Sei sulla pagina 1di 39

Certification Candidate Handbook

Program Overview
Policies & Procedures
Exam Application

4301 N. Fairfax Drive Suite 301 | Arlington, VA 22203-1633 | www.aami.org | 703-525-4890


2017
Testing Windows Application Deadline Late Registration Deadline
May 1-15, 2017 April 12, 2017 April 19, 2017
November 1-15, 2017 October 13, 2017 October 20, 2017

CBET, CLES, and CRES are ANSI accredited under ISO/IEC 17024 Personnel
Certification.

#1163
ISO/IEC 17024
Personnel Certification

ACI
4301 N. Fairfax Drive, Suite 301
Arlington, VA 22203
(P) 703-525-4890 ext. 1207
(F) 703-276-0793
Email: aci@aami.org

1/1/2017
Table of Contents

ACI Objective ............................................................................................................................. 3


ACI Statement of Fairness ......................................................................................................... 3
Impartiality.................................................................................................................................. 3
Code of Conduct ........................................................................................................................ 3
Types of Certification ................................................................................................................. 3
Scope of Certification ................................................................................................................. 3
Certified Biomedical Equipment Technician ................................................................ 3
Certified Radiology Equipment Specialist .................................................................... 4
Certified Laboratory Equipment Specialist ................................................................... 4
Certified Healthcare Technology Manager .................................................................. 5
Certified Quality System Manager ............................................................................... 5
Candidate Eligibility .................................................................................................................... 5
CBET, CLES, CRES Eligibility ................................................................................................... 5
Full Certification ........................................................................................................... 5
Candidate Status ......................................................................................................... 5
CHTM Eligibility .......................................................................................................................... 6
CQSM Eligibility ......................................................................................................................... 7
Application Process.................................................................................................................... 7
Eligibility Appeals ......................................................................................................... 7
Accommodations ......................................................................................................... 8
Registration.................................................................................................................. 8
Scheduling a Computer-based Test ........................................................................... 8
Preparing for the Exam .............................................................................................................. 8
Exam Content Outlines ................................................................................................ 8
References .................................................................................................................. 8
Exam Day .................................................................................................................................. 8
Candidate Check-in ..................................................................................................... 8
Policies During Exam Administration ........................................................................... 8
Policies After Exam Administration .............................................................................. 9
Inclement Weather ..................................................................................................................... 9
Security ...................................................................................................................................... 9
Security Violations/Cheating ........................................................................................ 9
Scoring and Results ................................................................................................................... 9
Scoring Process........................................................................................................... 9
Notification of Results .................................................................................................. 9
Appeal of Exam Results .............................................................................................. 9
Appeal of Exam Administration .................................................................................. 10
Rescheduling an Exam ............................................................................................................ 10
Cancellation Policy ................................................................................................................... 10
Withdrawing an Application ...................................................................................................... 10
Failure to Appear for an Exam ................................................................................................. 10
Retaking the Exam ................................................................................................................... 10
Change of Contact Information ................................................................................................ 10
Use of Certification Marks and Designations ........................................................................... 10
Introduction ................................................................................................................ 10
Acceptable Use.......................................................................................................... 10
Certificate................................................................................................................... 11
Maintaining Certification ........................................................................................................... 11
Rationale.................................................................................................................... 11

1
Introduction ................................................................................................................ 11
Recertification Policy (After to January 1, 2017) ...................................................................... 11
Recertification Cycle ................................................................................................................ 12
Recertification Procedures (After to January 1, 2017) ............................................................. 12
Late Renewal Submittal & Reactivation ..................................................................... 12
Certified on or After January 1, 1992 ......................................................................... 12
Certified on or Before December 31, 1991 ................................................................ 12
CCE Certificate Holders............................................................................................. 12
Multiple Certifications................................................................................................. 12
Military Active Duty .................................................................................................... 12
CEU Audits .............................................................................................................................. 13
CEU Audit Reinstatement Policy.............................................................................................. 13
Change Scope of Certification ................................................................................................. 13
Leave of Absence .................................................................................................................... 14
Emeritus Status........................................................................................................................ 14
Complaint of Disciplinary Violation ........................................................................................... 14
Withdrawal/Revocation .............................................................................................. 15
Suspension ................................................................................................................ 15
Appeals ...................................................................................................................... 15
Filing an Appeal ......................................................................................................... 15
Appeals Body............................................................................................................. 15
Fees ........................................................................................................................... 15
ACI Board Consideration of the Appeal ..................................................................... 15
Complaint Form ......................................................................................................... 15
Certified Biomedical Equipment Technician Detailed Content Outline ..................................... 16
Certified Radiology Equipment Specialist Detailed Content Outline ........................................ 18
Certified Laboratory Equipment Specialist Detailed Content Outline ....................................... 20
Certified Healthcare Technology Manager Detailed Content Outline ....................................... 22
Certified Quality System Manager Detailed Content Outline ................................................... 24
Exam Resources ...................................................................................................................... 24
CBET, CLES, CRES .................................................................................................. 24
CHTM ........................................................................................................................ 27
CQSM ........................................................................................................................ 29
Study Guides and Review Courses ........................................................................... 29
Certification Exam Pricing ........................................................................................................ 30
ACI Recertification Categories (After January 1, 2017) ........................................................... 31
Definitions ................................................................................................................................ 33
Exam Registration Form .......................................................................................................... 34

2
ACI Objective discrimination against clients, colleagues, or
customers.
ACIs objective is to be the trusted source for quality 6. I will maintain the privacy of individuals and
professional development and credentials for confidentiality of information obtained in the
healthcare technology-oriented professionals and course of my duties unless disclosure is
entities in higher education, industry, and healthcare required by legal authority.
delivery. 7. I will obey all applicable laws, regulations,
and codes.
ACI Statement of Fairness 8. I will follow all certification policies,
procedures, guidelines, and requirements of
The ACI adheres to principles of fairness and due the ACI.
process and endorses the principles of equal
opportunity. In administering the credentialing Types of Certification
programs, ACI shall not discriminate or deny
opportunity to anyone on the grounds of gender, age, The AAMI Credentials Institute (ACI) maintains the
religion, national or ethnic origin, marital status, certification programs for biomedical equipment
veteran status, sexual orientation, or disability. technicians (CBET), radiology equipment specialists
(CRES), laboratory equipment specialists (CLES),
Impartiality healthcare technology managers (CHTM), and quality
system managers (CQSM). Each certification requires
ACI understands the importance of impartiality in a separate, complete application and a separate
carrying out its certification activities, manages examination. Applicants may test in only one
conflict of interest and ensures the objectivity of its discipline per testing window.
certification activities.
AAMI Membership is not a prerequisite for
Code of Conduct certification.

The Code is designed to provide both appropriate Scope of Certification


ethical practice guidelines and enforceable standards
of conduct for all ACI applicants, certificants, and The certification programs recognize healthcare
candidates. The Code also serves as a professional technology management professionals whose
resource for healthcare technology practitioners, as practice reflects a high degree of knowledge about
well as for those served by ACI certificants and medical devices and clinical practice as well as skill in
candidates in the case of a possible ethical violation. implementing electro-mechanical talent in the repair
and maintenance of devices used in the delivery of
All ACI applicants, candidates, and certificants must healthcare. Achieving ACI Certification indicates that
agree to comply with the ACI Code of Conduct as certification candidates have demonstrated a broad
outlined below: knowledge skill-set in the specific certification area,
1. I will conduct my professional activities with general biomedical technologies, clinical laboratory
honesty and integrity. technologies and medical imaging technologies,
2. I will uphold my professional conduct to the including regulatory requirements.
highest ethical standards.
3. I will represent my certifications and Exams are offered in English only.
qualifications honestly and provide only
those services for which I am qualified to Certified Biomedical Equipment Technician
perform. (CBET)
4. I will maintain and improve my professional Healthcare technology management professionals
knowledge and competence through regular that desire a CBET certification are expected to have
self-assessments, continuing practice, experience in a wide-range of electromechanical
continuing education or training. devices, computers, networks and software used in
5. I will act in a manner free of bias and the delivery of healthcare. Generally, candidates

3
desiring for certification in this category may work for Troubleshoot medical devices in a clinical
medical device manufacturers, hospitals, clinics, setting and/or bench/depot setting
home healthcare providers, medical device repair (corrective maintenance)
companies, regulatory bodies/agencies, and software Manufacture software, parts or devices for
manufacturers such as EMR or device integration use in patient care especially imaging
providers. systems
Ensure compliance with all regulatory
CBET candidates typically perform some of the processes necessary (i.e. CMS, FDA GMP,
following duties on a daily basis: etc)
Test and calibrate medical devices Manage medical software/hardware
(preventive maintenance) systems (i.e. PACS Administrator,
Troubleshoot medical devices in a clinical Integration Specialist, etc)
setting and/or bench/depot setting Educate the proper use, care and
(corrective maintenance) maintenance of medical devices
Manufacture software, parts or devices for Review technical manuals
use in patient care Document any and all maintenance and
Ensure compliance with all regulatory repairs and maintain records of
processes necessary (i.e. CMS, FDA GMP, maintenance activities
etc) Troubleshoot medical device networks
Manage medical software/hardware
systems (i.e. PACS Administrator, Certified Laboratory Equipment Specialist (CLES)
Integration Specialist, Alarm Management, Healthcare technology management professionals
RTLS Systems, etc) that desire a CLES certification are expected to have
Perform corrective and preventive experience with a wide-range of clinical laboratory
maintenance on steam systems devices, electromechanical devices, computers,
Educate the proper use, care and networks and software used in the delivery of
maintenance of medical devices healthcare. Generally, candidates desiring for
Review technical manuals certification in this category may work for medical
Document any and all maintenance and device manufacturers, hospitals, clinics, medical
repairs and maintain records of device repair companies, regulatory bodies/agencies,
maintenance activities and software manufacturers such as EMR, LIS or
Troubleshoot medical device networks device integration providers.

Certified Radiology Equipment Specialist (CRES) CLES candidates typically perform some of the
Healthcare technology management professionals following duties on a daily basis:
that desire a CRES certification are expected to have Test and calibrate medical devices
experience in a wide-range of medical imaging (preventive maintenance)
modalities, electromechanical devices, computers, Troubleshoot medical devices in a clinical
networks and software used in the delivery of setting and/or bench/depot setting
healthcare. Generally, candidates desiring for (corrective maintenance)
certification in this category may work for medical Manufacture software, parts or devices for
device manufacturers, hospitals, clinics, medical use in patient care especially imaging
device repair companies, regulatory bodies/agencies, systems
and software manufacturers such as EMR or device Ensure compliance with all regulatory
integration providers. processes necessary (i.e. CMS, CAP, FDA
GMP, etc)
CRES candidates typically perform some of the Manage medical software/hardware
following duties on a daily basis: systems (i.e. LIS Administrator, Integration
Test and calibrate medical devices Specialist, etc)
(preventive maintenance)

4
Educate the proper use, care and Candidate Eligibility
maintenance of medical devices
Review technical manuals CBET, CLES, CRES Eligibility
Document any and all maintenance and
repairs and maintain records of Full Certification
maintenance activities Certified Biomedical Equipment Technician (CBET),
Troubleshoot medical device networks Certified Radiology Equipment Specialist (CRES)*, or
Certified Laboratory Equipment Specialist (CLES)*:
Certified Healthcare Technology Manager (CHTM)
The healthcare technology manager is a person Applicants must meet ONE of the following
responsible for planning and directing activities of minimum eligibility requirements as of the
other healthcare technology management application deadline:
professionals, monitoring their work, and taking
corrective actions when necessary. 1. Associates degree in biomedical equipment
technology program and two years full-time
This HTM certification covers two major areas in BMET work experience; OR
healthcare technology management: the 2. Completion of a U.S. military biomedical
management of healthcare technology operations; equipment technology program and two
and, the management of personnel. The functions of years full-time BMET work experience; OR
the manager are to include the participation in the 3. Associates degree in electronics technology
leadership of the business enterprise. The manager and three years full-time BMET work
is also expected to have the skills and understanding experience; OR
needed to perform strategic, business, and change 4. Four years full-time BMET work experience.
management as well as employee relations.
Additional eligibility routes for CLES
Certified Quality System Manager (CQSM) Applicants only:
The CQSM certification goes beyond assessing
knowledge of standards and regulation. It is based on 5. Associates degree in medical laboratory
a holistic view of the roles and responsibilities of technology and three years full-time BMET
experienced quality system professionals and how work experience; OR
they contribute to better, safer products. 6. Bachelors degree in medical laboratory
technology and two years full-time BMET
Quality system managers oversee all aspects of work experience.
quality assurance including establishing metrics,
applying industry best practices, and developing new *CRES and CLES Applicants for full certification:
tools and processes to ensure that quality goals are At least 40 percent of work experience over the last
met. They also manage the process and resources two years or 25 percent over the last five years must
for identifying, correcting, and improving non- be in the designated specialty area.
conformities in product specific policies, procedures,
and protocols as well as product specifications. Candidate Status
Additionally, all of this is accomplished in a manner Applicants desiring full certification, but do not yet
that insures compliance to all relevant regulatory meet the eligibility requirements (as listed above),
requirements. Finally, quality system managers may apply through candidate status. Successful
control, direct and/or lead the establishment and candidates are given five years to meet the minimum
maintenance of an acceptable quality system and eligibility requirements and be awarded full
report on the performance of the quality system to certification.
executive management.
To test as a candidate for any of the certifications, an
applicant must meet ONE of the following minimum
eligibility requirements as of the application deadline:

5
1. Associates degree in biomedical equipment equipment maintenance technician (DOD
technology program; OR BMET) training program with at least three
2. Completion of a U.S. military biomedical years of work experience, military or civilian,
equipment technology program; OR as an HTM supervisor or manager in the last
3. Associates degree in electronics technology five years. If the individual does not have the
and one year full-time BMET work title of supervisor or manager, he/she would
experience; OR have to confirm that he/she performs
4. Two years of full-time BMET work management duties either through self or
experience. third party attestation.

