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NORTHWESTERN MEDICAL CENTER INC 133 FAIRFIELD STREET SAINT ALBANS, VT 05478 June 7, 2017
VIOLATION: QAPI Tag No: A0263
The Condition of Participation: Quality Assurance/Performance Improvement was not met as evidenced by the failure of the hospital to effectively evaluate, fully analyze and fully implement immediate actions when a significant adverse patient event occurred.

Refer to TAG: A-0286
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on staff interview and record review there was a failure of Quality Assurance/Performance Improvement (QA/PI) department to effectively evaluate, fully analyze and fully implement immediate actions when a significant adverse patient event occurred for 1 applicable patient. (Patient #4) Findings include:

Although the Risk Management, as part of the QA/PI department, has an established event reporting system to collect information related to patient adverse events, there was a failure by staff to expediently analyze the cause of a specific event which occurred on 5/21/17 in an effort to identify opportunities for improvement and implement preventive actions in a timely manner.

Per record review and patient interview, on 5/21/17 Patient #4 presented to the Emergency Department (ED) and was Triaged at 16:05 with a chief complaint of recurrent hives. Patient #4's vital signs were stable and no respiratory distress was identified. At 16:17 the ED physician examined the patient and initiated the following orders: Insert IV (intravenous catheter) for medication administration; draw blood for specific tests and administer medications. The following medications included: Benadryl 50 mg (antihistamine) orally; Solu-Medrol 125 mg IV (synthetic corticosteroid used for allergic reactions); Pepcid 20 mg orally (antacid also used for allergic reactions) and Epinephrine 0.3 mg injection subcutaneous (Adrenaline/used to treat allergic reactions). At approximately 16:57, Nurse #1 administered the oral medications, discontinued the completed infusion of Solu-Medrol and after drawing up the Epinephrine from an ampoule proceeded to administer the Epinephrine 0.3 mg intravenously instead of subcutaneous.

As a result of the incorrect route of Epinephrine, Patient #4 immediately began responding physically to the effects of the medication error. Per interview on 6/6/17 at 8:15 AM Nurse #1 stated upon administration of the medication the patient suddenly complained of intense chest pain and became "...pale and dusky" and Patient #4 stated to the nurse s/he "could not see". Nurse #1 responded by placing the patient in Trendelberg position (laying patient flat on their back and raising the legs) and called for assistance stating s/he needed the ED physician immediately. Nurse #1 applied oxygen, checked Patient #4's blood pressure (B/P) which had become elevated at 165/100 (at Triage B/P: 133/74, Heart rate: 70) Heart rate was now recorded as 112. Three additional nurses arrived along with the ED Physician. Nurse #1 informed the ED physician s/he had administered the medication IV. The ED physician acknowledged this was a medication error and stated the order was Epinephrine 0.3 mg by SC injection not IV. Patient #4 was rapidly transferred into the Cardiac Room, placed on bedside telemetry to monitor cardiac status to include heart rate and blood pressure. An EKG (electrocardiogram) was also performed. Nurse #1 stated Patient #4 was "...moaning and remained dusky...". Meanwhile, in response to the patient's chest pain, the ED physician ordered at 17:12 Morphine 2 mg IV, Nitroglycerin 0.4 mg Sublingual, Lorazepam 0.5 mg IV (anti-anxiety agent). Morphine 2 mg was again ordered at 17:29 and 17:53 which assisted in resolving the patient's chest pain. Later, after the acute symptoms subsided, the ED physician and Nurse #1 disclosed to Patient #4 and family in attendance of the medication error. Due to the patient's past medical history, elevated Troponin blood level (test used to determine heart damage) which was completed prior to receiving the Epinephrine, and the issues related to the adverse event and hives, Patient #4 was transferred to a medical center for further testing and monitoring.

