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MASSACHUSETTS GENERAL HOSPITAL 55 FRUIT STREET BOSTON, MA 02114 Aug. 20, 2014
VIOLATION: QAPI Tag No: A0263
Based on record review, policy and procedure review and interviews, the Hospital failed to implement immediate action steps to prevent a similar adverse patient event for one patient, (Patient # 2) out of a total sample of ten patients, when an Anesthesiology Resident improperly reused a previously opened intravenous (IV) solution to flush an IV line which resulted in the rapid infusion of air into Patient #2. This action resulted in an air embolus (a serious condition caused by air introduced into the circulatory system) leading to Patient #2's death three days later.

The Internal Investigation Narrative, submitted by the Hospital to the Department of Public Health on 7/15/14, indicated that re-education was provided to the Anesthesia Team regarding safe intravenous flush practices. However, at the time of the CMS authorized survey, the Hospital was unable to provide verification that re-education was completed.

See A-0286 for details.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review, policy and procedure review and staff interviews, the Hospital failed to follow the Hospital policy for adverse patient events and implement preventive actions and mechanisms after one (1) patient (Pt. #2), in a total sample of ten (10) patients, sustained an air embolus in the Operating Room (OR).
Findings include:

The Hospital Policy titled Adverse Events and Medical Error, last revised on 5/23/2012, indicated that the Hospital was to respond promptly to unexpected adverse outcomes of medical care and eliminate immediate hazards to further care.

1.) Review of Pt. #2's Medical Record on 8/19/14, indicated that Pt. #2 was admitted on [DATE], for a partial left hepatectomy (removal of part of the liver) for a suspected hepatocellular [DIAGNOSES REDACTED] (cancer of the liver). Pt. #2's Medical Record indicated that Pt. #2 received multiple units of blood intraoperatively (during the surgery).

The Surveyors interviewed the Anesthesiology Resident at 3:00 P.M., on 8/19/14. The Anesthesiology Resident said during Pt. #2's surgery on 7/7/14, he was relieved for lunch by the Certified Registered Nurse Anesthetist (CRNA). The Anesthesiology Resident said that when he returned from lunch a 6th unit of blood was infusing. The Anesthesiology Resident said that when the blood was finished he reconnected the previously used bag of 500 cubic centimeters (cc) of normal saline, which had been set aside by the CRNA. The Anesthesiology Resident said a pressure bag (an inflatable bag which can be placed over an IV bag to infuse the solution at a fast rate) was used to infuse the saline. The Anesthesia Resident said a short time later the Attending Anesthesiologist re-entered the OR and noted the tubing was partially filled with air. According to review of Pt. #2's Medical Record, Pt. #2 became hypotensive (low blood pressure) and bradycardic (low heart rate). Attempts were made to stabilize Pt. #2 and he/she was transferred to the Intensive Care Unit (ICU). Pt. #2 remained in critical condition, was eventually made comfort measures only and died 3 days later.

Observation of a 500 cc bag of normal saline noted that it is imprinted with the words "single dose container" on the front of the bag indicating that the IV bag should not be reused after removing from the IV tubing.

The Surveyors interviewed the Department Quality Chair Physician for the Department of Anesthesia, Critical Care and Pain Management (DACCPM) at 3:00 P.M. on 8/19/14. The Quality Chair for the DACCPM said education was planned for mid-September to address this and other patient safety issues. The Surveyors asked the Quality Chair for the DACCPM if the practice of reusing a previously opened IV bag had been eliminated and communication disseminated to all pertinent personnel. The Department Quality Chair Physician indicated that it had not.

The Surveyor interviewed the Anesthesia Vice Chair for the Department of Anesthesia, Critical Care and Pain Management (DACCPM) at 5:15 P.M., on 8/19/14. The Vice Chair said he felt everyone in the OR had heard of the incident. The Vice Chair said a Departmental on-line safety program was in design and would become an annual program. The Vice Chair said Department wide notification was not done because it was felt re-use of IV solutions was not a common practice and because of a sensitivity for the practitioners involved.

The Corrective Measures Narrative included on the Incident Report Form forwarded to the Department of Public Health on 7/15/14 indicated that re-education was provided to the Anesthesia Team regarding safe intravenous flush practices and that the internal investigation into the root causes of the event was continuing.

At the CMS Survey entrance conference, on 8/19/14, the Surveyors requested evidence of re-education for staff. The Chief Compliance Officer provided a memorandum from the Anesthetist-in-Chief to Anesthesia Clinicians sent at 12:33 P.M. on 8/20/14, the second day of the Survey.