FELA Evaluative Criteria - American Academy of Clinical

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Federation of Electrodiagnostic Laboratory Accreditation
Laboratory Accreditation Self Study
PROVIDER
Provider: The following criteria relate to provider requirements
P-1. Each accredited laboratory must designate a provider with the title of Laboratory Director.
Narrative: Build a case that the laboratory director is a competent director. Document clinical
experience, training, leadership abilities/experience, board certification, continuing education,
and other qualities the support the position of director. Comment on current patient case load
(studies per month).
Appendices P1:
- CV of laboratory director which includes continuing education
- Copy of state licensure, board certification certificate
- Copy of any diploma or completion certificate(s) of residency or other significant
formal training (see definition of formal training in the glossary) experience in clinical
electrophysiology (as appropriate for other professional providers other than the director)
- Copies of basic provider level CPR training
Requirement
Evidence (rows below for reviewer use only)
Formal training
Years of experience as a
clinician (5 minimum)
Years of experience as an
Electromyographer (3 minimum)
Board Certification (ABPTS* or
ABEM+ required); Copies of
license, certifications, and/or
residencies completed
Leadership experience
Basic provider CPR
*American Board of Physical Therapy Specialties
+
American Board of Electrodiagnostic Medicine
P-2. Each accredited laboratory is permitted to employ professional providers to perform
complete clinical electrophysiological examinations (as allowed by state law).
Narrative: Summarize the state's scope of practice laws regarding providers in the laboratory
that perform and interpret complete EMG/NCV studies.
Appendices P2:
- Excerpts from state practice acts that demonstrates EMG/NCV clinical practice is
within the scope of the providers in the laboratory
- Copy of state licensure, board certification certificate (as appropriate for other
professional providers other than the director)
- Copy of any diploma or completion certificate(s) of residency or other significant
formal training (see definition of formal training in the glossary) experience in
clinical electrophysiology (as appropriate for other professional providers other than
the director)
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- Copies of basic provider level CPR training (as appropriate for other professional
providers other than the director)
Requirement
State practice act is consistent
with licenses/qualifications of
providers
Copies of license, certifications,
residencies, and/or certificates of
formal training of each provider
(other than laboratory director)
Basic provider CPR for each
provider
Evidence (Rows below for reviewer use only)
P-3. Each accredited laboratory is permitted to employ certified technicians to perform nerve
conduction studies under the direction and on-site supervision (see definition of direction and onsite supervision in the glossary) of the laboratory director or designee. The supervisor must be a
professional, licensed health care provider, appropriately trained in EMG/NCV (meets either
criteria in P-1 or P-2), and be immediately available to the technician.
Narrative: Summarize the state's laws regarding performance of nerve conduction studies by a
technician under on-site supervision of a licensed health care provider. Document the type of
formal training (see definition of formal training in the glossary) the certified technician
underwent. Comment whether or not the technician has had his/her competency evaluated by the
laboratory director or his/her representative (must meet criteria in P1 or P2).
Appendices P3:
- Excerpts from state practice acts that demonstrates EMG/NCV clinical practice is
within the scope of the providers in the laboratory (specifically technicians)
- Copy of diploma or completion certificate with active technician certification number
demonstrating certification in the performance of nerve conduction studies.
- Copy of high school diploma or equivalent
- Document that confirms competency in the various nerve conduction techniques
(evaluation rubric or indicate the page number(s) in the policy and procedure manual
that states how technician competency is determined)
- Copies of Basic provider level CPR training
Requirement
Evidence (Rows below for reviewer use only)
State law is consistent with
laboratory's use of technicians
Copy of diploma or completion
certificate with active technician
certification number for each
technician
Copy of high school diploma or
equivalent for each technician
Documentation of competency
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within the current laboratory
Basic provider CPR for each
provider
P-4. Each accredited laboratory is permitted to employ non-certified technicians to perform
nerve conduction studies under the direction and on-site supervision (see definition of direction
and on-site supervision in the glossary) of the laboratory director or designee. The supervisor
must be a professional, licensed health care provider, appropriately trained in EMG/NCV (meets
either criteria in P-1 or P-2), and be immediately available to the technician.
Narrative: Summarize the state's laws regarding performance of nerve conduction studies under
direct supervision of a licensed health care provider. Document the type of formal training (see
definition of formal training in the glossary) the technician underwent. Comment whether or not
the technician has had his/her competency evaluated by the laboratory director or his/her
representative (must meet criteria in P1 or P2).
