Certification Candidate Handbook

Certification Candidate Handbook
Program Overview, Policies and Procedures

CBET, CLES, CRES, CHTM, CQSM
Testing Windows
March 5-12, 2016
June 15-22, 2016
September 9-17, 2016
December 2-10, 2016
Application Deadline
February 5, 2016
May 16, 2016
August 9, 2016
November 4, 2016
Late Registration Deadline

February 19, 2016
May 27, 2016
August 23, 2016
November 18, 2016
ACI
4301 N. Fairfax Drive, Suite 301
Arlington, VA 22203
(P) 703-525-4890 ext. 1207
(F) 703-276-0793
Email: aci@aami.org
11/9/2015
ACI
Table of Contents
ACI Objective ............................................................................................................................. 4
ACI Statement of Fairness ......................................................................................................... 4
Code of Conduct ........................................................................................................................ 4
Types of Certification ................................................................................................................. 4
Scope of Certification ................................................................................................................. 4
Certified Biomedical Equipment Technician ................................................................ 4
Certified Radiology Equipment Specialist .................................................................... 5
Certified Laboratory Equipment Specialist ................................................................... 5
Certified Healthcare Technology Manager .................................................................. 6
Certified Quality System Manager ............................................................................... 6
Candidate Eligibility .................................................................................................................... 6
CBET, CLES, CRES Eligibility ................................................................................................... 6
Full Certification ........................................................................................................... 6
Candidate Status ......................................................................................................... 6
CHTM Eligibility .......................................................................................................................... 7
CQSM Eligibility ......................................................................................................................... 8
Application Process.................................................................................................................... 8
Eligibility Appeals ......................................................................................................... 8
Accommodations ......................................................................................................... 8
Registration.................................................................................................................. 9
Preparing for the Exam .............................................................................................................. 9
Exam Content Outlines ................................................................................................ 9
References .................................................................................................................. 9
Exam Day .................................................................................................................................. 9
Candidate Check-in ..................................................................................................... 9
Policies During Exam Administration ........................................................................... 9
Security ...................................................................................................................................... 9
Security Violations/Cheating ........................................................................................ 9
Scoring and Results ................................................................................................................. 10
Scoring Process ....................................................................................................................... 10
Notification of Results ................................................................................................ 10
Appeal of Exam Results ............................................................................................ 10
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 ................................................................................................................... 11
Logo/Designation Use .............................................................................................................. 11
Maintaining Certification ........................................................................................................... 11
Category 1: Experience, Professional Engagement and Contributions to the Field... 11
Category 2: Education, Skills Development, Self-Study ............................................ 11
Category 3: Enhancing the Profession ...................................................................... 12
Recertification Cycle .................................................................................................. 12
Recertification Procedures ....................................................................................................... 12
Certified on or After January 1, 1992 ......................................................................... 12
Certified on or Before December 31, 1991 ................................................................ 12
CCE Certificate Holders ............................................................................................. 12
2
Multiple Certifications................................................................................................. 12
Military Active Duty .................................................................................................... 12
Leave of Absence ...................................................................................................... 12
Emeritus Status ......................................................................................................... 13
Complaint of Disciplinary Violation ........................................................................................... 13
Appeals ...................................................................................................................... 14
Filing an Appeal ......................................................................................................... 14
Appeals Body............................................................................................................. 14
Fees ........................................................................................................................... 14
ACI Board Consideration of the Appeal ..................................................................... 14
Compliant Form ......................................................................................................... 14
Certified Biomedical Equipment Technician Detailed Content Outline ..................................... 15
Certified Radiology Equipment Specialist Detailed Content Outline ........................................ 17
Certified Laboratory Equipment Specialist Detailed Content Outline ....................................... 19
Certified Healthcare Technology Manager Detailed Content Outline ....................................... 21
Certified Quality System Manager Detailed Content Outline ................................................... 23
Exam Resources ...................................................................................................................... 24
CBET, CLES, CRES .................................................................................................. 24
CHTM ........................................................................................................................ 26
CQSM ........................................................................................................................ 28
Study Guides and Review Courses ........................................................................... 28
Certification Exam Pricing ........................................................................................................ 29
Definitions ................................................................................................................................ 30
Exam Registration Form .......................................................................................................... 31
ACI Objective
and codes.
8. I will follow all certification policies,
procedures, guidelines, and requirements of
the ACI.
ACIs objective is to be the trusted source for quality

professional development and credentials for
healthcare technology-oriented professionals and
entities in higher education, industry, and healthcare
delivery.
Types of Certification
The AAMI Credentials Institute (ACI) maintains the
certification programs for biomedical equipment
technicians (CBET), radiology equipment specialists
(CRES), laboratory equipment specialists (CLES),
healthcare technology managers (CHTM), and quality
system managers (CQSM). Each certification requires
a separate, complete application and a separate
examination. Applicants may test in only one
discipline per testing window.
ACI Statement of Fairness

The ACI adheres to principles of fairness and due
process and endorses the principles of equal
opportunity. In administering the credentialing
programs, ACI shall not discriminate or deny
opportunity to anyone on the grounds of gender, age,
religion, national or ethnic origin, marital status,
veteran status, sexual orientation, or disability.
AAMI Membership is not a prerequisite for

certification.
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.
Scope of Certification
The certification programs recognize healthcare
technology management professionals whose
practice reflects a high degree of knowledge about
medical devices and clinical practice as well as skill in
implementing electro-mechanical talent in the repair
and maintenance of devices used in the delivery of
healthcare. Achieving ACI Certification indicates that
certification candidates have demonstrated a broad
knowledge skill-set in the specific certification area,
general biomedical technologies, clinical laboratory
technologies and medical imaging technologies,
including regulatory requirements.
All ACI applicants, candidates, and certificants must

agree to comply with the ACI Code of Conduct as
outlined below:
1. I will conduct my professional activities with
honesty and integrity.
2. I will uphold my professional conduct to the
highest ethical standards.
3. I will represent my certifications and
qualifications honestly and provide only
those services for which I am qualified to
perform.
4. I will maintain and improve my professional
knowledge and competence through regular
self-assessments, continuing practice,
continuing education or training.
5. I will act in a manner free of bias and
discrimination against clients, colleagues, or
customers.
6. 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.
7. I will obey all applicable laws, regulations,
Certified Biomedical Equipment Technician

(CBET)
Healthcare technology management professionals
that desire a CBET certification are expected to have
experience in a wide-range of electromechanical
devices, computers, networks and software used in
the delivery of healthcare. Generally, candidates
desiring for certification in this category may work for
medical device manufacturers, hospitals, clinics,
home healthcare providers, medical device repair
companies, regulatory bodies/agencies, and software
manufacturers such as EMR or device integration
providers.
CBET candidates typically perform some of the
following duties on a daily basis:
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Test and calibrate medical devices

(preventive maintenance)
Troubleshoot medical devices in a clinical
setting and/or bench/depot setting
(corrective maintenance)
Manufacture software, parts or devices for
use in patient care
Ensure compliance with all regulatory
processes necessary (i.e. CMS, FDA GMP,
etc)
Manage medical software/hardware
systems (i.e. PACS Administrator,
Integration Specialist, Alarm Management,
RTLS Systems, etc)
Perform corrective and preventive
maintenance on steam systems
Educate the proper use, care and
maintenance of medical devices
Review technical manuals
Document any and all maintenance and
repairs and maintain records of
maintenance activities
Troubleshoot medical device networks

systems (i.e. PACS Administrator,
Integration Specialist, etc)
Certified Laboratory Equipment Specialist (CLES)

that desire a CLES certification are expected to have
experience with a wide-range of clinical laboratory
devices, electromechanical devices, computers,
networks and software used in the delivery of
healthcare. Generally, candidates desiring for
certification in this category may work for medical
device manufacturers, hospitals, clinics, medical
device repair companies, regulatory bodies/agencies,
and software manufacturers such as EMR, LIS or
device integration providers.
CLES candidates typically perform some of the
use in patient care especially imaging
systems
processes necessary (i.e. CMS, CAP, FDA
GMP, etc)
systems (i.e. LIS Administrator, Integration
Specialist, etc)
Certified Radiology Equipment Specialist (CRES)

that desire a CRES certification are expected to have
experience in a wide-range of medical imaging
modalities, electromechanical devices, computers,
networks and software used in the delivery of
healthcare. Generally, candidates desiring for
certification in this category may work for medical
device manufacturers, hospitals, clinics, medical
device repair companies, regulatory bodies/agencies,
and software manufacturers such as EMR or device
integration providers.
CRES candidates typically perform some of the
use in patient care especially imaging
systems
processes necessary (i.e. CMS, FDA GMP,
etc)
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Certified Healthcare Technology Manager (CHTM)

