Coordinator Quality Assurance & Control

SUMMARY:
Under the direction of the Laboratory Director and in collaboration with the Laboratory Management team, develops, coordinates, and facilitates quality assurance and quality control for maintaining continuous compliance standards, performance improvement programs and processes throughout the laboratory to meet all regulatory requirements, to assure customer satisfaction, and to quantitatively establish and maintain a quality environment.

ESSENTIAL FUNCTIONS:

Supports quality improvement initiatives through team participation, data collection, process change implementations, and other activities.

Ensures Quality Assurance Quality Control Program fulfills all accreditation and regulatory requirements of local, state and federal agencies and affiliates (e.g., CAP, JCAHO, CLIA, FDA, OSHA, AABB, etc.).

Provides and communicates current regulatory guidelines, legislative changes and accreditation criteria to laboratory management team, all sections of the laboratory and Respiratory Therapy. 

Works with Directors, management team, and quality improvement teams, to coordinate and establish annual quality assurance calendar. Assures all quality improvement and monitoring activities are completed in a timely manner. 

Develops and proposes, in collaboration with the management team, appropriate improvement projects utilizing statistical process controls, including but not limited to: measurement of customer satisfaction and perception of quality, measurement of cost effectiveness and productivity, and reduction/elimination of non-quality improvement processes and unnecessary redundancies.

Facilitates the CQI (Continuous Quality Improvement) and SPC (Statistical Process Control), process in each section of the laboratory.  Works with appropriate staff to identify key indicators of service, establish methods for monitoring performance, and to initiate improvement activities. 

Facilitates the implementation of processes to assure the best quality outcome is delivered to customers/clients in a customer-focused manner.

Provides support to the technical and non-technical managers to target, measure, and report quality improvement opportunities. 

Facilitates, trains, and/or sets up teams for problem solving, implementation, and follow-up.  Supports technical managers through review of proficiency survey reports and recommends corrective actions as indicated.

Assures laboratory personnel are trained in the theories, concepts, and implementation of quality management to include CQI, SPC tools such as EP Evaluator, Levy-Jennings control chart and Westgard quality control.

Serves as the main resource to laboratory staff in matters relating to quality assurance and quality control.

Coordinates the development, review, maintenance, revision and formatting of Laboratory testing and Standard Operating Procedures, protocols, QC forms, validations and/or verifications. Facilitates the revision of all laboratory policy and procedure manuals to meet standards of all regulatory agencies, to ensure document control, assure consistency of practices throughout the laboratory department, and to improve the quality of patient results and reports.

Participates in the development, validation and implementation of new laboratory procedures and techniques.

Responsible for the oversight of internal and external inspections and findings including all follow-up activities and responses.

Initiates corrective action as soon as QA/QC deficiencies are identified. Works collaboratively with the Laboratory Management team in effort to resolve issues and complaints in a prompt and timely manner.

Tracks and analyze statistical trends and shifts to ensure recommended corrections for improvements are implemented and maintained.

Assists TMC Quality, Directors and managers with planning and development of workflow processes to improve laboratory services to all customers.  Participates in QA/QC projects as assigned.

Adheres to and supports team members in exhibiting TMCH values of integrity, community, compassion, and dedication. 

Adheres to TMCH organizational and department-specific safety and confidentiality policies and standards.

Performs related duties as assigned.

MINIMUM QUALIFICATIONS

EDUCATION:  Bachelor's degree in Medical Laboratory Science or equivalent.

EXPERIENCE:  Minimum of 5 years experience in a Clinical Laboratory.  Must be able to train others to use CQI and related SPC tools.

LICENSURE OR CERTIFICATION: Medical Technologist (ASCP) Certification or equivalent.

KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledge of quality control test measurements and regulations regarding analyzing specimens.

• Skill in evaluating tests and identifying measures outside the norm, and whether any follow up testing might be required.

• Demonstrates effective computer skills including programs such as Microsoft Office Suite, email, PDF, and internet searches.

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.

• Ability to complete routine reports and correspondence.

• Ability to listen and accurately interpret others’ communication or instructions to take appropriate action.

• Ability to speak effectively before groups of customers or employees of organization.

• Ability to calculate figures and compute rate, ratio, and percent and to draw and interpret bar graphs and apply basic algebraic concepts.

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.