Appendices (P4):
- Excerpts from state practice acts that demonstrates EMG/NCV clinical practice is
within the scope of the providers in the laboratory (specifically technicians)
- Copy of high school diploma or equivalent
- Document that confirms competency in the various nerve conduction techniques
(evaluation rubric or indicate the page number(s) in the policy and procedure manual
that states how technician competency is determined)
- Copies of Basic provider level CPR training
Requirement
Evidence (Rows below for reviewer use only)
State law is consistent with
laboratory's use of technicians
Documentation of formal
training
Copy of high school diploma or
equivalent for each technician
Documentation of competency
within the current laboratory
Basic provider CPR for each
provider
P-5. Licensed health care providers complete thorough reports of EMG/NCV studies
Appendices P5: For each licensed health care provider who is NOT board certified by the
American Board of Physical Therapy Specialties or the American Board of Electrodiagnostic
Medicine, provide three complete reports to include one of each of the following: entrapment
neuropathy, radiculopathy or plexopathy, and polyneuropathy.
Requirement
Copies of the following studies
provided: entrapment
neuropathy, radiculopathy or
plexopathy, and polyneuropathy
Evidence (Rows below for reviewer use only)
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Scores a minimum of 70% for
each study on the score sheets
(appendices)
P-6. All licensed health care providers and technicians provide evidence of continuing
education. Continuing education can be formal courses, journal club, or similar activities
Appendices P6: Provide a listing of continuing education activities for each licensed health care
provider. This can be presented in table format if desired. Twenty-four contact hours are the
minimum required each three years.
Requirement
Continuing Education in
EMG/NCV and/or
neuromuscular related education
(24 hours in last 3 years
required). Provided for each
clinician
Evidence (Rows below for reviewer use only)
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SUPERVISION AND ADMINISTRATION
Supervision and Administration: The following criteria relate to supervision and
administration
SA 1. There is a clearly communicated organizational chart so all personnel involved in the
provision of EMG/NCV services understand the chain of command. Satellite facilities should be
included in this organizational chart.
Narrative: indicate where in the policy and procedure manual an organizational chart can be
found.
Requirement
Organizational chart
present that clearly
depicts leadership and
relationships among
different clinics.
Page #
Evidence (rows below for reviewer use only)
SA 2. There is a clear job description/responsibilities of each of the following types of providers
(as appropriate for your laboratory): laboratory director, board certified provider, non-board
certified provider, NCV technicians.
Narrative: indicate where in the policy and procedure manual these job descriptions can be
found. If the laboratory does not utilize some of the above providers, please indicate so.
Requirement
Page #
Laboratory Director
Position Description
(PD)
Board certified provider
PD
Non-board certified
provider PD
Technician provider PD
PDs are consistent with
supervision
requirements noted in
SA 3.
Evidence (Rows below for reviewer use only)
SA 3. Supervision requirements are clearly spelled out for technicians and non-board certified
providers.
Narrative:
Technicians: Describe the process of a patient encounter when a nerve conduction technician is
used. Include the following: 1) indicate when the patient is examined by a licensed provider, 2)
who makes the decision as to what specific nerves will be tested, 3) when/how is the NCV data
reviewed by the licensed provider, 4) when and if a needle EMG is performed and who performs
the EMG exam, 5) the location of the supervising licensed provider when an NCV technician is
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performing the exam. Also describe how licensed providers respond to questions an NCV
technician may have in the middle of an EMG/NCV exam.
Non-board certified licensed health care providers: Comment on supervision of non-board
certified licensed health care providers. Include whether supervision is on-site or distance; also
include your peer review process of non-board certified licensed health care providers.
Also indicate where these policies can be found in the policies and procedures manual. If the
laboratory does not use NCV technicians and non-board certified providers, just indicate so.
Requirement
Supervision is direct and
appropriate for technicians
Supervision is appropriate for
non-board certified licenses
providers
Evidence (Rows below for reviewer use only)
SA 4. NCV technicians and non-board certified licensed providers have competency verified by
board certified providers.
Narrative: Describe how the laboratory verifies that an NCV technician and non-board certified
providers are competent to perform various NCV and/or EMG procedures.
Appendices SA 4: grading rubrics or check-off sheets used to document competency (may be
the same documents used for criteria P3 and P4).
Requirement
Procedures to assure competency
for technician providers is
appropriate
Procedures to assure competency
for non-board certified licensed
providers is appropriate
Evidence (Rows below for reviewer use only)
SA 5. There is a medical record retention policy in the facility.
Narrative: Describe the medical record retention policy and indicate if the policy is consistent
with state law (length of time held, method of storage, etc.). Indicate where in the policy and
procedure manual this policy can be found. Also state whether medical records are electronic or
paper.
