Point-of-care Point of Care: Keeping “Humans” and “Errors” Apart Christopher FETTERS Global Manager, Upstream Marketing Abbott Point of Care © 2009. All Rights Reserved. Unauthorized duplication is a violation of applicable laws.

Objectives Understand Medical Errors Rates Review Case Studies Create Awareness Share experiences Inspire you to further research and learning Not here to teach you how to perform an FMEA, Fault Trees, or Risk Analysis

Institute of Medicine

To Err is Human - Building a Safer Health System A Report From The National Academies of Science, Institute of Medicine 44,000 – 98,000 patients killed each year by preventable medical mistakes Key Recommendations Focus greater attention on patient safety Center for patient safety National mandatory reporting Peer review protections FDA should increase attention to safe use of drugs

Principle of Risk Creep Risk Creep is when risks are accepted due to familiarity or saturation. This is a skewed perception. Result can be a sudden crisis after years of acceptance. Example – highway injuries and fatalities. In 30 years, over one million deaths. People view nuclear power as a high risk, yet not a high risk statistically.

Nurse training Right Patient Right Drug Right Dose Right Route Right Time 770,000 untoward drug errors

It is not the strongest of the species that survives, not the most intelligent, but the one most responsive to change. Charles Darwin

Causes of Medical Mistakes 15-20% is mechanical failure 60-80% is human error Active errors Latent errors

Goal Goal in Point of Care? Goal in the Laboratory? Goal in the Hospital? Golden Rule: Do unto others as you would have them do unto your mother.

IDIOT Not this one It can be simple “er” – Season finale Romano’s accident Not this one IDIOT

Three phases of laboratory testing Pre-analytical Analytical Post-analytical

hile point-of-care testing (POCT) has significantly improved the timely delivery of diagnostic information for clinical decision making, the wide range of settings and operators involved in POCT add a layer of complexity to an institution’s effort to ensure consistently high-quality results.” W Gerald J. Kost, MD, PhD. “Using operator lockout to improve the performance of point-of-care blood glucose monitoring.” 2000.

82% of Patient Data Still Manually Recorded Source: 1999 EAC US Hospital POC Survey

Tighter Control = Higher Quality = Improved Safety = Better Patient Care !!

Is 99.9% Good Enough? 1 hour of unsafe drinking water every month; There will be no telephone, electricity or television for 15 minutes each day. 315 entries in Webster's Dictionary will be misspelled 114,500 mismatched pairs of shoes will be shipped/year 811,000 faulty rolls of 35MM film will be purchased this year. 880,000 credit cards in circulation will turn out to have incorrect cardholder information on their magnetic strips 2,488,200 books will be shipped in the next 12 months with the wrong cover. 5,517,200 cases of soft drinks produced in the next year will be flatter than a bad tire. 1,314 phone calls will be misplaced by telecommunications services every minute. 18,322 pieces of mail will be mishandled/hour 22,000 checks will be deducted from the wrong bank accounts in the next 60 minutes. 2,000,000 documents will be lost by the IRS this year Your heart fails to beat 32,000 times each year. Twelve babies will be given to the wrong parents each day. 2,500 newborn babies will be dropped in the next month. 107 incorrect medical procedures will be performed by the end of the day today. 500 incorrect surgical operations each week; 200,000 drug prescriptions will be filled incorrectly in the next 12 months. A typical day would be 24 hours long (give or take 86.4 seconds) Jeff Dewar

Healthcare Personnel Shortages Other Hospital Professions 25% Registered Nurses 75% As many as 168,000 hospital positions are unfilled in six selected job categories. Three out of four vacancies are nursing positions Note: Other hospital professions include pharmacists, radiological technologists, laboratory technologists, billing/coders, and housekeeping/maintenance staff.

Harrisburg Sunday Patriot-News, September 9, 2001.

Three approaches to quality Remedial Alleviate the symptoms of the existing problem Corrective Eliminate the cause of existing problems or undesirable situation to prevent recurrence Preventive Eliminate the cause of potential problems

Improving performance without changing the process is not process improvement, it’s performance improvement. Tony Joseph

Quality Principles Respect human limits in process design Avoid reliance on memory Use constraints and forcing functions (eg, lockouts) Simplify and standardize the work process Anticipate the unexpected Adopt a proactive approach Design for recovery Improve access to accurate, timely information Create a learning environment

Use Errors vs. User Errors Use error is repetitive and can be predicted. User error is due to fundamental errors by humans that has no possibility of prediction. (Renamed Abnormal Use in the standards) FDA distinguishes between 2 kinds of errors.

