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Out of Center Sleep Test

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Out of Center Sleep Test

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© © All Rights Reserved
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You are on page 1/ 16

Standards for Accreditation of

Out of Center Sleep Testing (OCST) in Adult Patients


Standards for Accreditation of
Out of Center Sleep Testing (OCST) in Adult Patients

Introduction

Accreditation by the American Academy of Sleep Medicine (AASM) is a voluntary


program offered to sleep programs that meet the standards contained in this
document. These standards have been developed for the primary purpose of
ensuring the highest quality care be delivered to patients with a sleep disorder.
These standards address out of center sleep testing for adults.

For the purpose of clarity and brevity the remainder of this document will use the
term “sleep service entity” when referring to entities performing Out of Center
Sleep Testing (OCST). Out of Center Sleep Testing is defined as sleep testing
performed outside of the sleep center. Remotely monitored studies performed
independent of other testing are not covered by these standards.

In broad terms, the Standards for Accreditation describe the required structural,
professional and human resources, clinical and technical standards, and
emergency and quality assurance methods required for accreditation by the
AASM. Sleep service providers achieving accreditation are recognized in the
community as a resource for expertise in sleep medicine.

The AASM uses a rigorous evidence-based process to establish Practice


Parameters on a variety of topics that are relevant to the practice of Sleep
Medicine. Accredited sleep service entities must adopt and follow the standards
in all active AASM Practice Parameter papers. Standards can easily be identified
as they are all in bolded print in every Practice Parameter paper. In addition, it is
recommended that accredited sleep service entities adopt and follow all active
AASM Clinical Guidelines and Best Practices.

The AASM recognizes that the practice of Sleep Medicine, like all other medical
disciplines, is dynamic, complex and requires clinical judgment. AASM Practice
Parameters are not designed to limit physicians from using their medical
judgment which, in individual patients, may require deviation from AASM Practice
Parameters. AASM accredited sleep service entities are expected to document
instances requiring deviation from AASM Practice Parameters.

The AASM reserves the right to modify, add, or remove accreditation standards
at its own discretion without notice.

American Academy of Sleep Medicine


2510 North Frontage Road
Darien, IL 60561

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Preamble
AASM accredited sleep service entities must be in compliance with all
accreditation standards at the time of application. If it is determined in the
application review process that a sleep service entity is not in compliance with
the required standards, the application will be returned and the sleep service
entity will need to resubmit it with the required standards being met.

Denial of accreditation will be recommended by the site visitor, reviewers,


accreditation committee, or staff when one or more of the following conditions are
identified:

1. The sleep service entity fails to meet any of the accreditation standards that
are indicated as “MANDATORY.” Sleep service providers will not be issued
provisos for accreditation standards indicated as MANDATORY.

2. The sleep service entity is determined to be non-compliant with more than


thirteen (13) accreditation standards provisos.

3. The sleep service entity fails to resolve proviso(s) within the period of time
allotted to correct the proviso(s).

4. The AASM has evidence that the sleep service entity submitted falsified
documents or misrepresented information in seeking to achieve or retain
accreditation.

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Table of Contents of AASM Out of Center Sleep Testing in Adult Patients
Accreditation Standards

General Standards
A-1 Provider License (MANDATORY) p. 5
A-2 Medical Code of Ethics (MANDATORY) p. 5
Personnel
B-1 Medical Director (MANDATORY) p. 5
B-2 Medical Director Qualifications (MANDATORY) p. 5
B-3 Medical Director Responsibilities (MANDATORY) p. 6
B-4 Medical Director Continuing Medical Education (MANDATORY) p. 6
B-5 Interpreting Physician (MANDATORY) p. 6
B-6 Interpreting Physician Qualifications (MANDATORY) p. 6
Interpreting Physician Continuing Medical Education
B-7 p. 7
(MANDATORY)
B-8 Technical Personnel p. 7
B-9 Scoring Personnel p. 7
B-10 Technical Personnel Continuing Education p. 7
B-11 OCST Technical Personnel Training p. 8
B-12 OCST On-Call Coverage (MANDATORY) p. 8
Patient Policies
C-1 Patient Acceptance p. 8
C-2 Practice Parameter Requirements p. 8
Facility and Equipment
D-1 Phone Access p. 9
D-2 Stationery p. 9
D-3 Portable Recording Equipment p. 9
Policies and Procedures
E-1 Policy and Procedure Manual p. 9
E-2 Protocols p. 10
E-3 Equipment Maintenance p. 10
E-4 Equipment Maintenance Continued p. 10

