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Allied Health: Articles of Interest  

Utilizing a risk management assessment to improve immunotherapy procedures
by Arline Gerard, RN

Medical and nursing errors contribute annually to the deaths of numerous patients in the United States. Such errors are often the result of a momentary lapse of cognitive function, commonly called "brain fade." In busy departments where some tasks are repetitive, "confirmation bias" may allow the nurse to confirm (s)he has the "correct" vial. Because it has been correct on most previous occasions, the nurse can fail to recognize, in this singular instance, it is NOT the intended vial.

While rare, immunotherapy (IT) fatalities do occur and one-third are attributed to errors1. When the circumstances of the error are identified, valuable lessons can be learned. Most practice’s systems of delivery and documentation evolved slowly and were not designed for the volume of patients currently being managed by that system. Recognizing this in our practice, we set about to improve our IT systems.

Utilizing principles of risk management (RM), we assessed the existing office IT protocols and processes. Utilizing that assessment, we standardized an IT administration model at our six offices. Prior to the assessment, our reaction rate averaged 2.6 reactions per 1,000 IT visits. We defined a reaction as any occurrence when epinephrine was administered. Following a non-punitive review of our nursing error rate, we upgraded our IT documentation, reduced errors and lowered the number of reactions. For the past three years, our patient reaction rate has been 0.2 per 1,000 visits.

Reducing "known" errors
Patient medical record ID numbers are used and checked on everything. We check the ID numbers of all patients, including those we know by sight. A second check is made before the patient’s full name is called from the chart. Patients without a check-in slip and two identically named patients are asked their birth dates, which is then checked with the chart.

Our STOCK vials now have designated FORMULA numbers, which are written in red ink on the STOCK label, and at the top of the patient’s injection record column. Patients’ own SPECIAL vials have a unique lot number and the patients’ ID numbers. These are also written in red on the IT record. All the numbers and the patient’s complete name are checked several times: when the vial is pulled, when drawing up from the vial and when setting down the vial. We stress this triple checking.

STOCK trays, for our 15 commonly used STOCKS, are set up the same at every office. This insures that nurses who float between clinics find the position of the antigens to be in the same tray locations, no matter which office site they are working. Using colored plastic caps and colored labels on vials, enhanced our original rudimentary color-coded dilution designation system. We also use pastel-colored marking pens to highlight the IT records of patients receiving dilutions below a range considered routine maintenance. A complementary-colored system was designated to color-code for antigens configured in UNITS, as well as weight per volume.

Avoiding possible mistakes
Mixing procedures no longer include making a set of dilutions in assembly line fashion. Instead, each dilution is carefully mixed, and double-checked, before proceeding to the next. A separate needle and syringe are used for each item. IT vials are never combined. All ID numbers, as well as the antigen’s name, are double-checked. A "no interruptions" policy means that items are tossed if there is any uncertainty or possibility of error. For the first dose from a fresh vial, we drop the dose by 50%. The patient is told they have received a "first dose from their fresh vial" and are reminded of their risk.

We flag overdue patient charts and obtain restart orders for patients who have not received IT for more than 12 weeks. Standing policies outline other time-interval dose adjustments. Asthmatic patients have a peak flow check before their injection(s) and are advised not to come when symptomatic, as they will not receive IT. Selected patients have seasonal dosage adjustments.

Waiting period after IT
All doctors and staff expect each patient to wait after every injection. Patients who leave prior to the designated time are advised that they will not be allowed to continue IT if they leave early again. Risk from systemic reactions is discussed with patients prior to starting IT and repeated if indicated. Patients who have ever had a reaction are told they have a higher risk. Their waiting time may be extended based upon the clinician’s judgment. Highly sensitive patients, as determined by testing results, have their IT record marked as "increase cautiously." Patients are taught that most IT fatalities have started unfolding within 30 minutes after injections. We post signs outlining symptoms, which may be an indication of a systemic reaction. In our office, we have written standing orders for administering epinephrine, and nurses are advised to assess patients immediately, "Give EPI stat," and then get the doctor. In our practice, we do not need to ask permission to give epinephrine however, this may vary depending on state guidelines regarding standing orders. Emergency medications are readily accessible for administration.

Transfer patients
Recognizing that transfer patients and college students are at increased risk, we will not continue antigens from another practice without complete supporting documentation. We expect an injection record listing dates, dosages, dilutions, outcomes, doctor’s orders and ingredients lists. When there is doubt about the transfer antigens re-testing may be recommended. Home injections are never permitted.

Written orders and training
We stress clear, legible charting from all doctors and staff. The IT order sheets are pre-printed, which allows our doctors to check the boxes of antigens desired without the need to write out items or dilutions. This eliminates potential ordering mishaps. Care is taken to insure that all vials pulled are correct.

New nurses are paired with experienced IT nurses for months before considered ready to give IT injections without a nursing mentor. There is a doctor present at each office when IT is being administered. Staff is taught there are no "dumb" allergy questions. We discuss close call lessons and scrupulously analyze causes to prevent reoccurrences. Continuing education is stressed. The nurses and allergists involved in this ongoing project agree that enhanced IT processes are preferable to the need to treat preventable anaphylaxis. We all concluded RM assessment has successfully contributed to safer IT visits in our practice.

1) Reid MJ, Lockey RF. Survey from skin testing and immunotherapy 1985-1989. J. Allergy Clin Immunol 1993.

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