In an effort to mitigate risks associated with outpatient parenteral antimicrobial therapy (OPAT), a failure modes and effects analysis (FMEA) program was developed at Johns Hopkins, a tertiary-care, academic medical center in Baltimore, to identify barriers to the safe and effective completion of OPAT during transitions of care (TOC) to either home or a skilled nursing facility (SNF). The researchers also sought to develop targeted solutions to potentially resolve or improve identified barriers.

FMEA is an adaptable, systematic method used to identify and minimize potential failures in high-risk processes. Its use is recommended by the Joint Commission to help prevent iatrogenic problems by identifying and analyzing healthcare and patient-care errors.

A descriptive report has been published that describes the steps involved in developing and formalizing an OPAT program, with particular focus on identifying and eliminating barriers that may adversely impact patient care. This paper provides a blueprint for others trying to develop or enhance their OPAT program. After mapping out the processes involved in an OPAT program and engaging with the key stakeholders, the authors identify five areas of focus for targeted improvement. These include the OPAT electronic order set, critical tasks that need to be completed prior to patient discharge, identification of patient-education needs, provision of patient follow-up and laboratory monitoring, and improved communication with SNF (if the patient is being discharged to long-term care).

Among the identified barriers involving the order set were not using the electronic health record for ordering and not including all IV antimicrobials and diluents, premedications, and pertinent laboratory monitoring in the order set.

Obstacles to effective discharge included limited timeframe to assess an OPAT patient's candidacy, lack of awareness by prescribers to electronically send orders to the home-infusion agency, being unknowledgeable about the concept of drug steady-state and its implications, the need to reevaluate OPAT if 3 days or more have passed since the initial order, and failure to communicate modifications to OPAT orders or discharge date by phone.

Barriers in SNFs involve the need to reevaluate OPAT if 3 days or more have passed since the initial order, placing too much reliance on a hospital's discharge note and not on an infectious disease (ID) consult, and failure to perform a "warm handoff" from the hospital nurses to the SNF nurses. Estimates of 30-day remissions directly related to OPAT complications range from 10% to 30%.

The FMEA process also identified patient-education needs, which included educating on allergies, adverse events, and catheter complications. Patient-education materials were developed to address these concerns.

Patient follow-up and laboratory monitoring barriers included lack of up-to-date information in the "OPAT note" by the ID consult, difficulty for the home-care pharmacist to communicate with the outpatient provider regarding the OPAT order, lack of outpatient-clinic follow-up to inform the outpatient provider of laboratory results (including drug levels), and failure of patients to return to clinic within 2 weeks of discharge. Several of these obstacles (i.e., issues with the OPAT note and lack of laboratory and drug monitoring) also occur within SNFs.

In order to improve communication with SNFs, the facilities were given a 24/7 pager number for the hospital pharmacy administrator to help clarify any problems that may arise during TOC.

Although a before-and-after analysis of this FMEA strategy has not yet been conducted, this paper provides valuable insight for pharmacists interested in enhancing their OPAT program.

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