Quality Clinical Specialist

Job Summary/Scope

The Quality Clinical Specialist is responsible for monitoring organizational compliance with CMS, FDA, UNOS, AOPO, and AATB standards and/or regulations. The primary responsibilities are to promote compliance and quality improvement by performing internal quality audits for organ recovery and Quality Control (QC) for tissue recovery. Duties include but are not limited to: scheduling and performing planned periodic audits and QC review in addition to providing support and assisting with pre and post site surveys, quality metrics and process improvement programs. The Quality Clinical Specialist must possess an extensive knowledge of medical terminology and be able to interpret medical records (i.e. lab results, infusions/transfusions). Additionally, they are required to exhibit proficient computer skills and will support the Director of Quality Systems with preparation of site surveys and audits by regulatory agencies such as CMS, FDA, UNOS, AOPO, and Tissue Partners who follow AATB guidelines.

Essential Functions

1. Manages audits of documentation related to the comprehensive organ recovery process:
2. Interprets operational policies & organ regulations to maintain effective business operations.
3. Performs Quality Audits within iTransplantsm on donor referral, authorization, medical & social history, donor management, UNet ? (organ allocation), organ OR, and Post Recovery documentation at a minimum.
4. Has the authority to analyze, formulate, and assign Corrective and Preventive Action (CAPA) associated with regulatory non-compliance:
5. Collaborates with Organ Procurement Coordinators (OPCs) and Managers of Organ Procurement to ensure accurate and timely updates of donor records.
6. Provides expert advice to management and employees on established Organ policies and procedures.
7. Manages Quality Control (QC) review of recovery records related to the tissue donation process:
8. Work jointly with tissue partners to facilitate the release of recovered tissue in a timely manner.
9. Interprets operational policies & tissue regulations to maintain effective business operations.
10. Perform QC review within iTransplantsm on donor referral, authorizations, medical & social history, tissue outcomes, ComCenter Checklist and tissue recovery documentation at a minimum.
11. Documents review outcomes. Formulates, assigns, and analyzes, Corrective Action (CA) associated with regulatory non-compliance.
12. Collaborates with Manager of Tissue Recovery and Tissue Recovery Coordinators (TRCs) to direct timely updates of donor records.
13. Provides expert advice to management and employees on established Tissue policies, procedures, and regulatory compliance.
14. Interprets and applies federal regulatory, as well as, industry guidelines and standards as it relates to compliance with UNOS donor management guidelines, and Organ allocation requirements, compliance with FDA tissue suitability and recovery guidelines and verification of CMS requirements for donor recovery, using the employee’s discretion, judgement and professional experience.
15. Manages Organ and Tissue non-conformances and recommended action(s), as appropriate:
16. Assumes responsibility to proactively identify and anticipate risk of non-compliance in a complex environment and escalate issues/problems to management to ensure that event notification to Medical and Executive Directors, insurance agencies, transplant programs, eye bank, processing agencies, UNOS, etc., is effective and timely.
17. Demonstrates proficiency in various Electronic System Databases such as Q-Pulse®, iTransplantsm, DonorNet®, SRTR, etc., at a minimum.
18. Serves as Safety Officer for organization.
19. Responsible for creating, revising, and training of safety related SOP’s.
20. Oversees Safety Committee.
21. Responsible for scheduling and coordinating annual safety drills.
22. Support Process Improvement (PI) plans, collate improvement data and identify and implement quality improvement initiatives:
23. Maintain and document evidence of ongoing PI within each assigned department
24. Identify areas for standardization
25. Support PI activities and teams through staff PI training and education
26. Collaborates with staff and management to identify Key Performance Indicators (KPI).
27. Manages Clinical Specialist KPI data:
28. Provides feedback reports and metrics to management to optimize operations and continuous improvement.
29. Assist the Director of Quality Systems and Quality Operations Specialist in establishing Clinical Specialist objectives and ensures KPI targets are achieved through effect quality performance monitoring, measurement, analysis, goal achievement and reporting.
30. Provides advice regarding potential areas for Process Improvement (PI) and KPI for clinical/hospital-based functions.
31. Collaborates with Quality Systems to develop Quality department KPI.
32. Fosters effective relationships with Quality Systems department staff, Leadership Team, and stakeholders to maintain quality and help introduce new quality objectives.

