Risk Management:   A focused and global look  

1. What is risk management?  
1. The better question to ask is, where is there risk in the work place?   How does one prevent an accident from occurring?   Are there short term and long term issues that one must look at to better assess risk?   The appropriate application of risk assessment should result in the improvement of the quality of patient care.  
2. Now let's think about where there is risk in a nuclear medicine.   In an attempt to answer these questions I have done a little "brainstorming" by myself and come up with the following answers.   As we go over this I want you to add to this list
1. Equipment failure
1. Whole body contouring doesn't contour
2. Collimator is not attached correctly
3. Equipment not registered with the FDA
4. There is a dark hole in my AM flood
2. Patient safety issues
1. Patient falls off the imaging table
2. Inappropriate transferring of the patient
3. Cardiac arrest in the stress lab
4. Patient falls in the hallway
5. Mis-administration - Diagnostic vs. therapeutic.   What's the difference?
3. Hot lab issues
1. Sulfur colloid was a cooking in the hot lab and the vial just exploded
2. Putting the wrong label on a radiopharmaceutical vial resulting in the mis-administration of three bone patients before it was caught
3. Gee, I thought it was μCi that I was looking at on the dose calibrator, but it was mCi
4. What happen to that 50 μCi ⁵⁷Co point source? Was it still attached to the patient when he/she left the department?
4. Technologist issues
1. Your badges (hand and whole body) are above the ALARA level II this month
2. Why didn't you hand in your badges from last month?
3. Acquiring data under the wrong name
4. BioAssay is pass the trigger level
5. Your hands are always contaminated by the end of the day
6. I thought I had the heart on the acquisition, but gee it was gal bladder
7. I know the PM on that equipment is past due
5. Physician issues
1. Doctor never palpates the thyroid patient
2. Doesn't play an active role in the department
3. Receives poor history for a study and mis-diagnosis the exam
4. Faulty correction matrix puts holes into a liver scan
5. Motion correction doesn't correct the artifact
3. Now what I want you all to do is go back up to the beginning of the nuclear list and define ways to prevent the above issues from happening
4. As you can see, there is a probability that (a) mistake(s) or accident(s) can happen.   So what can you do to prevent it?   It's not just management responsibility, but technologists as well! Everyone should have an active role to preventing error(s) from occurring
5. There are two types of errors to consider when identifying RISK
   1. Medical Error - A medical error is a preventable adverse effect of care, whether or not it is evident or harmful to the patient. This might include an inaccurate or incomplete diagnosis or treatment of a disease, injury, syndrome, behavior, infection, or other ailment. http://en.wikipedia.org/wiki/Medical_error
   2. Adverse Event (AE) - In medicine, an adverse event is an undesired harmful effect resulting from a medication or other intervention such as surgery. http://en.wikipedia.org/wiki/Adverse_event
      1. Expected AE is any adverse event that has been previously observed and documented
      2. Unexpected AE - (a) While it may have been anticipated it has never occurred prior to the incident and/or (b) adverse drug event that has never occurred nor been documented
6. Medical Event according to the NRC (does not necessary result in harm to the patient)
1. "The dose1 administered to a patient differs from the prescribed dose by at least 20 percent, either too high or too low
2. the wrong radioactive drug is administered
3. the radioactive drug is administered by the wrong route
4. the dose is administered to the wrong individual
5. the patient receives a dose to a part of the body other than the intended treatment site that exceeds by 50 percent or more the dose expected by proper administration of the prescription
6. a sealed source used in the treatment leaks"
2. Risk from a global perspective - a health care systems: defining probable risk and trying to prevent it
1. What are the issues today in Risk Management?
2. According to MHA (Mississippi Hospital Association) Society for Health care Risk Management the following areas are what hospitals must focus on: http://mhanewsnow.typepad.com (broken link). In the past this site has defined health care risk into the following areas (2018)
1. Bioterrorism
2. HIPPA
3. Quality and safety of Patient care
4. Work force shortage
5. Access to coverage
6. Voter registration
7. Medicare changes
8. CDC and antimicrobial issues (5% of patients get an infection after being admitted)
9. H1N1 and how to prevent the spread of the flu virus
10. Lawsuits may cause doctors to OVER prescribe antibiotics
11. Hand washing
3. ECRT 2023 Health Care Hazards of 2023
4. ECRT Institute defines the Top 10 Health Technology Hazards for 2022

