Leveraging a multidisciplinary oversight committee to ensure USP <797> and <800> compliance at a Veterans Affairs health system.

PURPOSE: Producing compounded sterile preparations (CSP) of the highest quality and ensuring safe hazardous drug handling are well-established priorities for pharmacy departments. Maintaining compliance with United States Pharmacopeia general chapters 797 and 800 (USP <797> and <800>) must also be a priority for health-system leadership. This report describes how a pharmacy-driven multidisciplinary committee was created to provide USP <797> and <800> oversight within a multicampus Veterans Affairs health system and the facility and safety outcomes achieved. SUMMARY: The Veterans Health Administration required facilities to establish an oversight committee to ensure USP-compliant CSP procedures and the safe handling of hazardous drugs in all aspects of the medication-use process. Spearheaded by the pharmacy department, the VA Palo Alto Health Care System (VAPAHCS) chartered the CSP Advisory Committee to achieve this goal.The membership was composed of department heads in the areas of pharmacy, nursing, environmental management services, engineering, facility planning, safety, industrial hygiene, employee health, supply chain services, infection control, and quality management and the health system's director's office. The medication safety officer served as the executive secretary for the advisory committee and was responsible for agenda development, minutes, and coordinating timely follow-ups on action items; the VAPAHCS deputy director served as chair. Monthly meetings were conducted to receive updates on targeted sterile compounding and hazardous drug handling objectives: environmental controls and monitoring, compliance with regulatory requirements, staff competency, hazardous drug exposure event analyses, and development of well-defined health-system policy to guide practice. CONCLUSION: Taking a multidisciplinary approach to USP <797> and <800> compliance facilitated communications, created engagement, and ensured completion of action plans.

Complementing Root Cause Analysis With Improvement Strategies to Optimize Venous Thromboembolism Prophylaxis in Patients With Epidural Catheters.

BACKGROUND AND OBJECTIVES: High reliability organizations in health care must identify defects and systematically approach causal factors with subsequent process redesign to achieve goals important to patients, families, and staff. Root cause analysis (RCA) is a commonly leveraged strategy for reviewing adverse events and can yield immense benefits toward patient safety when applied alongside complementary change management strategies such as Lean and Six Sigma. We performed an RCA in response to a hospital-acquired venous thromboembolism (VTE) event in a postoperative patient for which pharmacologic VTE prophylaxis was not appropriately resumed following removal of an epidural catheter. METHODS: A multidisciplinary stakeholder team was assembled to further understand the details of the event. A current process map was created and non-value-added steps were identified. Causal analysis revealed that frequent staff turnover, variable methods of communication between stakeholders, inconsistent responsibilities with respect to ordering and administering pharmacologic VTE prophylaxis, and lack of an established standard work process were key contributors toward the defect of concern. Several countermeasures were introduced to combat these identified root causes, including shifting responsibility for managing VTE prophylaxis orders periepidural catheter removal from the surgical house staff to our regional anesthesia service, and creation of an epidural catheter heparin restart order set, which in one step places an order to resume prophylaxis following catheter removal at a specific time. Recommendations from this session were disseminated to staff through previously established huddles that are a component of our daily management system. RESULTS: Postintervention, review of our updated process demonstrated a reduction in variability through establishment of standard work that is primarily owned by a constant factor in this care pathway (our regional anesthesia team). On review of the subsequent 10 cases of patients with epidural catheters, all patients receiving pharmacologic VTE prophylaxis had a maximum of 1 dose stopped for epidural catheter removal, therefore minimizing time without VTE prophylaxis. CONCLUSIONS: RCA can be utilized in the aftermath of an adverse event to establish causal factors and identify countermeasures to prevent recurrence of such an event. It can be further augmented with additional change management strategies including Lean, Six Sigma, the Model for Improvement, and failure modes and effects analysis. These strategies allowed us to design effective error-reducing strategies to achieve a more reliable process, which yielded reduced VTE prophylaxis administration defects that in turn has prevented recurrence of hospital-acquired VTE in patients with epidural catheters.

Integrating patient-centric indications into the prescribing process: Experience at a tertiary academic medical center.

PURPOSE: To describe the development of and implementation of a patient-centric clinical indications library (CIL) into the prescribing process and determine the operational and humanistic outcomes (from prescriber, pharmacist, and patient perspectives) of including indications on outpatient prescription labels. METHODS: A descriptive retrospective data analysis was conducted. Multiple stakeholder groups were engaged to develop and integrate the CIL into the prescription package. After CIL integration, prescribers, pharmacists, and patients were surveyed. A focus group discussion consisting of Veterans and caregivers was held. RESULTS: Following implementation of the CIL, the proportion of prescriptions associated with an indication increased from 88% to 96%. Surveyed clinicians responded that indications helped them better understand a patient's profile (61.1% of prescribers and 100% of pharmacists). Among surveyed pharmacists, 61.5% and 53.8%, respectively, believed that indications helped them catch instances of wrong medications and wrong doses ordered. Veterans surveyed found that indications on their prescription labels helped them know what their medications were for (91.0% of respondents) and why it is important to take their medications (70.7%). In focus group discussions, Veterans and family members and/or caregivers expressed a preference to see indications that describe how a medication works (eg, "to lower blood sugar" vs "for diabetes") because they felt that type of phrasing is measurable, action oriented (which was appealing due to Veterans' military background), provides surreptitious education, and tells the users what to expect. CONCLUSION: Engaging multidisciplinary stakeholder groups, optimizing the electronic health record system, and authorizing pharmacists to add known indications to prescriptions increased the number of prescriptions with indications, decreased the perceived time spent on order entry and verification, and enabled better understanding of each medication's purpose by providers and patients.