| 1 |
Definitions
of terms |
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| 1.1 |
Home
Telehealth - Home Telehealth encompasses remote care delivery
or monitoring between a health care provider and a patient outside
of a clinical health facility, in their place of residence (home
or assisted living residence). |
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| 1.2 |
Interactive
Home Telehealth - Interactive Home Telehealth includes the
utilization of two-way interactive audio video involving the
patient and a health provider. This service provides remote
care delivery (i.e. assessment, education, data collection).
Interactive Home Telehealth may include devices collecting clinical
data from the patient and delivered to the health provider. |
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| 1.3 |
Telemonitoring
-Telemonitoring includes the collection of clinical data
and the transmission of such data between a patient at a distant
location and a health care provider through a remote interface
so that the provider may conduct a clinical review of such data
or provide a response relating to such data. This includes the
use of automated laboratory or other health monitoring equipment,
as well as the manual entry of data. |
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| 1.4 |
Self
Monitoring - The periodic and scheduled use of a device
by the patient to obtain clinical data that is used by the patient
to measure their own health status. Commonly measured data include
blood pressure, glucose, weight and temperature. These guidelines
do not address self monitoring. |
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| 1.5 |
Patient
Encounters - Home Telehealth may or may not involve a patient
encounter. A patient encounter is the communication of a set
of information between a patient and a provider that establishes
the plan of care, has the potential to change the plan of care,
or implements the plan of care. A videoconference between a
health care provider and a patient can be a patient encounter.
The interactive transmission of a set of vital sign data from
the patient to the nurse who can make a care decision is a patient
encounter. Encounters also may include therapy sessions to implement
the plan of care. The collection of patient vital signs at a
remote site generally does not involve a patient encounter. |
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| 2
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Generic
Guidelines
The following guidelines apply to both Interactive Home
Telehealth and Telemonitoring. |
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| 2.1 |
Patient
Criteria |
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2.1.1 |
Inclusion/Exclusion
Guidelines: Patient inclusion and exclusion criteria should
be established for every type of home telehealth program, detailing
who is eligible and appropriate for each type of technology. |
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2.1.2 |
Patient
enrollment and set up procedures must be established |
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2.1.3 |
Patient
Informed Consent |
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2.1.3.1 |
Written
informed consent should be obtained from the patient or designee
before beginning the use of Home Telehealth. |
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2.1.3.2 |
Written
informed consent must be included as a part of any clinical
record. |
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2.1.3.3 |
The
patient may terminate the use of Home Telehealth at any time
without fear of loss of healthcare from health care providers,
payers or other participating providers. |
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2.1.4 |
Patient
Privacy and Confidentiality |
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2.1.4.1 |
Patient
privacy must be maintained at all times while receiving Home
Telehealth. This includes provisions at the patient's location
as well as the location receiving the patient's information. |
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2.1.4.2 |
Any
collected data that is made available outside of the clinical
environment must be presented in the aggregate |
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2.1.5
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Patient/Caregiver/Home
Assessment: |
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2.1.5.1 |
During
a face-to-face encounter, a comprehensive patient assessment
needs to be completed in order to accurately apply inclusion
and exclusion criteria. A face-to-face visit may be completed
in the home, hospital, office, clinic, school, etc. |
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2.1.5.2 |
Patients
who require special assistance must be identified prior to installing
a Home Telehealth tool. Organizational policy and procedures
need to be developed and implemented to manage language or physical
barriers in order to assure that these patients are not discriminated
against. |
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2.1.5.3 |
During
a face-to-face visit, the caregiver will be evaluated to determine
their willingness and ability to assist the patient in Home
Telehealth encounter as appropriate. |
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2.1.5.4 |
During
a face-to-face visit, an assessment must be conducted to determine
access to utilities and safety concerns appropriate for equipment
installation. |
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2.1.6
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Patient
Plan of Care - Care plans are developed differently for different
needs such as disease management, rehabilitation, remote vital
sign collection, interactive home care, etc. The format and
requirements may differ depending on the service provided but
the following principles should always be followed. |
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2.1.6.1 |
The
patient's plan of care will be developed in collaboration with
the patient and all appropriate providers. The plan of care
will include Home Telehealth encounter frequency. |
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2.1.6.2 |
The
use of Home Telehealth must be included in the Plan of Care
and customized based upon specific needs identified for each
patient. |
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2.1.6.3 |
The
patient's physician and/or health care provider should be informed
of Home Telehealth. A physician order may be obtained as appropriate.
