has succeeded in expansion of a system that already helps reduce medication administration errors at the patient bedside, but now also includes verification for specimen collection and blood transfusion. Since we have a fully functional prototype, the next step would be to pilot and implement the e. MEDS system into a hospital in order to test the software and the hardware. Fitt’s Law Pharma. Sys, Inc. is an international full service contract compliance and validation firm specializing in industries that must comply with 21 CFR (Pharmaceuticals, Bioscience, Medical Devices and Clinical Trials) located in Cary, North Carolina. • They are currently developing the system, expanding the functionality, and testing the e. MEDs system in a hospital environment. • Identification Technology Fitt’s Law • Describes the time taken to acquire a visual target using some kind of manual input device. (finger, mouse etc. ) • Although there are many variants on Fitts' law the most commonly used is: Mean Time = C 1 + C 2 log 2(D/W + 0. 5) (1) D - is the distance to the center of the target W - is the target width C 1/C 2 - are experimentally determined constants. Screen Shots For future direction, it will be important to expand the system to include verification for breast milk delivery, as well as to make the system compatible for the emergency room (ER) and the operating room (OR) environments. In the new future, Pharma. Sys Hospital Solutions plans on piloting our prototype system for use in a hospital setting. In conclusion, our prototypes and our expansion of the e. MEDS system are just a starting point for future design and development of this bar-coding system. Acknowledgements Benefits of Linear Barcodes (FDA) • Well known technology • Lower cost • Easy to copy and print • Manual process ISBT 128 is the “global standard for the identification, labeling and information processing of human blood, tissue and organ products across international borders and disparate health care systems. ” (http: //iccbba. org) Incorporate patient photographs into the patient record Background color changing indicator to the boxes that contains mismatching scans Color changing indicator on the “Notes” tab if there are notes attached Automatic updates to the databases {e. TAR & e. SCAR} Compatibility with RFID technology Incorporate daily calendar to schedule reminders for pre/post transfusion vital checks Verification that vitals are within acceptable range to continue with action Provide voice recording mechanism for patient consent We would not have succeeded without the patience, consideration and assistance of the following individuals: • • • Charles Lankford, CEO, Pharma. Sys Patrick Harris, e. MEDS Product Manager, Pharma. Sys Hospital Solutions David Roth, systems engineer, Pharma. Sys Hospital Solutions Paul King, Ph. D. , Vanderbilt University School of Engineering Dr. Doris Quinn, Asst Professor , Division of Medical Education, Director, Improvement Education Aggie Read, MSN, RN, Instructor of Pediatrics Vanderbilt University School of Nursing