EMRAM Acute Care Stage-6 Preparatory Guide 2018V4
EMRAM Acute Care Stage-6 Preparatory Guide 2018V4
EMRAM Acute Care Stage-6 Preparatory Guide 2018V4
2018V4
Organization Reviewed:
Review Date:
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Welcome
Congratulations to your organization for the progress you have made in getting to this
point in your Electronic Medical / Patient Record adoption journey. As you prepare for
your official Stage 6 validation, we present you this Acute Care EMRAM Stage 6
Preparatory Guide as a tool to help steer you through the validation process. To initiate
the process, contact your nearest HIMSS Analytics representative.
The EMRAM Stage 6 validation process consists of two parts: A Pre-Validation Planning
Conference Call to review the agenda, discuss the scope of the validation, address any
outstanding questions and confirm the validation date. The second part is the on-site
validation itself
The On-Site Validation visit will focus on all Stage 6 criteria. It will include an opening
presentation followed by visits to several hospital departments. It will also include
interviews with clinical staff (nurses, doctors, pharmacists, allied health professionals,
etc.) to validate processes in use as they relate to the EMR and overall technology
environment.
At the conclusion of the on-site visit, the reviewer will announce the official validation
decision and lead a summarized discussion of the organization’s observed strengths and
opportunities for improvement. The on-site validation is not a pass or fail exercise, but
more an external test of capabilities. The onsite validation process is an opportunity for
the hospital to formally measure itself against the capabilities prescribed by the HIMSS
Analytics EMR Adoption Model.
The Stage 6 status is valid for three years. We will contact you in advance of the expiration
date to begin the revalidation process. However, we would encourage you to continue
progressing and achieve Stage 7 before your validation expires. We will provide to you a
Stage 6 certificate to be prominently and proudly displayed in the hospital. More
information on the revalidation and Stage 6 certificate will be provided upon successful
completion of a Stage 6 validation.
Please share internally and make the best use of this document during your Stage 6
preparations as it will also be used by the reviewer during the validation visit. Once again,
congratulations and we wish you the very best outcome from our time onsite with you.
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Pre-Validation, Planning Conference Call
During the Pre-Validation conference call, HIMSS Analytics will guide your team through
the On-Site Visit agenda. This is an opportunity for your team and HIMSS Analytics to
ensure you are ready for the On-Site Visit. You should review the sample agenda
(Appendix A) and the requirements in the Preparatory Guide in detail in advance of this
call and then use the opportunity to ask questions or receive clarifications.
By the end of the conference call, both parties should feel comfortable moving forward
with the validation, at which point HIMSS Analytics will begin making travel
arrangements for the assessment.
The expected hospital participants for this call should include the core EMRAM Stage 6
project team and any others the hospital deems necessary.
The review team will ascertain the comprehensive nature of nursing and allied health
professional documentation in the system. To reach Stage 6, it is required that (≥90%) of
all nursing and allied health professional documentation and that (≥50%) of physician
documentation is in the EMR, excluding the Emergency Department.
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IT Security
IT security (ITSEC) deals with the protection of information technology against
unauthorized access to, or modification of information, whether in storage, processing,
or transit and against denial of service attacks that prevent authorized users from
accessing the network and systems, including those measures necessary to detect,
document, and counter such threats. It also deals with the protection and maintenance of
data confidentiality, integrity, availability, and accountability. The tools used to enable
IT security capabilities may include encryption, firewalls, single sign-on, spam/spyware
filters, anti-virus/anti-malware applications, etc. The EMRAM security requirements
become progressively more comprehensive from Stage 2 through to Stage 7.
To qualify for EMRAM Stage 6, the organization must have the capabilities listed in the
following table. The hospital must provide a presentation that addresses the items
outlined in the table below.
P: Present A: Absent
P A
Physical access policy to IT system / datacenters in place.
1.
[DATE]______________ Physical access policy was last reviewed/updated
EMR new user security training program is in place.
2.
__________% new users trained before gaining access to the EMR
EMR refresher security training program in place.
3.
__________% existing users trained in last 12 months
Acceptable use policy for IT system is in place.
4.
[DATE]______________ Policy was last reviewed/updated
Training program for acceptable use of the IT system is in place.
5.
__________% all users trained in last 12 months
6. Storage of patient data on local devices is prevented.
Data destruction policy in place.
7.
[DATE]______________ Policy was last reviewed/updated
8. Device encryption in place (e.g., hard drives, SSDs, external storage devices, etc.).
9. Anti-virus, anti-malware tools in place.
10. Intrusion detection system in place.
11. Intrusion prevention system in place.
Portable/mobile devices (hospital-owned assets) security.
12. - Devices recognized and authorized to operate on network
- Devices can be remotely controlled / wiped
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Portable/mobile device security policies apply to BYOD4.
Addresses types of devices allowed and services and applications available
13. Addresses use or prohibition of personal (owner) messaging tools/apps (e-
mail, text, etc…) to process and/or communicate patient information
Addresses storage of patient information on personal devices (e.g., encryption
requirements, remote wiping requirements, etc.)
Business Continuity
As with IT security, the review team needs to see how the investment in business
continuity has become an operational priority recognizing the enormous risk the hospital
faces from prolonged downtime. Therefore, the hospital should provide a high-level
overview of how it makes a summary of patient information available to clinicians during
a downtime and describe how they access this information.