Additional eligibility routes for CLES Path 3: An Associates degree in biomedical


Applicants only: technology, related healthcare discipline,
information technology or business with at
5. Associates degree in medical laboratory least three years of work experience as an
technology and one year full-time BMET HTM supervisor or manager in the last five
work experience; OR years. If the individual does not have the title
6. Bachelors degree in medical laboratory of HTM supervisor or manager, he/she
technology. would have to confirm that he/she performs
management duties either through self or
IMPORTANT: If claiming eligibility based in full or in third party attestation.
part on an Associates or Bachelors degree, a copy
of the diploma MUST be included with the application Path 4: A Bachelors degree or higher in
and fees. A copy of the diploma is required for biomedical technology, engineering, related
individuals applying under the completion of a U.S. healthcare discipline, information technology
military biomedical program. Official college or business with at least two years as a
transcripts may be requested at the discretion of the manager within the last five years. If the
application reviewer, but required from international individual does not have the title of
applicants. NOTE: A Bachelors degree does not supervisor or manager, he/she would have
replace work experience requirements. to confirm that he/she performs
management duties either through self or
CHTM Eligibility third party attestation.

Individuals interested in pursuing the CHTM Path 5: Work experience with or without a
designation must meet on of the following paths to be degree not related to biomedical technology,
eligible for the program. related healthcare discipline, information
technology, or business management.
Path 1: A current certification as a clinical Seven years of work experience in the HTM
engineer (CCE), biomedical equipment field with three years of management
technician (CBET), radiology equipment experience in the last five years. If the
specialist (CRES), or a laboratory equipment individual does not have the title of
specialist (CLES) with at least three (3) supervisor or manager, he/she would have
years of work experience as a supervisor or to confirm that he/she performs
manager in the last five (5) years. If the management duties either through self or
individual does not have the title of third party attestation.
supervisor or manager, he/she would have
to confirm that he/she performs APPROVED DISCIPLINES
management duties either through self or The following list of engineering, healthcare, and
third party attestation. business disciplines is a preliminary list. Please
contact the ACI office if you have a degree that is not
Path 2: Successful completion of the listed.
Department of Defenses biomedical

6
Accounting, Anesthesia and Surgical Services, centers nationwide during the four testing windows.
Bioengineering, Biomedical Engineering, Business Completed application forms should be sent to the
Administration, Business Management, Clinical ACI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA
Engineering, Computer Engineering and Computer 22203, or fax to 703-276-0793.
Science, Customer Service Management, Dentistry
and Dental Hygiene, Electrical and Electronics The application forms can be found on ACIs website,
Engineering, Finance, Healthcare Administration, www.aami.org/certification. Applications are reviewed
Healthcare Engineering Technology, Healthcare to verify information and documentation to determine
Engineering Technology Management, Healthcare eligibility and will be kept confidential. Candidates will
Information Technology, Hospital Administration, not be discriminated against based on race, religion,
Human Factors Engineering, Imaging Services, creed, age, gender or national origin or ancestry.
Informatics, Mechanical Engineering, Medical
Laboratory Technology, Medicine, Nursing, Oncology Candidates who meet the program requirements will
and Nuclear Medicine Technologist, Operations receive confirmation of their acceptance into the
Management, Pharmaceutical Services, Physical program via email. They will then be able to register
Therapy, Product Design Engineering, Public Health for a specific exam site and time to take the test.
Administration, Respiratory Services, Software Candidates who do not meet the program
Engineering, Technical Writing. requirements will receive a status letter indicating the
month and year they will be eligible to take the
CQSM Eligibility exam(s).

Individuals interested in pursuing the CQSM If the application is incomplete, the candidate will
designation must meet on of the following paths to be receive a letter or e-mail explaining what is missing
eligible for the program. and will have a 30-day time period to respond. If the
candidate does not respond, the candidate must then
Path 1: Five years managing quality system submit in writing a request for a refund minus the
programs with five years of management work application fee. The application may be deemed
experience prior to application. incomplete for reasons such as:

Path 2: Bachelors degree in the field of engineering, Application is not completely filled out
or science plus three years as a quality systems Application is not signed
manager. Appropriate fees are not submitted
Proper documentation is not submitted
APPROVED DISCIPLINES
The following list of engineering and healthcare If the application is denied, the candidate will receive
disciplines illustrative of the disciplines acceptable for a letter or email stating the reason for the denial.
candidacy. Please contact the ACI office if you have a Candidates will have 30 days to respond. The
degree that is not listed. application may be denied for reasons such as:
Biology, Chemistry, Physics, Engineering, Failure to demonstrate eligibility in
Environmental Engineering, Chemical Engineering, academic, work experience, or specialized
Nuclear Science, Biomedical Engineering, Industrial training
Engineering, Electrical Engineering, Environmental Falsification of any information on the
Engineering, Biomedical Technology, and Medicine. exam application
Application Process Eligibility Appeals
The candidate must submit the completed application, Candidates will be notified in writing or electronically
registration form and appropriate fees at least 30 their status in the certification program. If a candidate
days in advance of the exam date. Exams are fails to meet the eligibility requirements for the exam,
delivered through computer-based testing at testing

7
the candidate has 30 days to appeal the decision. References
The candidate must submit his or her request in References for each exam are listed at the back of
writing to the ACI staff. The request will then be sent this handbook.
to the ACI Board for review.
Exam Day
Accommodations
Candidate Check-in:
ACI complies with the provisions of the Americans Computer-based testing candidates are required to
With Disabilities Act and Title VII of the Civil Rights provide the exam proctor two (2) forms of
Act, as amended (42 U.S.C. 2000e. et. seq.) in identification (one must be a photo government
accommodating disabled candidates who need issued ID). Secondary identification would be a credit
special arrangements. The request must be submitted card, bank debit card, employee identification card.
in writing with supporting documentation from a NOTE: In the United States a Social Security card is
physician or other qualified professional reflecting a not an acceptable form of identification. Candidates
diagnosis of the candidates condition and should also bring their confirmation email that
explanation of exam aids or modifications needed. contains the exam launch code with them on testing
Please contact the ACI, at aci@aami.org, if the day in order to begin the test. The confirmation email
candidate has any questions concerning ADA will include the test date, time, testing center location
arrangements. and exam the candidate is taking. If the candidate
loses or does not receive his/her confirmation email
Registration after scheduling the exam, please contact the ACI at
To register for a certification exam, the candidate 703-525-4870
must meet the specific requirements for the exam.
The registration forms and fees can be found at the The candidate must arrive at the exam location at
back of this handbook. Candidates must register at least 15 minutes prior to the exam starting time. Late
least 30 days prior to the exam window. arrivals will not be admitted to the room and will be
considered no shows and lose all exam fees paid.
Scheduling a Computer-based Exam
After the application has been approved, and the Policies During Exam Administration
exam registration fee has been paid, the candidate The following list is the policies that will be maintained
will receive e-mails with logon information and during the testing session:
instructions on how to schedule his or her exam at a Candidates are admitted only to their assigned
testing center. Exams must be scheduled at least 24 test center at their assigned time.
hours in advance. No guests are permitted in the exam room.
No reference material, books, papers, translation
Preparing for the Exam aids, personal items are allowed in the exam
room.
Candidates should register at least 30 days in No electronic devices, such as pager, cell phone
advance of the exam testing window. All certification or smart watches, any device with internet
programs are self-study. Education courses are not access, or google glasses are allowed in exam
required to sit for any of the ACIs certification exams. room.
No weapons may be brought into the exam room.
Exam Content Outlines No test materials, documents, memos of any sort
Exam content outlines are available for every exam. are allowed to be taken from the exam room.
Candidates can find the outlines at the back of this Candidates are not allowed to communicate with
handbook. The content outline provides information others test takers. Proctors are authorized to
such as the number and type of questions; how long maintain a secure and proper test administration.
the candidate will have to complete the exam; what
Candidates will be given the opportunity to write
materials the candidate may bring to the exam; and
comments about exam items during the exam.
percentage of question per category.

8
Candidates are provided scratch paper and a score validity or the identity of an exam candidate, the
pencil during the exam. ACI staff will investigate and determine whether it is
Breaks are not allowed during the exam. appropriate to void the exam score. The ACI Board
Food and beverage is not allowed in the exam maintains and adheres to a security policy which is
room. available to board members and staff for the
Candidates may not copy in writing, transmit or administration of exams and maintaining the
record exam questions and/or answers of any certification program.
exam material.
Scoring and Results
Policies After Completing the Exam
A candidate who completes the exam may leave the Scoring Process
testing room after turning in all related exam Exams are scored making every effort to ensure that
materials. Please try to do this as quietly as possible the score is reported within a reasonable time period
so that those still working on the exam will not be and that the score accurately reflects the points
disturbed. The administrator will make sure that the received by the candidate. This may involve hand
candidate returns all materials. scoring exams to verify results and/or reviewing
candidate comments. Candidates are encouraged to
Inclement Weather write comments in the comment section of the exam.
Comments can be related to a specific question; the
If a candidate in unable to arrive at the designated administration of the exam; or the exam site
exam site because of inclement weather, terrorist conditions. Comments that would affect whether a
acts, natural disasters, or other unforeseen candidate passes or fails an exam will be reviewed
emergencies beyond the control of the candidate as before the exam is scored. All other comments are
determined by ACI, the candidate will be allowed to reviewed by the ACI Board at their regularly
take the next regularly scheduled exam without being scheduled meetings.
charged the retesting fee.
Notification of Results
If for any reason the exam is unable to be Preliminary results will be reported for immediately
administered, then the exam will be rescheduled following the completion of the exam and with 24
within a reasonable period of time. Candidates may hours of completing their exam via email. Results are
take the exam at the next testing window without any reported as pass or fail.
additional cost. Candidates are responsible for their
own associated expenses. Candidates who pass an exam and achieve a
certification will be notified of their passing status
Security within 30 days. They will receive an official ACI
certificate and a wallet card that they may carry with
Security Violations/Cheating them.
No spouses, children, parents, friends, or other
outside parties are permitted near the testing room. Candidates who fail an exam will be provided with
Upon completion of the exam, candidates must leave diagnostic information. The analysis of performance
the testing area immediately. identifies the knowledge areas in which the
candidates performance is deficient and is intended
Any candidate who gives or receives help during the to help the candidate become better prepared before
exam will be asked to leave and his/her exam will not sitting for the exam again.
be scored. Exam fees will not be refunded and the
candidate may be prohibited from taking ACI exams Appeal of Exam Results
for a specified period of time. Candidates may request a verification of their score
which may involve hand scoring and/or a review by
The performance of all candidates is monitored and the ACI Board. Any scoring alteration found as a
may be analyzed to detect fraud. At any time after the consequence of an appeal of exam results will be
exam administration should there be a question about applied to all candidates whose pass-fail status was

