The Massachusetts General Hospital (MGH) Coordinator of Quality Operations and Compliance is responsible for the management a comprehensive quality assurance and compliance program for inpatient and ambulatory pharmacy operations and pharmaceutical compounding within the MGH Department of Pharmacy. This includes all inpatient and ambulatory operations quality and compliance programs and ensuring the sterile and non-sterile preparations are of the highest quality standards are in place coupled with regulatory requirements. In collaboration with the operations managers and compounding managers-of-record, the coordinator will be responsible for ensuring a robust auditing, monitoring, and surveillance program to identify process improvement initiatives and guarantee a constant state of survey readiness for all applicable regulatory and accreditation standards. The coordinator will collaborate with Quality, Safety, and Compliance colleagues from across disciplines at MGH and Partners Healthcare.
Sterile Compounding Quality and Compliance
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.
Leads the Pharmacy Compounding Manager of Record Committee
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.
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.
Participates in work related to the development of strategic compounding initiatives (i.e. Centralized compounding center, Internal Testing Program, etc.)
Project lead for organizational initiatives directly related to compounding activities and improvements ( i.e. CSTD, PPE, cleaning. etc).
Serves as the subject manager expert when conducting compounding related facility renovations across the department
Leads written responses to federal/state agencies and professional organizations related to operations and/or sterile compounding regulations and consultation as needed
Ensure proper documentation and filing of all training and compounding environmental monitoring, room and hood certifications, calibrations, cleaning, and other documents related to survey readiness.
Ensure that all equipment calibration, certification and/or recertification is carried out as scheduled
Ensure full and ongoing compliance with USP <797>, <795>, <71>, <800>, and Massachusetts Board of Registration in Pharmacy (BORP) and Massachusetts DPH regulations in pharmacy operations at compounding areas at MGH.
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.
Quality & Safety Management
Leads the conduct of quarterly quality medication management audits to all pharmacy areas (onsite and offsite); oversees reports to managers and follows up with managers around non-compliance issues.
Performs ongoing analysis 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
Develops and maintains an operational quality dashboard
Documents written risk assessment and communicates results from monitoring and audit activities and recommends action when necessary and /or plans of correction.
Interprets quality assurance data and collaborates with managers to predict emerging areas of need and adjust monitoring and evaluation strategies quickly and appropriately.
Operation, Optimization & Innovation
Involvement as requested by operations managers on additional large-scale initiatives and process improvement plans
Ensures standardized workflow processes across the department including utilizing same vendors, testing, cleaning/protective products, etc.
Utilize technology to develop a consistent communication method for best practices and common concerns.
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
Possesses knowledge of quality assurance methods as well as the external regulatory environments to develop a short and long-term quality assurance plan for the pharmacy department.
Ambulatory Quality and Compliance
MGH has over 250 affiliated clinics in Boston and the surrounding cities. The Quality, Compliance, and Regulatory Affairs team conducts over 75 audits per quarter to Ambulatory clinics. The Coordinator will be responsible for working with the clinics on process improvement and compliance with non-conformities.
Collaborates with the MGH Ambulatory Quality and Safety team in the Office of Practice Improvement
Delivers medication management overview at Ambulatory Nursing Orientation quarterly
Ensure standardized practices across ambulatory infusion pharmacies and practices within the MGH Cancer Center related to medication processes
Staff Testing, Training & Education
Develops and oversees annual and new employee staff sterile and non-sterile compounding training.
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 operations and/or 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
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.
Works as an active member of operations and/or clinical pharmacy team to collaborate with healthcare providers and pharmacy staff, place practice priority on the delivery of patient-centered care, and provide accurate, safe, timely, and appropriate medication therapy based on patient needs.
Provides consultation, guidance and technical assistance to the Pharmacy Leadership regarding operations and 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.
About Massachusetts General Hospital
Founded in 1811, Massachusetts General Hospital (MGH) is a 1,035 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 2019, Mass General was named No. 2 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.