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

3. 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

4. Institute of Medicine

5. 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

6. 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.

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

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

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

10. 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.

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

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

13. 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.”

14. 82% of Patient Data Still Manually Recorded
Source: 1999 EAC US Hospital POC Survey

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

16. 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

17. 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.

18. Harrisburg Sunday Patriot-News, September 9, 2001.

19. 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

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

21. 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

22. 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.

23. 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.

24. 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

25. 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

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

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

29. AS/NZ 4360:1995 Risk Management Overview

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

31. 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.

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

33. 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

34. 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

35. Questions? Christopher Fetters Abbott Point of Care (781) 330-1113