The healthcare technology manager is a person
responsible for planning and directing activities of
other healthcare technology management
professionals, monitoring their work, and taking
corrective actions when necessary.
Applicants must meet ONE of the following

minimum eligibility requirements as of the
application deadline:
1. Associates degree in biomedical equipment
technology program and two years full-time
BMET work experience; OR
2. Completion of a U.S. military biomedical
equipment technology program and two
years full-time BMET work experience; OR
3. Associates degree in electronics technology
and three years full-time BMET work
experience; OR
4. Four years full-time BMET work experience.
This HTM certification covers two major areas in

healthcare technology management: the
management of healthcare technology operations;
and, the management of personnel. The functions of
the manager are to include the participation in the
leadership of the business enterprise. The manager
is also expected to have the skills and understanding
needed to perform strategic, business, and change
management as well as employee relations.
Additional eligibility routes for CLES

Applicants only:
Certified Quality System Manager (CQSM)

The CQSM certification goes beyond assessing
knowledge of standards and regulation. It is based on
a holistic view of the roles and responsibilities of
experienced quality system professionals and how
they contribute to better, safer products.
5. Associates degree in medical laboratory

technology and three years full-time BMET
work experience; OR
6. Bachelors degree in medical laboratory
technology and two years full-time BMET
work experience.
Quality system managers oversee all aspects of

quality assurance including establishing metrics,
applying industry best practices, and developing new
tools and processes to ensure that quality goals are
met. They also manage the process and resources
for identifying, correcting, and improving nonconformities 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, quality system managers
control, direct and/or lead the establishment and
maintenance of an acceptable quality system and
report on the performance of the quality system to
executive management.
*CRES and CLES Applicants for full certification:

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
Applicants desiring full certification, but do not yet
meet the eligibility requirements (as listed above),
may apply through candidate status. Successful
candidates are given five years to meet the minimum
eligibility requirements and be awarded full
certification.
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:
Candidate Eligibility
CBET, CLES, CRES Eligibility
1. Associates degree in biomedical equipment

technology program; OR
2. Completion of a U.S. military biomedical
equipment technology program; OR
3. Associates degree in electronics technology
and one year full-time BMET work
experience; OR
4. Two years of full-time BMET work
experience.
Full Certification
Certified Biomedical Equipment Technician (CBET),
Certified Radiology Equipment Specialist (CRES)*, or
Certified Laboratory Equipment Specialist (CLES)*:
Additional eligibility routes for CLES

Applicants only:
Path 3: An Associates degree in biomedical

technology, related healthcare discipline,
information technology or business with at
least three years of work experience as an
HTM supervisor or manager in the last five
years. If the individual does not have the title
of HTM supervisor or manager, he/she
would have to confirm that he/she performs
management duties either through self or
third party attestation.
5. Associates degree in medical laboratory

technology and one year full-time BMET
work experience; OR
6. Bachelors degree in medical laboratory
technology.
IMPORTANT: If claiming eligibility based in full or in
part on an Associates or Bachelors degree, a copy
of the diploma MUST be included with the application
and fees. A copy of the diploma is required for
individuals applying under the completion of a U.S.
military biomedical program. Official college
transcripts may be requested at the discretion of the
application reviewer, but required from international
applicants. NOTE: A Bachelors degree does not
replace work experience requirements.
Path 4: A Bachelors degree or higher in

biomedical technology, engineering, related
healthcare discipline, information technology
or business with at least two years as a
manager within the last five years. If the
individual does not have the title of
supervisor or manager, he/she would have
to confirm that he/she performs
CHTM Eligibility
Individuals interested in pursuing the CHTM
designation must meet on of the following paths to be
eligible for the program.
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 work experience in the HTM
field with three years of management
experience in the last five years. If the
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 (3)
years of work experience as a supervisor or
manager in the last five (5) years. If the
APPROVED DISCIPLINES
The following list of engineering, healthcare, and
business disciplines is a preliminary list. Please
contact the ACI office if you have a degree that is not
listed.
Path 2: Successful completion of the

Department of Defenses biomedical
equipment maintenance technician (DOD
BMET) training program with at least three
years of work experience, military or civilian,
as an HTM supervisor or manager in the last
five years. If the individual does not have the
title of supervisor or manager, he/she would
have to confirm that he/she performs
Accounting, Anesthesia and Surgical Services,

Bioengineering, Biomedical Engineering, Business
Administration, Business Management, Clinical
Engineering, Computer Engineering and Computer
Science, Customer Service Management, Dentistry
and Dental Hygiene, Electrical and Electronics
Engineering, Finance, Healthcare Administration,
Healthcare Engineering Technology, Healthcare
Engineering Technology Management, Healthcare
Information Technology, Hospital Administration,
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Human Factors Engineering, Imaging Services,

Informatics, Mechanical Engineering, Medical
Laboratory Technology, Medicine, Nursing, Oncology
and Nuclear Medicine Technologist, Operations
Management, Pharmaceutical Services, Physical
Therapy, Product Design Engineering, Public Health
Administration, Respiratory Services, Software
Engineering, Technical Writing.
not be discriminated against based on race, religion,

creed, age, gender or national origin or ancestry.
Candidates who meet the program requirements will
receive confirmation of their acceptance into the
program via email. They will then be able to register
for a specific exam site and time to take the test.
Candidates who do not meet the program
requirements will receive a status letter indicating the
month and year they will be eligible to take the
exam(s).
CQSM Eligibility
Individuals interested in pursuing the CQSM
designation must meet on of the following paths to be
eligible for the program.
If the application is incomplete, the candidate will

receive a letter or e-mail explaining what is missing
and will have a 30-day time period to respond. If the
candidate does not respond, the candidate must then
submit in writing a request for a refund minus the
application fee. The application may be deemed
incomplete for reasons such as:
Path 1: Ten years managing quality system

programs with five years of management work
experience prior to application.
Path 2: Bachelors degree in the field of engineering,
or science plus five years as a quality systems
manager.
Application is not completely filled out

Application is not signed
Appropriate fees are not submitted
Proper documentation is not submitted
APPROVED DISCIPLINES
The following list of engineering and healthcare
disciplines illustrative of the disciplines acceptable for
candidacy. Please contact the ACI office if you have a
degree that is not listed.
If the application is denied, the candidate will receive

a letter stating the reason for the denial with a 30-day
time period to respond. The application may be
denied for reasons such as:
Biology, Chemistry, Physics, Engineering,

Environmental Engineering, Chemical Engineering,
Nuclear Science, Biomedical Engineering, Industrial
Engineering, Electrical Engineering, Environmental
Engineering, Biomedical Technology, and Medicine.
Failure to demonstrate eligibility in

academic, work experience, or specialized
training
Falsification of any information on the
exam application
Application Process
Eligibility Appeals
The candidate must submit the completed application,

registration form and appropriate fees at least 30
days in advance of the exam date. Exams are
delivered through computer-based testing at testing
centers nationwide during the four testing windows.
Completed application forms should be sent to the
ACI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA
22203, or fax to 703-276-0793.
Candidates will be notified in writing or electronically

their status in the certification program. If a candidate
fails to meet the eligibility requirements for the exam,
the candidate has 30 days to appeal the decision.
The candidate must submit his or her request in
writing to the ACI staff. The request will then be sent
to the ACI Board for review.
The application forms can be found on ACIs website,

www.aami.org/certification. Applications are reviewed
to verify information and documentation to determine
eligibility and will be kept confidential. Candidates will
Accommodations
ACI complies with the provisions of the Americans
With Disabilities Act and Title VII of the Civil Rights
8
Act, as amended (42 U.S.C. 2000e. et. seq.) in

accommodating disabled candidates who need
special arrangements. The request must be submitted
in writing with supporting documentation from a
physician or other qualified professional reflecting a
diagnosis of the candidates condition and
explanation of exam aids or modifications needed.
Please contact the ACI, at aci@aami.org, if the
candidate has any questions concerning ADA
arrangements.
Exam Day
Candidate Check-in:
Computer-based testing candidate must present one
form of identification that has current photo
identification with signature (drivers license, stateissued id, or passport). Candidates should also bring
their confirmation email that contains the exam launch
code with them on testing day in order to begin the
test. The confirmation email will include the test date,
time, testing center location and exam the candidate
is taking. If the candidate loses or does not receive
his/her confirmation email after scheduling the exam,
please contact the ACI at 703-525-4870
Registration
To register for a certification exam, the candidate
must meet the specific requirements for the exam.
The registration forms and fees can be found at the
back of this handbook. Candidates must register at
least 30 days prior to the exam window.
The candidate must arrive at the exam location at

least 15 minutes prior to the exam starting time. The
candidate may not bring books, papers, study aids,
translation aids, or other materials into the exam
room. Late 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
exam registration fee has been paid, the candidate
will receive e-mails with logon information and
instructions on how to schedule his or her exam at a
testing center. Exams must be scheduled at least 24
hours in advance.
Policies During Exam Administration

