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Based on observations, records reviewed and interviews the Condition of Participation for Quality Assessment and Performance Improvement (QAPI) was found out of compliance
Findings included:

The Hospital failed to ensure, for two patients (Patients #1 and Patient #11) of 11 sampled medical records, that QAPI activities were data-driven, including analysis and preventative corrective actions to reduce medical errors after Patient #1's medication error and Patient #11's wrong site surgery.
Refer to TAG: A-0273

The Hospital failed to ensure for two patients (Patients #1 and Patient #4) of 11 sampled medical records that QAPI interventions identified during the Hospital's Internal Investigation review were instituted and monitored to ensure that the corrective actions were effective and a like event would be prevented.
Refer to TAG: A-0283

Based on observation, records reviewed and interviews the Hospital failed to adhere to the Hospital's Quality Improvement Plan and Root Cause Analysis Process for two of two patients (Patient #1 and Patient #11) who underwent the Internal Investigation Process.
Findings include:

Surveyor #1 reviewed the Patient Safety and Performance Improvement Plan, dated 2015-2020 on 1/16/18. The Plan indicated that the Hospital utilized an enhanced Plan-Do-Study-Act (PDSA) structure to define, measure, analyze, improve, sustain and communicate Performance Improvement projects. The enhanced PDSA promotes a thoughtful connection between goals, data, root cause and the improvement plan.

1.) Surveyor #1 reviewed the Hospital's reported incident for Patient #1. The Hospital report indicated that Patient #1 provided information of significant allergies, anaphylaxis (a severe, life-threatening allergic reaction), when Patient #1 arrived at the Hospital. Despite these allergies being documented in Patient #1's Electric Medical Record (EMR) the Provider was able to order a medication containing the allergen and the Pharmacist then verified the order for the medication that was later administered to Patient #1. Subsequently, Patient #1 experienced a severe allergic reaction which necessitated his/her transfer to the Hospital's Intensive Care Unit.

At the time of survey, the event had occurred approximately six weeks prior.

The Surveyors interviewed Nursing Informatics and the Chief Pharmacist at 9:30 A.M. on 1/10/18. The Surveyors were presented with multiple examples (screen shots) of the process that the Provider and Pharmacist would use to order and verify medications.

The Chief Pharmacist said he believed that the allergy information was not available for the Pharmacist at the time she verified the medication order for Patient #1.

The Surveyors interviewed Pharmacist #1 at 9:45 A.M. on 1/10/18. Pharmacist #1 demonstrated how the EMR would bring the Pharmacist to a hard stop in the verification process if a severe allergy (i.e. anaphylaxis) was entered into a patient's profile.

During the review of the EMR process it was determined that the allergy information screen contained the name of the medication, the reaction information that was provided by the patient (i.e. rash, vomiting etc.) and the determination by the person entering the allergy information if the reaction constituted a mild, moderate, severe or unknown was then entered onto the severity scale. Despite severe reactions such as cardiac arrhythmia or anaphylaxis being documented, unless the severity scale was documented as "severe" the Pharmacist was not provided with the hard stop that was designed as a safety feature in the EMR. It was also determined that if the severity scale was left empty, the Pharmacist was not provided with the hard stop designed to stop the line and have the Pharmacist who was about to verify the medication closely review the order.

The Surveyors interviewed the Risk Manager at 11:45 A.M. on 1/10/18. The Risk Manager said that the stakeholders involved in this event did not meet together as was the usual process. The Risk Manager said the individuals involved were interviewed separately.
The Risk Manager provided the Surveyors with the 30 day report that indicated the event was preventable and besides counseling the Provider who placed the order and the Nurse who administered the medication, the Internal Investigation provided some recognition that an element of "alert fatigue" on the part of the Physicians and Pharmacists. The report also indicated that the Hospital was shortening the override list. The Risk Manager said she believed that both the Medical Staff and the Pharmacy Staff were aware of the occurrence.

The Surveyors interviewed Pharmacist #2, who overrode Patient #1's medication order, at 10:00 A.M. on 1/11/18. Pharmacist #2 said she worked per diem in the Hospital Pharmacy and had been contacted by the Chief Pharmacist about the medication event on Patient #1. Pharmacist #2 said, at the time the Chief contacted her, it was believed that she did not commit the error and that Patient #1's allergy information had not been entered into the EMR. Pharmacist #2 said she was contacted on 1/11/18 by the Chief Pharmacist who told her that the allergy information on Patient #1 was available to her at the time she verified the order.