   Top 10 Health Technology Hazards (before 2014) Top 10 Health Technology Hazards 2020 Cross contamination from endoscopes Misuse of Surgical Staplers Alarms from equipment that is malfunctioning (example: IV. to ventilators) and it being ignored Adoption of Point-of-Care Ultrasound - out pacing safeguards Surgical fires (~600 last year) from oxygen enriched surgical areas Infection risk for sterile processing errors in medical and dental offices CT radiation dose to patients Hemodialysis risk with central venous catheters - home dialysis increase this danger Devices left in patients after surgery Unproven surgical robotic procedures - similar to last year Needle sticks. Alarms, alerts, and notification overload Implementation of HIS and networking with other departmental systems Cybersecurity risks with home healthcare environment - last year Failure of surgical staples causes prolonged surgical Missing implant data can delay, cause danger MRI scan MR and metal objects in the area Medication errors from dose timing discrepancies Fiber optic light-source burns are causes by high intensity light (ex. xenon lap in surgery) Loss nuts and bolts can lead to catastrophic device failure and severe injury



5. Perhaps one of the greatest concerns in a health care may be in the area of mis-administration of drugs to patient (a medical error).   Please read the article entitled, " Improving medication safety: the measurement conundrum and where to start."  PubMed.   The article states some interesting statistics:
1. The eighth leading causes of death in the United States are caused by medical errors
2. Medical errors may lead to adverse events which can be prevented
3. What do you focus on to improve the quality of care:   medical errors or adverse events?
4. Computerized Model is identified in this article as a method to reduce error in the healthcare arena