A candidate who completes the exam may leave the
testing room after turning in all related exam
materials. Please try to do this as quietly as possible
so that those still working on the exam will not be
disturbed. The administrator will make sure that the
candidate returns all materials.
Preparing for the Exam

Candidates should register at least 30 days in
advance of the exam testing window. All certification
programs are self-study. Education courses are not
required to sit for any of the ACIs certification exams.
Security
Security Violations/Cheating
No spouses, children, parents, friends, or other
outside parties are permitted near the testing room.
Upon completion of the exam, candidates must leave
the testing area immediately.
Exam Content Outlines

Exam content outlines are available for every exam.
Candidates can find the outlines at the back of this
handbook. The content outline provides information
such as the number and type of questions; how long
the candidate will have to complete the exam; what
materials the candidate may bring to the exam; and
percentage of question per category.
Any candidate who gives or receives help during the

exam will be asked to leave and his/her exam will not
be scored. Exam fees will not be refunded and the
candidate may be prohibited from taking ACI exams
for a specified period of time.
References
References for each exam are listed at the back of
this handbook.
The performance of all candidates is monitored and

may be analyzed to detect fraud. At any time after the
exam administration should there be a question about
score validity or the identity of an exam candidate, the
ACI staff will investigate and determine whether it is
appropriate to void the exam score. The ACI Board
9
maintains and adheres to a security policy which is

available to board members and staff for the
administration of exams and maintaining the
certification program.
of receiving exam results to ACI and can be faxed to

703-276-0793 or emailed to aci@aami.org.
Scoring and Results
Testing conditions should be such that each

candidate has an equal opportunity to be successful.
Test sites should be comfortable, accessible, well lit
and free of distracting noise. Proctors should provide
clear and uniform instructions and monitor testing
conditions throughout the entire session. If conditions
of the exam administration do not meet these
standards, notify ACI as soon as possible. Any
special considerations made for testing conditions
that are deemed unacceptable as a consequence of
an appeal will be applied to all candidates whose
pass-fail status was affected; not just the candidate
requesting the appeal.
Appeal of Exam Administration
Scoring Process
Exams are scored making every effort to ensure that
the score is reported within a reasonable time period
and that the score accurately reflects the points
received by the candidate. This may involve hand
scoring exams to verify results and/or reviewing
candidate comments. Candidates are encouraged to
write comments in the comment section of the exam.
Comments can be related to a specific question; the
administration of the exam; or the exam site
conditions. Comments that would affect whether a
candidate passes or fails an exam will be reviewed
before the exam is scored. All other comments are
reviewed by the ACI Board at their regularly
scheduled meetings.
Rescheduling an Exam
Candidates who would like to reschedule a
certification exam within five business days of their
scheduled exam date must do so in writing and send
to the attention of ACI certification by fax, 703-2760793 or email, aci@aami.org. A rescheduling fee will
be assessed to the candidate who would like to
reschedule an exam.
Notification of Results
Preliminary results will be reported for immediately
following the completion of the exam and with 24
hours of completing their exam via email. Results are
reported as pass or fail.
Cancellation Policy
Candidates who pass an exam and achieve a

certification will be notified of their passing status.
They will receive an official ACI certificate and a
wallet card that they may carry with them.
A cancellation fee will be assessed to the candidate

who fails to cancel a scheduled exam at least five
business days before the exam date. Cancellations
must be made in writing and sent to the attention of
ACI by fax, 703-276-0793, or email, aci@aami.org.
Candidates who fail an exam will be provided with

diagnostic information. The analysis of performance
identifies the knowledge areas in which the
candidates performance is deficient and is intended
to help the candidate become better prepared before
sitting for the exam again.
Withdrawing an Application
All application changes must be made in writing and
sent to the attention of ACI by fax, 703-276-0793, or
email, aci@aami.org.
Appeal of Exam Results

Candidates may request a verification of their score
which may involve hand scoring and/or a review by
the ACI Board. Any scoring alteration found as a
consequence of an appeal of exam results will be
applied to all candidates whose pass-fail status was
affected; not just the candidate requesting the appeal.
All requests should be made in writing within 30 days
Failure to Appear
If a candidate does not appear to take a scheduled
exam, the candidate will forfeit all fees. All fees will
need to be paid again if the candidate decides to
reschedule at a later date.
10
Retaking the Exam
ACI adopted the evidence of continuing practice

program that was implemented by ACIs predecessor,
the ICC, effective January 1, 1992.
No retake exam may be scheduled by anyone in the

exam process until the candidate has been officially
notified of the results of his/her previously taken
exam. No candidate will be allowed to retake an exam
until 60 days have passed. There is no refund for
failed exams. A candidate will be allowed to take the
exam no more than three times within a two-year
period. If unsuccessful on the third attempt, the
candidate must wait one year before he/she will be
allowed to re-apply to the program and take the
exam.
To retain an ACI certification, a certified professional

must accumulate a minimum of 15 activity points over
a three-year-period and submit a continuing practice
journal with the applicable fees. Activity points can be
accumulated through a wide range of professional
activities, including attending educational meetings
and conferences, speaking, reading, writing and
participating in professional organizations. ACI
recertification program is flexible to accommodate the
diverse learning styles and approaches to
professional involvement. At least 15 activity points
must be accumulated in activities directly related to
the HTM field.
Logo Use
ACI provides logos for use by certified individuals in
good standing (current with certification fees and
continuing education). The individual certification
logos are the exclusive property of the AAMI. The
certification logos may be used by certified
professionals in good standing, as long as they
comply with the certification logo conditions of use,
provided as part of the logo artwork download. Logos
are provided only for certified professionals' own use.
Sharing these files and use by all other individuals,
corporations and entities is strictly prohibited without
prior, express, written approval from AAMI.
The structure includes continuing practice activities

for the following major categories:
Category I: Experience, Professional Engagement,
and Contributions to the Field
Experience: Certification holders must have been
actively employed as a manager or as performing
management functions at least 50% of his/her time
during the certification renewal cycle.
Professional Engagement: Professional activities
must be related directly to the role of manager.
Publications/Presentations: Content of these
publications and presentations must be directly
related to management functions, knowledge areas,
and skills.
Maintaining Your Certification

It is universally understood that rapid technological
advancement is inherent to the medical
instrumentation profession. In a profession that
regularly undergoes such constant change; the
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
knowledge and skill, that is consistent with the
standards according to which certification was initially
conferred.
Category II: Education, Skills Development, SelfStudy

Academic: Content of the courses attended must be
related directly to management functions, knowledge
areas, and skills
Continuing Education: Workshops, seminars,
symposia designed to improve the managerial skills
set and knowledge areas.
Self-Learning: Self-motivated career development
activities involving readings, formal discussions,
organized meetings with peers and senior staff
regarding topics directly related to management skills,
knowledge areas and tasks.
Certification is only as valuable as the standard it

represents, if the standard is maintained.
Recertification programs are extremely important
because they require holders of the credential to
present evidence that they are maintaining the
established standard. This, in turn, enables
certification to retain meaning and value for every
individual who achieves it, particularly as the years
pass after the credential is issued. Recognizing this,
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Category III: Enhancing the Profession
D. Multiple Certifications
If certified in more than one discipline (CQSM, CHTM,
CCE, CBET, CRES, CLES), certificants will be
charged an additional $75.00 every three years for
each certification beyond the primary one in order to
maintain active status in each certification. There is
no need to complete a Continuing Practice Journal for
each certification. One journal will suffice. However,
multiple certification holders are required to submit
three additional points per certification in addition to
the minimum 15 points for the primary certification.
Providing job-related training, workshops,

mentoring in management functions, knowledge
areas, and skills.
Recertification Cycle
The journal is to be used to record professional
activities achieved throughout the three-year cycle.
Initial certification covers the remaining year of
original certification and expires December 31 of the
following year (i.e. May 6, 1999 through December
31, 2000). In the year your certification is to expire
(i.e. 2000) you will receive a notice reminding you
that, by December 31, renewal fees are due, which
will extend certification through the next three-year
cycle (i.e., 2001, 2002, 2003). Thereafter, renewal
fees and a continuing practice journal, with a record
of professional activities during previous three years,
are due December 31 of the third year after the initial
certification period.
E. Military Active Duty

