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Concerns Related to an Inpatient’s Response to Oxycodone and Facility Actions at the Baltimore VA Medical Center, Maryland

Report Information

Issue Date
Report Number
18-05731-176
VISN
State
Maryland
District
VA Office
Veterans Health Administration (VHA)
Report Author
Office of Healthcare Inspections
Report Type
Hotline Healthcare Inspection
Recommendations
6
Questioned Costs
$0
Better Use of Funds
$0
Congressionally Mandated
No

Summary

Summary
The VA Office of Inspector General (OIG) conducted a healthcare inspection to evaluate concerns related to a patient’s response to oxycodone, an opioid pain mediation, including initial post-surgery care and during an acute change in condition (event) at the facility. The OIG also assessed management actions taken by the facility after the event. The OIG found that although providers ordered and nursing staff administered oxycodone consistent with manufacturer’s recommendations, the patient developed signs and symptoms of altered mental status, slowed breathing, and low oxygen in the tissues. The patient was administered naloxone and the symptoms immediately improved. Naloxone has no effect as an antidote in reversing adverse drug event symptoms when given to patients who have not taken opiates. Naloxone’s effectiveness in treating the signs and symptoms supports that the patient was having a response to oxycodone. Providers assessed and treated the patient’s adverse drug event symptoms and the patient did not have further episodes. Facility managers did not consider the patient’s response to oxycodone as one that required a review to determine causative factors and did not report the event to the Veterans Health Administration Adverse Drug Event program or conduct a root cause analysis or an aggregate review. These reviews would have allowed for communication between facility staff and leaders, and patient safety improvement considerations regarding the oxycodone vulnerabilities. The OIG found a clinical disclosure, though warranted, was not documented. An institutional disclosure was conducted approximately six weeks after the event. The Director did not ensure compliance with facility’s peer review policy. In addition, the Surgical Work Group did not meet monthly and meeting minutes lacked discussion of required data. The OIG made six recommendations related to resident supervision; reviewing, capturing and reporting adverse drug events; peer reviews; and documentation of clinical disclosures, and Surgical Work Group meetings.

Open Recommendation Image, SquareOpenClosed and Implemented Recommendation Image, CheckmarkClosed-ImplementedNot Implemented Recommendation Image, X character'Closed-Not Implemented
No. 1
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
The VA Maryland Health Care System director takes steps to ensure resident supervision meets requirements, and monitors for compliance with Veterans Health Administration policy.
No. 2
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
The VA Maryland Health Care System director verifies the capture and reporting of adverse drug events to the national Veterans Health Administration Adverse Drug Event Reporting System, and monitors for compliance.
No. 3
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
The VA Maryland Health Care System director ensures staff complete root cause analyses or aggregated reviews for adverse events as required by Veterans Health Administration policy and monitors to ensure completion.
No. 4
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
The VA Maryland Health Care System director verifies documentation of clinical disclosures when perceptible effects of an adverse event have occurred, as required, and monitors for compliance.
No. 5
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
The VA Maryland Health Care System director ensures peer reviews are evaluated according to VA Maryland Health Care System policy and monitors for compliance.
No. 6
Closed and Implemented Recommendation Image, Checkmark
to Veterans Health Administration (VHA)
The VA Maryland Health Care System director verifies that the Surgical Work Group meets and documents minutes as required to include improvement data presentation, discussion, and performance tracking, and monitors for compliance.