The Surveyors interviewed The Nurse Practitioner who ordered Patient #1's medication at 1:30 P.M. on 1/10/18. The Nurse Practitioner said that she was unable to remember seeing the allergy to the medication "NSAIDs" the medication class that she ordered. The Nurse Practitioner said she was counseled by the Chief of the Hospital Service and was being more aware during the ordering of medications.

The Surveyors interviewed the Chief of the Hospitalist Service at 11:50 A.M. on 1/11/18. The Chief of the Hospitalist Service said he had counseled the ordering Practitioner regarding reading all alerts and had brought this information to approximately 7 of 20 Hospitalists during another meeting. The Chief of the Hospitalist Service said he believed that the other members of the Hospitalist group would have heard about the medication event from the other Hospitalists in the group.

The Surveyors interviewed the Chief Medical Officer at 12:10 P.M. on 1/11/18. The Chief Medical Officer said that the review process was ongoing and the Medical Staff would be made aware that day.

On 1/11/18 the Medical, Pharmacy and Nursing Staff were notified about the changes in the EMR that no longer required a severity determination when an anaphylaxis reaction is documented. The memo also reminded staff about allergy safety.

2.) The Surveyors randomly selected another Serious Reportable Event to evaluate the Hospital's process.

The Surveyors interviewed the Risk Manager at 2:05 P.M. on 1/16/18 about the Internal Investigation for Patient #11 who experienced a wrong site surgery.

The Risk Manager said the stakeholders convened a meeting to determine the root cause of the event and it was determined that three interventions were identified in an effort to prevent a like occurrence. The Risk Manager said the event occurred six weeks prior to survey. The Internal Investigation indicated 1.) The Surgeon was relatively new and had failed to adhere to the Hospital Policy for site marking 2.) The Surgeon noted that the room set up was a mirror image of how he preferred to have his room set-up and in the future he would insist that it be set up according to his preference. 3). The Team had done a time out as required, however, the procedure was both a bronchoscopy and the placement of a chest tube and only one time out was done prior to positioning Patient #11 for the chest tube placement.

The Risk Manager said the monitoring for the interventions was being done in the Operating Room; however, when the Risk Manger approached the Chief of Surgery about the monitoring, the Risk Manager said that the Chief of Surgery determined that no monitoring was needed at this time. The Surgeon had completed nine surgical cases since the wrong site event.

Based on records reviewed and interviews the Hospital failed to provide timely monitoring of corrective actions identified during internal investigations for two of two patients (Patient #1 and Patient #11).

1.) Patient #1 had been administered a medication when a significant allergy had been documented in the Electronic Medical Record (EMR) prior to the Provider ordering the medication, the Pharmacist verifying the order for the medication and the Nurse administering the medication. The interventions had identified a possible "alert fatigue" associated with the medication ordering and verifying process.

The Surveyors interviewed the Risk Manager at 11:45 A.M. on 1/10/18. The Risk Manager said the Hospital's Corporate group was working with the EMR vendor to facilitate reduction of the alerts associated with the medication ordering and verification system but no changes had yet been made.

2.) Patient #11 had experienced a wrong side surgery. The interventions had identified the Surgeon failed to follow the Hospital policy for site marking. Also, the Operating Room set up had been a mirror image of how he was used to performing this procedure and may have contributed to the wrong side being chosen. While the Surgeon was counseled by the Chief of Surgery, no physician monitoring had been done during the six weeks and nine surgical procedures that followed.

Based on records reviewed and interviews the Hospital failed to adhere to its policy for multi-dose medication handling.

The Hospital Policy titled "Multi-Dose Vials" indicated that whenever possible a multi-dose vial was to be dedicated to a single patient. If a multi-dose vial must be used for more than one patient, they shall not be kept or accessed in the immediate patient care area.

The Surveyors reviewed an Internal Investigation report of a medication incident that had occurred at the Hospital. According to the statement, signed by the nurse, she had brought several vials of medication including a multi-dose insulin vial to the Patient #4's bedside and mistakenly administered an excessive dose of insulin.

The Surveyors interviewed Emergency Department Registered Nurse #3 at 9:00 A.M. on 1/10/17. Emergency Department Registered Nurse #3 said that insulin was removed from the medication room and taken to the patient's bedside where it was drawn up and checked by another nurse.

The Surveyors interviewed Geriatric Psychiatric Registered Nurse #1 at 10:55 A.M. on 1/11/17. Geriatric Psychiatric Registered Nurse #1 said when a patient required an insulin injection she would bring the multi-dose vial to the bedside where it was drawn up, scanned into the electronic medical record and checked by a second nurse.