all about the qualification in science (qbrs) exam...baccalaureate masters associate 1 yr 2 yrs 3...
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All About the Qualification in Biorepository Science (QBRS) Exam
Brent Schacter MD FRCPCChair
QBRS Steering CommitteeA Task Force of the ISBER Standards Committee
Outline
1) Rationale for and development of the QBRS exam2) Application Process and Resources3) Requirements for exam application4)Scope of the exam5) Exam process and details6) Advantages of the QBRS credential7) Questions
ISBER and ASCP BOC Have Joined Forces
• ISBER is the leading international society promoting and focusing on Quality in Biobanking
• The American Society for Clinical Pathology Board of Certification (ASCP BOC) provides excellence in global medical laboratory professional certification
• ISBER and ASCP BOC have together created a qualification examination for biobanking professionals
• The qualification is designated as the QBRS –Qualification in Biorepository Science
Rationale for the QBRS Examination
• Modern biobanking is a complex activity that requires highly trained and skilled staff
• Well‐trained staff are essential to ensure high quality biospecimens for precision medicine, biomarker development and biomedical research as a whole
• Prior to the QBRS Exam no formal qualification program existed to define the level required to ensure quality in technical biobanking skills
• Following detailed discussions between ISBER and ASCP BOC an MOU was signed in November 2017
• The Exam Workgroup was proposed to ASCP BOC after a detailed search for ISBER volunteers to serve was conducted
• The Workgroup members had to be an experienced practicing biobanker or an individual with expertise in the principles and practice of biobanking
Development of the QBRS Exam
Development of the QBRS Exam
• Workgroup members are responsible for developing, reviewing and updating the biobanking item bank, performing job task analyses and updating the examination content guidelines, eligibility requirements and candidate experience documentation forms required
QBRS Exam Development and Launch
• QBRS examination development began in December 2018 and was facilitated by face to face and online meetings of the Exam workgroup
• The QBRS Certificate program was completed within a year and made available for application in January 2020
• The exam itself became available for candidates to take in April 2020• By September 2020, 17 applications were received, 12 candidates of the 12
who took the exam had passed and were awarded the QBRS certificate, 4 applications were in process, and one application did not meet the qualification criteria.
Details of QBRS Governance
• The Exam Workgroup, consisting of eight members chosen with geographical and professional diversity in mind by ISBER, were proposed and accepted by the ASCP BOC Board of Governors
• The Exam Workgroup members are appointed for a three‐year term, renewable
Details of QBRS Governance
• Annually, the Workgroup will provide a report to the ASCP BOC Board of Governors and a program report to the ISBER Board of Directors
• Broad oversight of the activities of this initiative is provided by a Steering Committee of ISBER members with appropriate background in standards development appointed as a sub‐group of the ISBER Standards Committee. ASCP BOC is represented on this committee by the executive director of the ASCP BOC
Management Processes
• The Exam Workgroup has set the parameters for the exam, developed the supporting documents for the application process, including information about the scope of the exam and has created and standardized exam questions
• The Steering Committee has reviewed and provided comment on the supporting materials in order to clarify and focus the content.
Application Process
The application form and resource documents for the QBRS examination are available at
www.isber.org/qualificationOR
https://www.ascp.org/content/board-of-certification/get-credentialed/#qbrs
Resource Details
The Resource documents available on the websites include:• Application form• Requirements for eligibility and eligibility assessment• Work experience documentation form• List of Regional Accrediting Bodies for North American colleges and universities as
well as for those outside North America• Examination topic outline• List of suggested reading for exam preparation ( journals, texts, online materials • FAQ
Requirements for Examination Application
• Generally speaking, the requirements prior to application include both academic and work experience documentation
• There are six possible eligibility routes that have been established, as follows:
ROUTE 1• ASCP technologist/scientist or specialist certification• AND a Baccalaureate degree from a US or non‐US regionally accredited
college/university with a major in biology, chemistry, biotechnology or related field• AND one year of full‐time acceptable experience in a biorepository within the last
five years
Requirements for Examination Application
ROUTE 2• Baccalaureate degree as above• AND two years of full‐time acceptable experience in a biorepository within the last
five yearsROUTE 3• Master’s degree ( or PhD) from a US or non‐US regionally accredited
college/university with a major in biology, chemistry, biotechnology or a related field• AND one year of full‐time acceptable experience in a biorepository within the last
five years
Requirements for Eligibility (Continued)
ROUTE 4• Valid ASCP technician certification• AND an associate degree or two‐year diploma from a US or non‐US regionally accredited
college/university OR 60 semester hours of academic credit from a US or non‐US regionally accredited college including a combination of 12 semester hours in biology and chemistry
• AND two years of full‐time acceptable experience in a biorepository within the last five years
ROUTE 5• Associate degree or two‐year diploma OR 60 semester hours as in ROUTE 3• AND three years of full‐time acceptable experience in a biorepository within the last six
years
Requirements for Eligibility (Continued)
ROUTE 6*• High school graduation or equivalent• AND five years of full‐time acceptable experience in a biorepository within the last
ten years
* grandfathered for 3 years
QBRS Routes – Summary
RouteHigh School Graduation
ASCPTechnologist Certification
Degree in biology, chemistry, biotechnology or related field
Degree or Diploma in biology and chemistry
Full time acceptable experience in a
biorepository within the last five years
Full time acceptable
experience in a biorepository
within the last 5 years
Baccalaureate Masters Associate 1 yr 2 yrs 3 yrs 5 yrs
1 x x x
2 x x
3 x x
4 x x x
5 x x
6 x x
Biorepository Experience
Experience is required in at least 4 of the 9 areas listed:• Subject consent• Specimen/Data Collection• Specimen/Data De‐identification• Specimen/Data Processing• Sample/Data Storage• Sample/Data Distribution• Sample/Data Quality Control• Equipment Quality Control (e.g. maintenance, validation, calibration)• Enhanced Technical Areas ( e.g. histology, tissue microarray, slide imaging, microdissection, viable cell
isolation, nucleic acid/protein extraction)
Scope of the QBRS Examination
The Exam questions encompass the major content areas within Biorepository Science, including:• Specimen handling (collection, processing and storage)• Sample/data inventory management and quality control• Safety and infection control• Biorepository operationsThe Scope document in the website provides further details of possible topics within each of these areasEach of these topic areas will comprise 25‐30% of the exam questions (except for biorepository operations which will be 15‐20%)There are 50 questions in total on the examThe questions may be theoretical or procedural
Exam Process
• The Exam is a 50 question, multiple choice, timed test is self‐administered on your own computer on the date and time of your choice within the 60 day examination period indicated on your admission notification, following a successful application
• The cost for application is US$240• The examination may be re‐attempted up to 3 times if initially unsuccessful• QBRS certificate holders will be required to revalidate their qualification every 3
years by documentation of required continuing education or other educational activities as defined by ASCP BOC
Advantages of the QBRS Credential
The ISBER/ASCP BOC partnership has facilitated the development of the global QBRS credential program which will be an essential piece of establishing the future for sustainable quality biobanking.
The QBRS designation earned by biobankers will establish their ability to provide skilled work as a benchmarked quality biorepository scientist.
The QBRS will become the standard which defines the required level of quality in biobankers and assures sustained quality in biobanking.
Frequently Asked Questions (FAQ)
www.isber.org/qualificationhttps://www.ascp.org/content/board-of-
certification/get-credentialed/#qbrs
Questions?www.isber.org/qualification
https://www.ascp.org/content/board-of-certification/get-credentialed/#qbrs