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2.1.6.4 |
Home
Telehealth may be incorporated into critical pathways. |
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2.1.7
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Patient
Education |
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2.1.7.1 |
Patients
or their designees should receive training on equipment to be
used in monitoring and managing their health care needs prior
to their use of any Home Telehealth equipment. |
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2.1.7.2
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Education
about the home telehealth equipment should include: proper handling,
storage, operation, and electrical connection, phone requirement
if any, cleaning. |
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2.1.7.3 |
Additional
information should include any peripherals to be used, the purpose
of each peripheral and their proper use, frequency of monitoring,
and/or visit schedule. |
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2.1.7.4 |
Clear,
simplified written information regarding procedures to operate
and maintain equipment must be provided. Such information may
include diagrams and pictures, to facilitate the appropriate
place and use of peripheral equipment and available in different
languages as needed. |
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2.1.7.5 |
Patients
must be given clear written instructions as to who to call in
case technical problems arise with the medical equipment. |
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2.1.7.6 |
Safety
instructions should be given to patients and reviewed at installation
and future times as necessary. |
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2.1.7.7 |
Education
and training should be used to empower patients about appropriate
self-care. |
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2.1.7.8 |
Written
instructions must be provided to patients for after-hours care
when or if appropriate. |
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2.1.7.9
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Patients
need to be informed in writing of the difference between using
Home Telehealth and an emergency medical response system to
avoid a potential delay in need for "911" emergency care. |
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2.1.7.10 |
Patients
or their designated caregiver must demonstrate the ability to
use and maintain the equipment according to organizational policy. |
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2.1.8 |
Performance
Improvement - Organizations providing patient care must have
plans to measure quality of and satisfaction with care. |
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2.1.8.1 |
Patient
satisfaction regarding Home Telehealth should be a part of the
Performance Improvement Process. |
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2.1.8.2 |
Provider
satisfaction regarding the use of Home Telehealth should be
a part of the Performance Improvement Process. |
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| 2.2 |
Health
Provider Criteria
Organizations provide Home Telehealth as a tool that enables
health care providers to improve care delivery and empower patients
to actively participate in their care. |
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2.2.1 |
Home
Telehealth Providers |
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2.2.1.1 |
Home Telehealth
may be provided by a licensed health care provider including
but not limited to:
- Registered
Nurses
- Pharmacists
- Physical
Therapists
- Social
workers
- Speech
Therapists
- Physicians
- Psychologists
- Occupational
Therapists
- Licensed
Practice Nurses
- Nutritionists
- Nurse
Practitioners
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2.2.2 |
Provider
Education |
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2.2.2.1 |
Home
Telehealth providers as listed in this section must be trained
and competency validated in performing Home Telehealth with
the technology being used by the organization. |
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2.2.3 |
Administration |
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2.2.3.1 |
In
case of equipment failure, a procedure to ensure prompt patient
contact and measures to ensure continuity of care must be in
place (i.e. conduct an in-home visit, go to the Emergency Room,
etc.). |
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2.2.3.2
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The
patient's medical record will comply with organizational standards
for documentation. |
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2.2.3.3 |
Each
state will determine reciprocity regarding interstate Home Telehealth
practice. |
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2.2.3.4 |
Providers
of Home Telehealth should provide evidence of HIPAA compliance. |
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| 2.3 |
Technology
Criteria |
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2.3.1 |
Patient/Patient
need |
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2.3.1.1
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The
type of technology used should be based on the patient's clinical
needs and functional ability to use the equipment and the availability
and cost effectiveness of the technology to meet these needs. |
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2.3.2 |
Organizational
Criteria |
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2.3.2.1 |
Organizational
policies and procedures should be developed and followed regarding
equipment quality control standards. |
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2.3.2.2 |
Procedures
must be written and in place to clean and maintain equipment
(per organizational health and safety codes and infection control
standards) at installation, while in the patient's home and
on return to organization. |
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2.3.2.3 |
Installation
kits should be developed with written instructions for the staff
and should include supplies if needed. |
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| 3 |
Interactive
Home Telehealth Guidelines
These guidelines are specific to the use of Interactive Home
Telehealth. |
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| 3.1 |
Patient
Criteria |
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3.1.1 |