Each occurrence of persons being called into active
duty, while military forces of the United States are
involved in hostile activities, will be handled on a
case-by-case basis. The certificant is to contact the
ACI to inform them of the military status and the
proposed duration, and should present a copy of
his/her military assignment. The general policy will be
that persons who will be on active duty within 60 days
of date of the actual deadline for renewal, the
recertification deadline be postponed until 180 days
after discharge from their active duty or return to their
standard responsibilities. If the certificant will not be
performing his military assignment in the HTM field,
the certification(s) should be placed in leave of
absence until the certificant is released from his/her
assignment and back to working in the field. ACI
would then work with the certificant to determine what
information is needed to continue to keep the
certification active.
Recertification Procedures
A. Certified on or after January 1, 1992
Individuals certified in the BMET program on or after
January 1, 1992, who submit their continuing practice
journals and recertification fees over 30 days after the
recertification date and up to one year after the date
of certification expiration will be inactive, but will not
be revoked. At the end of one full year, if the journal
and the fees have not been received, certification will
be revoked. Once certification has been revoked, it
will be necessary to take the certification examination
again to regain certification.
The information above only applies to those either

deployed to an assignment or called to active duty
while the countrys military forces are on alert, and
they need to provide the ACI with a copy of their
military assignment. Those certified and on standard
military assignments in the HTM field are expected to
follow all recertification policies and procedures.
B. Certified on or before December 31, 1991

Individuals certified on or before December 31, 1991
are not required to renew their certification, and will
not have their certification revoked if they do not
comply with the recertification requirements of
submitting a journal. However, their certification will
be considered inactive.
Leave of Absence
Should a certificant, at any time, leave active
employment in the HTM field to pursue other
interests, he/she may request a leave of absence. If
the leave is granted, there is no need to submit a
continuing practice journal. To retain the certification
during the leave of absence, there is a recertification
fee of $25.00 for the triennial cycle. To apply for a
leave of absence, the status change request form
C. CCE Certificate Holders

Individuals certified in the U.S. CE program under the
ICC/USCC on or after January 1, 1992 are under the
same policy. However, if the CE certification is
revoked, there currently are no means of regaining
the certification under the ACI.
12
should be sent directly to ACI, providing the name

and telephone number of the last employer, so that
ACI can verify the retirement, and include the
applicable recertification fees. Should certificants wish
to return to active status in the future, they need to
notify ACI of their return to active employment at the
time it occurs. The continuing practice journal and
regular fees need to be submitted at the time of the
next regularly scheduled recertification (based on the
original certification year).
The ACI Board will establish procedures to fairly and

consistently address alleged violations. Disciplinary
procedures are designed to ensure that valid and
actionable complaints are investigated and
considered, and that all parties involved in the
complaint have an opportunity to document
circumstances warranting the complaint and to
respond to the complaint.
Emeritus Status
1. Purpose: To recognize a demonstrated effort
through continuing practice, in order to reach new
levels of knowledge in the HTM field.
2. Qualifications for Emeritus Status: Eligible
candidates must submit the status change request
form and meet one of the following requirements:
All complaints will first be reviewed by the ACI staff

who will then report the complaint to the ACI Chair. If
the complaint can be verified and resolved without
further documentation or investigation, staff will notify
the Board chair and the complaint will be closed.
Retired from full-time employment in the

HTM profession, whose number of years
certified, when added to their years of work
experience in the HTM field, is greater or
equal to 30 years; or;
Retired from full-time employment in the
HTM field, and held at least 15 years of
continuous years of active certification
status.
If the complaint requires additional information, the

complainant will be required to submit a signed ACI
complaint form with supporting documents within 30
days of request for further actions to be considered.
Upon receipt and review of the complaint form and
supporting documentation, the ACI staff may inform,
in writing, the accused and/or complainant of the
official opening of an investigation.
Individuals earning the Emeritus status will no longer

be required to submit a continuing practice journal or
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
the opportunity to respond to the complaint made
against him/her within 30 days of notification of the
investigation.
Complaints of Disciplinary Violation

The ACI Board chair, vice-chair and one other ACI
Board member will be responsible for implementing
disciplinary policies and procedures as established by
the ACI Board. Grounds for disciplinary action shall
include, but are not limited to the following:
certification status, logos and/or acronyms.

Violation of established ACI certification
policies, rules and requirements.
Conviction of a felony or other crime of moral
turpitude under federal or state law.
Gross negligence, willful misconduct, or
other unethical conduct in the performance
of services for which the individual has
achieved certification from ACI.
Following the investigation, the ACI Chair will inform

the complainant of the decision in writing. The
complainant will be notified in writing that a decision
was reached. If disciplinary action is imposed, the
complainant may submit an appeal of the decision to
the full ACI Board. This appeal must be submitted in
writing to the ACI Chair. A signed appeal must be
submitted in writing within 60 days from receipt of the
written notification that a disciplinary action is
imposed and must clearly state the grounds for
appeal.
Evidence of falsification of information

provided on documents submitted to the ACI
or its agents.
Cheating on certification exams or audits.
Evidence of non-compliance with the Code
of Conduct.
Evidence of improper use of the ACI
13
associated with such a hearing (including but not

limited to travel expenses of the ACI Board, if the
appellant wishes to have a hearing in person).
Appeals
In addition to appeals of disciplinary action, an
individual or certificant who was denied certification or
had his/her certification revoked may file an appeal
within 60 days of receipt of notice of the action taken
that is eligible for appeal.
Complaint Form
Certificants or other individuals within the industry can
request a complaint form by contacting ACI at
aci@aami.org.
Filing of Appeal
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.
ACI staff makes an initial determination of whether
the appeal has been properly filed and includes all
needed documentation and rationale. Appellants will
be notified within 60 days of ACIs receipt whether the
appeal has been filed properly for an appealable
action.
Appeals Body
The ACI Board is the appeals body that hears
appeals. The full ACI Board is the final body to hear
an appeal and there are no further appeals once the
full ACI Board has acted. The ACI Board ruling is
final.
Fee
The fee for an appeal with the ACI Board is $750
(U.S.D.) payable by the individual filing the appeal.
The fee for a subsequent appeal to the full ACI Board
is an additional $1,000 (U.S.D.). Fees are payable
with the filing of the appeal. An appellant may request
that ACI to reduce these fees and must provide a
rationale for this request (e.g., demonstrable financial
hardship). The decision to reduce any appeal fee will
be made by the ACI Board Chair after review of the
request and rationale.
ACI Board Consideration of the Appeal
The ACI Board reviews all properly filed and
documented appeals to determine if significant
evidence exists of a substantive error or omission in
the certification process or outcome. Decisions
require a (2/3) two-thirds vote by committee
members. When the ACI Board reaches a decision,
the appellant will be notified in writing within 60 days
of such decision being made. The appellant may
request a hearing on the appeal, but is responsible for
paying all administrative expenses of the ACI
14
Certified Biomedical Equipment Technician

Content Outline
3. FDA
a. SMDA
b. Other
4. OSHA
5. Other (NEC, ANSI, FCC, etc.)
Anatomy & Physiology Approximately 12%

A. Systems
1. Respiratory
2. Gastrointestinal
3. Nervous
4. Circulatory
5. Musculoskeletal
6. Endocrine
B. Organs
1. Heart
2. Lungs
3. Liver
4. Kidneys
5. Brain
6. Gallbladder
7. Pancreas
8. Other
C. Blood
1. Components
2. Metabolism
D. Terminology
Fundamentals of Electricity & Electronics

Approximately 13%
A. Transducers
B. Calculations and Conversions
1. Hex/Decimal/Binary
2. Other
C. Circuits and Components
1. Active Devices
a. Solid-State Devices
1. Analog
2. Digital
b. Other (CRTs, X-Ray tubes, photomultipliers,
etc.)
2. Power Supplies
3. Passive Devices
D. Power Distribution and Storage Systems
1. Transformers
2. Distribution
3. Batteries
4. UPS/Line Conditioning
E. Terminology
Public (employee, patient, visitor) Safety in the

Healthcare Facility Approximately 15%
A. Electrical
1. Microshock/Electrical Safety Testing
2. Other
B. Chemical
1. Material Safety Data Sheet
2. Other
C. Radiation Hazards
1. Light Spectrum
2. Types of Rays
D. Biological
1. Standard Precautions
2. Other
E. Fire
1. Class
2. Fire Extinguishers
F. Codes and Standards
1. Credentialing and Certification
a. Joint Commission Comprehensive
Accreditation Manual
b. AABB
c.. American College of Radiology
2. NFPA 99
a. Gas and Vacuum Systems
b. Electrical Systems
Healthcare Technology and Function

