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Lab Quality & Regulatory Program Manage - Methodist University Hospital

Summary:

Responsible for managing the implementation and evaluation of system-wide Quality System Essentials for Laboratory Services.  Develops standard policies, operating procedures, and validation plans.  Reviews and ensures proper application of regulatory and accreditation standards to work processes. Works closely with facility operational leaders to achieve goals and objectives for laboratory services. Models appropriate behavior as exemplified in MLH Mission, Vision and Values. Models appropriate behavior as exemplified in MLH Mission, Vision and Values.

Education/Training & Experience:

REQUIRED:

Bachelor’s degree in Clinical Laboratory Science or Medical Technology.

Minimum of five years of experience in Laboratory Quality Management. 

  • Current TN Licensure as Medical Technologist Generalist or Medical Technologist Special Analyst.
  • Current certification as a specialist in Blood Banking (SBB ASCP)

PREFERRED:

Master’s Degree in Clinical Laboratory Science or Medical Technology.

Certification as an Quality auditor (CQA) from  American Society for Quality (ASQ) preferred

Knowledge/Skills/Abilities:

  • Strong knowledge of the cycle and properties of blood production and distribution methods and theories.
  • Strong knowledge of regulatory and accreditation standards as they apply to Transfusion Medicine, Apheresis, and Laboratory Services.
  • Demonstrated skills in technical writing with emphasis on creation of standard operating procedures.
  • Good working knowledge of computers and software applications such as spreadsheets, word processing, and database applications.  Basic knowledge of laboratory information systems.
  • Demonstrated knowledge in the application of quality tools and methodologies.
  • Demonstrates strong skills in analytical thinking, problem solving, and high attention to detail.
  • Ability to effectively instruct others in technical and regulatory requirements.
  • Ability to effectively relate and communicate with internal and external customers.
  • Ability to organize tasks and projects and works independently to complete tasks.
  • Will require travel to multiple MLH facilities; must have valid driver’s license and insurance.

Key Job Responsibilities:

  • Manages the implementation and evaluation of system-wide Quality System Essentials for Transfusion Service, Apheresis Services, and Laboratory Services.
  • Identifies, coordinates and implements quality monitoring to ensure compliance with regulatory requirements, quality standards, compliance activities, and policies and procedures.
  • Develops and recommends procedures to improve operational efficiency and quality of service.
  • Performs quality audits, identifies inconsistencies, and recommends corrective actions for processes and procedures.
  • Establishes and maintains efficient and reliable mechanisms for monitoring, analysis, and reporting of quality outcomes and performance improvement initiatives.  Ensures the integration of aggregate data into performance improvement planning and problem resolution.
  • Manages the development and standardization of policies, standard operating procedures, protocols and validation plans for the adult MLH transfusion services.
  • Develops, composes, validates, publishes, and implements use of standard operating procedures for Transfusion Services, Apheresis Services and   Laboratory Services.
  • Communicates policy and procedure information and initiates appropriate changes to ensure compliance.
  • Serves as System Administrator of the Transfusion Services and Apheresis Services document control system (WellSky) for the adult transfusion services of the MLH system.
  • Responsible for review of regulatory (CAP, FDA, CLIA and CMS) and accreditation standards (AABB, CAP, FACT) applicable to Transfusion Services, Apheresis Services and other lab functions.
  • Manages the review of regulatory and accreditation standards applicable to Transfusion Services, Apheresis Services and Laboratory Services.
  • Regularly reviews regulatory standards and updates as assigned to ensure processes are performed at or above the applicable regulatory standards.
  • Modifies, updates, and executes established programs to maintain compliance.  Supports or leads projects for the timely completion of corrective actions.
  • Identifies, recommends, and/or presents educational programs and materials to enhance the staff’s knowledge of accreditation and regulatory standards.
  • Provides support for ongoing compliance and survey readiness with laboratory accrediting bodies and other applicable regulatory agencies.
  • Coordinates clinical trials with principal investigators, study coordinators, quality assurance and compliance.
  • Performs special projects including clinical trial involving cellular therapy products.

Supervision Provided by this Position:

  • Provides direction, directly and indirectly, for Associates and leadership regarding implementation and evaluation of the Laboratory, Apheresis and Transfusion Quality Systems.

Lab Quality & Regulatory Program Manage - Methodist University Hospital

United States
Full Time
Management (Manager/Director of Staff)
Bachelor's

Published on 09/19/2022

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