Patient
Privacy and Confidentiality |
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3.1.1.1 |
Patients
should not be viewed through the video or heard through audio
without their knowledge or prior written consent. |
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3.1.1.2
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If
other telehealth personnel or visitors come into the audio and/or
video-receiving site, the patient must be made aware of their
presence, and patient's approval must be obtained for such personnel
to participate in the Interactive Home Telehealth encounter. |
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3.1.1.3 |
If a third remote site is participating in the Interactive Home
Telehealth encounter the patient must again be aware and approve
of such participation. |
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3.1.1.4 |
Patient
photographs cannot be used without the patient's written permission. |
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3.1.1.5 |
Patient
data may not be viewed at the central station or other remote
networked location without the Clint's prior written consent. |
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3.1.2 |
Patient
Plan of Care |
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3.1.2.1 |
An
Interactive Home Telehealth encounter frequency order needs
to be incorporated into any plan of care. |
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3.1.2.2 |
Each TeleHealth encounter should be documented according to
organizational policy. |
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3.1.2.3 |
Changes
in telehealth frequency will be treated like changes in other
parts of the plan of treatment and should be approved by the
physician and/or health care provider. |
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3.1.2.4 |
If data is obtained during the Home Telehealth encounter, the
data must be placed in the patient's chart. |
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| 4 |
Telemonitoring
Guidelines
These guidelines are specific to the use of telemonitoring. |
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| 4.1 |
Health
Provider Criteria |
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4.1.1 |
Health
provider |
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4.1.1.1 |
Organizations
use data monitoring to monitor patient parameters and to initiate
a plan of care when parameters deviate from the norm. Organizations
should develop guidelines, policies and procedures to be used
regarding the monitoring of patient parameters and what to do
if data deviates from the norm. |
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4.1.2 |
Organizational
guidelines and policies should: |
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4.1.2.1 |
Establish the method for monitoring each data element enumerated
in the data definitions. |
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4.1.2.2 |
Include
reference to the frequency of monitoring, the mode of monitoring,
as well as the timing, frequency and method of data capture
and transmission (e.g., Will the glucose data be uploaded daily,
weekly, immediately?) |
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4.1.2.3 |
Define procedures to review and respond to the monitored data.
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4.1.2.4 |
Address
definition of acceptable values and actions in response to out
of range values. |
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4.1.2.5 |
Expected timeliness of response to patient data |
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4.1.2.6 |
Define
policy for off-hours coverage of uploaded data and the use of
automated alert systems. |
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4.1.2.7 |
Clarify
the policy regarding the inclusion of monitored data in the
patient's longitudinal medical record/EMR. The policy will include
the personnel or organization that decides on the inclusion
of data in unclear cases. The policy will state the inclusion
of data in the EMR based on clinical significance, anticipated
future value, or other factors. |
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4.1.3 |
Procedures
for handling "unwanted events" should be established and available
for all involved persons. |
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4.1.4 |
A
process should be developed to ensure competencies in the delivery
of health care through data monitoring technology. |
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| 4.2 |
Technology
Criteria |
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4.2.1 |
The
data elements being monitored will be clearly defined. |
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4.2.2 |
All
clinically relevant distinctions will be made in the definitions.
These distinctions may include automated capture vs. manual
entry, type of instrumentation, etc., and may include other
distinctions in method or data source if clinically important. |
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4.2.3 |
Monitored
parameters should be available for manual and computer based
analysis both separately and together. |
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4.2.4 |
Every
change made at the remote monitoring equipment should be logged
with a date and the ID of the user who performed the operation. |
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4.2.5 |
Data
should be date and time stamped and protected from tampering
as compliant with HIPAA. |
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4.2.6 |
Use
of Sensor Technology |
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4.2.6.1 |
If a detached remote sensor is employed for a home communications
unit the following is required: |
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4.2.6.1.1 |
Indication
of out of range for wireless operation |
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4.2.6.1.2 |
Indication
for low battery status |
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4.2.6.1.3 |
Indication
that the sensor is working properly |
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4.2.6.2 |
The
sensors should not damage or irritate the patient's skin, and
should not irritate the patient during sleep. |
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4.2.6.3 |
The
sensors should not contain elements that pose a danger if chewed,
licked or otherwise manipulated by the patient. |