Approximately 25%
A. Monitoring Systems (ECG, EEG, Blood Pressure,
Pulse Oximetry, Fetal Monitor)
B. Portable Equipment (Infusion Devices, Syringe
Pumps, PCA Pumps, Hypo/Hyperthermia)
C. Life Support Equipment (Defibrillators,
Anesthesia Machines, Critical Care Ventilators,
Balloon Pumps)
D. Therapeutic Equipment (Infant Warmers,
Ultrasound Therapy)
E. Laboratory Equipment (Centrifuges, Water Baths,
Analyzers)
F. Diagnostic Imaging (Ultrasound,
Radiographic/Fluoroscopy)
G. Operating Room (Electro Surgical Generators,
Video Carts, Lasers, Tourniquets, Sterilizers,
Warmers)
H. Test Equipment (Electrical Safety, Defibrillator,
Electro Surgical, Physiologic Simulators,
Oscilloscopes, Meters)
I. Diagnostic Equipment
J. Terminology
15
Healthcare Technology Problem Solving

Approximately 25%
A. Electronic Component Level, Block Level
B. Monitoring Systems (ECG, EEG, Blood Pressure,
Pulse Oximetry, Fetal Monitor)
C. Portable Equipment (Infusion Devices, Syringe
Pumps, PCA Pumps, Hypo Hyperthermia)
D. Life Support Equipment (Defibrillators,
Hemodialysis, Anesthesia Machines, Critical Care
Ventilators, Balloon Pumps)
E. Therapeutic Equipment (Infant Warmer,
Ultrasound Therapy)
F. Laboratory Equipment (Centrifuges, Water Baths
Analyzers)
G. Diagnostic Imaging (Ultrasound,
Radiographic/Fluoroscopy)
H. Operating Room (Electro Surgical Generators,
Video Carts, Lasers, Tourniquets, Sterilizers,
Warmers)
I. Diagnostic Equipment
J. Situational (User Error, User Training,
Applications)
d. Other
2. Integration
a. Bedside Medical Device Integration (BMDI)
b. Medical Device Integration (MDI) (Labs,
Printers, etc.)
c. Mobile Devices (Handhelds, Smart Phones,
Tablets, etc.)
3. Test Equipment
a. Cable Test Devices (Copper, Fiber)
b. Network Test Devices
4. Security
D. Problem Solving
1. Computer Networks
2. Integration
3. PCs, Switches, Hubs
E. Terminology
The CBET exam is a three-hour closed

book exam consisting of 165 multiple
choice questions.
Candidates are allowed to bring a nonprogrammable four function calculator.
Cell phones, iPads or other electronic
devices that have internet capabilities
cannot be used as a calculator or brought
into the testing room.
Healthcare Information Technology

Approximately 10%
A. Regulatory and Safety
1. Medical Device Data Systems (MDDS)
2. IEC 80001 Application of Risk Management
for IT Networks
3. Health Insurance Portability and Accountability
Act (HIPAA)
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
Score required to pass: The minimum

score required to pass the CBET
examinations is 116/165.
16
Certified Radiology Equipment Specialist

Content Outline
3. FDA
a. SMDA
b. Other
4. OSHA

A. Systems
1. Respiratory
2. Gastrointestinal
3. Nervous
4. Circulatory
5. Musculoskeletal
6. Endocrine
B. Organs
1. Heart
2. Lungs
3. Liver
4. Kidneys
5. Brain
6. Gallbladder
7. Pancreas
8. Other
C. Blood
1. Components
2. Metabolism
D. Terminology

Approximately 13%
A. Transducers
2. Other
1. Active Devices
1. Analog
2. Digital
etc.)
2. Power Supplies
3. Passive Devices
1. Transformers
2. Distribution
3. Batteries
E. Terminology

A. Electrical
2. Other
B. Chemical
2. Other
1. Light Spectrum
2. Types of Rays
D. Biological
2. Other
E. Fire
1. Class
b. AABB
2. NFPA 99

Approximately 25%
A. Equipment Types
1. Test Equipment
2. Film Processors
3. X-Ray Tubes
4. TV Camera
5. Intensifying Screens
6. Image Intensifier
7. Other
B. Systems
1. X-Ray Machines
2. Nuclear Medicine
3. Magnetic Resonance Imaging
4. Linear Tomography Systems
5. Ultrasound Diagnostics
6. Mammography
7. Digital Imaging
8. CT
9. Health Care Information Systems (PACS, LIS,
RIS)
10. Other (Support Equipment, EKG, Defibrillator)
C. Quality Control
17
D. Terminology

1. Hardware
c. Peripherals
d. Other
2. Integration
Printers, etc.)
Tablets, etc.)
3. Test Equipment
4. Security
D. Problem Solving
2. Integration
E. Terminology

Approximately 25%
A. Component Level (Electronic Circuit)
B. Equipment Types
1. Film Processors
2. X-Ray Tubes
3. TV Cameras/Displays
4. Intensifying Screens
5. Image Intensifier
6. Digital Imaging
7. CT
8. Other (Support Equipment, EKG, Defibrillator)
C. Systems
1. X-Ray Machines
2. Nuclear Medicine
3. Magnetic Resonance Imaging
4. Linear Tomography Systems
5. Ultrasound Diagnostic
6. Mammography
7. Other
D. Situational
1. Prioritizing Work
2. Operator vs. Equipment
3. Applications
4. Other
The CRES exam is a three-hour closed

choice questions.

Approximately 10%
for IT Networks
Act (HIPAA)
B. Foundations
1. Hardware
a. Topology
f. Other
a. EMR/EHR
RIS)

score required to pass the CRES
examinations is 116/165.
18
Certified Laboratory Equipment Specialist

Content Outline
3. FDA
a. SMDA
b. Other
4. OSHA

A. Systems
1. Respiratory
2. Gastrointestinal
3. Nervous
4. Circulatory
5. Musculoskeletal
6. Endocrine
B. Organs
1. Heart
2. Lungs
3. Liver
4. Kidneys
5. Brain
6. Gallbladder
7. Pancreas
8. Other
C. Blood
1. Components
2. Metabolism
D. Terminology

Approximately 13%
A. Transducers
2. Other
1. Active Devices
1. Analog
2. Digital
etc.)
2. Power Supplies
3. Passive Devices
1. Transformers
2. Distribution
3. Batteries
E. Terminology

A. Electrical
2. Other
B. Chemical
2. Other
1. Light Spectrum
2. Types of Rays
D. Biological
2. Other
E. Fire
1. Class
b. AABB
2. NFPA 99

Approximately 25%
A. Equipment Types
1. Test Equipment
2. Common Lab Equipment
a. Centrifuges
b. Microscopes
c. Blood Gas Analyzers
d. Refrigerators
3. Chemistry Equipment
4. Hematology Equipment
5. Microbiology Equipment
6. Blood Bank Equipment
7. Urinalysis Equipment
8. Histology Equipment
9. Other
B. Systems
1. Lab Information
2. Other
C. Quality Control
D. Terminology
19

Approximately 25%
A. Component Level (Electronic Circuit)
B. Equipment Types
1. Common Lab Equipment
a. Centrifuges
b. Microscopes
c. Blood Gas Analyzers
d. Refrigerators
2. Chemistry Equipment
3. Hematology Equipment
4. Microbiology Equipment
5. Blood Bank Equipment
6. Urinalysis Equipment
7. Histology Equipment
8. Other
C. Systems
1. Lab Information
2. Other
D. Situational
1. Prioritizing Work
2. Operator vs. Equipment
3. Applications
4. Other

c. Peripherals
d. Other
2. Integration
Printers, etc.)
Tablets, etc.)
3. Test Equipment
4. Security
D. Problem Solving
2. Integration
E. Terminology
The CLES exam is a three-hour closed

choice questions.