9
affected; not just the candidate requesting the appeal. Retaking the Exam
All requests should be made in writing within 30 days
of receiving exam results to ACI and can be faxed to No retake exam may be scheduled by anyone in the
703-276-0793 or emailed to aci@aami.org. exam process until the candidate has been officially
notified of the results of his/her previously taken
Appeal of Exam Administration exam. Candidates must wait at least 60 days to
Testing conditions should be such that each retake an exam. There is no refund for failed exams.
candidate has an equal opportunity to be successful. A candidate will be allowed to take the exam no more
Test sites should be comfortable, accessible, well lit than three times within a two-year period. If
and free of distracting noise. Proctors should provide unsuccessful on the third attempt, the candidate must
clear and uniform instructions and monitor testing wait one year before he/she will be allowed to re-
conditions throughout the entire session. If conditions apply to the program and take the exam.
of the exam administration do not meet these
standards, notify ACI as soon as possible. Any Change of Contact Information
special considerations made for testing conditions
that are deemed unacceptable as a consequence of It is the certified professionals responsibility to ensure
an appeal will be applied to all candidates whose that AAMI has their most current contact information
pass-fail status was affected; not just the candidate including, mailing address, phone number and email
requesting the appeal. address. Payments and journals are due by
December 31 of their expiration year.
Rescheduling an Exam
Use of Certification Marks and Designations
Candidates are allowed to reschedule an exam once.
Certification exams rescheduled within five business Introduction
days of their scheduled exam date will forfeit all exam After receiving notification of earning an ACI
fees and must notify ACI in writing by email at designation, the credential(s) granted may be used
aci@aami.org . Exams rescheduled outside five only as long as the individuals ACI certification
business days of their scheduled exam will be remains valid and in good standing.
charged a rescheduling fee in order to sit for the
exam. Individuals may not use the credential(s) until they
have received specific written notification that they
Cancellation Policy have successfully completed all requirements,
including passing the required exam(s). Certificants
A cancellation fee will be assessed to the candidate must comply with all recertification requirements to
who fails to cancel a scheduled exam at least five maintain use of the credential(s).
business days before the exam date. Cancellations
must be made in writing and sent to the attention of The use and/or display of the official ACI acronyms or
ACI by fax, 703-276-0793, or email, aci@aami.org. designation names, except as permitted by this
policy, is prohibited. Individuals who fail to maintain
Withdrawing an Application ACI certification / recertify or whose ACI certification
is suspended or revoked must immediately
All application changes must be made in writing and discontinue use of the certification mark(s) and are
sent to the attention of ACI by fax, 703-276-0793, or prohibited from stating or implying that they hold the
email, aci@aami.org. ACI certification.

Failure to Appear Acceptable Use


Individuals who have earned the credential(s) may
If a candidate does not appear to take a scheduled identify themselves as an ACI Certified
exam, the candidate will forfeit all fees. All fees will Professional.
need to be paid again if the candidate decides to
reschedule at a later date.

10
The name and official acronym may be used only as knowledge and skill, that is consistent with the
long as the individuals certification is valid and in standards according to which certification was initially
good standing. ACI certification is a non-transferable, conferred.
revocable, limited, non-exclusive license to use the
certification designation and is subject to compliance Certification is only as valuable as the standard it
with the policies and procedures of the ACI Board. represents, if the standard is maintained.
Certified individuals may not make misleading, Recertification programs are extremely important
deceptive, or confusing statements regarding their because they require holders of the credential to
ACI certification status. present evidence that they are maintaining the
established standard. This, in turn, enables
Certificate certification to retain meaning and value for every
Each certificant will receive a certificate for each individual who achieves it, particularly as the years
credential granted. Each certificate will include, at a pass after the credential is issued. Recognizing this,
minimum, the following information: ACI adopted the evidence of continuing practice
Name of the credential program that was implemented by ACIs predecessor,
Name of the certified individual the ICC, effective January 1, 1992.
Unique certification number
Signature of the ACI Board Chair and Recertification Policy Beginning January 2017
signature the Certification Director As of January 1, 2017, to retain an ACI certification, a
Reference to the scope and limitations of the certified professional must accumulate a minimum of
certification, including that the individual has 30 Continuing Education Units (CEU) over a three-
met all of the requirements of the designated year-period and submit a continuing practice journal
certification program. with the applicable fees. CEUs can be accumulated
Effective date through a wide range of professional activities,
Expiration date including attending educational meetings, classes,
and seminars, leadership roles, presenting, teaching
Disclaimer stating that the ACI retains sole
or developing educational content, and continual work
ownership of the certificate
in the HTM field as a few examples.
Individuals who renew their certification (recertify) will
ACIs recertification program is flexible to
receive a certification renewal card with a new
accommodate the diverse learning styles and
expiration date.
approaches to professional involvement. At least 30
CEUs must be accumulated in activities directly
Maintaining Your Certification
related to the HTM field during the three year cycle.
Rationale
The structure includes continuing practice activities
ACI's goals for recertification are to ensure that ACI
for the following major categories:
certified professionals remain current with best
practices, broaden their understanding of the industry,
Category I: Earn an additional HTM-related
and continue to be recognized as the leading
certification
providers of healthcare technology management.
Category II: Leadership roles
Given the moderate rate of change for the HTM field,
Category III: Development of educational content
including the standards upon which it relies, the ACI
Category IV: Professional Development
Board believes a three-year recertification cycle is
Category V: College or university courses
appropriate.
Category VI: Work experience
Introduction
The complete recertification break down can be found
In a profession that regularly undergoes change; the
at the end of this handbook.
importance of certification is growing rapidly. The
purpose of this program is to ensure that those who
are actively certified maintain a level of professional

11
Recertification Cycle A. Certified on or after January 1, 1992
The journal is to be used to record professional Individuals certified in an ACI program on or after
activities achieved throughout the three-year cycle. January 1, 1992, who submit their continuing practice
Initial certification covers the remaining year of journals and recertification fees over 30 days after the
original certification and expires December 31 of the recertification date and up to one year after the date
following year (i.e. May 6, 1999 through December of certification expiration will be inactive, but will not
31, 2000). In the year your certification is to expire be revoked. At the end of one full year, if the journal
(i.e. 2000) you will receive a notice reminding you and the fees have not been received, certification will
that, by December 31, renewal fees are due, which be revoked. Once certification has been revoked, it
will extend certification through the next three-year will be necessary to take the certification examination
cycle (i.e., 2001, 2002, 2003). Thereafter, renewal again to regain certification.
fees and a continuing practice journal, with a record
of professional activities during previous three years, B. Certified on or before December 31, 1991
are due December 31 of the third year after the initial Individuals certified on or before December 31, 1991
certification period. who choose not to submit the required continuing
education and renewal payments to renew their
Recertification Procedures certification will be given the designation of CBET-I,
All certified professionals are required to submit CRES-I and CLES-I to show that their certification is
documentation for all activities they are submitting inactive and that they are not maintaining the
for their renewal. Acceptable documentation is continuing education requirements. These individuals
considered but not limited to: certificates, transcripts, will not be listed in the directory of active certified
letters from class sponsors or badges or onsite individuals.
programs for conference attendance.
C. CCE Certificate Holders
Upon receipt of the Continuing Practice Journal and Individuals certified in the U.S. CE program under the
renewal payment, the journal will be reviewed. When ICC/USCC on or before January 1, 1992 are not
approved, a wallet card showing the new certification required to renew their certification, and will not have
expiration date will be issued and mailed out with a their certification revoked if they do not comply with
letter of renewal confirmation. the renewal requirements of submitting a Journal.
However, their certification will be considered
When the journal does not meet the minimum inactive. If the CE certification is ever revoked, there
required for approval, the certification holder will be currently is no means of regaining the certification
asked to update his journal by the reviewer. If the under the ACI.
certification holder does not comply with the
requirements, he will be notified by ACI that the D. Multiple Certifications (after January 1, 2017)
renewal was denied. If certified in more than one discipline (CQSM, CHTM,
CCE, CBET, CRES, CLES), certificants will be
Late Renewal Submittal and Reactivation charged an additional $75.00 every three years for
A $ 100.00- reactivation fee applies if materials are each certification beyond the primary one in order to
submitted after the renewal due date. This fee should maintain active status in each certification.
be paid along with the current renewal fees and a
Continuing Practice Journal must be submitted for the There is no need to complete a Continuing
current triennial period. Failure to pay the reactivation Practice Journal for each certification. 30 hours
fee will result in the certification remaining in an is required for the three-year period, regardless of
inactive status, even if the renewal fees and Journal the number of certifications one has.
have been submitted.
E. Military Active Duty
Certified professionals must immediately inform ACI Each occurrence of persons being deployed, while
of matters that affect his/her capability to continue to military forces of the United States are involved in
fulfill the certification requirements. hostile activities, will be handled on a case-by-case
basis. The certificant is to contact the ACI to inform

12
them of the military status and the proposed duration, The individual is not in compliance and will
and should present a copy of his/her military be given 45 days from the date of their
assignment. status letter to take corrective action.

The general policy will be that persons who will be on For those people who do not respond to the
active duty within 60 days of date of the actual corrective action letter, second notices will be mailed
deadline for renewal, the recertification deadline be requiring a signature. These individuals will have an
postponed until 180 days after discharge from their additional 15 days to respond to the request. There
active duty or return to their standard responsibilities. are two possible ACI Board responses after the
If the certificant will not be performing his military second letter is sent. They are:
assignment in the HTM field, the certification(s)
should be placed in leave of absence until the Documentation is received and the individual
certificant is released from his/her assignment and is in compliance and no further action is
back to working in the field. ACI would then work with required.
the certificant to determine what information is Documentation is received and the individual
needed to continue to keep the certification active. is not in compliance and will be given 30
days from the date of their letter to take
The information above only applies to those either corrective action.
deployed to an assignment or called to active duty
while the countrys military forces are on alert, and For those individuals who dont respond to the
they need to provide the ACI with a copy of their corrective action letter, their certifications will be
military assignment. Those certified and on standard revoked on December 31of the year following their
military assignments in the HTM field are expected to deadline. This letter will be mailed requiring a
follow all recertification policies and procedures. signature receipt to the individual. These individuals
will need to retake all exams, at full price, in order to
CEU Audits become certified again. Renewal fees are non-
At the end of each CEU cycle, random CEU audits refundable.
consisting of 10 percent of all certified individuals
within the cycle will be conducted. The ACI Board CEU Audit Reinstatement Policy
may add additional certified individuals, at their
discretion, to the randomly chosen list of certified Any person who was audited but did not respond to
individuals to investigate claims or suspicion of the corrective action letter, but submits information
impropriety. prior to February 1 following the calendar year after
the certification has been revoked can be reinstated
Individuals chosen to participate in the CEU audit will to the program. This late submittal needs to be
be notified that their renewal submission is being complete and have no deficiencies in order to be
audited to ensure compliance with the recertification accepted. A late submittal fee will be required for
policies. Individuals will be notified of their status processing. If there are deficiencies in the submission
upon completion of the audit and will be notified of and the individual ends up with less than the required
any deficiencies that they may have. Individuals will CEUs for certification renewal, they will lose their
have an opportunity to resolve any issues by certifications. These individuals will need to retake all
submitting additional hours or further documentation exams, at full price, in order to become certified
to prove attendance in an event. again. This letter will be mailed requiring a signature
Status letters from ACI will be mailed and emailed on receipt.
a weekly basis. There are two possible CB
responses: Changing Scope of Certification
In the event that a certificant is no longer able to meet
The individual is in compliance and no action the requirements of the certification, the certified
is required. Status letter will be mailed person must inform ACI, without delay, of matters that
regular mail. can affect the capability of the certified person to
continue to fulfil the certification requirements.