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Data Acquisition, Scoring and Report
F-1 OCST Reports p. 10
F-2 OCST Recording Equipment p. 10
F-3 RDI Scoring Equivalency p. 10
F-4 Computer-Assisted Scoring p. 11
F-5 Review of Raw Data p. 11
Patient Evaluation and Care
G-1 Patient Management (MANDATORY) p. 11
G-2 Post-Test Follow-up and Management p. 11
G-3 Documenting Patient Evaluation and Management p. 12
G-4 PAP Titration or Therapy During OCST (MANDATORY) p. 12
Follow-up After PAP Titration or Therapy During OCST
G-5 p. 12
(MANDATORY)
G-6 PAP Assessment (MANDATORY) p. 12
Patient Records
H-1 Medical Records p. 13
H-2 Database p. 13
Emergency Procedures
I-1 Emergency Plan p. 13
Quality Assurance
J-1 Quality Assurance Program p. 14
J-2 Quality Assurance Reporting p. 14
J-3 Quality Improvement p. 14

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A. General Standards

Standard

A-1 – Provider License (MANDATORY)


AASM accredited sleep service entities must maintain a valid license, certificate
of occupancy, and/or permit, when required by applicable law and regulation, to
provide health care services. It is the responsibility of AASM accredited sleep
service entities to maintain compliance with all licensing acts, local building codes
and Federal and State laws relevant to the entity’s operation. Failure to comply
with the stipulations in this paragraph is sufficient for denial and/or revocation
of accreditation. An entity’s valid health care license, certificate of occupancy or
business permit fulfills this standard. If applicable law does not require a sleep
service entity to have a healthcare license, certificate of occupancy or business
permit, written attestation of such by the Medical Director is required.

The accredited sleep service entity must maintain a professional office with a
physical, stationary address recognized by the United States Post Office.

A-2 – Medical Code of Ethics (MANDATORY)


AASM accredited sleep service entities are required to follow the Code of
Medical Ethics of the American Medical Association which the AASM adopted
as official policy in 1998. The sleep service entity must have on hand the Code
of Medical Ethics of the American Medical Association Council on Ethical and
Judicial Affairs Current Opinions.

B. Personnel

Standards B-1 through B-4 relate to the appointment, responsibilities and


continuing medical education of a physician medical director.

Standard

B-1 – Medical Director (MANDATORY)


AASM accredited sleep service entities must designate a single medical director
who is a physician with a valid state medical license. A copy of the medical
director’s state medical license must be submitted with the application.

B-2 – Medical Director Qualifications (MANDATORY)


The designated medical director must be a sleep specialist. This requirement is
defined by at least one of the following:

1. A physician who is board-certified in sleep medicine by the American


Board of Sleep Medicine or an individual certified in sleep medicine by
either a member board of the American Board of Medical Specialties or a

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member board of the American Osteopathic Association.

2. A physician who has been accepted by an ABMS or AOA approved board


to sit for the examination in sleep medicine. To retain the accreditation,
the examination in sleep medicine must be passed within 2 examination
cycles.
To meet this requirement, the individual must provide, in the application
packet, a letter of acceptance to sit for the examination by the ABMS or
AOA approved board. Upon completion of the examination, the individual
must provide a copy of the official notification from the ABMS or AOA
board indicating final status.

3. A physician who has completed a 12 month ACGME accredited fellowship


in sleep medicine and is awaiting the first available opportunity to apply
to an ABMS board to sit for the sleep medicine examination. To retain
accreditation, the ABMS examination in sleep medicine must be passed
within 2 examination cycles.

B-3 – Medical Director Responsibilities (MANDATORY)


The medical director:

a. is responsible for the ongoing oversight of testing, including ongoing


oversight of the testing protocols, the quality of testing and the proper
operation and calibration of the equipment;
b. is responsible for the qualifications of all medical and technical personnel;
and
c. is responsible for the quarterly review, report, and modification as
necessary of the sleep service entities’ quality assurance program.

B-4 – Medical Director Continuing Medical Education (MANDATORY)


The medical director must participate in at least 10 credits per year averaged
over three years of AMA PRA Category 1 CME credit in sleep medicine.
Compliance with CME requirements must be documented.

B-5 – Interpreting Physician(s) (MANDATORY)


The interpreting physician(s) must have a valid state license in all states for
which the physician provides interpretation of studies and diagnoses of patients.

