The Massachusetts General Hospital (MGH) Coordinator of Sterile Compounding Quality and Compliance is responsible for the creation, implementation and management the comprehensive a quality assurance and compliance program for pharmaceutical compounding within the Massachusetts General Hospital Department of Pharmacy. This includes all sterile and non-sterile preparations to ensure the highest of quality standards are in place coupled with regulatory requirements. In collaboration with compounding managers-of-record, the coordinator will be responsible for developing a robust monitoring, surveillance and audit program to ensure necessary measures and interpretation of documented results and/or excursions related to environmental monitoring, personnel, standard operating policy and procedure, end product testing and corrective action preventive action plans are handled properly. The Coordinator will work with other Partners Healthcare hospitals to promote compliance and best practices, as well as conduct audits to 503A and 503B facilities that Partners hospitals purchase compounded preparations from.
Quality & Safety Management
Develops, maintains and coordinates a comprehensive and standardized compounding quality assurance program for the department which facilitates the achievement of positive outcomes, is consistent with current accepted practice in pharmacy, and can be integrated with service programs in all compounding areas
Work with compounding pharmacy management and staff to review and analyze findings to provide guidance to facilitate change and implement plans of correction, if applicable, through the established pharmacy compounding corrective action/preventative action (CAPA) program to ensure proper remediation and closure
Serve as a subject matter expert to assist in identifying and mitigating ongoing risk through review of data and analytics, reviewing day-to-day deviations/excursions/concerns in the quality assurance plans to remediate in real-time, performing trend analysis to identify possible risk at the local and Partners systems-level through a hierarchical escalation process.
In conjunction with vendor contractual agreements, will lead external audits with vendors, perform routine quality data and/or reports oversight and evaluation to ensure a high level of service to meet our regulatory and accreditation agency commitments.
Provide knowledge and support to the compounding areas, with compliance-centric process audits, root cause analysis, and quality assurance and performance improvement initiatives.
Visit all compounding areas (including offsite areas) to observe pharmacy-related practices and audit drug-related controls to identify areas of vulnerability, correct deficiencies and ensure consistent standard of practice. Oversee and manage database programs to facilitate the ongoing compliance of training, procedures and documentation essential to ensure patient safety and mitigate risk to meet the needs of the institution.
Interprets quality assurance data and collaborates with managers to predict emerging areas of need and adjust monitoring and evaluation strategies quickly and appropriately.
Performs ongoing analyze of clinical and operational data and documentation in addition to direct observation, to identify and eliminate existing and/or potential problems, and proposes or independently implements strategies to resolve problems
Documents written risk assessment and communicates results from monitoring and audit activities and recommends action when necessary and /or plans of correction.
Present data and findings to appropriate pharmacy forums
Ensures all products are compounded in accordance state and federal guidelines and all individual lot production records are completed accurately and stored in accordance with BUD dating, if applicable.
Assists with reporting adverse drug reactions within the safety reporting system for full assessment.
Operation, Optimization & Innovation
Project lead for organizational initiatives directly related to compounding activities and improvements ( i.e. CSTD, PPE, cleaning. etc).
Ensures standardized workflow processes across the department including utilizing same vendors, testing, cleaning/protective products, etc…
Assists with the implementation and operational integration of compounding process improvements working with staff and/or outside vendors.
Serves as a primary consultant to assess compounding advanced technology, software, equipment, infrastructure and practices to promote efficiencies and safety enhancements in congruency with the legislative and regulatory standards working in conjunction with the Chief, Director of Finance, Director of Inpatient Operations, Assistant Director of Quality, Compliance, and Regulatory and Area Managers.
Serves as the subject manager expert when conducting compounding related facility renovations across the department
Participates in work related to the development of strategic compounding initiatives (i.e. Centralized compounding center, Internal Testing Program, etc.)
Leads written responses to federal/state agencies and professional organizations related to sterile compounding regulations and consultation as needed
Utilize technology to develop a consistent communication method for best practices and common concerns.
Works closely with customers and business affiliates on preparations, product line or enhancement options for consideration
Maintains up-to-date knowledge of industry trends, cutting-edge practices and techniques, current publications and regulations relevant to role and business and seeks advanced knowledge sponsored by national certification programs
Identifies need for and implements administrative systems to plan for and carry out quality assurance activities and projects in a cost-effective and timely fashion.
Regulatory & Accreditation Compliance
Ensure full and ongoing compliance with USP <797>, <795>, <71>, <800>, and Massachusetts Board of Registration in Pharmacy (BORP) and Massachusetts DPH regulations
Consistently keeps abreast of any FDA Warning Letters, Form 483b, and obtains follow-up related to the corrective actions taken and continuous quality improvement programs implemented.
Ensure proper documentation and filing of all training, environmental monitoring. Follows up with manager-of-record around non-compliance issues.
Knowledge of quality assurance methods and issues as well as the external regulatory environments to develop a short and long-term compounding quality assurance plan for the pharmacy department.
Ensure that all equipment calibration, certification and/or recertification is carried out as scheduled
Staff Testing, Training & Education
Develops and oversees annual and new employee staff sterile and non-sterile compound training. Providing staff training and testing as needed.
Provides routine staff education and training in accordance with needs identified through different methodologies
In collaboration with the Directors and Area Managers, he/she facilitates the development, implementation, and evaluation of institution-wide compounding competency materials to ensure proper staff education, quality improvements, patient safety and risk mitigate on strategies are understood and enforced.
Consultative Services & External Partnerships
Participates in budget planning including supply, equipment, testing, and renovation estimations
Work with other Partners Healthcare institutions and regional affiliated sites
Provides consultation, guidance and technical assistance to the Pharmacy Leadership regarding compounding related quality assurance issues in pharmacy.
Works in conjunction with Chief Pharmacy Officer, Assistant Director of Quality, Compliance and Regulatory Affairs, Directors, and Area Managers to assess and consolidate outsource vendor and supplier services provided to help ensure appropriate resource allocation.
Bachelors of science degree (ie.Microbiology)/advance degree preferred or Bachelor of Science in Pharmacy or Doctor of Pharmacy degree
Expertise in compliance standards and regulations promulgated by the relevant agencies: DPH, BORP, TJC, CMS, FDA, USP
Leadership capabilities to provide oversight and guidance for all MGH pharmacy compounding personnel and external business affiliates
About Massachusetts General Hospital
Founded in 1811, Massachusetts General Hospital (MGH) is a 1,000 bed academic medical center, the third oldest general hospital in the US, a teaching hospital of Harvard Medical School, and conducts the largest hospital-based research program in the country. Mass General has consistently placed among the top hospitals on the U.S. News & World Report Best Hospitals Honor Roll since the survey began in 1990. In 2018, Mass General was named No. 4 in the nation based on our quality of care, patient safety and reputation in 16 clinical specialties. In 2018, Mass General was also re-designated a Magnet hospital, the highest honor for nursing excellence awarded by the American Nurses Credentialing Center.