13
Leave of Absence the ACI Board. Grounds for disciplinary action shall
Should a certificant, at any time, leave active include, but are not limited to the following:
employment in the HTM field to pursue other
interests, he/she may request a leave of absence. If Evidence of falsification of information
the leave is granted, there is no need to submit a provided on documents submitted to the ACI
continuing practice journal. To retain the certification or its agents.
during the leave of absence, there is a recertification Cheating on certification exams or audits.
fee of $25.00 for the triennial cycle. Evidence of non-compliance with the Code
of Conduct.
To apply for a leave of absence, the status change Evidence of improper use of the ACI
request form should be sent directly to ACI, providing certification status, logos and/or acronyms.
the name and telephone number of the last employer, Violation of established ACI certification
so that ACI can verify status, reason for leave of policies, rules and requirements.
absence and include the applicable recertification Conviction of a felony or other crime of moral
fees. turpitude under federal or state law.
Gross negligence, willful misconduct, or
Should certificants wish to return to active status in other unethical conduct in the performance
the future, they need to notify ACI of their return to of services for which the individual has
active employment at the time it occurs. A continuing achieved certification from ACI.
practice journal for the last three years and regular
fees need to be submitted at the time of the next The ACI Board will establish procedures to fairly and
regularly scheduled recertification (based on the consistently address alleged violations. Disciplinary
original certification year). procedures are designed to ensure that valid and
actionable complaints are investigated and
Emeritus Status considered, and that all parties involved in the
1. Purpose: To recognize a demonstrated effort complaint have an opportunity to document
through continuing practice, in order to reach new circumstances warranting the complaint and to
levels of knowledge in the HTM field. respond to the complaint.
2. Qualifications for Emeritus Status: Eligible All complaints will first be reviewed by the ACI staff
candidates must submit the status change request who will then report the complaint to the ACI Chair. If
form and meet one of the following requirements: the complaint can be verified and resolved without
further documentation or investigation, staff will notify
Retired from employment in the HTM the Board chair and the complaint will be closed.
profession, whose number of years certified,
when added to their years of work If the complaint requires additional information, the
experience in the HTM field, is greater or complainant will be required to submit a signed ACI
equal to 30 years; or; complaint form with supporting documents within 30
Retired from employment in the HTM field, days of request for further actions to be considered.
and held at least 15 years of continuous Upon receipt and review of the complaint form and
years of active certification status. supporting documentation, the ACI staff may inform,
Individuals earning the Emeritus status will no longer in writing, the accused and/or complainant of the
be required to submit a continuing practice journal or official opening of an investigation.
recertification fee, and they will be listed in the on-line
registry as "Emeritus. ACI staff will acknowledge receipt of complaint form
and supporting documentation. The accused will have
Complaints of Disciplinary Violation the opportunity to respond to the complaint made
against him/her within 30 days of notification of the
The ACI Board chair, vice-chair and one other ACI investigation.
Board member will be responsible for implementing
disciplinary policies and procedures as established by

14
Following the investigation, the ACI Chair will inform ACI staff makes an initial determination of whether
the complainant of the decision in writing. The the appeal has been properly filed and includes all
complainant will be notified in writing that a decision needed documentation and rationale. Appellants will
was reached. If disciplinary action is imposed, the be notified within 60 days of ACIs receipt whether the
complainant may submit an appeal of the decision to appeal has been filed properly for an appealable
the full ACI Board. This appeal must be submitted in action.
writing to the ACI Chair. A signed appeal must be
submitted in writing within 60 days from receipt of the Appeals Body
written notification that a disciplinary action is The ACI Board is the appeals body that hears
imposed and must clearly state the grounds for appeals. The full ACI Board is the final body to hear
appeal an appeal and there are no further appeals once the
full ACI Board has acted. The ACI Board ruling is
Below are two possible decisions that the ACI board final.
may make in regards to a complaint.
Fee
Withdrawal/Revocation The fee for an appeal with the ACI Board is $750
When a complaint is received by ACI which upon (U.S.D.) payable by the individual filing the appeal.
investigation by the policies and processes laid out The fee for a subsequent appeal to the full ACI Board
appears to be due to negligence or intentional is an additional $1,000 (U.S.D.). Fees are payable
malpractice or violation of the code of conduct, the with the filing of the appeal. An appellant may request
ACI Board may withdraw certification. In the event of that ACI to reduce these fees and must provide a
withdrawal, the certified professional must refrain rationale for this request (e.g., demonstrable financial
from further use of all references to certified status. hardship). The decision to reduce any appeal fee will
be made by the ACI Board Chair after review of the
Suspension request and rationale.
When a complaint is received by ACI which upon
investigation by the policies and processes laid out ACI Board Consideration of the Appeal
appears to be due to accidental causes, unintentional The ACI Board reviews all properly filed and
negligence or oversight, the ACI Board may suspend documented appeals to determine if significant
the certificants certification for a specific period. The evidence exists of a substantive error or omission in
ACI Board may establish monitoring procedures the certification process or outcome. Decisions
during the suspension which the certificant must require a (2/3) two-thirds vote by committee
conform to. During the time of suspension the members. When the ACI Board reaches a decision,
certificant must refrain from further promotion of his or the appellant will be notified in writing within 60 days
her certification. If the certificant does not remedy the of such decision being made. The appellant may
conditions of the suspension, the certificants request a hearing on the appeal, but is responsible for
certification may be withdrawn. paying all administrative expenses of the ACI
associated with such a hearing (including but not
Appeals limited to travel expenses of the ACI Board, if the
In addition to appeals of disciplinary action, an appellant wishes to have a hearing in person).
individual or certificant who was denied certification or
had his/her certification revoked may file an appeal Complaint Form
within 60 days of receipt of notice of the action taken
that is eligible for appeal. Certificants or other individuals within the industry can
request a complaint form by contacting ACI at
Filing of Appeal aci@aami.org.
The appeal shall state the nature of the objection,
including the details, and the specific remedial action
that the appellant is requesting. Upon the filing of a
properly executed appeal, the original action will be
suspended until final action is taken on the appeal.

15
Certified Biomedical Equipment Technician 3. FDA
Content Outline a. SMDA
b. Other
Anatomy & Physiology Approximately 12% 4. OSHA
A. Systems 5. Other (NEC, ANSI, FCC, etc.)
1. Respiratory
2. Gastrointestinal Fundamentals of Electricity & Electronics
3. Nervous Approximately 13%
4. Circulatory A. Transducers
5. Musculoskeletal B. Calculations and Conversions
6. Endocrine 1. Hex/Decimal/Binary
B. Organs 2. Other
1. Heart C. Circuits and Components
2. Lungs 1. Active Devices
3. Liver a. Solid-State Devices
4. Kidneys 1. Analog
5. Brain 2. Digital
6. Gallbladder b. Other (CRTs, X-Ray tubes, photomultipliers,
7. Pancreas etc.)
8. Other 2. Power Supplies
C. Blood 3. Passive Devices
1. Components D. Power Distribution and Storage Systems
2. Metabolism 1. Transformers
D. Terminology 2. Distribution
3. Batteries
Public (employee, patient, visitor) Safety in the 4. UPS/Line Conditioning
Healthcare Facility Approximately 15% E. Terminology
A. Electrical
1. Microshock/Electrical Safety Testing Healthcare Technology and Function
2. Other Approximately 25%
B. Chemical A. Monitoring Systems (ECG, EEG, Blood Pressure,
1. Material Safety Data Sheet Pulse Oximetry, Fetal Monitor)
2. Other B. Portable Equipment (Infusion Devices, Syringe
C. Radiation Hazards Pumps, PCA Pumps, Hypo/Hyperthermia)
1. Light Spectrum C. Life Support Equipment (Defibrillators,
2. Types of Rays Anesthesia Machines, Critical Care Ventilators,
D. Biological Balloon Pumps)
1. Standard Precautions D. Therapeutic Equipment (Infant Warmers,
2. Other Ultrasound Therapy)
E. Fire E. Laboratory Equipment (Centrifuges, Water Baths,
1. Class Analyzers)
2. Fire Extinguishers F. Diagnostic Imaging (Ultrasound,
F. Codes and Standards Radiographic/Fluoroscopy)
1. Credentialing and Certification G. Operating Room (Electro Surgical Generators,
a. Joint Commission Comprehensive Video Carts, Lasers, Tourniquets, Sterilizers,
Accreditation Manual Warmers)
b. AABB H. Test Equipment (Electrical Safety, Defibrillator,
c.. American College of Radiology Electro Surgical, Physiologic Simulators,
2. NFPA 99 Oscilloscopes, Meters)
a. Gas and Vacuum Systems I. Diagnostic Equipment
b. Electrical Systems J. Terminology

16
Healthcare Technology Problem Solving d. Other
Approximately 25% 2. Integration
A. Electronic Component Level, Block Level a. Bedside Medical Device Integration (BMDI)
B. Monitoring Systems (ECG, EEG, Blood Pressure, b. Medical Device Integration (MDI) (Labs,
Pulse Oximetry, Fetal Monitor) Printers, etc.)
C. Portable Equipment (Infusion Devices, Syringe c. Mobile Devices (Handhelds, Smart Phones,
Pumps, PCA Pumps, Hypo Hyperthermia) Tablets, etc.)
D. Life Support Equipment (Defibrillators, 3. Test Equipment
Hemodialysis, Anesthesia Machines, Critical Care a. Cable Test Devices (Copper, Fiber)
Ventilators, Balloon Pumps) b. Network Test Devices
E. Therapeutic Equipment (Infant Warmer, 4. Security
Ultrasound Therapy) D. Problem Solving
F. Laboratory Equipment (Centrifuges, Water Baths 1. Computer Networks
Analyzers) 2. Integration
G. Diagnostic Imaging (Ultrasound, 3. PCs, Switches, Hubs
Radiographic/Fluoroscopy) E. Terminology
H. Operating Room (Electro Surgical Generators,
Video Carts, Lasers, Tourniquets, Sterilizers,
Warmers) The CBET exam is a three-hour closed
I. Diagnostic Equipment book exam consisting of 165 multiple
J. Situational (User Error, User Training, choice questions.
Applications)
Candidates will have access to a simple
Healthcare Information Technology calculator during the exam. Cell phones,
Approximately 10% iPads or other electronic devices that have
A. Regulatory and Safety internet capabilities are not allowed into
1. Medical Device Data Systems (MDDS) the testing room.
2. IEC 80001 Application of Risk Management
for IT Networks Score required to pass: The minimum
3. Health Insurance Portability and Accountability score required to pass the CBET
Act (HIPAA) examinations is 116/165.
4. Digital Millennium Copyright Act (DMCA)
B. Foundations
1. Hardware
a. Topology
b. PCs/Laptops/Servers
c. Wiring/Structured Cabling/Connectors
d. Switches/Hubs/Routers
e. Wireless Communications
f. Other
2. Software/Middleware/Applications
a. EMR/EHR
b. Healthcare Information Systems (PACs, LIS,
RIS)
c. Network Protocols (IP, CCP, UDP)
d. Operating Systems
C. Function and Operation
1. Hardware
a. PCs, Switches, Patch Panels
b. Networks, Topology
c. Peripherals

17
Certified Radiology Equipment Specialist 3. FDA
Content Outline a. SMDA
b. Other
Anatomy & Physiology Approximately 12% 4. OSHA
A. Systems 5. Other (NEC, ANSI, FCC, etc.)
1. Respiratory
2. Gastrointestinal Fundamentals of Electricity & Electronics
3. Nervous Approximately 13%
4. Circulatory A. Transducers
5. Musculoskeletal B. Calculations and Conversions
6. Endocrine 1. Hex/Decimal/Binary
B. Organs 2. Other
1. Heart C. Circuits and Components
2. Lungs 1. Active Devices
3. Liver a. Solid-State Devices
4. Kidneys 1. Analog
5. Brain 2. Digital
6. Gallbladder b. Other (CRTs, X-Ray tubes, photomultipliers,
7. Pancreas etc.)
8. Other 2. Power Supplies
C. Blood 3. Passive Devices
1. Components D. Power Distribution and Storage Systems
2. Metabolism 1. Transformers
D. Terminology 2. Distribution
3. Batteries
Public (employee, patient, visitor) Safety in the 4. UPS/Line Conditioning
Healthcare Facility Approximately 15% E. Terminology
A. Electrical
1. Microshock/Electrical Safety Testing Healthcare Technology and Function
2. Other Approximately 25%
B. Chemical A. Equipment Types
1. Material Safety Data Sheet 1. Test Equipment
2. Other 2. Film Processors
C. Radiation Hazards 3. X-Ray Tubes
1. Light Spectrum 4. TV Camera
2. Types of Rays 5. Intensifying Screens
D. Biological 6. Image Intensifier
1. Standard Precautions 7. Other
2. Other B. Systems
E. Fire 1. X-Ray Machines
1. Class 2. Nuclear Medicine
2. Fire Extinguishers 3. Magnetic Resonance Imaging
F. Codes and Standards 4. Linear Tomography Systems
1. Credentialing and Certification 5. Ultrasound Diagnostics
a. Joint Commission Comprehensive 6. Mammography
Accreditation Manual 7. Digital Imaging
b. AABB 8. CT
c.. American College of Radiology 9. Health Care Information Systems (PACS, LIS,
2. NFPA 99 RIS)
a. Gas and Vacuum Systems 10. Other (Support Equipment, EKG, Defibrillator)
b. Electrical Systems C. Quality Control