B-6 – Interpreting Physician(s) Qualifications (MANDATORY)


The physician(s) responsible for interpretation of OCST data and diagnoses of
patients must be a sleep specialist. This requirement is defined by at least one of
the following:

1. A physician who is board-certified in sleep medicine by the American

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Board of Sleep Medicine or an individual certified in sleep medicine by
either a member board of the American Board of Medical Specialties or a
member board of the American Osteopathic Association.

2. A physician who has been accepted by an ABMS or AOA approved board


to sit for the examination in sleep medicine. To retain the accreditation,
the examination in sleep medicine must be passed within 2 examination
cycles. To meet this requirement, the individual must provide, in the
application packet, a letter of acceptance to sit for the examination by the
ABMS or AOA approved board. Upon completion of the examination, the
individual must provide a copy of the official notification from the ABMS or
AOA board indicating final status.

3. A physician who has completed a 12 month ACGME accredited fellowship


in sleep medicine and is awaiting the first available opportunity to apply
to an ABMS board to sit for the sleep medicine examination. To retain
accreditation, the ABMS examination in sleep medicine must be passed
within 2 examination cycles.

B-7 – Interpreting Physician(s) Continuing Medical Education (MANDATORY)


All interpreting physicians must participate in at least 10 credits per year
averaged over three years of AMA PRA Category 1 CreditTM in sleep medicine.
Compliance with CME requirements must be documented.

B-8 – Technical Personnel


AASM accredited sleep service entities must maintain appropriately trained,
supervised, and, where required by state and federal law, licensed technical
personnel to perform the sensor application and/or patient education. Technical
staffing must be adequate to address the workload of the sleep service entity,
and assure the patient’s safety and understanding of the test.

B-9 – Scoring Personnel


Appropriate scoring technical personnel include sleep technicians, sleep
technicians with the CPSGT certification or other board approved certifications,
sleep technologists, respiratory therapists with the sleep disorders specialist (SDS)
certification, or electroneurodiagnostic technicians with additional sleep certification.

B-10 – Technical Personnel Continuing Education


The sleep service entities’ technical scoring personnel must each participate in
an average of 10 hours per year of AMA PRA Category 1 CreditTM or CEC sleep-
related educational activities over a three year period. This must be documented
for each technical personnel member. Education sessions conducted by the
service entities are acceptable for fulfilling this standard provided the session
has defined educational objective(s) and attendance is documented by a roster
signed by the sleep service entities’ medical director.

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B-11 – OCST Technical Personnel Training
Either the medical director, board certified sleep physician, or a sleep
technologist must provide education to the technical personnel on the proper use
of OCST devices including:

a. application of sensors;
b. instruction of patients in the use of OCST devices;
c. troubleshooting of OCST problems; and
d. scoring of data.

B-12 – OCST On-call Coverage (MANDATORY)


Sleep service entities must provide nighttime (on-call) coverage by the medical
director or a licensed physician board certified in sleep medicine or appropriately
trained technical personnel addressed in standard B-8 to address problems
encountered in OCST.

C. Patient Policies

Standard

C-1 – Patient Acceptance


The sleep service entities’ Policy and Procedures Manual must address patient
acceptance policies. Written policies for patient acceptance must include:

a) age limitations;
b) a mechanism for acceptance;
c) criteria for exclusion; and
d) information required from a referring health-care provider prior to all out
of center sleep tests that adhere to the criteria of high pretest probability
for OSA with limited co-morbidities as described in the current versions
of AASM practice parameters, AASM clinical guidelines and AASM best
practice guidelines pertaining to the diagnosis of obstructive sleep apnea
syndrome in adults (see Appendix A).

C-2 – Practice Parameter Requirements


The clinical evaluation of patients accepted for sleep testing conducted in the
sleep service entity and OCST must comply with the current versions of AASM
practice parameters, AASM clinical guidelines and AASM best practice guidelines
pertaining to the diagnosis of obstructive sleep apnea syndrome in adults (see
Appendix A). Evidence of compliance with this standard must be included in the
medical record.

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D. Facility and Equipment

Standard

D-1 – Phone Access


The program must have 24 hour telephone access to the personnel defined in
standard B-8.

D-2 – Stationery
AASM accredited sleep service entity must have stationery identifying the sleep
service entity and, at a minimum, include the sleep service entity address and
phone number. For hospital-based sleep service entities this standard will be met
provided the sleep service entity is located in the building carrying the primary
address listed on the hospital’s stationery.

D-3 – Portable Recording Equipment


The OCST equipment must meet the minimum definitions described in at least
one of the CPT codes 95800, 95801 or 95806.