Approximately 10%
for IT Networks
Act (HIPAA)
B. Foundations
1. Hardware
a. Topology
f. Other
a. EMR/EHR
RIS)
e. Other
1. Hardware

score required to pass the CLES
examination is 116/165.
20
B. Assure integrity of data collection, storage, and

security associated with healthcare technology
(e.g., HIPAA, PACS, EKG management, EMR).
C. Recommend processes, procedures, or policies
to control or reduce risk.
D. Apply risk-assessment models or methodologies,
(e.g., FMEA, root cause analysis).
E. Participate in incident investigations.
F. Produce reports that outline findings, explain risk
positions, or recommend changes (e.g., SMDA,
sentinel event alerts).
G. Manage recalls, hazards, and safety advisories in
use in healthcare technology.
Certified Healthcare Technology Manager

Content Outline
Financial Management Approximately 19%
3 Recall Questions
13 Application Questions
3 Analysis Questions
A. Participate in financial planning, budgeting, or
procurement activities of all or part of an
organization (e.g., capital planning, technology
planning, reporting, accounting, billing, collections,
payroll, and budgeting duties).
B. Develop departmental control policies, guidelines,
and/or procedures for activities such as financial
administration.
C. Assure compliance with organizational policies
and procedures and generally accepted
accounting principles (GAAP).
D. Prepare program financial statements, business
activity reports, financial forecasts, or annual
budgets.
E. Analyze the financial details of past, present, and
expected operations to identify development
opportunities and areas where improvement is
needed.
F. Authorize requests for disbursements in
accordance with company policies and
procedures.
G. Advise management in determining life
expectancy (i.e., capital asset planning) of
healthcare technology devices.
H. Advise management on actions regarding the fair
market value of purchase, lease, or asset recovery
value of disposed healthcare technology.
I. Review sourcing options for parts, service, training
and test equipment/tools.
Operations Management Approximately 46%

11 Recall Questions
A. Oversee activities directly related to providing
services (e.g., scheduled and unscheduled work,
project management, customer satisfaction).
B. Coordinate activities of service providers and
vendors concerned with planning, acquisition,
contracting, installation, or service of healthcare
technology.
C. Review financial statements, activity reports, and
other performance data to measure productivity
and goal achievement and to determine areas
needing cost reduction and program
improvement.
D. Develop departmental and/or team policies and
procedures, goals, and objectives.
E. Manage departmental policies and procedures,
goals and objectives (e.g. prepare work
schedule, assign specific duties).
F. Determine departmental and/or staffing
requirements.
G. Comply with regulatory and accreditation
requirements (e.g. TJC,ANSI, AAMI, NFPA,
OSHA, CAP, AABB, CMS, FDA, FCC, HIPAA,
DNV, AOA, ACR, IAC, IEC, NRC, DOH, NEC,
CLIA, COLA, MQSA).
H. Report departmental operations performance to
other departments or committees in accordance
Risk Management Approximately 12%

2 Recall Questions
A. Evaluate key risks associated with the use of
healthcare technology ( e.g., patient safety,
operations, finance, emergency preparedness).
21
I.
J.
K.
L.
M.
N.
O.
P.
Q.
R.
S.
D. Conduct orientation sessions and on-the-job

training for staff.
E. Assure availability of training manuals (e.g.,
service manuals, operations manuals, training
media, and other educational materials).
F. Collaborate with clinical departments on
healthcare technology training (e.g., MRI and
radiation safety, equipment use, use-error
trending).
G. Collaborate with non-clinical departments on
healthcare technology training (e.g., infection
prevention, environmental services, and supply
management).
with the MEMP (e.g., environment of care,

patient safety, risk management, value-added,
benchmarking).
Oversee departmental and/or team meetings and
communications.
Ensure resources are available to complete
departmental and/or team activities (e.g., tools,
test equipment, supplies, technical information,
and training).
Review project plans to coordinate project
activity.
Consult with users, management, vendors, and
technicians to access healthcare technology
needs and requirements.
Meet with department heads, managers,
supervisors, vendors, and others to solicit
cooperation and resolve problems.
Evaluate healthcare technology proposals to
assess project feasibility and requirements.
Collaborate with other stakeholders (e.g., IT,
nursing, vendors) to manage device integration.
Participate in construction planning meetings.
Collaborate with other departments on utility
maintenance and interruption (e.g., network,
telecom, electrical, plumbing, mechanical
systems, change management, downtime
procedures).
Oversee the management of healthcare
technology assets, inventory accuracy, backups,
security, CMMS, non-hospital owed equipment.
Ensure competency of HTM department staff and
healthcare technology service vendors.
Human Resources Approximately 12%

3 Recall
9 Application
0 Analysis
A. Recommend compensation, promotion, and
career path of departmental and/or team staff.
B. Perform personnel management duties (e.g.,
employee relations, staffing, conflict
management, disciplinary procedures, and
performance development plan).
C. Ensure department and/or team practices are in
compliance with state and federal labor laws
(e.g., ADA, EEOC, FMLA, and NLRA).
D. Participate in the requirement, selection,
retention, and termination of employees.
E. Conduct performance evaluations of
departmental and/or team staff.
F. Collaborate with labor relations organizations.
G. Represent organization at personnel-related
hearings and investigations.
Education & Training Approximately 11%

4 Recall
7 Application
0 Analysis
The CHTM exam is a two-hour closed book exam

consisting of 100 multiple choice questions. In
addition, there are 15 pre-test questions that do not
affect the overall score.
A. Evaluate the effectiveness of training programs.

B. Analyze training needs based on cost,
operations, requirements, competency, customer
requirements, resources, etc.
C. Oversee ongoing technical training and personal
development classes for staff members.
Candidates are allowed to bring a nonprogrammable four function calculator. Cell phones,
iPads or other electronic devices that have internet
capabilities cannot be used as a calculator or
brought into the testing room.
Score required to pass: The minimum score
required to pass the CHTM examination is 72/100.
22
A. Facilitate compliance with regulations and

standards.
1. 21 CFR (7, 801, 806, 820, 803)
2. ISO (Vigilance requirements, 13485, 14971)
3. Guidance Documents
a. Global Harmonization Task Force
(GHTF/SG3/N99) quality management
systems process validation guidance.
b. FDA General Principles of Software
Validation.
B. Assess potential organization impact of changes
to regulations and standards.
Certified Quality System Manager

Content Outline
Establishment of a Medical Device Quality System
Approximately 37%
7 Recall
22 Application
8 Analysis
A. Ensure the quality system includes regulatory
requirements, business needs, and product
requirements (e.g., product classification, sterile
or non-sterile).
B. Establish metrics and performance indicators to
monitor quality outcomes and measure the health
of the quality system.
1. Report to management about the
effectiveness of the quality systems.
2. Oversee quality system and evaluate its
ongoing stability.
3. Identify suitable metrics.
4. Analyze data (sub-system specific,
cross-sub system).
5. Use statistical techniques.
6. Initiate actions based on data analysis.
C. Establish validation framework including process,
software, device design, and test method.
D. Ensure the development of training framework
applicable to regulatory compliance and
company-specific procedures, quality
management and quality engineering principles.
E. Risk management
1. Apply risk management tools to the
quality system.
2. Approve risk management plans and
reports.
3. Participate in risk management analysis.
4. Approving Medical Device Report
(MDR) and vigilance reports.
5. Lead health hazard evaluations.
Management Approximately 40%

8 Recall
8 Application
24 Analysis
A. Lead the design, development, and
implementation of a compliant quality system.
B. Lead the management review process.
C. Ensure effective resource planning for the quality
system.
D. Manage the quality of the internal audit subsystems.
E. Develop quality plans.
F. Manage monitoring and feedback
1. Corrective and preventive actions
2. Non-conformance
3. Complaints
4. Recommend courses of action when noncompliance is discovered
5. Audits
6. Ensure mechanisms exist to effectively
capture, report and trend customer feedback
G. Establish the quality policy, strategy (objectives),
and tactics for the organization.
H. Manage quality operations ( control, assurance
and engineering)
I. Act as liaison to support the organizations
interactions with notified bodies and regulatory
organizations on compliance and management
issues.
J. Act as liaison to support the organizations
external audits and inspections.
K. Ensure training needs are assessed.
Medical Device Quality System Compliance

Approximately 23 %
18 Recall
5 Application
0 Analysis
23
The CQSM exam is a two-hour closed book exam

consisting of 100 multiple choice questions. In
addition, there are 15 pre-test questions that do not
affect the overall score.
Safety and Regulatory-Public and Patient Safety

in the Health Care Facility
(General/Radiology/Laboratory)
AABB: American Association Blood Banks
http://www.aabb.org/
Candidates are allowed to bring a nonprogrammable four function calculator. Cell

phones, iPads or other electronic devices that have
internet capabilities cannot be used as a calculator
or brought into the testing room.
ANSI: American National Standards Institute

http://webstore.ansi.org/ansidocstore/default.asp
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
FR/CFRSearch.cfm
The following is not intended to be a complete listing

of every source available, nor should applicants feel
they must purchase and study every item on this list.
Most texts in a particular category are redundant. The
list is purposely long to increase the probability that
everyone will have access to at least some of the
sources listed. Other generally accepted texts may be
of equal value in preparation for the examinations.
Comprehensive Accreditation Manual of Hospitals:

The Joint Commission
http://www.jointcommission.org/
MQSA: Mammography Quality Standards Act
http://www.fda.gov/cdrh/mammography/
CBET, CLES, CRES References

Anatomy, Physiology, and Medical Terminology
(General, Radiology, Laboratory)
NCRP (Report 99, 102): National Council on

Radiation Protection and Measurements
http://www.ncrponline.org/
Hole, John W. Jr.: Essentials of Human Anatomy &

Physiology, (ISBN: 0697267695 ISBN-13:
9780697267696) McGraw-Hill Higher Education
NEMA Standards (Publication No. XR 8, XR9, XR11,

XR12): National Electrical Manufacturers Association
http://nema.org/
Martini, Frederick and Bartholomew, Edwin: Structure

& Function of the Human Body, Prentice Hall, Upper
Saddle River, NJ, 1999.
NFPA (70, 99, 101): National Fire Protection

Association http://www.nfpa.org/
OSHA: Occupational Safety & Health Administration
http://www.osha.gov/
Patton, Kevin T. and Thibodeau, Gary A.: Anthonys

Textbook of Anatomy & Physiology, Mosby Yearbook
Co., St. Louis, MO (ISBN: 0-323-01630-8) 17th
Edition, 2002.
Electronics and Devices

(General/Radiology/Laboratory)
Beyda, William J.: Data Communications, from Basics
to Broadband, Prentice-Hall, Englewood Cliffs, NJ
(ISBN: 0-1309-6139-6) 3rd Edition, 2000.
Stedman, Thomas: Stedmans Medical Dictionary,

Lippicott, Williams & Wilkins, NY (ISBN: 0-7817-44946) 27th Edition, 2002.
Floyd, Thomas L.: Digital Fundamentals, Prentice

Hall, Englewood Cliffs, NJ (ISBN: 0-1308-08540-4) 7th
Edition, 2000.
Tortora, Gerard J. and Grabowski, Sandra Reynolds:

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.
24
Grob, Bernard and Schultz, Mitchel: Basic

Electronics, Macmillan/McGraw-Hill, Westerville, OH
(ISBN: 0-0782-7124-X) 9th Edition, 2003.
MacIntyre, Neil R. and Branson, Richard D.:

Mechanical Ventilation, W.B. Saunders Company
(ISBN: 0-7216-7361-9) 1st Edition, 2001.
Malvino, Albert Paul, PhD: Electronic Principles,

McGraw-Hill Book Co., New York, NY (ISBN: 0-02802833-3) 6th Edition, 1999.
Robbins, Allan and Miller, Willhelm: Circuit Analysis:

Theory and Practice, Thomson Delmar Learning, New
York, 2nd edition, 2006.
Paynter, Robert T.: Introductory Electronic Devices

and Circuits, Prentice Hall, Englewood Cliffs, NJ
(ISBN: 0-1392-7203-8) 5th Edition, 2000.
Street, Laurence: Introduction to Biomedical

Engineering Technology, CRC Press, Boca Raton,
FL, 2008.
Williams, Joseph: An Introduction to Computing

Infrastructure: Hardware and Opening Systems, Que
Education and Training (ISBN: 1-5757-6355-9) 1997.
Health Care Information Technology

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

& SNOMED: Health Informatics Series (ISBN: 978-184882-802-5) 2010.
AAMI, A Practicum for Healthcare Technology

Management, (ISBN: 1-57020-589-2), 2015
ECRI Institute: Medical Technology for the IT

Professional (ISBN: 978-0-9819241-1-3).
Atles, Leslie, R., Segalewitz, Scott, Marquette

Electronics: Affinity Reference Guide for Biomedical
Technician, Dubuque, Iowa Kendall/Hunt Pub. 1995
(ISBN: 0787200654 9780787200657 0787243272
9780787243272)
Radiology
Bushong, Stewart: Radiologic Science for
Technologists: Physics, Biology, and Protection,
Mosby Yearbook Co., St. Louis, MO (ISBN: 0-32301337-6) 7th Edition, 2001.
Carr, Joseph J. and Brown, John M.: Introduction to

Biomedical Equipment Technology, John Wiley &
Sons, Inc., NY (ISBN: 0-1301-0492-2) 4th Edition,
2001.
Callaway, W. J.: Mosbys Comprehensive Review of

Radiography: The Complete Study Guide and
Planner, Elsevier Science (ISBN: 0-3230-1839-4) 3rd
Edition, 2002.
Chan, Anthony: Biomedical Device Technology:

Principles and Design, Charles C Thomas Publisher,
Ltd., Springfield, IL (ISBN: 978-0-398-07699) 2008.
Papp, J.: Quality Management in the Imaging

Sciences, Elsevier Science (ISBN: 0-3230-1624-3) 2nd
Edition, 2002.
Christe, Barbara: Introduction to Biomedical

Instrumentation: The Technology of Patient Care,
Cambridge University Press, New York (ISBN: 978-0521-5152-2) 2009.
Saia, D. A.: Appleton & Langes Review for the

Radiography Examination, McGraw Hill (ISBN: 08385-0389-6) 4th Edition, 2000.
Cromwell, and Others: Biomedical Instrumentation

and Measurements, Prentice-Hall, Inc., Englewood
Cliffs, NJ (ISBN: 0-1307-6448-5) 2nd Edition, 1980.
Laboratory
Khandpur, Raghbir: Biomedical Instrumentation:

Technology and Applications, McGraw-Hill, New York
(ISBN: 0-07-144784-9) 2005.
Estridge, Barbara H., Reynolds, Anna P., & Walters,

Norma J. PhD: Basic Medical Laboratory Techniques,
Delmar (Thomas Learning), Albany, NY (ISBN: 07668-1206-5) 4th Edition, 2000.
25
Fischbach, Francis RN, BSN, MSN: A Manual of

Laboratory & Diagnostic Tests, Lippincott Williams &
Wilkins, Philadelphia, PA (ISBN: 0-7817-1969-0) 6th
Edition, 2000.
Lehman, PhD, Craig A., Leiken, Alan, Ward, PhD.,
Kory M.: Clinical Laboratory Instrumentation and
Automation: Principles, Applications, and Selection,
W.B. Saunders Co., Philadelphia, PA (ISBN: 0-72164218-7) 1st Edition, 1994.
Stiefel, Robert: Medical Equipment Management

Manual (ISBN: 1-57020-350-4) RHS Biomedical
Engineering Consulting, LLC, 2009
Taktak, Azzam, Ganney, Paul, Long, David, and
White, Paul: Clinical Engineering: A Handbook for
Clinical and Biomedical Engineers (ISBN-10:
0123969611) 1st Edition, 2014
Wang, Binseng: Medical Equipment Maintenance:
Management and Oversight (Synthesis Lectures on
Biomedical Engineering) 2012 Articles
Mahon, C., Smith, L., Burno, C.: An Introduction to

Clinical Laboratory Science, W.B. Saunders Co.,
Philadelphia, PA (ISBN: 0-7216-4990-4) 1st Edition,
1998.
Baretich, Matthew: The Value of Certification.

Biomedical Instrumentation & Technology , Jan 2012,
Vol. 46, No. 1, pp. 68-71.
Mangle, James I., Nortica, PhD., Solomon, Petit, MD,

J.E.: Albas Medical Technology: Board Examination
Review and Complete Clinical Laboratory Text,
Berkeley Scientific Publications (ISBN: 0-91024-18-8)
12th Edition, 1996.
Braeutigam, David: Dollars and Sense: Get a Handle

on Managing Service Costs Biomedical
Instrumentation & Technology, Sep 2010, Vol. 44, No.
5, pp. 395-396.
Segen, Joseph C. MD and Stauffe, Joseph PhD: The

Patients Guide to Medical Tests, Facts on File, Inc.,
New York, NY (ISBN: 0-8160-4652-2) 2nd Edition,
2002.
Schlabig Williams, Jill Revamping: In-House Clinical

Engineering Services in 90 Days Biomedical
Instrumentation & Technology ,Sep 2008, Vol. 42, No.
5, pp. 377-379.
Maintenance Manual for Laboratory Equipment, 2nd

Edition, World Health Organization,
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
Biomedical Instrumentation & Technology, Jul 2010,
Vol. 44, No. 4, pp. 346-349.
CHTM References
Hegarty, Francis,Togneri MacMahon, Silvana, Byrne,

Patricia, and McCaffery, Fergal: Assessing a
Hospitals Medical IT Network Risk Management
Practice with 80001-1 Biomedical Instrumentation &
Technology, Jan 2014, Vol. 48, No. 1, pp. 64-71.
AAMI, A Practicum for Healthcare Technology