18
D. Terminology C. Function and Operation
1. Hardware
Healthcare Technology Problem Solving a. PCs, Switches, Patch Panels
Approximately 25% b. Networks, Topology
A. Component Level (Electronic Circuit) c. Peripherals
B. Equipment Types d. Other
1. Film Processors 2. Integration
2. X-Ray Tubes a. Bedside Medical Device Integration (BMDI)
3. TV Cameras/Displays b. Medical Device Integration (MDI) (Labs,
4. Intensifying Screens Printers, etc.)
5. Image Intensifier c. Mobile Devices (Handhelds, Smart Phones,
6. Digital Imaging Tablets, etc.)
7. CT 3. Test Equipment
8. Other (Support Equipment, EKG, Defibrillator) a. Cable Test Devices (Copper, Fiber)
C. Systems b. Network Test Devices
1. X-Ray Machines 4. Security
2. Nuclear Medicine D. Problem Solving
3. Magnetic Resonance Imaging 1. Computer Networks
4. Linear Tomography Systems 2. Integration
5. Ultrasound Diagnostic 3. PCs, Switches, Hubs
6. Mammography E. Terminology
7. Other
D. Situational
1. Prioritizing Work
2. Operator vs. Equipment The CRES exam is a three-hour closed
3. Applications book exam consisting of 165 multiple
4. Other choice questions.

Healthcare Information Technology Candidates will have access to a simple


Approximately 10% calculator during the exam. Cell phones,
A. Regulatory and Safety iPads or other electronic devices that have
1. Medical Device Data Systems (MDDS) internet capabilities are not allowed into
2. IEC 80001 Application of Risk Management the testing room.
for IT Networks
3. Health Insurance Portability and Accountability Score required to pass: The minimum
Act (HIPAA) score required to pass the CRES
4. Digital Millennium Copyright Act (DMCA) examinations is 116/165.
B. Foundations
1. Hardware
a. Topology
b. PCs/Laptops/Servers
c. Wiring/Structured Cabling/Connectors
d. Switches/Hubs/Routers
e. Wireless Communications
f. Other
2. Software/Middleware/Applications
a. EMR/EHR
b. Healthcare Information Systems (PACs, LIS,
RIS)
c. Network Protocols (IP, CCP, UDP)
d. Operating Systems

19
Certified Laboratory Equipment Specialist 3. FDA
Content Outline a. SMDA
b. Other
Anatomy & Physiology Approximately 12% 4. OSHA
A. Systems 5. Other (NEC, ANSI, FCC, etc.)
1. Respiratory
2. Gastrointestinal Fundamentals of Electricity & Electronics
3. Nervous Approximately 13%
4. Circulatory A. Transducers
5. Musculoskeletal B. Calculations and Conversions
6. Endocrine 1. Hex/Decimal/Binary
B. Organs 2. Other
1. Heart C. Circuits and Components
2. Lungs 1. Active Devices
3. Liver a. Solid-State Devices
4. Kidneys 1. Analog
5. Brain 2. Digital
6. Gallbladder b. Other (CRTs, X-Ray tubes, photomultipliers,
7. Pancreas etc.)
8. Other 2. Power Supplies
C. Blood 3. Passive Devices
1. Components D. Power Distribution and Storage Systems
2. Metabolism 1. Transformers
D. Terminology 2. Distribution
3. Batteries
Public (employee, patient, visitor) Safety in the 4. UPS/Line Conditioning
Healthcare Facility Approximately 15% E. Terminology
A. Electrical
1. Microshock/Electrical Safety Testing Healthcare Technology and Function
2. Other Approximately 25%
B. Chemical A. Equipment Types
1. Material Safety Data Sheet 1. Test Equipment
2. Other 2. Common Lab Equipment
C. Radiation Hazards a. Centrifuges
1. Light Spectrum b. Microscopes
2. Types of Rays c. Blood Gas Analyzers
D. Biological d. Refrigerators
1. Standard Precautions 3. Chemistry Equipment
2. Other 4. Hematology Equipment
E. Fire 5. Microbiology Equipment
1. Class 6. Blood Bank Equipment
2. Fire Extinguishers 7. Urinalysis Equipment
F. Codes and Standards 8. Histology Equipment
1. Credentialing and Certification 9. Other
a. Joint Commission Comprehensive B. Systems
Accreditation Manual 1. Lab Information
b. AABB 2. Other
c.. American College of Radiology C. Quality Control
2. NFPA 99 D. Terminology
a. Gas and Vacuum Systems
b. Electrical Systems

20
Healthcare Technology Problem Solving a. PCs, Switches, Patch Panels
Approximately 25% b. Networks, Topology
A. Component Level (Electronic Circuit) c. Peripherals
B. Equipment Types d. Other
1. Common Lab Equipment 2. Integration
a. Centrifuges a. Bedside Medical Device Integration (BMDI)
b. Microscopes b. Medical Device Integration (MDI) (Labs,
c. Blood Gas Analyzers Printers, etc.)
d. Refrigerators c. Mobile Devices (Handhelds, Smart Phones,
2. Chemistry Equipment Tablets, etc.)
3. Hematology Equipment 3. Test Equipment
4. Microbiology Equipment a. Cable Test Devices (Copper, Fiber)
5. Blood Bank Equipment b. Network Test Devices
6. Urinalysis Equipment 4. Security
7. Histology Equipment D. Problem Solving
8. Other 1. Computer Networks
C. Systems 2. Integration
1. Lab Information 3. PCs, Switches, Hubs
2. Other E. Terminology
D. Situational
1. Prioritizing Work
2. Operator vs. Equipment
3. Applications The CLES exam is a three-hour closed
4. Other book exam consisting of 165 multiple
choice questions.
Healthcare Information Technology
Approximately 10% Candidates will have access to a simple
A. Regulatory and Safety calculator during the exam. Cell phones,
1. Medical Device Data Systems (MDDS) iPads or other electronic devices that have
2. IEC 80001 Application of Risk Management internet capabilities are not allowed into
for IT Networks the testing room.
3. Health Insurance Portability and Accountability
Act (HIPAA) Score required to pass: The minimum
4. Digital Millennium Copyright Act (DMCA) score required to pass the CLES
B. Foundations examination is 116/165.
1. Hardware
a. Topology
b. PCs/Laptops/Servers
c. Wiring/Structured Cabling/Connectors
d. Switches/Hubs/Routers
e. Wireless Communications
f. Other
2. Software/Middleware/Applications
a. EMR/EHR
b. Healthcare Information Systems (PACs, LIS,
RIS)
c. Network Protocols (IP, CCP, UDP)
d. Operating Systems
e. Other
C. Function and Operation
1. Hardware

21
Certified Healthcare Technology Manager B. Assure integrity of data collection, storage, and
Content Outline security associated with healthcare technology
(e.g., HIPAA, PACS, EKG management, EMR).
Financial Management Approximately 19% C. Recommend processes, procedures, or policies
3 Recall Questions
13 Application Questions to control or reduce risk.
3 Analysis Questions D. Apply risk-assessment models or methodologies,
(e.g., FMEA, root cause analysis).
A. Participate in financial planning, budgeting, or E. Participate in incident investigations.
procurement activities of all or part of an F. Produce reports that outline findings, explain risk
organization (e.g., capital planning, technology positions, or recommend changes (e.g., SMDA,
planning, reporting, accounting, billing, collections, sentinel event alerts).
payroll, and budgeting duties). G. Manage recalls, hazards, and safety advisories in
B. Develop departmental control policies, guidelines, use in healthcare technology.
and/or procedures for activities such as financial
administration. Operations Management Approximately 46%
11 Recall Questions
C. Assure compliance with organizational policies
11 Application Questions
and procedures and generally accepted 24 Analysis Questions
accounting principles (GAAP).
D. Prepare program financial statements, business A. Oversee activities directly related to providing
activity reports, financial forecasts, or annual services (e.g., scheduled and unscheduled work,
budgets. project management, customer satisfaction).
E. Analyze the financial details of past, present, and B. Coordinate activities of service providers and
expected operations to identify development vendors concerned with planning, acquisition,
opportunities and areas where improvement is contracting, installation, or service of healthcare
needed. technology.
F. Authorize requests for disbursements in C. Review financial statements, activity reports, and
accordance with company policies and other performance data to measure productivity
procedures. and goal achievement and to determine areas
G. Advise management in determining life needing cost reduction and program
expectancy (i.e., capital asset planning) of improvement.
healthcare technology devices. D. Develop departmental and/or team policies and
H. Advise management on actions regarding the fair procedures, goals, and objectives.
market value of purchase, lease, or asset recovery E. Manage departmental policies and procedures,
value of disposed healthcare technology. goals and objectives (e.g. prepare work
I. Review sourcing options for parts, service, training schedule, assign specific duties).
and test equipment/tools. F. Determine departmental and/or staffing
requirements.
Risk Management Approximately 12% G. Comply with regulatory and accreditation
2 Recall Questions
8 Application Questions requirements (e.g. TJC,ANSI, AAMI, NFPA,
2 Analysis Questions OSHA, CAP, AABB, CMS, FDA, FCC, HIPAA,
DNV, AOA, ACR, IAC, IEC, NRC, DOH, NEC,
A. Evaluate key risks associated with the use of CLIA, COLA, MQSA).
healthcare technology ( e.g., patient safety, H. Report departmental operations performance to
operations, finance, emergency preparedness). other departments or committees in accordance

22
with the MEMP (e.g., environment of care, D. Conduct orientation sessions and on-the-job
patient safety, risk management, value-added, training for staff.
benchmarking). E. Assure availability of training manuals (e.g.,
I. Oversee departmental and/or team meetings and service manuals, operations manuals, training
communications. media, and other educational materials).
J. Ensure resources are available to complete F. Collaborate with clinical departments on
departmental and/or team activities (e.g., tools, healthcare technology training (e.g., MRI and
test equipment, supplies, technical information, radiation safety, equipment use, use-error
and training). trending).
K. Review project plans to coordinate project G. Collaborate with non-clinical departments on
activity. healthcare technology training (e.g., infection
L. Consult with users, management, vendors, and prevention, environmental services, and supply
technicians to access healthcare technology management).
needs and requirements.
M. Meet with department heads, managers, Human Resources Approximately 12%
3 Recall
supervisors, vendors, and others to solicit
9 Application
cooperation and resolve problems. 0 Analysis
N. Evaluate healthcare technology proposals to
assess project feasibility and requirements. A. Recommend compensation, promotion, and
O. Collaborate with other stakeholders (e.g., IT, career path of departmental and/or team staff.
nursing, vendors) to manage device integration. B. Perform personnel management duties (e.g.,
P. Participate in construction planning meetings. employee relations, staffing, conflict
Q. Collaborate with other departments on utility management, disciplinary procedures, and
maintenance and interruption (e.g., network, performance development plan).
telecom, electrical, plumbing, mechanical C. Ensure department and/or team practices are in
systems, change management, downtime compliance with state and federal labor laws
procedures). (e.g., ADA, EEOC, FMLA, and NLRA).
R. Oversee the management of healthcare D. Participate in the requirement, selection,
technology assets, inventory accuracy, backups, retention, and termination of employees.
security, CMMS, non-hospital owed equipment. E. Conduct performance evaluations of
S. Ensure competency of HTM department staff and departmental and/or team staff.
healthcare technology service vendors. F. Collaborate with labor relations organizations.
G. Represent organization at personnel-related
Education & Training Approximately 11% hearings and investigations.
4 Recall
7 Application
0 Analysis The CHTM exam is a two-hour closed book exam
consisting of 100 multiple choice questions.
A. Evaluate the effectiveness of training programs.
B. Analyze training needs based on cost, Candidates will have access to a simple calculator
operations, requirements, competency, customer during the exam. Cell phones, iPads or other
requirements, resources, etc. electronic devices that have internet capabilities are
not allowed into the testing room.
C. Oversee ongoing technical training and personal
development classes for staff members. Score required to pass: The minimum score
required to pass the CHTM examination is 72/100.