95800 Sleep study, unattended, simultaneous recording; heart rate, oxygen


saturation, respiratory analysis (eg, by airflow or peripheral arterial tone), and
sleep time

95801 Sleep study, unattended, simultaneous recording; minimum of heart rate,


oxygen saturation, and respiratory analysis (eg, by airflow or peripheral arterial
tone)

95806 Sleep study, unattended, simultaneous recording of, heart rate, oxygen
saturation, respiratory airflow, and respiratory effort (eg, thoracoabdominal
movement)

Equipment used must have the capability to meet all OCST accreditation
standards outlined in Sections F and J.

E. Policies and Procedures

The sleep service entity must maintain written protocols, in paper or


electronic form, for all testing procedures conducted by the entity. There
are additional standards in sections I and J that are required to be included
in the Policy and Procedure Manual.

Standard

E-1 – Policy and Procedures Manual


AASM accredited sleep service entities must maintain a Policy and Procedures

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Manual that is easily accessible, in paper form or digital form, to all professional
and technical staff. The manual must contain all policies, procedures and protocols
specific to the sleep service entity, and the current versions of AASM practice
parameters, AASM clinical guidelines and AASM best practice guidelines pertaining
to the diagnosis of obstructive sleep apnea syndrome in adults (see Appendix A).

E-2 – Protocols
The sleep service entity must maintain written, paper or electronic format
protocols for OCST for obstructive sleep apnea.

E-3 – Equipment Maintenance


The entity must have a written protocol for cleaning and inspecting equipment
after each use that is consistent with the manufacturers’ recommendations,
federal and state health policy regulations and institutional standards.

E-4 – Equipment Maintenance Continued


A written plan for yearly monitoring of all patient-related equipment for electrical
and mechanical safety is required. The written plan must include specific
instructions regarding documentation of compliance, including an equipment
maintenance log. The plan must address: visual inspection of equipment for
apparent defects; adhering to manufacturer’s recommendations for monitoring
and maintenance of recording equipment.

F. Data Acquisition, Scoring and Reporting

Standard

F-1 – OCST Reports


OCST reports must include at minimum:

a) an RDI (an estimate of the apnea and hypopneas per unit time);
b) evaluation of oxygen saturation during recording period;
c) recording duration of test; and
d) technical adequacy of test.

F-2 – OCST Recording Equipment


Equipment must provide an RDI based on measures that approximates an
AHI based on full polysomnography. Equipment must also measure oxygen
saturation and heart rate and meet the criteria for the codes designated in
standard D-3. Equipment must allow for the display of raw data for manual
scoring or editing.

F-3 – RDI Scoring Equivalency


Sleep service entities performing OCST must use equipment that provides a
measure of respiratory events per unit time (RDI). The Medical Director must

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determine that the device provides a measure that is equivalent to an apnea-
hypopnea index (AHI) based on full polysomnography.

F-4 – Computer-assisted Scoring


If used, computer-assisted scoring of OCST recordings must be reviewed and
edited for accuracy by a board certified sleep physician.

F-5 – Review of Raw Data


The board certified sleep physician interpreting an OCST must conduct an epoch
by epoch review of the entire raw data recording for every study interpreted. The
review of the data must assure that the quality of the recording and the scoring
of sleep and associated events is sufficient to allow for interpretation. Signed
attestation of this review must be kept in the patient record in the form of a
signature or on the report of the test.

G. Patient Evaluation and Care

Standard

G-1 – Patient Management (MANDATORY)


A follow-up in-person visit with a physician, nurse practitioner or physician
assistant must be per­formed on all patients undergoing OCST to discuss the
results of the test and treatment options. Appropriate follow-up for patients who
require continued management must be available from the sleep service entity or
by referral.

Options for treatment of OSA found on OCST may include:

a) Referral to an accredited AASM sleep center for a PAP titration or split-


night study;
b) APAP home trial; and
c) Determination of an alternate to PAP therapy

If continued management is not provided by the sleep service entity, it must


demonstrate, in writing, an existing relationship with an accessible AASM
accredited sleep center that can provide this care. The sleep service entity
must demonstrate that either the treating physician, nurse practitioner, physician
assistant or the AASM accredited sleep center have reviewed the sleep study
results with the patient. The entity must supply the referring physician with
contact information regarding the local AASM accredited center(s) in their
network.

G-2 – Post-test Follow-up and Management


Technical failures due to equipment malfunction must be documented (See
Standard J-1) and the study repeated.