Management, (ISBN: 1-57020-589-2), 2015
Carr, Joseph and Brown, John: Introduction to
Biomedical Equipment Technology, (ISBN-13:
9780130104922) Prentice Hall, 4th Edition, 2001
Dyro, Joseph: Clinical Engineering Handbook Biomedical Engineering (ISBN-10:012226570X) 1st
Edition, 2004
Mankovich, Nick and Fitzgerald, Brian: Managing

Security Risks With 80001 Biomedical
Instrumentation & Technology Managing Medical
Devices on the IT Network, Sep 2011, Vol. 45, No.
s2, pp. 27-32.
Frize, Monique: Health Care Engineering Part I:

Clinical Engineering and Technology Management Synthesis Lectures on Biomedical Engineering (ISBN:
1608453669) 2013
Janssen, Martin and Schrenker, Rick: Guidelines

From 80001 Maintaining a Medical IT Network
Vol. 45, No. 4, pp. 295-299.
Papa, Mike: Responsibility Agreements Ensure
Accountability Under 80001 Biomedical
26

s2, pp. 33-35.
Hall, Andrea: Manage Contractors Like Employees to

Ensure JCAHO Compliance Biomedical
Instrumentation & Technology, Mar 2006, Vol. 40, No.
2, pp. 128-129.
Cooper, Todd and Eagles, Sherman: 80001:New Era

Dawns for Medical Devices Biomedical
Instrumentation & Technology, Jan 2011, Vol. 45, No.
1, pp. 16-25.
Links
Association for the Advancement of Medical
Instrumentation (AAMI)
80001-1 Managing Medicai1T-Networks: 2012
Grimes, Stephen: Using 80001 to Manage Medical

Devices on the IT Network Biomedical
s2, pp. 23-26.
Federal Communications Commission

WMTS
U.S. Department of Labor (DOL)
Americans with Disabilities Act
Disability Resources
Fair Labor Standards Act
Family and Medical Leave
Family and Medical Leave Act
Federal Wage Garnishments
Wage and Hour Division
Cooper, Todd and Fuchs, Ken: Technology Risk

Assessment In Healthcare Facilities Biomedical
Instrumentation & Technology, May 2013, Vol. 47,
No. 3, pp. 202-207.
Delvecchio, Karen: Step-by-Step Risk Management
for Medical IT Networks Biomedical Instrumentation &
Technology Managing Medical Devices on the IT
Network, Sep 2011, Vol. 45, No. s2, pp. 37-43.
U.S. Food and Drug Administration (FDA)

Safe Medical Devices Act Family
FDA 21 CFR 800 and 1000 series
Swim, Richard: Keeping Data Secure: Protected

Health Information and Medical Equipment
Vol. 46, No. 4, pp. 278-280.
Various Links
AHA Healthcare Data Viewer
American National Standards Institute ANSI
ASHE: Registration of Equipment Operating in WMTS
Band
CMS Categorical Waiver for Power Strips Use in
Patient Care Areas
CMS Medical Equipment Standards
Code of Federal regulations CCPA 29CFR 870
GAAP
HIPAA
IEC
MQSA Mammography Quality Standards Act
MRI Facility Design Guide
NFPA 70, 99, 101
NLRB: Rights We Protect
OSHA
U.S.EEOC
Swim, Richard: Understanding the Wireless Spectrum

in a Healthcare Facility Biomedical Instrumentation &
Technology, May 2013, Vol. 47, No. 3, pp. 212-214.
Hayhurst, Chris: Is Your Patient Data Secure?
Biomedical Instrumentation & Technology, May 2014,
Vol. 48, No. 3, pp. 166-173.
Holden, William: Bridging the Culture Gap Between
Healthcare IT and Medical Device Development
Biomedical Instrumentation & Technology Connecting
the Dots, Sep 2014, Vol. 48, No. s2, pp. 22-28.
Krenc, Tina: Risk Management: Its Not Just FMEA
Biomedical Instrumentation & Technology, May 2010,
Vol. 44, No. 3, pp. 242-244.
Ridgway, Malcom: Analyzing Planned Maintenance
(PM) Inspection Data by Failure Mode and Effect
Analysis Methodology Biomedical Instrumentation &
Technology, May 2003, Vol. 37, No. 3, pp. 167-179.
27
CQSM References
21 CFR 7
21 CFR 801
21 CFR 803
21 CFR 806
21 CFR 820
Global Harmonization Task Force

GHTF/SG3/N99-10:2004 - (Edition 2)
International Standards Organization (ISO)
Medical device software - Part 1: Guidance on the
application of ISO 14971 to medical device software
ISO 13485:2009
ISO 14971:2007
International Medical Device Regulators Forum

(IMDRF)
Study Guides and Review Courses
It is considered a conflict of interest for any certifying
organization or commission to help individuals attain
the credential it issues. The ACI does not sponsor or
endorse any refresher course, study guides, or study
materials of any kind. Contact a local biomedical
society or ask colleagues about organizing study
groups or arranging for review courses.
Association for the Advancement of Medical

Instrumentation (AAMI)
ANSI/AAMI/IEC TIR80002-1:2009
The Quality System Compendium: CGMP
Requirements and Industry Practice, 3rd Edition
U.S. Food and Drug Administration (FDA):
General Principles of Software Validation
28
Certification Exam Pricing

(Beginning November 2015)
Member Fee
Non-member Fee
Exam Fees
CBET, CLES, CRES Exam Fee
CBET, CLES, CRES Retake Fee
(non-refundable)
CHTM Exam Fee
CHTM Retake Fee
(non-refundable)
CQSM Exam Fee

CQSM Retake Fee
(non-refundable)
International Exams
(outside North America)
Late Registration Fee

(after deadline non-refundable)
Rescheduling Fee
(outside of 5 business days)
Rescheduling Fee
(inside of 5 business days)
No Show Fee
Recertification
Recertification Fees
(non-refundable)
Additional Fee for multiple

certification
Late Fee
$350
$400
(includes $100 application fee)
$225
$275
$420
$500
$300
$350
$420
$500
$300
$350
$100 additional
$100 additional
$50 additional
$50 additional
$25
$25
Forfeit all exam fees
$100
$150
$50 (per additional certification) $75 (per additional certification)

$25
$25
Reactivation Fee
$100
$100
Miscellaneous
Upgrade Fee
New Certificate
$25
$25
$25
$25
(received after December 31)
The $100 application fee is non-refundable.
29
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.
30
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What are the different types of certifications covered?

What are the different types of certifications covered?

What are the eligibility requirements for each certification?

What are the eligibility requirements for each certification?

Certification Candidate Handbook

Program Overview, Policies and Procedures

Late Registration Deadline

ACIs objective is to be the trusted source for quality

ACI Statement of Fairness

AAMI Membership is not a prerequisite for

All ACI applicants, candidates, and certificants must

Certified Biomedical Equipment Technician

Test and calibrate medical devices

Manage medical software/hardware

Certified Laboratory Equipment Specialist (CLES)

Certified Radiology Equipment Specialist (CRES)

Certified Healthcare Technology Manager (CHTM)

Applicants must meet ONE of the following

This HTM certification covers two major areas in

Additional eligibility routes for CLES

Certified Quality System Manager (CQSM)

5. Associates degree in medical laboratory

Quality system managers oversee all aspects of

*CRES and CLES Applicants for full certification:

1. Associates degree in biomedical equipment

Additional eligibility routes for CLES

Path 3: An Associates degree in biomedical

5. Associates degree in medical laboratory

Path 4: A Bachelors degree or higher in

Path 5: Work experience with or without a

Path 1: A current certification as a clinical

Path 2: Successful completion of the

Accounting, Anesthesia and Surgical Services,

Human Factors Engineering, Imaging Services,

not be discriminated against based on race, religion,

If the application is incomplete, the candidate will

Path 1: Ten years managing quality system

Application is not completely filled out

If the application is denied, the candidate will receive

Biology, Chemistry, Physics, Engineering,

Failure to demonstrate eligibility in

The candidate must submit the completed application,

Candidates will be notified in writing or electronically

The application forms can be found on ACIs website,

Act, as amended (42 U.S.C. 2000e. et. seq.) in

The candidate must arrive at the exam location at

Scheduling a Computer-based Exam

Policies During Exam Administration

Preparing for the Exam

Exam Content Outlines

Any candidate who gives or receives help during the

The performance of all candidates is monitored and

maintains and adheres to a security policy which is

of receiving exam results to ACI and can be faxed to

Scoring and Results

Testing conditions should be such that each

Appeal of Exam Administration

Candidates who pass an exam and achieve a

A cancellation fee will be assessed to the candidate

Candidates who fail an exam will be provided with