23
Certified Quality System Manager A. Facilitate compliance with regulations and
Content Outline standards.
1. 21 CFR (7, 801, 806, 820, 803)
Establishment of a Medical Device Quality System 2. ISO (Vigilance requirements, 13485, 14971)
Approximately 37%
7 Recall 3. Guidance Documents
22 Application a. Global Harmonization Task Force
8 Analysis (GHTF/SG3/N99) quality management
systems process validation guidance.
A. Ensure the quality system includes regulatory b. FDA General Principles of Software
requirements, business needs, and product Validation.
requirements (e.g., product classification, sterile B. Assess potential organization impact of changes
or non-sterile). to regulations and standards.
B. Establish metrics and performance indicators to
monitor quality outcomes and measure the health Management Approximately 40%
8 Recall
of the quality system.
8 Application
1. Report to management about the 24 Analysis
effectiveness of the quality systems.
2. Oversee quality system and evaluate its A. Lead the design, development, and
ongoing stability. implementation of a compliant quality system.
3. Identify suitable metrics. B. Lead the management review process.
4. Analyze data (sub-system specific, C. Ensure effective resource planning for the quality
cross-sub system). system.
5. Use statistical techniques. D. Manage the quality of the internal audit sub-
6. Initiate actions based on data analysis. systems.
C. Establish validation framework including process, E. Develop quality plans.
software, device design, and test method. F. Manage monitoring and feedback
D. Ensure the development of training framework 1. Corrective and preventive actions
applicable to regulatory compliance and 2. Non-conformance
company-specific procedures, quality 3. Complaints
management and quality engineering principles. 4. Recommend courses of action when non-
E. Risk management compliance is discovered
1. Apply risk management tools to the 5. Audits
quality system. 6. Ensure mechanisms exist to effectively
2. Approve risk management plans and capture, report and trend customer feedback
reports. G. Establish the quality policy, strategy (objectives),
3. Participate in risk management analysis. and tactics for the organization.
4. Approving Medical Device Report H. Manage quality operations ( control, assurance
(MDR) and vigilance reports. and engineering)
5. Lead health hazard evaluations. I. Act as liaison to support the organizations
interactions with notified bodies and regulatory
Medical Device Quality System Compliance organizations on compliance and management
Approximately 23 % issues.
18 Recall
J. Act as liaison to support the organizations
5 Application
0 Analysis external audits and inspections.
K. Ensure training needs are assessed.

24
The CQSM exam is a two-hour closed book exam
consisting of 100 multiple choice questions. Safety and Regulatory-Public and Patient Safety
in the Health Care Facility
Candidates will have access to a simple calculator (General/Radiology/Laboratory)
during the exam. Cell phones, iPads or other
AABB: American Association Blood Banks
electronic devices that have internet capabilities
http://www.aabb.org/
are not allowed into the testing room.
NOTE: Since this is a new exam, the results will be ANSI: American National Standards Institute
reviewed prior to being released. You will receive http://webstore.ansi.org/ansidocstore/default.asp
your results directly from AAMI within the thirty
days of the testing window. CLIA: Clinical Laboratory Improvement Amendments
http://www.fda.gov/cdrh/clia/

Exam Resources Code of Federal Regulations, Title 21, Subchapter J.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfC
The following is not intended to be a complete listing FR/CFRSearch.cfm
of every source available, nor should applicants feel
they must purchase and study every item on this list. Comprehensive Accreditation Manual of Hospitals:
Most texts in a particular category are redundant. The The Joint Commission
list is purposely long to increase the probability that http://www.jointcommission.org/
everyone will have access to at least some of the
sources listed. Other generally accepted texts may be MQSA: Mammography Quality Standards Act
of equal value in preparation for the examinations. http://www.fda.gov/cdrh/mammography/

CBET, CLES, CRES References NCRP (Report 99, 102): National Council on
Radiation Protection and Measurements
Anatomy, Physiology, and Medical Terminology http://www.ncrponline.org/
(General, Radiology, Laboratory)
NEMA Standards (Publication No. XR 8, XR9, XR11,
Hole, John W. Jr.: Essentials of Human Anatomy & XR12): National Electrical Manufacturers Association
Physiology, (ISBN: 0697267695 ISBN-13: http://nema.org/
9780697267696) McGraw-Hill Higher Education
NFPA (70, 99, 101): National Fire Protection
Martini, Frederick and Bartholomew, Edwin: Structure Association http://www.nfpa.org/
& Function of the Human Body, Prentice Hall, Upper
Saddle River, NJ, 1999. OSHA: Occupational Safety & Health Administration
http://www.osha.gov/
Patton, Kevin T. and Thibodeau, Gary A.: Anthonys
Textbook of Anatomy & Physiology, Mosby Yearbook Electronics and Devices
Co., St. Louis, MO (ISBN: 0-323-01630-8) 17th (General/Radiology/Laboratory)
Edition, 2002. Beyda, William J.: Data Communications, from Basics
to Broadband, Prentice-Hall, Englewood Cliffs, NJ
Stedman, Thomas: Stedmans Medical Dictionary, (ISBN: 0-1309-6139-6) 3rd Edition, 2000.
Lippicott, Williams & Wilkins, NY (ISBN: 0-7817-4494-
6) 27th Edition, 2002. Floyd, Thomas L.: Digital Fundamentals, Prentice
Hall, Englewood Cliffs, NJ (ISBN: 0-1308-08540-4) 7th
Tortora, Gerard J. and Grabowski, Sandra Reynolds: Edition, 2000.
Principles of Anatomy and Physiology, Wiley
Publishing (ISBN: 0-471-41501-4) 10th Edition, 2002. Floyd, Thomas L.: Electronic Devices, Prentice Hall,
Englewood Cliffs, NJ (ISBN: 0-1364-3138-3) 5th
Edition, 1999.

25
Grob, Bernard and Schultz, Mitchel: Basic MacIntyre, Neil R. and Branson, Richard D.:
Electronics, Macmillan/McGraw-Hill, Westerville, OH Mechanical Ventilation, W.B. Saunders Company
(ISBN: 0-0782-7124-X) 9th Edition, 2003. (ISBN: 0-7216-7361-9) 1st Edition, 2001.

Malvino, Albert Paul, PhD: Electronic Principles, Robbins, Allan and Miller, Willhelm: Circuit Analysis:
McGraw-Hill Book Co., New York, NY (ISBN: 0-0280- Theory and Practice, Thomson Delmar Learning, New
2833-3) 6th Edition, 1999. York, 2nd edition, 2006.

Paynter, Robert T.: Introductory Electronic Devices Street, Laurence: Introduction to Biomedical
and Circuits, Prentice Hall, Englewood Cliffs, NJ Engineering Technology, CRC Press, Boca Raton,
(ISBN: 0-1392-7203-8) 5th Edition, 2000. FL, 2008.

Williams, Joseph: An Introduction to Computing Health Care Information Technology


Infrastructure: Hardware and Opening Systems, Que
Education and Training (ISBN: 1-5757-6355-9) 1997. Arnold, Steven: Guide to the Wireless Medical
Practice. Himss (ISBN: 0-9777903-8-X) 2008.
Biomedical Instrumentation (General)
Benson, Tim: Principles of Health Interoperability HL7
AAMI, A Practicum for Healthcare Technology & SNOMED: Health Informatics Series (ISBN: 978-1-
Management, (ISBN: 1-57020-589-2), 2015 84882-802-5) 2010.

Atles, Leslie, R., Segalewitz, Scott, Marquette ECRI Institute: Medical Technology for the IT
Electronics: Affinity Reference Guide for Biomedical Professional (ISBN: 978-0-9819241-1-3).
Technician, Dubuque, Iowa Kendall/Hunt Pub. 1995
(ISBN: 0787200654 9780787200657 0787243272 Radiology
9780787243272)
Bushong, Stewart: Radiologic Science for
Carr, Joseph J. and Brown, John M.: Introduction to Technologists: Physics, Biology, and Protection,
Biomedical Equipment Technology, John Wiley & Mosby Yearbook Co., St. Louis, MO (ISBN: 0-323-
Sons, Inc., NY (ISBN: 0-1301-0492-2) 4th Edition, 01337-6) 7th Edition, 2001.
2001.
Callaway, W. J.: Mosbys Comprehensive Review of
Chan, Anthony: Biomedical Device Technology: Radiography: The Complete Study Guide and
Principles and Design, Charles C Thomas Publisher, Planner, Elsevier Science (ISBN: 0-3230-1839-4) 3rd
Ltd., Springfield, IL (ISBN: 978-0-398-07699) 2008. Edition, 2002.

Christe, Barbara: Introduction to Biomedical Papp, J.: Quality Management in the Imaging
Instrumentation: The Technology of Patient Care, Sciences, Elsevier Science (ISBN: 0-3230-1624-3) 2nd
Cambridge University Press, New York (ISBN: 978-0- Edition, 2002.
521-5152-2) 2009.
Saia, D. A.: Appleton & Langes Review for the
Cromwell, and Others: Biomedical Instrumentation Radiography Examination, McGraw Hill (ISBN: 0-
and Measurements, Prentice-Hall, Inc., Englewood 8385-0389-6) 4th Edition, 2000.
Cliffs, NJ (ISBN: 0-1307-6448-5) 2nd Edition, 1980.
Laboratory
Khandpur, Raghbir: Biomedical Instrumentation:
Technology and Applications, McGraw-Hill, New York Estridge, Barbara H., Reynolds, Anna P., & Walters,
(ISBN: 0-07-144784-9) 2005. Norma J. PhD: Basic Medical Laboratory Techniques,
Delmar (Thomas Learning), Albany, NY (ISBN: 0-
7668-1206-5) 4th Edition, 2000.

26
Fischbach, Francis RN, BSN, MSN: A Manual of Synthesis Lectures on Biomedical Engineering (ISBN:
Laboratory & Diagnostic Tests, Lippincott Williams & 1608453669) 2013
Wilkins, Philadelphia, PA (ISBN: 0-7817-1969-0) 6th
Edition, 2000. Stiefel, Robert: Medical Equipment Management
Manual (ISBN: 1-57020-350-4) RHS Biomedical
Lehman, PhD, Craig A., Leiken, Alan, Ward, PhD., Engineering Consulting, LLC, 2009
Kory M.: Clinical Laboratory Instrumentation and
Automation: Principles, Applications, and Selection, Taktak, Azzam, Ganney, Paul, Long, David, and
W.B. Saunders Co., Philadelphia, PA (ISBN: 0-7216- White, Paul: Clinical Engineering: A Handbook for
4218-7) 1st Edition, 1994. Clinical and Biomedical Engineers (ISBN-10:
0123969611) 1st Edition, 2014
Mahon, C., Smith, L., Burno, C.: An Introduction to
Clinical Laboratory Science, W.B. Saunders Co., Wang, Binseng: Medical Equipment Maintenance:
Philadelphia, PA (ISBN: 0-7216-4990-4) 1st Edition, Management and Oversight (Synthesis Lectures on
1998. Biomedical Engineering) 2012 Articles