Secondary Functions

1. Executes limited responsibilities of Quality Compliance Generalist (QCG) and Quality Operations Specialist [QOS (except for Q-Pulse® SA duties)] as required. Have a basic working knowledge of QCG and QOS operations.
2. Prepares PowerPoint slide shows on QS topics or topics as assigned.

Organizational Expectations

1. Maintains regular and punctual attendance at assigned work location.
2. Accurately document timekeeping records.
3. Completes and maintains appropriate documentation in a timely and thorough manner including activities. Examples include: training documentation, mileage, expenses, electronic schedule of ARORA events, and other forms.
4. Proofs work for accuracy and completeness.
5. Exhibits and models ARORA’s conduct standards, mission, and organizational clarity (core purpose, core values, business definition, and strategic anchors) in all job functions and interactions both internal and external to ARORA.
6. Utilize the ARORA strategic anchors: Creating a Culture of Donation, Financially Sound and Quality during work activities and in the decision-making process.
7. Attendance at staff meetings, training programs, and/or in-services meetings, as required.
8. Demonstrates professional appearance, behavior and standards in all business dealings and interactions.
9. Demonstrates professional conduct and behavior reflective of ARORA’s respect, honor, admiration and reverence for the donor and donor family.
10. Fosters effective relationships with client representatives.
11. Performs other duties as assigned.

Potential Risk Factors:

1. Risk Exposure to Blood/Body Fluids: While performing some essential functions of your position, you may be exposed to blood or body fluids. Established procedures identify the appropriate personal protective measures that you should use when performing essential functions of your position. The ARORA Safety program will provide you with the appropriate procedures and guidelines in which you should perform the essential duties of your job. If you need additional training or resources, please see your supervisor or the ARORA Safety Officer.
2. Repetitive Motion: While performing some essential functions of your position, you may be required to perform some functions repeatedly. When such tasks are not performed properly, injury can result.
3. Minimum Weight Lifting Requirement: While performing some essential functions of your position, you may be required to do some lifting, moving, pushing, or pulling. When such tasks are not performed properly, injury can result. Must have the ability to lift minimum weight of 20 lbs.
4. Prolonged Sitting, Standing, and Bending: While performing some essential functions of your position, you may be required to sit, stand, or bend for an extended period of time. When such tasks are not performed properly, injury can result. Precautions and/or equipment should be used when performing this task.
5. Competency Evaluation: Competency evaluations are required for this position. Your supervisor will notify you when your evaluation is to be conducted.
6. Training: You may need additional training to better understand the performance requirements of your essential job functions. Training classes are available and can be requested and/or assigned. Your attendance at such classes is mandatory.

Work Environment

1. Works in normal office environment.
2. Infrequent travel required by personal vehicle to fulfill the duties and responsibilities of the position.
3. Required to carry a cellular telephone for business purposes.
4. May require travel by commercial or chartered aircraft.
5. Non-smoking office.
6. Drug Free Workplace.

Work Hours

Forty-hour workweek with occasional weekends, holidays, or evenings.

Minimum Job Requirements

1. A licensed Registered Nurse (AD, BS, or Diploma), Physician’s Assistance or BS/BA in a health-related field.
2. Proficiency in medical terminology and/or Health Information Management.
3. Minimum five years Quality Systems experience preferred.
4. Strong organizational skills.
5. Good oral and written communications skills.
6. Maintain a valid driver’s license, reliable automobile, and proof of automobile insurance.
7. Able to perform job duties with limited supervision.
8. Consistent demonstration of attention to detail, precision, accuracy, and customer satisfaction.
9. Possess strong prioritization skills and the ability to effectively manage multiple projects and tasks.
10. Excellent problem solving, conflict resolution and interpersonal skills (i.e. has the ability to make decisions based on situational circumstance, company policy and customer relations).
11. Ability to utilize general office equipment, software, and must be proficient in Microsoft Office Suite.

Security Requirements

This position is responsible for requesting, managing and storing confidential records and ensuring that information is protected, handled discretely and professionally, according to the recognized standards, regulations, and standards for maintaining patient and employee safety records.