What Works
Automated product recall management service ensures Inova Health System has the ‘right answers’ during audits


Bea Haupt, JD, CPHQ Recall and Safety Manager,  Inova Health System

The Hospital:
Inova Health System
The Problem:
Needed to improve turn-around time for managing product recalls.
The Solution:
Implemented Risk and Safety Management Alert System (RASMAS).
The Vendor:
Mitretek Systems Inc.

Inova Health System is a not-for-profit health care system based in Northern Virginia that consists of five hospitals and other health services, including urgent care centers, nursing homes, mental health, and blood donor services. With more than 92,000 inpatient admissions, 243,000 emergency room visits and over 400,000 outpatient visits, Inova uses a lot of products in its health care delivery. So as you can imagine, managing a product recall when it occurs is no small task.

As one of our nations’ top healthcare delivery systems, Inova has a comprehensive product recall process in place. In 2004, Inova was invited to become a Beta site for Mitretek Systems’ Risk and Safety Management Alert System (RASMAS). This service was being developed in collaboration with Johns Hopkins Health System to automate many of the manual and redundant recall processes hospitals face. Literally located across the Beltway from Mitretek Systems, Inova accepted the challenge to help shape a service that could potentially simplify alert management for all our nation’s hospitals.

"The key reason for Inova to implement the RASMAS service", said Bea Haupt, JD, CPHQ, was "due to the increasing volume and complexity of recalls." "We simply felt that it was taking us too long to turn the alerts around and to have the insight needed when an audit came about. Inova completed a pre-implementation survey with Mitretek to examine the time required for alert management and the data demonstrated that "on average, alert turnaround was 27 – 30 days," said Haupt.

Prior to RASMAS, when a recall occurred, each alert was assigned an internal tracking number, and the notice was then scanned and converted into a PDF document to forward electronically to the Information Services (IS) department. The IS staff then posted the alert on Inova’s Material Management intranet site, InovaNet. Next, a link to the alert was sent to "Recall Coordinators" who reviewed the alerts. The coordinators then forwarded the URL via email to the appropriate department for action. Staff could print the email responses from InovaNet and file them with the original recall notice.

About RASMAS
 RASMAS is a web-based service that automates the distribution, receipt, and tracking of product alerts and recalls. It provides centralized recall oversight from a management perspective for alerts spanning across all products used in the health care environment. This is accomplished through the use of knowledge management technology and the skills of the National RASMAS Center clinical staff. Alerts are located from more than 20 national and international sources and processed for release. Assigned to one of fourteen product domains (such as biomedical devices, medical supplies, and pharmaceutical products), the system directs the alert automatically to the appropriate coordinator in the healthcare organization for processing. The coordinator reviews the alert and makes an assignment to staff responsible for taking action. These responders remove the product from shelves, quarantine the product for maintenance, or perform other actions required to close out an alert. If progress on an alert is delayed, RASMAS automatically sends notices up the chain of command for prompt assessment of the delay and additional intervention if necessary. A complete documentation trail is established for each alert, and an array of reports can be quickly generated for review by hospital management or regulatory/licensure groups.


 Inova Health System Pre-and Post-RASMAS Average Days to Close Alerts

Inova Health System Average Days to Close Alerts by Domain Oct. 2004 - Sept. 2005

"Ensuring that recalls are received by the correct individual/department and handled in an appropriate timeframe is critical to ensure the safest care delivery possible for our patients," said Haupt. "RASMAS provides the automated tracking we lacked in our previous process that helps to ensure that proper action has been taken on the alert. By May of 2004, just four months into using RASMAS, our average alert management time was cut from 20 days to 5. RASMAS is now in place throughout all Inova facilities with average processing time around 5 – 6 days."

The recall
On August 26, 2005, RASMAS alerted its subscribers that the U.S. Army Medical Materiel Agency had issued a field correction for the GE Healthcare Centricity Cardiology A11000 Workstation. The correction was issued because the radiology device had the potential to mix images from multiple patients and compromise a patient’s condition or diagnosis and treatment. On September 7, 2005, this notice was followed up by an FDA Class II Recall. The recall required hospitals to install a software upgrade that would prevent the workstations from mixing patient images.

On August 26 and September 7, Inova Health System received these notices through the RASMAS product recall management service. Inova, following their standard recall procedures, located the product, performed the corrective action via the manufacturer, and then closed the alert using RASMAS.

The audit
On November 8, two months after the FDA issued its recall, Bea Haupt, Inova Health System Recall and Safety Manager, received a phone call from an FDA auditor seeking information about the manufacturer’s notification for the GE Healthcare Centricity Cardiology A11000 Workstation. Haupt answered the call and immediately opened her browser and navigated to RASMAS. She searched her closed alerts and found the GE Centricity recall. A quick glance at the "Work History" told her that the recall only affected one of Inova’s 10 facilities. She was then able to tell the FDA auditor the date Inova received the alert, when they began working on it, who handled the alert, and the details of the corrective measures that were taken.

Haupt was able to satisfy the FDA auditor that the recall was handled correctly in a timely manner and that Inova’s documentation was complete.

The outcome
 Inova had followed their recall procedures and thoroughly documented every action associated with the GE Centricity recall notices. Inova cardiology patients benefited from Inova’s swift actions in responding to the recall and updating the workstation’s software. The representative from the FDA was impressed that Inova had the recall information at their fingertips and could document their actions so thoroughly that the FDA did not need to travel to Inova for an on-site inspection and personal interview. "The costs of recall management, of course, truly depend on each alert and its complexity," stated Haupt, "but clearly since we’ve implemented RASMAS we are saving time and money." In addition, when audits arise, Inova has peace of mind. HPN

Inova Health System is a five-hospital, not-for-profit health care system based in Northern Virginia. Governed by a voluntary board of community members, Inova’s mission is to improve the health of the diverse community they serve through excellence in patient care, education, and research.

To contact RASMAS: Call toll-free 877-727-6276 or Email: rasmasSales@mitretek.org. Website: http://rasmas.mitretek.org

May
2006