BTS Compliance Officer

Massachusetts General Hospital   •  

Boston, MA

Industry: Healthcare

  •  

5 - 7 years

Posted 165 days ago

This job is no longer available.

Description

GENERAL SUMMARY/ OVERVIEW STATEMENT:  

The Compliance Officer is a key resource in the highly regulated environment of the Blood Transfusion Service at MGH which is an AABB accredited, FACT accredited, FDA licensed facility. 

The Compliance Officer reports directly to the Director (Responsible Head) and has broad responsibilities for compliance, quality assurance and performance improvement.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Regulatory Agencies:

  • Be completely familiar with and a resource-person regarding pertinent regulations for the FDA, AABB, FACT, NMDP, CLIA’88, JCAHO, Commonwealth of Massachusetts, NRC and OSHA
  • Regularly review BTS policies and procedures for compliance with regulations
  • Effect changes in policies and procedures for compliance with regulations
  • Review AABB Standards, FDA Guidances and FACT Standards for compliance
  • Prepare for inspections/assessments:
    • FDA performs periodic unscheduled inspections
    • AABB performs scheduled assessments every other year
    • JCAHO performs lab inspections every other year and hospital-wide inspections every 3 years
    • Department of Public Health and OSHA perform inspections as necessary
    • FACT inspects every 3 years (stem cell apheresis collections as well as the stem cell lab)
    • NMDP inspects the Apheresis Collections area periodically
  • Accompany inspectors/assessors and aid them in performing inspections
  • Prepare responses to inspectionreports and maintain all documentation and correspondence
  • Effect appropriate changes in policies and procedures in response to inspection or assessment findings and ensure that the effectiveness of the changes is monitored
  • Conduct interim mock inspections, especially prior to AABB assessments and JCAHO inspections
  • Respond to regulatory directives from the FDA
  • Maintain FDA licenses and apply for additional licenses as needed
  • Prepare the FDA, NHSN and HHS NBCUS Annual Reports
  • Complete FDA registration on an annual basis
  • Complete annual renewal of blood irradiator permit
  • Reports adverse transfusion reactions to NHSN, MA DPH

Quality Control

  • Oversee, assist in the development, and review systems, procedures, and reporting mechanisms for quality control of reagents, equipment, test procedures and components
  • Perform periodic review of quality data with BTS Director as part of the surveillance program of the Quality Plan
  • Ensure all sections of the Quality Plan and HPC Quality Manual continue to be followed and update as necessary

Procedure Manual

  • Oversee annual review of all procedures
  • Oversee procedural revisions and new procedures
  • Develop and/or assist supervisors in the development of new procedures
  • Maintain master procedure manual as well as all area procedure manuals (including Donor Guideline Manual)
  • Maintain file of all obsolete procedures
  • Responsible for version/document control of all paper and electronic copies of procedures and Donor Guideline Manual.

Training/Competency Evaluation

  • Assist supervisors in maintaining a system for documenting training of new staff and training of present staff in new policies/procedures
  • Oversee system and assist supervisors in performing and documenting periodic competency evaluations of staff

Proficiency Testing

  • Periodically review regulatory requirements and current proficiency testing programs to ensure compliance
  • Review results of all proficiency testing and maintain documentation
  • Investigate and document findings of all incorrect results and maintain documentation

Computer Validation

  • Assist Systems Manager in the validation of all new software or releases and its documentation
  • Effect changes in policies and procedures to reflect changes in computer software

Quality and Safety

  • Oversee system of incident reporting, investigation, corrective action and follow-up including:
    • MGH Safety Reports
    • Laboratory Error and Accident Reports (LEARs)
    • Wrong Blood in Tube incidents (WBIT)
    • Biological Product Deviations (BPD) reported to the FDA
    • Reporting fatalities to the FDA and the Department of Public Health
    • BTS Exceptions
    • Reportable errors to the Department of Public Health and Corporate Compliance
    • Gather and report other data on quality and safety as requested by medical directors
  • Review and maintain all above reports
  • Prepare quarterly summary of all above reports

Management Reports

  • FDA Annual Report
  • Report summary of the following on a quarterly basis to directors/supervisors:
    • All safety reports (as above)
    • BTS Exceptions
    • Self Assessments
    • Follow-up on previous quarter’s LEARs
    • Minutes from previous quarterly meeting
  • Review Permanent and Temporary Deferral reports for possible withdrawals/recalls
  • Review HIV and HCV reactive test sheets for possible lookbacks

Teaching

  • Review QA program with fellows, residents and medical technology students as needed
  • Annual cGMP training for Blood Donor Center, Patient Services and Laboratory Staff

Validations

  • Maintain documentation for validation of all new procedures, processes and equipment 
    • Computer validation documentation is maintained by the Systems Manager
  • Assist supervisors in developing validations plans and maintaining data

Recalls/Withdrawals/Lookbacks

  • Perform BTS initiated recalls/withdrawals/lookbacks
  • Respond to external recalls/withdrawals/lookbacks
  • Maintain all documentation related to recalls/withdrawals/lookbacks
  • Assist in investigating post transfusion events (HIV, Hepatitis, TRALI and other adverse events)
  • Review deferral reports to determine if a recall or withdrawal is needed

Self- Assessments

  • Assist supervisors/staff in performing quarterly self-assessments
  • Maintain all self-assessment documentation

Performance Improvement

  • Represents the BTS Patient Services as necessary at monthly BMT Program meetings
  • Prepare PI indicator data for the quarterly Transfusion Committee meetings

 Qualification

QUALIFICATIONS:  

  • MT(ASCP) and Bachelor’s degree in medical technology is required
  • Subspecialty certification (e.g. ASCP BB or SBB) is desirable
  • Minimum 5 years of experience in a transfusion service, blood bank apheresis program or donor center
  • Comprehensive knowledge of FDA, AABB, TJC, FACT, DPH and other regulatory requirements is desirable
  • Experience in more than one area, as listed above, or in compliance, is desirable

  

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

  • Basic computer skills (word processing, organizing and maintaining files, spreadsheets, use blood bank information system) is required
  • Ability to write and speak clearly (e.g. procedures, explanatory notes, responses to inspections) is desirable
  • Ability to function with a high degree of independence; think critically; assume responsibility
  • Excellent interpersonal skills
  • Ability to analyze complex problems
  • Ability to work well with Medical Directors, Nurse Managers, Lab Supervisors and Pathology Leadership and leadership of other departments (Operating room, Emergency room, Patient Care Services, Office of Quality and Safety)
  • Excellent communication and writing skills
  • Ability to deal fairly and consistently will problems and staff
  • Handle confidential information appropriately (HIPPA)

 WORKING CONDITIONS:   

  • The Compliance Officer shares an office with 1 or 2 other people.  
  • The office is located inside the Transfusion Service laboratory and one floor from the Blood Donor Center and Patient Services Division on the MGH hospital campus.