Requirement
An appropriate medical retention
policy is evident
Evidence (Row below for reviewer use only)
SA 6. There is a HIPAA compliance policy. At a minimum, the facility’s HIPAA Policies and
Procedures should establish a formal information privacy and security training program and set
forth the person who has responsibilities for determining training requirements and conducting
the training, the content and frequency of training, and the proper documentation of attendance at
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training sessions. Note: the facility can establish the appropriate frequency of training for their
facility unless changes in HIPAA policy occur.
Narrative: Indicate where in the policy and procedure manual the HIPAA compliance policy can
be found.
Appendices SA 6: include documentation of HIPAA compliance training or all providers in the
laboratory.
Requirement
An appropriate HIPAA policy is
evident
Evidence (Row below for reviewer use only)
SA7: Each provider and staff person in the laboratory must have evidence of Fraud, Waste and
Abuse Prevention compliance training every three years. There must be a clearly identified
compliance officer or contact person for laboratory staff to report potential or real problems (the
contact person may be a member of the clinic staff in which the laboratory is housed).
Requirement
Documentation of
policy concerning
fraud, waste and abuse
compliance training in
the policy and
procedures manual
Fraud, waste and abuse
contact person
identified
Evidence of training of
all laboratory personnel
supplied
Page # Evidence (Row below for reviewer use only)
SA8: The facility must have a policy and process for managing supplies (ordering, replacing
expired supplies, etc.) and indicate the person responsible for managing supplies/equipment.
Narrative: Please state where this can be found in the in the policy and procedure manual.
Requirement
An appropriate supply
management policy is
evident
Page # Evidence (Row below for reviewer use only)
SA9: The facility must have a process for acquiring annual electrical checks and certification of
electrical safety for all machines used by the main facility and satellite clinic(s). Note: All
laboratories must provide documentation of at least one electrical check within the last year prior
to accreditation.
Narrative: Please state where the policy regarding electrical checks can be found in the in the
policy and procedure manual.
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Appendices SA9: Provide documentation of an electrical check for each piece of equipment
used for EMG/NCV testing within the last year.
Requirement
An appropriate
electrical safety policy
is evident
Documentation of
electrical check(s) are
provided
Page #
Evidence (Row below for reviewer use only)
SA10: For laboratories where more than one person is employed in the performance of
EMG/NCV studies, there must be a human resources policy that indicates hiring and termination
policies. These policies should also include: hours of work, probationary periods (if any),
annual performance review requirements, grievance procedures, employment benefits, vacation
and sick leave, workers compensation benefits, and similar policies.
Appendices SA9: human resources manual (note: for laboratories where only one person is
employed, this is not necessary).
Requirement
Human resource policies are
evident and appropriate
Evidence (Row below for reviewer use only)
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PATIENT CARE
Patient Care: The following criteria relate to policies regarding patient care
PC1: The facility has a procedure handbook that details the general procedures for performance
of NCV and EMG procedures performed in the laboratory. This handbook (with references)
should include general procedures for: Motor and sensory NCS, F-waves, H reflexes, mixed
NCV studies, EMG, Blink reflex, others if performed by the clinic.
Appendices PC1: include the procedures handbook.
Requirement
Procedures are consistent with
current standards of care
Evidence (Row below for reviewer use only)
PC2: The facility has a document that details the normal values used for NCV and EMG
procedures performed in the laboratory. Normal values must be referenced.
Appendices PC2: include the normal values document.
Requirement
A referenced normal values table
is provided
Evidence (Row below for reviewer use only)
PC3: The policy and procedure manual list the procedures followed during medical
emergencies, who is responsible to perform emergency procedures, and what equipment is
available for use in these situations (crash cart, de-fibrillator, etc.).
Narrative: Indicate in the procedure manual where these policies can be found.
Requirement
Appropriate medical emergency
procedures are evident
Evidence (Row below are for reviewer use only)
PC4: There is a universal precautions and blood borne pathogens policy in the policy and
procedure manual.
Narrative: Indicate in the procedure manual where these policies can be found.
Requirement
An appropriate universal
precautions and blood borne
pathogens policy is evident
Evidence (Rows below for reviewer use only)
PC5: Number and type of studies performed in the main clinic and satellite facilities.
Narrative: State the approximate number of studies performed in the main clinic and each
satellite facility. Also include the percentage of entrapment neuropathies, radiculopathies,
polyneuropathies, and other (myopathy, NMJ disorder, plexopathy, etc.). Also indicate the
percentage of studies that have both EMG and NCV procedures performed, percentage
performed by a technician, and percentage where the studies are performed on site and
interpreted offsite. A table with this data may be helpful to insert below.