Use Error Examples from IEC 62366 Operator confuses two buttons and presses the wrong button. Operator misinterprets the icon and selects the wrong function. Operator enters incorrect sequence and fails to initiate infusion. Operator fails to detect a dangerous increase in heart rate because the alarm limit is mistakenly set too high and operator is over-reliant on alarm system. Operator cracks catheter connector when tightening or loosening the connector. A centrifugal pump is cleaned with alcohol. It is made from material that is known to be incompatible with alcohol. It is reasonably foreseeable that alcohol might be used to clean the pump as alcohol is readily available in the hospital. Unintentional use of pipette out of its calibration range. Analyser placed in direct sunlight causing higher reaction temperature than specified. Technician brings a steel oxygen tank into the presence of the magnet in the MRI system suite and it moves swiftly across the room into the magnet. Operator is under time pressure and uses a shortcut on excessively lengthy instructions, procedures, pre-use checklist, etc, thereby abbreviating them. Discuss these use error examples. Note that they are foreseeable and therefore predictable.

Abnormal Use Examples from IEC 62366 The following abbreviated descriptions of events that occurred despite proper accompanying documents, proper design, and proper training, and were determined to be beyond any reasonable means of risk control by the manufacturer. Deliberate, premeditated violation of instructions, procedures, pre-use checklist, calibration, or maintenance, etc., as specified in the accompanying documents. Failure to stop using an X-ray tube after having ignored the warning light that indicates it is overheating. The X-ray equipment subsequently stops operating or fails and that delays or prevents completion of a therapeutic procedure. Use of equipment prior to completing installation or the initial performance checks as specified by the accompanying documents. Deliberate failure to conduct prescribed device checks prior to each use as defined by the accompanying documents. Continued use of equipment beyond the prescribed maintenance interval as clearly defined in the accompanying documents as a result of user’s failure to arrange for maintenance. Contrary to the instructions for use, the equipment was not sterilized prior to implantation. Use of electrosurgical device on a pacemaker patient while deliberately ignoring the clear warning in the instructions for use to take proper precautions, resulting in the need to re-program the pacemaker or explant the device. A pacemaker programmer is not available. Patient harmed because user had not ensured that the operator was adequately trained. The equipment is working in accordance to specifications. During placement of a pacemaker lead, an untrained physician perforates the heart. The labelling for a centrifugal pump clearly indicates that it is intended for use in by-pass operations of less than 6 hours in duration. Finding no other pump available, the clinician decides to use the pump in a paediatric extra-corporeal membrane oxygenation (ECMO) procedure that can last several days. The pump fails due to fatigue cracking and the patient bleeds to death. Discuss: Examples of Abnormal Use

Point of Care Errors MD Pocket Developer Documentation of ACT Results Distilled Water Sensa v. Non-sensa Documentation of ACT Results Documentation of urines Timing urine dipsticks Wrong level of QC creates outliers Bad Patient/Operator ID’s Timeliness of data (docking) CHANGE THE PROCESS

Operator Action Taxonomy from IEC 60601-1-6 and IEC 62366 Discuss what is below and above the dotted line which represents manufacturers responsibility.

It is necessary to create a culture of change that embraces patient safety through shared accountability within a blameless culture. Rosina Jones, LHRM, CHRM

AS/NZ 4360:1995 Risk Management Overview

Risk Assessment – Key Concept Risk = Severity X Probability of Occurrence

Some common errors / misconceptions in doing human factors risk analysis “If the operator does that, it is not our responsibility.” Vague description of the fault / use error (e.g. “operator error”, “programming error”, “sample mishandled”) Not documenting a fault/ hazard because the mode of control is assumed effective. Not documenting a fault/ hazard because: “no one will ever do that !” Not documenting a fault / hazard because “we would be liable if it happens (and we don’t have a mode of control for it)” Here are some common misconceptions / mistakes people make when dealing with human error. If a forseeable use error, it is the manufacturers responsibility. If too general, mitigations cannot be credibly applied to fixing the problem, and you are likely to overlook real hazards. Should strive to document all use error problems including those already taken care of. You should take credit for your designs. Should strive to document all use error problems including those with low probability. May be true, but if it is not addressed because of this fear, negligence can be another charge added. Also if not listed, there is much less a chance of ever addressing or mitigating the problem.

Become an auto-didact FMEA Six-Sigma LEAN IHI.org

POC Critical Success Factors Standardize the process Open communication Clear understanding of regulations Positive feedback for successes Immediate corrective action Access to information Lockouts and forcing functions PMA

Your mission… Be aware Risk Analysis Improvement Ramps Institute of Medicine Institute for Healthcare Improvement Risk Analysis Job functions Pre-analytical, analytical, post-analytical What steps? List what could go wrong? (Risk Analyis) Prioritize (Severity) Improvement Ramps Plan, Do, Study, Act Change the process / re-educate Audit Retool

Questions? Christopher Fetters Abbott Point of Care (781) 330-1113 christopher.fetters@abbott.com