COMPLIANCE SPECIALIST REGULATORY

Under the direction of the Regional Manager, Quality Assurance and POC testing supports the compliance and quality assurance activities within the department by acting as a resource to members of the Laboratory Quality Steering Committee, Blood Usage Committee, Blood Bank Quality Unit and Laboratory Compliance Committee. Supports lab-wide accreditation for CAP, FACT, FDA, AABB, ASHI, TJC.

Position Requirements:

Minimum Education:

Required: Bachelors Degree

Preferred: Masters Degree

Specify Degree(s): Medical Technology, Medical Laboratory Sciences, Chemistry or Biology

Residency: N/A

Minimum Experience:

Required: 3-5 years of previous job-related experience

Preferred: N/A

Managerial Experience: N/A

Licensure/Certifications:

Required:

Certified Medical Technologist, Medical Laboratory Scientist, laboratory discipline specific or

specialty certificate (ASCP or AMT)

Preferred:

Other: N/A

Computer Skills:

Required:

Basic Keyboarding Skills

Microsoft Excel

Microsoft Power Point

Microsoft Word

Preferred:

EPIC

Groupwise

Misys

Net Learning

Other: Ability to facilitate small groups, prepare meeting minutes and agendas, manage projects

and adhere to deadlines.

Typing Words Per Minute: N/A

Required Skills:

Ability to analyze and interpret data

Ability to communicate verbally

Ability to compile complex reports and develop presentations

Ability to compose letters and memorandums

Ability to deal calmly and courteously with people

Ability to deal with stressful situations

Ability to finish tasks in a timely manner

Ability to follow oral and written instructions and established procedures

Ability to function independently and manage own time and work tasks

Ability to lead work teams

Ability to maintain accuracy and consistency

Ability to maintain confidentiality

Ability to organize workflow

Ability to organize workflow

Ability to perform basic filing, office procedures and word processing

Ability to plan, coordinate and develop multiple projects

Ability to work as an effective team member

Other: Ability to facilitate small groups, prepare meeting minutes and agendas

Performing an ongoing GAP analysis between laboratory operations and

various regulatory and accreditation requirements, including FDA, IDPH

(CLIA), AABB, CAP, ASHI, CMS, FACT and CMS, to support continued

compliance. A.) Reviews regulations, accreditation requirements and

inspection deficiencies and non-conformances B.) Identifies gaps between

requirements and current practice and makes recommendations for

improvement C.) Develops corrective action plans following inspection

citations D.) Provides laboratory staff with ongoing regulatory training on

new issues regarding accreditation, compliance, patient safety and

medical error reduction E.) Conducts periodic audits of customer service

and satisfaction of physician, nursing and patient users of laboratory

services in accordance with accreditation requirements F.) Assists in

collating and submitting pre-inspection materials G.)Tracks PT

performance by laboratory and reviews exception reports prior to

presentation to the Laboratory Quality Steering Committee

Collaborating with the managers and directors in implementing projects

related to maintaining regulatory compliance and improving laboratory

performance. A.) Establishes a regular communication vehicle (by nursing

unit and location) for the tracking and communicating of specimen

labeling errors B.) Assists in the development of a new department-wide,

standardized electronic system for occurrence reporting, monitoring,

trending and process improvement C.)Acts as a resource to section

quality units as they develop monitors and projects