6. Regarding medication errors, how bad does it get?
1. "Medication-prescribing errors in a teaching hospital. A 9-year experience."   Lesar TS, Lomaestro BM, Pohl H. article is highlighted. Goal of this study was to assess how medical errors occurred and how they can be prevented
1. "A total of 11,186 confirmed medication-prescribing errors with potential for adverse patient consequences were detected and averted during the study period. The annual number of errors detected increased from 522 in the index years 1987 to 2115 in 1995 [sic]."
2. "The most common type of errors were dosing errors, prescribing medications to which the patient which he/she was allergic to, and prescribing inappropriate dosage forms."
3. "The results of this study suggest there may exist a progressively increasing risk of adverse drug events for hospitalized patients. The increased rate of errors is possibly associated with increases in the intensity of medical care and use of drug therapy."
2. In my attempt to define the percent of medication errors that occur in a hospital environment I noticed the figures ranged between 5 and 20 percent in any given institution.   Perhaps the most alarming article was "Medication errors observed in 36 health care facilities."   Key points:
1. One out of every five doses administered results in error
2. Those errors include:   "wrong time (43%), omission (30%), wrong dose (17%), and unauthorized drug (4%)."
3. Of those, 7% caused an adverse event
3. According to government sources medical errors is now #3 leading cause of death in the US (was #6) http://www.justice.org/cps/rde/justice/hs.xsl/8677.htm https://www.bmj.com/content/353/bmj.i2139
4. What can be done or how can we reduce the rate of medical errors/adverse event?
1. Computers is one solution
2. From the MHA group:   "Research indicates that Computerized Physician Order Entry (CPOE) has the potential to reduce medication errors and adverse drug events and thus improve the quality of care.   Approximately 99% of all hospitals have instituted this system - Healthcare Innovation
3. The development of HIS and RIS might be a more familiar term to us
4. Think about the different types of computer system/software throughout the hospital - do they communicate with each other?
7. General review of the state of Risk in the hospital environment can be noted at the following link http://www.medicalnewstoday.com/medicalnews.php?newsid=11856 (link no longer works).   In summery these points were made:
1. About 1.14 million patient-safety incidents occurred among the 37 million hospitalizations in the Medicare population over the years 2000-2002.
2. Of the total 323,993 deaths among Medicare patients in those years who developed one or more patient-safety incidents, 263,864, or 81 percent, of these deaths were directly attributable to the incident(s).
3. One in every four Medicare patients who were hospitalized from 2000 to 2002 and experienced a patient-safety incident died.
4. The 16 patient-safety incidents accounted for $8.54 billion in excess in-patient costs to the Medicare system over the three years studied. Extrapolated to the entire U.S. , an extra $19 billion was spent and more than 575,000 preventable deaths occurred from 2000 to 2002.
5. Patient-safety incidents with the highest rates per 1,000 hospitalizations were:   failure to rescue, decubitus ulcer and postoperative sepsis, which accounted for almost 60 percent of all patient-safety incidents that occurred. '
6. Overall, the best performing hospitals (hospitals that had the lowest overall patient safety incident rates of all hospitals studied, defined as the top 7.5 percent of all hospitals studied) had five fewer deaths per 1000 hospitalizations compared to the bottom 10th percentile of hospitals. This significant mortality difference is attributable to fewer patient-safety incidents at the best performing hospitals.
7. Fewer patient safety incidents in the best performing hospitals resulted in a lower cost of $740,337 per 1,000 hospitalizations as compared to the bottom 10th percentile of hospitals. "
8. Update on medical errors -- National Institutes of Health stated that over 250k patient will experience a medical event and 100k will die from it (10/31/2022)
   1. Third cause of death in US - When I first started lecturing on this topic "death" by medical error was initially 8th
   2. Higher than other developed countries
   3. Estimated that <10% are reported
3. What do we know about medication errors in radiology?  
1. "Safety Considerations In Contrast Media Handling And Administration." A survey was done on Of 315 hospitals and clinics over a five year period and "voluntary" reporting bases
2. There were 406 errors reported during the study
3. Approximately 12% of these errors harmed the patient
4. This article gave additional suggested to reduce the error rate in radiology
1. "The proper use, indications and routes of administration for contrast media and other medications used in radiology
2. Pharmacology, including drug interactions and contraindication.
3. Charting and documentation techniques.
4. Use of electronic medical records and information access and retrieval systems.
5. Communication skills as members of an interdisciplinary health care team."
5. Note the standards of practice defined by the ASRT,   "Practice Standards clearly state that the radiologic technologist is responsible for confirming patient identity, gathering pertinent information from the patient’s medical record and assessing factors that might contraindicate the procedure."
4. "Radiology education: a radiology curriculum for all medical students?" by Zwann L, et. al.
   1. Medical images can be read from multiple platforms throughout a healthcare facility
   2. Non-radiologist interpret radiographs
   3. Do to their lack of training significant errors have been made. trained and errors occur
   4. Article calls for all medical students to have some sort of radiology curriculum
5. "Diagnostic errors in a accident and emergency department." by HR Guly
   1. Data collected from a "busy district general hospital" from 1 February 1992 and 6 August 1996
   2. 953 diagnostic errors where identified in 934 patients
   3. 79.7% miss reads
   4. 13.4% missed fractures
   5. Twenty-two generated legal action
   6. Three patients died
   7. Conclusion stated: "Good clinical skills are essential. Most abnormalities missed on radiograph were not difficult to diagnose. Junior doctors in A&E should receive specific training and be tested on their ability to interpret radiographs correctly before being allowed to work unsupervised."
6. Radiation accidents and other events causing radiation casualties - a comprehensive, tabulated database last updated on 1/20/14