Mangle, James I., Nortica, PhD., Solomon, Petit, MD, Baretich, Matthew: The Value of Certification.
J.E.: Albas Medical Technology: Board Examination Biomedical Instrumentation & Technology , Jan 2012,
Review and Complete Clinical Laboratory Text, Vol. 46, No. 1, pp. 68-71.
Berkeley Scientific Publications (ISBN: 0-91024-18-8)
12th Edition, 1996. Braeutigam, David: Dollars and Sense: Get a Handle
on Managing Service Costs Biomedical
Segen, Joseph C. MD and Stauffe, Joseph PhD: The Instrumentation & Technology, Sep 2010, Vol. 44, No.
Patients Guide to Medical Tests, Facts on File, Inc., 5, pp. 395-396.
New York, NY (ISBN: 0-8160-4652-2) 2nd Edition,
2002. Schlabig Williams, Jill Revamping: In-House Clinical
Engineering Services in 90 Days Biomedical
Maintenance Manual for Laboratory Equipment, 2nd Instrumentation & Technology ,Sep 2008, Vol. 42, No.
Edition, World Health Organization, 5, pp. 377-379.
http://whqlibdoc.who.int/publications/2008/978924159
6350_eng_low.pdf Cohen, Theodore: AAMIs Benchmarking Solution:
Analysis of Cost of Service Ratio and Other Metrics
CHTM References Biomedical Instrumentation & Technology, Jul 2010,
Vol. 44, No. 4, pp. 346-349.
AAMI, A Practicum for Healthcare Technology
Management, (ISBN: 1-57020-589-2), 2015 Hegarty, Francis,Togneri MacMahon, Silvana, Byrne,
Patricia, and McCaffery, Fergal: Assessing a
Patrick Lynch, CHTM Study Guide, (ISBN 1-57020- Hospitals Medical IT Network Risk Management
627-9), 2016 Practice with 80001-1 Biomedical Instrumentation &
Technology, Jan 2014, Vol. 48, No. 1, pp. 64-71.
Carr, Joseph and Brown, John: Introduction to
Biomedical Equipment Technology, (ISBN-13: Mankovich, Nick and Fitzgerald, Brian: Managing
9780130104922) Prentice Hall, 4th Edition, 2001 Security Risks With 80001 Biomedical
Instrumentation & Technology Managing Medical
Dyro, Joseph: Clinical Engineering Handbook - Devices on the IT Network, Sep 2011, Vol. 45, No.
Biomedical Engineering (ISBN-10:012226570X) 1st s2, pp. 27-32.
Edition, 2004
Janssen, Martin and Schrenker, Rick: Guidelines
Frize, Monique: Health Care Engineering Part I: From 80001 Maintaining a Medical IT Network
Clinical Engineering and Technology Management - Biomedical Instrumentation & Technology, Jul 2011,
Vol. 45, No. 4, pp. 295-299.

27
Papa, Mike: Responsibility Agreements Ensure Analysis Methodology Biomedical Instrumentation &
Accountability Under 80001 Biomedical Technology, May 2003, Vol. 37, No. 3, pp. 167-179.
Instrumentation & Technology Managing Medical
Devices on the IT Network, Sep 2011, Vol. 45, No. Hall, Andrea: Manage Contractors Like Employees to
s2, pp. 33-35. Ensure JCAHO Compliance Biomedical
Instrumentation & Technology, Mar 2006, Vol. 40, No.
Cooper, Todd and Eagles, Sherman: 80001:New Era 2, pp. 128-129.
Dawns for Medical Devices Biomedical
Instrumentation & Technology, Jan 2011, Vol. 45, No. Links
1, pp. 16-25.
Association for the Advancement of Medical
Grimes, Stephen: Using 80001 to Manage Medical Instrumentation (AAMI)
Devices on the IT Network Biomedical 80001-1 Managing Medicai1T-Networks: 2012
Instrumentation & Technology Managing Medical
Devices on the IT Network, Sep 2011, Vol. 45, No. Federal Communications Commission
s2, pp. 23-26. WMTS

Cooper, Todd and Fuchs, Ken: Technology Risk U.S. Department of Labor (DOL)
Assessment In Healthcare Facilities Biomedical Americans with Disabilities Act
Instrumentation & Technology, May 2013, Vol. 47, Disability Resources
No. 3, pp. 202-207. Fair Labor Standards Act
Family and Medical Leave
Delvecchio, Karen: Step-by-Step Risk Management Family and Medical Leave Act
for Medical IT Networks Biomedical Instrumentation & Federal Wage Garnishments
Technology Managing Medical Devices on the IT Wage and Hour Division
Network, Sep 2011, Vol. 45, No. s2, pp. 37-43.
U.S. Food and Drug Administration (FDA)
Swim, Richard: Keeping Data Secure: Protected Safe Medical Devices Act Family
Health Information and Medical Equipment FDA 21 CFR 800 and 1000 series
Biomedical Instrumentation & Technology, Jul 2012,
Vol. 46, No. 4, pp. 278-280. Various Links
AHA Healthcare Data Viewer
Swim, Richard: Understanding the Wireless Spectrum American National Standards Institute ANSI
in a Healthcare Facility Biomedical Instrumentation & ASHE: Registration of Equipment Operating in WMTS
Technology, May 2013, Vol. 47, No. 3, pp. 212-214. Band
CMS Categorical Waiver for Power Strips Use in
Hayhurst, Chris: Is Your Patient Data Secure? Patient Care Areas
Biomedical Instrumentation & Technology, May 2014, CMS Medical Equipment Standards
Vol. 48, No. 3, pp. 166-173. Code of Federal regulations CCPA 29CFR 870
GAAP
Holden, William: Bridging the Culture Gap Between HIPAA
Healthcare IT and Medical Device Development IEC
Biomedical Instrumentation & Technology Connecting MQSA Mammography Quality Standards Act
the Dots, Sep 2014, Vol. 48, No. s2, pp. 22-28. MRI Facility Design Guide
NFPA 70, 99, 101
Krenc, Tina: Risk Management: Its Not Just FMEA NLRB: Rights We Protect
Biomedical Instrumentation & Technology, May 2010, OSHA
Vol. 44, No. 3, pp. 242-244. U.S.EEOC

Ridgway, Malcom: Analyzing Planned Maintenance


(PM) Inspection Data by Failure Mode and Effect

28
CQSM References 21 CFR 7
21 CFR 801
Global Harmonization Task Force 21 CFR 803
GHTF/SG3/N99-10:2004 - (Edition 2) 21 CFR 806
21 CFR 820
International Standards Organization (ISO)
Medical device software - Part 1: Guidance on the International Medical Device Regulators Forum
application of ISO 14971 to medical device software (IMDRF)
ISO 13485:2009
ISO 14971:2007 Study Guides and Review Courses

Association for the Advancement of Medical It is considered a conflict of interest for any certifying
Instrumentation (AAMI) organization or commission to help individuals attain
ANSI/AAMI/IEC TIR80002-1:2009 the credential it issues. The ACI does not sponsor or
The Quality System Compendium: CGMP endorse any refresher course, study guides, or study
Requirements and Industry Practice, 3rd Edition materials of any kind. Contact a local biomedical
society or ask colleagues about organizing study
U.S. Food and Drug Administration (FDA): groups or arranging for review courses.
General Principles of Software Validation

29
Certification Exam Pricing
(Beginning November 2015)

Member Fee Non-member Fee


Exam Fees
CBET, CLES, CRES Exam Fee $350 $400
(includes $100 application fee) (includes $100 application fee)
CBET, CLES, CRES Retake Fee
$225 $275
(non-refundable)
CHTM Exam Fee $420 $500
(includes $100 application fee) (includes $100 application fee)
CHTM Retake Fee $300 $350
(non-refundable)
CQSM Exam Fee $420 $500
(includes $100 application fee) (includes $100 application fee)
CQSM Retake Fee $300 $350
(non-refundable)
International Exams $100 additional $100 additional
(outside domestic USA & Canada)
Late Registration Fee $50 additional $50 additional
(non-refundable)
Rescheduling Fee $50 $50
(outside of 5 business days)
Rescheduling Fee Forfeit all exam fees Forfeit all exam fees
(inside of 5 business days)
No Show Fee Forfeit all exam fees Forfeit all exam fees

Recertification
Recertification Fees $100 $150
(non-refundable)
Additional Fee for multiple
$50 (per additional certification) $75 (per additional certification)
certification
Late Fee
(received after December 31 but before $25 $25
Feb 1)
Reactivation Fee (received after $100 $100
February 1)

Miscellaneous
Upgrade Fee $25 $25
New Certificate $25 $25

The $100 application fee is non-refundable.

30
ACI RECERTIFICATION CATEGORIES (Beginning January 1, 2017)

Category I: Earn an additional HTM-related certification (maximum CEUs allowed in this category is 15)

HTM related certifications including ACI certification programs (CBET, CRES, CLES,
CHTM, CQSM, CISS), and CCE 5 CEUs/certification
Healthcare-related Certifications (such as CHSP, CQSP, CMLT, dialysis
certifications) 2 CEUs/certification
Technology-related Certification (such as A+, NET+, S+, MSCE, CET) 2 CEUs/certification
Business Certifications (such as CPM) 2 CEUs/certification

Category II: Leadership roles (maximum CEUs allowed in this category is 15)

Paid or volunteer positions on HTM-related and healthcare committees, workgroups, 30+ hours per year: 4
or appointments (outside your position description) such as the following: CEUs
Less than 30 hours per
ACI Certification Board year: 2 CEUs
ACI Exam Committees (non-item writing committees)
HTM Society Role
Hospital Committee
Hospital/healthcare association roles (such as AHA , ACHE)
Engineering or technical association roles (such as ASHE, HIMSS, ASCP)
Volunteer activities (missions)

Category III: Development of educational content (maximum CEUs allowed in this category is 15)

Write Items for ACI 5 items = 1 CEU


Write an opinion based article -published (minimum of 500+ words) 1 CEU
Write a peer-reviewed published article (minimum of 1,200-1,500 words) 3 CEUs
Write a published technical article (minimum of 1,200-1,500 words) 3 CEUs
Write book 1 chapter = 3 CEUs

Category IV: Professional Development (minimum CEUs needed in this category is 15 No Maximum)

Attending education class (such as AAMI course) 1 CEU per hour of attendance
Attending an in-service (documented), vendor presentation or vendor school 1 CEU per hour of attendance
Attending a webinar (live or recorded) 1 CEU per hour of attendance
HTM Conferences (seminars/sessions) 1 CEU per hour of attendance
Presenting a webinar 2 CEU per hour of presentation
Teaching an education class/seminar 2 CEU per hour of teaching
Presenting a technical paper 2 CEU per hour of presentation
Courses indirectly related to HTM field (such as communication, management,
accounting) 0.5 CEU per hour of attendance

31
Category V: College or university courses (maximum CEUs allowed in this category is 15)

Courses must be directly related to obtaining an accredited degree (AA, BS, MBA, PHD, etc) and directly related to
the HTM profession (included on the exam content outlines) to receive credit. Students must receive a grade of "C"
or above and must supply a copy of their transcript as proof of attendance to submit college course.

Attending a course 1 CEU for 10 hours of class time


Teaching a course 3 CEU for 10 hours of teaching time

Category VI: Work experience (maximum CEUs allowed in this category is 6)

Full-time employment (working in the HTM field) 1.5 CEU per year
Part-time employment/Military Reserve Duty (working in the HTM field) 0.5 CEUs per year

32
Definitions
Business
Business is any discipline that teaches the application of financial and management principles to an organization of
people and resources with the goal of delivering goods and/or services that satisfy customers. Some examples are
academic degrees in business administration, accounting, finance, and management.

Engineering
Any discipline that teaches the application of scientific and mathematical principles to practical ends such as the
design, manufacture, support, and operation of efficient and economical structures, machines, processes, and
systems. Some examples are academic degrees in mechanical engineering, electrical/electronic engineering,
biomedical engineering, manufacturing engineering, and computing engineering.

Healthcare Technology Management Professional


A person who applies engineering, business, and healthcare principles to design, construct, maintain, or manage
medical devices or systems.

Healthcare Technology Manager


Healthcare technology manager is a person who is responsible for planning and directing the activities of other
healthcare technology management professionals, monitoring their work, and taking corrective action when
necessary.

Healthcare Related
Any discipline that teaches the organization, procedures, and methods of services associated to the diagnosis,
treatment, prevention, and management of disease. Some examples are academic degrees in medicine, nursing,
healthcare administration, public health, dentistry, pharmacy, and health informatics.

Quality System
Quality system means the organizational structure, responsibilities, procedures, processes, and resources for
implementing quality management (FDA 21 CFR 820.3(v)).