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Requirement
A minimum of 50 studies are
performed each year by each
licensed health care provider
There is an adequate variety of
patients (entrapment neuropathy,
polyneuropathy,
radiculopathy/plexopathy,
myopathy/NMJ disorders)
90% of the studies have both
EMG/NCV performed
90% of the studies are performed
and interpreted on site (not
interpreted by a 3rd party)
Evidence (Rows below for reviewer use only)
PC6: The laboratory monitors outcomes.
Appendices: List the types of outcome assessment performed. This can include patient
satisfaction surveys, referring physician satisfaction surveys, peer review, or similar activities.
Requirement
There is adequate monitoring of
outcomes
Evidence (Row below for reviewer use only)
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FACILITY
Facility: The following criteria relate to facility requirements
F1: State whether the laboratory is compliant with the American Disabilities Act
Narrative: Describe how the facility (main and satellite clinics) are compliant.
Requirement
Laboratory is fully accessible
and compliant with ADA
Evidence (Row below for reviewer use only)
F2: Describe the general types of facilities the main clinic and satellite clinics have.
Narrative: State if the facility has the following: restrooms for patients and staff, number of
exam rooms used for EMG/NCV, patient waiting room, secured file room for medical records,
break room for staff, and secure areas to store personal belongings.
Requirement
The facility has all of the
rooms/items noted in the criteria
above
Evidence (Row below for reviewer use only)
F3: Provide a listing of all equipment used for EMG/NCV testing.
Narrative: Include the following for capital expense equipment: manufacturer, model number,
date put in use. For other supplies, indicate the types of electrodes used for EMG and NCV, and
related supplies. A table may be helpful to display this data.
Requirement
The facility has necessary
equipment/supplies to perform
complete EMG/NCV studies.
Evidence (Row below for reviewer use only)
F4: Fire safety and evacuation plan for the main laboratory and any satellite laboratories. These
policies must include: procedures for reporting fires and similar emergencies, evacuation routes,
procedures to account for all employees and patients after an emergency evacuation has been
conducted, and location of fire extinguisher(s) and maintenance plan. Note: the OSHA website
may be helpful in developing these policies – www.osha.gov)
Appendices F4: Include this emergency preparedness document.
Requirement
Emergency procedures are
thorough and adequately
described
Evidence (Row below for reviewer use only)
F5: The facility must have a plan for power outages and methods for surge protection. Note: if
the facility has an uninterrupted electrical supply and surge protection in place, this statement is
all that is needed.
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Narrative: Indicate whether or not the facility has an uninterrupted power supply and surge
protection.
Appendices F5: If the facility does not have uninterrupted power supply and/or surge protection,
please include policies used when an electrical outage occurs or when there is potential for an
electrical outage to occur (storm).
Requirement
The facility has an uninterrupted
power supply (back up
generator) and surge protection
If the facility does not have an
uninterrupted power supply,
describe policies following when
an electrical outage occurs.
Evidence (Rows below for reviewer use only)
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Part Five – Glossary
Formal Training: Structured learning activities that progress from simple to complex taught by
board certified clinicians (American Board of Physical Therapy Specialties or American Board
of Electrodiagnostic Medicine) or clinicians with a minimum of 5 years experience. The
program must have stated objectives that cover all aspects of electrodiagnostic to include motor
nerve conduction studies (NCS), sensory NCS, late response (F-waves, H reflexes), needle
electromyography, classification and pathophysiology of peripheral neuromuscular disease, and
critical thinking. The program must assess competency of the students in all aspects of
electrodiagnostic as noted above.
General Supervision: The supervisor can be off-site but is available by phone. Peer review of
studies completed is completed on a regular basis.
On-site supervision: The supervisor is in the same building where the trainee or supervised
provider is performing clinical work. The supervisor can be in the same room as the supervised
provider in less than 5 minutes.
Qualifying continuing education: Structured learning activities taught by board certified
clinicians or clinicians with a minimum of 5 years experience. The program must have stated
objectives.
Substantive Change: Any change that would significantly alter the function of the laboratory.
Examples include: change of laboratory director, change of primary facility, and the addition of
satellite facilities.
Under the direction: The supervising clinician has detailed knowledge of the patient being
assessed through taking a history and performing a physical examination. The supervising
clinician then orders the licensed clinician or technician to perform specific nerve conduction
tests and/or EMG testing, as applicable.
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