Per record review, Patient #4 has a history of Coronary Artery Disease with Bypass Graft surgery and a previous MI (Myocardial Infarction). Because of Patient #4's medical history, the ED physician stated on 6/5/17 at 3:40 PM when discussing treatment with Patient #4 for hives and ongoing allergic symptoms that Epinephrine is one of the drugs used in treating the ongoing symptoms. The ED physician stated s/he discussed the mild side effects the patient may experience with the Epinephrine and Patient #4 was in agreement with the treatment plan. The ED physician stated Epinephrine 0.3 mg administered SC side effects even in a patient with cardiac disease was "...safe" and " innocuous" and would have "...much less of a response..." then what the patient experienced when administered incorrectly. The Epinephrine caused " ..restriction of the blood flow" and acknowledged Patient #4 showed ischemic changes on the patient's EKG taken during the adverse event. The ED Physician also noted the Epinephrine works rapidly and is short acting, which was evident with Patient #4's response. The ED physician stated the medications ordered in the Cardiac Room for Patient #4 were used to "...counter the effects..." the patient was experiencing after the medication error had occurred.

Subsequent to the medication error event, Nurse #1 completed on 5/21/17 a electronic event report and later contacted the ED Nurse Manager to discuss the event. On 5/22/17 the QA/PI & Risk Manager reviewed the event report and had a discussion with the ED Nurse Manager regarding the incident and a complaint filed by the patient. Per review of the hospital policy Event Report last revised on 6/16 states states: Analysis: " Department manager reviews the Confidential Report Form, investigates event as needed, documents his/her action taken on back, including details of investigation performed and plan of action, initials and forwards completed form to Risk Management within 72 hours from receiving the report". Per interview on 6/5/17 at 11:20 AM, the ED Nurse Manager confirmed "...nothing has been put in place.." no review had been conducted regarding the event, staff had not been counseled or provided further training regarding routes used for Epinephrine and s/he had not been asked to be a part of a causal analysis. The policy also states: Note: "An administrative review of any significant event is conducted within 24 hours of Risk Management becoming aware of an event to determine whether any interim measures are necessary". An administrative review was not conducted.

It was further confirmed on 6/6/17 at 2:45 PM by the SR. VP, Chief Nursing Officer (CNO) /Chief Operating Officer (COO) and the QA/PI & Risk Manager the policy Event Reporting was not followed despite the fact the event was categorized as Moderate, requiring the patient to receive "Increased Level of Care (both at the facility and transfer to a tertiary hospital) and also resulting in "Temporary harm" to include significant pain and changes in EKG during the adverse event. The hospital staff also failed to follow Event Report policy which further states: Causal Analysis and Action Plan: Moderate Events: "A multi-disciplinary investigation or concentrated review and/or a physician peer review process takes place to identify real or potential causes of the event and areas of system improvement". Both the Sr. VP, CNO/Chief Operating Officer and the QA/PI & Risk Manager acknowledged there was a failure to assess the event for significance when the report was received, failed to evaluate what went wrong, mitigate from happening again and conducting a root cause analysis to determine how the medication error occurred and what interventions, re-training and improvements need to be implemented. As of 6/6/17 no actions or formal investigation had been completed.

Per the American Society of Health Systems Pharmacists (ASHP) Medication Misadventures- Guidelines state in regard to Monitoring and Managing Medication Errors p. 229: "3. For clinically significant errors, fact gathering and investigation should be initiated immediately. Facts that should be determined and documented include what happened, where the incident occurred, why the incident occurred, how the incident occurred, and who was involved."
VIOLATION: REPORTING ADVERSE EVENTS Tag No: A0508
Based on staff interview and record review there was a failure of the Pharmacy Department to identify and consult with the Quality Assurance/Performance Improvement & Risk department regarding a significant adverse event involving a medication error for 1 applicable patient. (Patient #4) Findings include:

Per record review on 5/21/17 Patient #4 presented to the Emergency Department (ED) and was Triaged at 16:05 with a chief complaint of recurrent hives. Patient #4's vital signs were stable and no respiratory distress was identified. At 16:17 the ED physician examined the patient and initiated the following orders: Insert IV (intravenous catheter) for medication administration; draw blood for specific tests and administer medications. The following medications included: Benadryl 50 mg (antihistamine) orally; Solu-Medrol 125 mg IV (synthetic corticosteroid used for allergic reactions); Pepcid 20 mg orally (antacid also used for allergic reactions) and Epinephrine 0.3 mg injection subcutaneous (Adrenaline/used to treat allergic reactions). At approximately 16:57, Nurse #1 administered the oral medications, discontinued the completed infusion of Solu-Medrol and proceeded to administer the Epinephrine 0.3 mg intravenously instead of a subcutaneous injection. Patient #4 had an immediate adverse reaction from receiving the Epinephrine IV. The ED physician was notified by Nurse #1 of the medication error. Emergency interventions where initiated to counter act the intense chest pain and other symptoms experienced by Patient #4.

Later in the evening of 5/21/17 Nurse #1 completed an event report regarding the medication error. On 5/22/17 the Quality Assurance/Performance Improvement & Risk Manager distributed a copy of the event report to the Pharmacy Manager and to the ED Manager. Per interview on 6/6/17 at 1:00 PM, the Pharmacy manager stated s/he receives about 200 medication event reports each month and looks at them at a minimum of monthly. S/he further indicated the present Pharmacy Department on-line tracking system does not differentiate or rank severity. A multidisciplinary group meets once per month to review medication errors and discuss specific Pharmacy/drug issues and seek recommendations from representatives in attendance. The Pharmacy manager further confirmed s/he was not directly alerted about this specific event which occurred on 5/21/17, although the medication event report was sent to the Pharmacy department on-line depository for the manager's review noting s/he was only appraised of the medication error/adverse event on 6/5/17 but would have preferred to have known sooner.

Per review of the Adverse Drug Event (Reaction) policy last revised on 3/16 states Adverse Drug Event: "Any event thought to be unintended, unexpected, or exaggerated response to a drug. The severity of an adverse event is ranked based on its effect on the patient......" . It further states: " A pharmacist will evaluate each adverse drug event reported to the Pharmacy Department.....This evaluation will include a determination of probability of causative agent and preventability and severity ranking". The Pharmacy manager (who is also a pharmacist) stated what Patient #4 experienced would be categorized as a Adverse Drug event. S/he further stated that perhaps Epinephrine could possibly be added to the "High Risk" medications requiring additional precautions for staff who administer the drug.

When asked to describe the effects of Epinephrine, the Pharmacy manager stated a patient's blood pressure and pulse would become elevated due to restriction of blood flow. In the case of Patient #4 the effects were more pronounced and immediate due to the incorrect route of the medication, creating the intense response to include significant chest pain and ischemic cardiac changes as noted on the patient's EKG. Per the Institute for Safe Medication Practices Canada stated in an alert Safety Bulletin regarding : Wrong Route Incidents with Epinephrine/Volume 14 Issue 4, 4/16/14 states; " When given as an IV bolus, epinephrine produces an immediate and profound response, including a sharp rise in heart rate and blood pressure and an increase in ventricular contraction....if epinephrine 1 mg/ml (1:1000) from an ampule.....is erroneously given IV push....in situations where SC or IM (intramuscularly injection) is indicated, severe harm (e.g., cardiac arrhythmia or cerebrovascular hemorrhage) or death can occur."

Upon review of the adverse event, the Pharmacy manager noted nurses on the in-patient units recently received an in-service about the use and administration of Epinephrine, however this had not been offered or shared with the nurses in the ED. The Pharmacy manager further noted unlike the nurses administering medication on the in-patient units, the ED nurses do not have the safety benefit of bedside scanning of medications prior to administering a medication. Other error preventing strategies suggested by the Pharmacy manager included a change from ampoules of Epinephrine 1 mg/1 cc to autoinjectors to prevent inadvertently administering the medication IV. Despite more immediate opportunities that could assist in preventing significant medication errors and adverse patient events, there was a systems failure within the Pharmacy Department to assure attention was placed on high alert adverse events and a failure of QA/PI & Risk to consult expediently when made aware of the medication error/patient adverse event.