Quality System Manager


A quality system manager oversees all aspects of quality assurance including: establishing metrics, applying industry
best practices, and developing new tools and processes to ensure quality goals are met. A quality system manager
also manages the process and resources for identifying, correcting, and improving non-conformities in product
specific policies, procedures, and protocols as well as product specifications. Additionally, all of this is accomplished
in a manner that insures compliance to all relevant regulatory requirements. Finally, the quality system manager
controls, directs and/or leads the establishment and maintenance of an acceptable quality system and who reports
on the performance of the quality system to executive management.

Science
Science is the intellectual and practical activity encompassing the systematic study of the structure and behavior of
the physical and natural world through observation and experiment.

33
EXAMINATION APPLICATION FOR:
CERTIFIED BIOMEDICAL EQUIPMENT TECHNICIAN
CERTIFIED RADIOLOGY EQUIPMENT SPECIALIST
CERTIFIED LABORATORY EQUIPMENT SPECIALIST
CERTIFIED HEALTHCARE TECHNOLOGY MANAGER
CERTIFIED QUALITY SYSTEM MANAGER

DIRECTIONS: This application should be completed by all applicants. Failure to complete all information requested or provide
verifiable information will delay processing your application and may make you ineligible to sit for the examination.

A. PERSONAL DATA B. EMPLOYMENT DATA


Name: ____________________________________________________ Name of Current Employer: ______________________________________

Home Address: _____________________________________________ Work Address: ________________________________________________

__________________________________________________________ _____________________________________________________________

City______________________ State_____________ Zip Code_______ City_______________________ State __________ Zip Code ___________

Country ___________________________________________________ Country ______________________________________________________

Telephone: (Home) _________________ (Cell) __________________ Telephone: (Work) _________________ FAX: (Work) _________________

Home E-mail Address: _______________________________________ Work E-mail Address: ___________________________________________

*REQUIRED* - For certificates and other certification-related materials.


Preferred Mailing Address: Home Work Are you an AAMI Member? Yes AAMI ID____________
Preferred Email Address: Home Work No

C. Please complete the appropriate sections with your educational information, work experience, and military information
according to the eligibility option under which you are applying (refer to the Candidate Handbook for complete information).

EDUCATION: A copy of diploma must accompany the application.


Name of School Degree Attained Field of Study Year Degree Granted

WORK EXPERIENCE: Must be completed if using work experience as part of your eligibility.
% of Time Spent
Date of Employment Full Time /
Position Title Employer Employer Phone (xx/xxxx xx/xxxx) Part Time Biomed Rad Lab

U.S. MILITARY BIOMEDICAL EQUIPMENT TECHNOLOGY PROGRAM: A copy of diploma must accompany the application if using completion
of a military BMET program as part of your eligibility.

Name of Military Institution Course Name Date Completed

ACI - 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633


Phone +1 703-525-4890, ext. 1207 | Fax +1 703-276-0793 | aci@aami.org
1|P a g e
EXAMINATION APPLICATION FOR:
CERTIFIED BIOMEDICAL EQUIPMENT TECHNICIAN
CERTIFIED RADIOLOGY EQUIPMENT SPECIALIST
CERTIFIED LABORATORY EQUIPMENT SPECIALIST
CERTIFIED HEALTHCARE TECHNOLOGY MANAGER
CERTIFIED QUALITY SYSTEM MANAGER

D. EXAMINATION FOR WHICH YOU ARE APPLYING (Complete description of designations are available in Candidate Handbook).
_____ Certified Biomedical Equipment Technician (CBET) _____ Certified Healthcare Technology Manager (CHTM)

_____ Certified Laboratory Equipment Specialist (CLES) _____ Certified Quality System Manager (CQSM)

_____ Certified Radiology Equipment Specialist (CRES)

E. 2017 TESTING WINDOWS: May November


Country of Citizenship (required): _______________________________

F. ACCOMODATIONS
Will you need special accommodations in order to participate in the exam? Yes No

G. CERTIFICATION STATUS FOR WHICH YOU ARE APPLYING (Choose one option only)
Applicants must meet one of the following minimum requirements as of the application deadline.

CBET | CLES | CRES


FULL STATUS
(To fulfill requirements for CRES or CLES, at least 40 percent of work experience
over the last two years or 25 percent over the last five years MUST BE in the
designated specialty area.) CANDIDATE STATUS
OPTION 1: Associates degree in biomedical equipment technology OPTION 1: Associates degree in biomedical equipment technology
program and two years full-time BMET work experience program
OPTION 2: Completion of a U.S. military biomedical equipment technology OPTION 2: Completion of a U.S. military biomedical equipment
program and two years full-time BMET work experience technology program
OPTION 3: Associates degree in electronics technology and three years OPTION 3: Associates degree in electronics technology and one
full-time BMET work experience year full-time BMET work experience
OPTION 4: Four years full-time BMET work experience. OPTION 4: Two years full-time BMET work experience
OPTION 5: Associates degree in medical laboratory technology and three OPTION 5: Associates degree in medical laboratory technology
years full-time BMET work experience and one year full-time BMET work experience
(FOR CLES APPLICANTS ONLY) (FOR CLES APPLICANTS ONLY)
OPTION 6: Bachelors degree in medical laboratory technology and two OPTION 6: Bachelors degree in medical laboratory technology.
years full-time BMET work experience (FOR CLES APPLICANTS ONLY) (FOR CLES APPLICANTS ONLY)

CHTM
Path 1: A current certification as a clinical engineer (CCE), biomedical equipment technician (CBET), radiology equipment specialist (CRES), or a
laboratory equipment specialist (CLES) with at least three years of work experience as a supervisor or manager in the last five years

Path 2: Successful completion of the Department of Defenses Biomedical Equipment Maintenance Technician (DOD BMET) training program with at least
three years of F/T work experience, military or civilian, as an HTM supervisor or manager in the last five years
Path 3: An Associates degree in biomedical technology, related healthcare discipline, information technology or business with at least three years of F/T
work experience as an HTM supervisor or manager in the last five years
Path 4: A Bachelors degree or higher in biomedical technology, engineering, related healthcare discipline, information technology or business with at least
two years F/T as a manager within the last five years
Path 5: Work experience with or without a degree not related to biomedical technology, related healthcare discipline, information technology, or business
management. Seven years of F/T work experience in the HTM field with three years of management experience in the last five years

CQSM
Path 1: Five years managing quality system programs with five years of management work experience prior to application.
Path 2: Bachelor's degree in the field of engineering, or science plus three years as a quality system manager.

ACI - 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633


Phone +1 703-525-4890, ext. 1207 | Fax +1 703-276-0793 | aci@aami.org
2|P a g e
EXAMINATION APPLICATION FOR:
CERTIFIED BIOMEDICAL EQUIPMENT TECHNICIAN
CERTIFIED RADIOLOGY EQUIPMENT SPECIALIST
CERTIFIED LABORATORY EQUIPMENT SPECIALIST
CERTIFIED HEALTHCARE TECHNOLOGY MANAGER
CERTIFIED QUALITY SYSTEM MANAGER

H. NAME AND SIGNATURE OF CURRENT SUPERVISOR


I certify that the information contained in this application and the documents presented are true to the best of my knowledge.

________________________________ _______________________________________ _____________________


Printed Name of Current Supervisor Signature of Current Supervisor Telephone

I. CODE OF CONDUCT
The Code is designed to provide both appropriate ethical practice guidelines and enforceable standards of conduct for all ACI applicants,
certificants, and candidates. The Code also serves as a professional resource for healthcare technology practitioners, as well as for those
served by ACI certificants and candidates in the case of a possible ethical violation. All ACI applicants, candidates, and certificants must agree
to comply with the ACI Code of Conduct as outlined below:
I will conduct my professional activities with honesty and integrity.
I will uphold my professional conduct to the highest ethical standards.
I will represent my certifications and qualifications honestly and provide only those services for which I am qualified to perform.
I will maintain and improve my professional knowledge and competence through regular self-assessments, continuing practice,
continuing education or training.
I will act in a manner free of bias and discrimination against clients, colleagues, or customers.
I will maintain the privacy of individuals and confidentiality of information obtained in the course of my duties unless disclosure is
required by legal authority.
I will obey all applicable laws, regulations, and codes.
I will follow all certification policies, procedures, guidelines, and requirements of the ACI.

APPLICANT VERIFICATION/AUTHORIZATION
I certify that all statements given in this Application are true and correct and that ACI, its examination boards, and and/or its agents are hereby
authorized to verify the information in this application and to make inquiries necessary to ascertain the accuracy of this application and my
eligibility for certification. I also authorize any organization and individual listed to validate this application information. I understand that any
misrepresentation of the information I have provided will result in the rejection of this application and resulting examination. I also certify that I
have read the ACI Certification Handbook and understand and agree to the policies set forth therein. I understand that I must comply with the
ACI code of conduct and the renewal policy to maintain my certification. I release from all liabilities the ACI, its examination boards, and its
agents, and I am aware that any certification I may receive from the AAMI Credentials Institute (ACI) will not constitute and shall not be
construed as a license. Once certified by ACI, the certified person must notify ACI, without delay, of matters that can affect the capability of the
certified person to continue to fulfil the certification requirements.

NON-DISCLOSURE AGREEMENT AND GENERAL TERMS OF USE


This examination is confidential and proprietary. It is made available to you, the examinee, solely for the purpose of assessing your
competency in the area referenced in the title of this examination. You are expressly prohibited from recording, copying, disclosing, publishing,
reproducing, or transmitting this examination, in whole or in part, in any form or by any means, verbal or written, electronic or mechanical, for
any purpose, without the prior express written permission of the AAMI Credentials Institute (ACI). Non-compliance may lead to the revocation
of your certification.

By signing below, I agree to all statements listed above:

_________________________________ _____________________
Signature of Applicant Date

ACI - 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633


Phone +1 703-525-4890, ext. 1207 | Fax +1 703-276-0793 | aci@aami.org
3|P a g e
EXAMINATION APPLICATION FOR:
CERTIFIED BIOMEDICAL EQUIPMENT TECHNICIAN
CERTIFIED RADIOLOGY EQUIPMENT SPECIALIST
CERTIFIED LABORATORY EQUIPMENT SPECIALIST
CERTIFIED HEALTHCARE TECHNOLOGY MANAGER
CERTIFIED QUALITY SYSTEM MANAGER

ACI TESTING FEES

EXAM FEES (INCLUDING $100 APPLICATION FEE)*


CBET, CLES, & CRES CHTM & CQSM
AAMI Member Non-Member AAMI Member Non-Member
$350 $400 $420 $500
The reduced application fee for AAMI members is non-transferable between individuals or within departments and is available only to those individuals whose AAMI
membership dues are paid in full at the time of exam registration.

*The $100 application fee is non-refundable.

ADDITIONAL TESTING FEES (FOR ALL EXAMS)


CBET, CLES, & CRES CHTM & CQSM
AAMI Member Non-Member AAMI Member Non-Member
RETESTING FEE $225 $275 $300 $350
RESCHEDULING FEE (one-time only)
(outside of 5 business days) $50 $50 $50 $50
RESCHEDULING FEE
(inside of 5 business days) Forfeit exam fees Forfeit exam fees Forfeit exam fees Forfeit exam fees
NO SHOW FEE Forfeit exam fees Forfeit exam fees Forfeit exam fees Forfeit exam fees
LATE REGISTRATION
(after deadline Fee is non-refundable.) $50 $50 $50 $50
INTERNATIONALTESTING FEE** $100 $100 $100 $100
**International testing fees are charged for testing centers outside of domestic USA and Canada.

EXAM PAYMENT (Send completed application and payment to ACI at 4301 N. Fairfax Dr., Suite 301 Arlington, VA 22203, fax to 703-525-1424 or e-mail to
aci@aami.org )

Remit payment in U.S. dollars. Checks must be drawn on a U.S. bank.


(See all ACI examination fees above)

Check: Please make payable to AAMI.

$____________ Exam Fees

$____________ Additional Fees

Charge: $____________ Total Amount VISA MasterCard American Express

Account Number____________________________________ Cardholder Name_________________________________

Expiration (month/year)______________________________ Signature_______________________________________

ACI - 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633


Phone +1 703-525-4890, ext. 1207 | Fax +1 703-276-0793 | aci@aami.org
4|P a g e

Potrebbero piacerti anche