Compliance Officer, Blood Bank, Pathology BWH
Brigham & Women's Hospital(BWH)

Position Summary:

Under the general direction of the Technical Director (TD) and Medical Director, is responsible for directing compliance with applicable federal and state laws and regulations, accrediting agency standards, and Brigham and Women's, and any of its

collaborative efforts, standard operating procedures pertaining to the Transfusion Service.

Manages all matters related to compliance requirements.

Key Roles & Responsibilities:

1.

Works directly with the Technical Director and supervisory team to continually review, implement and manage the Quality Plan for the Blood Bank Transfusion Service and Donor Rooms in substantial compliance with the AABB Quality Program as outlined in the Quality Plan Manual and Self Assessment Manual. Systems required to be addressed in the Quality Plan are the Quality Program, Donor Suitability, Blood Collection, Component Processing, Testing, Review and Labeling, Storage and Distribution, Compatibility Testing, Blood Administration, Investigation of Adverse Effects and Information Management.

10%

2.

Evaluates, reviews, revises, creates, approves and collaborates on all documents in MediaLab.

Manages Document Control in MediaLab and includes oversight of Compass (competency), Personnel Documentation, and IQE. Oversees the Change Control process. Maintains and approves validations and Change Control and collaborates with TD and Supervisor teams in developing and revising SOPs with process improvement. Manages all FDA registrations (6) as the reporting official and CLIA documentation of personnel.

20%

3.

Works in concert with the Kraft Family Blood Donor Center (KFBDC) Compliance Specialist as the primary responsibility for the Transfusion Service resource and preparedness for external assessments provided by: Joint Commission (JC), American Association of Blood Banks (AABB), FDA, and MA Department of Health (MDPH). Provides a resource for regulations for FDA, AABB, CLIA'88, JC, MDPH, NRC, and OSHA. Develops audit schedule and performs, monitors, and reports on audits that challenge our systems for identifying weaknesses and discovering areas of process improvement. Evaluates, reviews, and submits Proficiency Testing (PT) and responds to PT failures.

Evaluates internal occurrences and develops corrective actions where applicable. Determines if root cause analysis applies in collaboration with the Technical Director (TD). Collaborates with Leadership team to communicate to and educate staff for awareness, education and prevention. Provides timelines and additional interdepartmental information when investigating BWH and DFCI Safety Reports.

30%

4.

In collaboration with leadership team and compliance team member, identify staff training needs, and ensure compliance training supports staff understanding and adheres to compliance standards. Provides Compliance Training and Irradiation Training with Trustworthy and Reliability Assessment (TRA) process.

10%

5.

Collaborates with Compliance Team member on equipment maintenance management, FDA Annual Reports and Biologic Product Deviations (BPD). Submits Transfusion Reaction Data to NHSN and Infectious Disease Marker requirements to MADPH where applicable according to regulatory standards. Evaluates and responds to recalls, withdrawals, lookbacks, deferrals, transfusion reactions, TRALI, Fatal and Infectious Disease events. Recruits, selects and coaches Compliance Team member(s).Participates in role related committees and serves as a BB laboratory liaison for the hospital.

30%

Problem Solving:

1. Requires advanced oral and written communication skills as well as ability to promote positive and constructive

working relationships in the Blood Bank, other hospital departments, and regulatory, and accrediting agencies.

2. Requires comprehensive knowledge/understanding of SOP's with demonstrated ability to review, develop, and

improve documentation.

3. Requires comprehensive understanding of standards accreditation, and regulatory guidelines as related to the

Blood Bank.

4. Requires in-depth understanding of technical laboratory procedures and operations, and ability to independently

resolve regulatory problems requiring timely solutions.

5. Requires proven leadership ability.

Impact:

Impacts the whole BB, Pathology and Hospital Clinical Laboratory. Works closely with medical teams across the hospital.

Interactions / Interpersonal Skills:

Must have strong interpersonal abilities with solid written and oral communication skills. Able to maintain cooperative working relationships within the department, and other department and external regulatory agencies. Ability to be self-directed and self-motivated and manage multiple priorities and bring tasks to completion within a reasonable time frame.

Qualifications
Education

Minimum: Bachelor's Degree in Laboratory Science. Associate Degree in Laboratory Science with at least 6 years of experience in Blood Banking.

Preferred: Advanced degree in related field.

Experience

Minimum: 4 years in clinical laboratory with 2 years in compliance related role

Preferred: 6 years in a clinical laboratory and 4-6 years of supervisory/managerial role

Licenses & Certifications

Required: MLS(ASCP), BB(ASCP), MLT(ASCP) or equivalent

Preferred: MLS(ASCP)SBB, CQA(ASQ)

EEO Statement
Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on the basis of disability.