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In-center polysomnography must be recommended in cases where OCST fails to
establish the diagnosis of OSA in patients with a high pre-test probability. If in-
center testing is not provided by the sleep service entity, the entity must provide
written documentation of a relationship with an AASM accredited sleep center.

G-3 - Documenting Patient Evaluation and Management


The sleep service entity’s medical staff must document ongoing evaluation and
management of patients with sleep disorders. The documentation must be part of
the patient’s medical record.

G-4 – PAP Titration or Therapy During OCST (MANDATORY)


PAP titration or therapy initiated or performed by the OCST entity must be
conducted in accordance with the standards described in the current AASM
practice parameters pertinent to autotitrating continuous positive airway pressure
(See Appendix A).

G-5 – Follow-up After PAP Titration or Therapy During OCST (MANDATORY)


Patients being treated with fixed CPAP on the basis of APAP titration or being
treated with APAP must have clinical follow up within 30 days of initiation of PAP
to determine treatment effectiveness and safety. This is especially important
during this period of PAP use. A reevaluation must be scheduled and, if
necessary, a standard attended PAP titration must be performed if symptoms are
not resolved or if the APAP treatment otherwise appears to lack effectiveness.

If the patient doesn’t accept or adhere to therapy following an APAP trial, they
must have an evaluation with a sleep specialist or at an accredited AASM sleep
center for further management.

Appropriate follow-up for patients who require continued management must be


available within the sleep service entity or by referral. If continued management
is not provided by the sleep service entity, they must demonstrate, by written
documentation, an existing relationship with an AASM accredited sleep center
that can provide this care. Documentation of referral must be maintained in the
patient record.

G-6 – PAP Assessment of Patients by OCST Entities Prescribing PAP


(MANDATORY)
Patients prescribed positive airway pressure treatment by the sleep service entity
medical staff must be offered a follow-up positive airway pressure assessment
within 12 weeks of treatment initiation. Positive airway pressure assessment
must minimally include a measurement of treatment use and clinical response to
the therapy such as:

a) direct patient inquiry;


b) office encounter with sleep service entity technical or medical staff;

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c) office encounter with the referring physician;
d) questionnaires;
e) telephone inquiry to the referring physician or the patient; or
f) an informatic system capable of obtaining positive airway pressure use
and a metric of clinical response.

The patient’s medical record must contain documentation of the assessment as


described above or written evidence of follow-up attempts to obtain the positive
airway pressure treatment assessment.

H. Patient Records

Standard

H-1 – Medical Records


AASM accredited sleep service entities must maintain appropriate medical charts
for each patient evaluated by the sleep service entity.

Medical charts of patients seen by sleep service entity medical staff must
document all patient interactions with the sleep service entity, including testing,
diagnosis, and any initial evaluation, treatment, PAP assessment and follow-up.

Prior to testing, all patient medical records must contain documentation


consistent with Standard C-1. Written indication that a sleep service entity
physician has reviewed and approved the proposed evaluation must be noted in
the record.

H-2 – Database
The sleep service entity must maintain a cumulative document or database of the
final diagnosis, using the most current ICD-9 codes, and procedures performed
for each patient evaluated using the most current CPT codes. For sleep service
entities affiliated with AASM accredited sleep centers, a single document or
database tracking both OCST and in-center patients is sufficient.

I. Emergency Procedures

Standard

I-1 – Emergency Plan


The accredited sleep service entity must instruct the patient to call emergency
services 911 in the event of an emergency.

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J. Quality Assurance

Standard
J-1 – Quality Assurance Program
The sleep service entity must have a quality assurance program that ensures
appropriate patient evaluation and management. Specific measures must be
determined by the Medical Director. The program must include at a minimum the
following measures:

1. Study failure rate;


2. Number of retests required including the reason for retesting;
3. Written criteria for assessing adequacy of data for clinical decision making; and
4. CPAP compliance for treated patients at 12 week follow-up (see standard
G-6).

J-2 – Quality Assurance Reporting


All quality assurance metrics must be reported and reviewed by the sleep service
entity’s medical director a minimum of once each quarter. The medical director
must sign and date the report. Quality assurance reports must be retained for the
duration of the accreditation cycle.

J-3 – Quality Improvement


The sleep service entity must establish thresholds for quality assurance metrics
and a written policy for remedial action when minimal standards are not met.
Remedial actions may include technologist training; changes to set up or take
down protocols; equipment modification, replacement or failure; determination of
cause of failure; or changes to patient follow-up procedures.

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American Academy of Sleep Medicine
2510 North Frontage Road
Darien, IL 60561-1511

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