7. Mad River pediatric CT radiation case - two-year old receives 151 CT scans in 68 minutes

8. Here some other examples of over exposure to CT. Two of the three images are linked to the original page, just click the image
9. Five most common causes of adverse imaging events in radiology by Marty Stempniak
10. Radiation Therapy has its problems - you tube video
11. Are we getting over exposed in America? Reports from the National Council of Radiation Protection and Measurement (NCRP)
    1. General search "radiation exposure"
    2. National Council on Radiation Protection and Measurements - NCRP 160
12. Responding to overexposure
    1. Image Wisely - for imaging
    2. Image Wisely - for therapy

1. One development of QM in nuclear medicine relates to reduces medical error. The NRC instituted written directives to accompany all therapeutic doses with the hope of reducing medical errors related to therapy. The nature of this type of event might cause an adverse event
2. Has the QM program helped reduce medical errors?  
1. Number of events vary  
2. NRC - Lodged capsule for 2.5 hours - 1798 rads to upper esophagus
3. Wrong patient received 27.3 mCi of 131Iodine - NRC report link lost
4. A Litany of therapeutic mis-administrations - NRC report
5. In one NRC report medical events included: "involved incorrect data entry and calculation errors, involved wrong source, wrong radiopharmaceutical, or wrong dose, involved the wrong treatment site, involved source migration/dislodgement, involved failure to administer the entire dose or dosage (the source or dosage (capsule) was left in the pig or tandem)."
6. NRC slide presentation (2014 and 2015)
7. NRC slide presentation (2020) - Has it gotten any better?
8. In another case a technologist misread the dose calibrator.   He/she read a 112 μCi of I-131 in 5 capsules, but instead gave ~112μCi per capsule totaling 560 μCi when the LED read-out displayed 112 μCi.   See report
9. Then there is the mislabeling of a radioactive vial.  The radionuclide and the amount of activity were correct, but the was compounded to the wrong pharmaceutical See report
10. NRC defines a medical event when: (Subpart M)
    1. The dose administered to a patient differs from the prescribed dose by at least 20 percent, either too high or too low (there covers diagnostic dose)
    2. The wrong radioactive drug is administered
    3. The radioactive drug is administered by the wrong route
    4. The dose is administered to the wrong individual
    5. Dose to tissue, organ, or skin other than the treatment site that exceeds:
       1. The patient receives a dose to a part of the body other than the intended treatment site that exceeds by 50 percent or more the dose expected by proper administration of the prescription
       2. 0.5 Sv (50 rem) or more the expected dose to that site from the procedure if the administration had been given in accordance with the written directive prepared or revised before administration
       3. Package insert for I-131
    6. A sealed source used in the treatment leaks
    7. Receiving an excessive dose (10 CFR 35.3045) and occupational dose limits (10 CFR 20.1201)
11. When the NRC sought civil action against a licensee the following reasons were given: See report
1. Failure to read and understand the conditions of the license.
2. Failure to train employees in the conditions of the license including the radiation safety procedures that are incorporated into the license.
3. Failure to control operations including failure of licensee employees
4. In conclusion, what one might say is no matter what you do in life there will always be risk, however, risk can be preventable and it is our job to make it so.   Remember the error no matter how small can lead to an adverse event.   Knowing this would you rather treat the initial error or just worry about how to stop the adverse event from happening
3. Adverse reaction
   1. Known adverse reactions from radiopharmaceuticals according to the SNMMI - This does not appear to be the right link.
   2. Adverse reactions in Japan
   3. In 1996 a European study of 17 NMT Departments where evaluated for adverse radiopharmaceutical events.  Excluding vasovagal reactions, 11 events were reported in 100,000 procedures.  In the US there were 2.3 per 100,000 events reported.  Of these there was no death or serious injury. (http://www.springerlink.com/content/m153337r867nj136/fulltext.pdf) - link doesn't work.

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