P A
Summary reports are available on PC/workstation on the wards when
16. the system is down – PC/workstations on a generator circuit or UPS and
direct connected to a printer on a generator circuit or UPS.
17. Summary reports include patient allergies.
18. . Summary reports include patient medication list.
19. Summary reports include patient problem/diagnosis list.
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Technology-enabled bedside identification must be in use for medication and blood
product administration. It must also be in use for human milk (mother’s expressed breast
milk) administration only if the milk is kept in communal storage.
Note
The hospital cannot be validated at Stage 6 if the process is used in less than 50% of the
hospital and is not available for use in the ED, and if all medications, mother’s milk or
blood products are not included where this process has been implemented.
P A
Patients attempted to scan at the bedside.
20. % (Std: ≥ 50% - no more than fifty (50) percent can be excluded from scanning for inpatients).
Hospital Tour
Medical and Surgical Wards
(NB: Visit at least one non-intensive care unit ... review medical / surgical charts)
In dialogue with nursing personnel, the review team will want to understand and see
demonstrated the key uses of the system for nursing professionals. These discussions will
focus on nursing notes, nursing diagnosis documentation, nursing orders or tasks,
nursing risk assessments, vital signs and flowsheets, care plans, medication review and
the e-MAR.
The review team will also speak with the professions allied to medicine to understand how
ancillary care documentation is used. They may ask to see representative samples of non-
nursing clinical documentation in both medical and surgical charts. Anything charted on
paper by any discipline considered part of the legal medical record must be treated as
clinically relevant.
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The reviewer will also speak with nurses on the process of administering blood products
and human milk. Achieving Stage 6 requires technology-enabled support for blood
products administration at the bedside for at least 50% of all administrations. It must
also be available for use in the ED. Technology-enabled verification must be part of the
process, the extent of which may vary depending upon whether the core EMR product is
approved by the government to communicate with a Blood Banking System. If it is
approved, the review team will expect full technology-enabled verification with the blood
products prepared by the blood bank personnel.
a) In the case where the core EMR has government clearance to communicate with a
non-core technology vendor product for blood products, the review team will
expect equally full communication through technology that the unit(s) prepared by
the blood bank personnel is indeed the unit(s) that is about to be administered to
the patient.
b) In the case where the core EMR is not approved to communicate with the blood
banking system, the review team will expect a process where blood bank personnel
scan the product(s) into the core EMR and nurses scan the products(s) to ensure
that the exact same products(s) are being administered to the patient.
The Stage 6 requirement for technology-enabled expressed mother’s milk support is that
it must be present and operational at least 50 percent of the time where mother’s milk is
communally stored and administered. The intent is that the mother’s milk can be
attributed to and verified as belonging to the baby or the mother. This process should be
described during the opening presentation using a process flow diagram and screen shots
of the solution in use. It will also need to be demonstrated as much as possible on the
applicable ward.
The review team will speak with clinicians focusing on CPOE, clinical decision support
(CDS) alerting, and physician documentation with structured templates generating
discrete data that can drive a rules engine. The review team will expect to see at least one
example of a CDS rule that is triggered by clinician documentation.
P A
24. At the bedside, nurse scans the patient’s technology-enabled wristband.
At the bedside, nurse scans technology-enabled medication, blood
25.
product, and human milk.
At the bedside, system performs “5 rights” check. Failure of any “right”
26.
triggers an alert for the nurse interrupting the administration process.
Otherwise the system provides clearance to administer the medication,
27.
blood product, or human milk.
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Once administered, the nurse verifies administration in the eMAR at the
28.
bedside and the patient’s medication profile is updated.
Overrides are possible; hospital has an override management review
29.
process. Explain:
Exceptions to ideal, paperless work flow:
Nurses can give medications without order present in the system or
30.
without order verification via approved nursing standards of practice.
Clinical Documentation
Success
The hospital implemented nursing applications that support the collection of patient care
documentation created from nursing interventions, tasks, nursing notes, vital signs, etc.
If nursing documentation is delivered via disparate systems for labor and delivery (L&D)
or other services, a clear workflow that supports the transition of care and required
documentation for problem lists and medications lists, allergies, etc., for nurses needs to
be demonstrated. There should not be any ancillary clinical disciplines charting on paper.
The structured format of nursing documentation should generate discrete data such that
nursing assessments and risk scores can interact with the clinical decision support
system. If the risk score is high, the nursing care plan should contain tasks that associate
with high risk. Likewise for when the risk is low. Selecting from a common list of tasks
regardless of risk score introduces variation and should be avoided. Typical alerts suggest
recommended nursing tasks, care plans, or triage recommendations in the ED for the
nurses to consider. The system should also be able to support nurses with auto-
calculation of risk scores.
Note
A Stage 6 validation cannot be given if less than 90% of nursing and allied health
professional documentation is captured in the EMR.
P A
Nurse notes, nursing diagnosis documentation, nursing orders or tasks,
31. % vital signs, flowsheets, care plans, medication review and the e-MAR.
32. Vital signs.
33. Flowsheets.
34. Nursing notes.
35. Risk assessments.
36. Care plans.
37. Electronic medication administration records (eMAR).
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Medication reconciliation processes occur at admission, discharge and
38. level transfers, including reconciliation with home medications to be
taken/resumed after discharge.
The following ancillary clinical disciplines also chart in the system:
39.
Success
CPOE with multiple rules developed and deployed. Exploding orders as well as approved
“per protocol orders” count as CPOE because a clinician selected an order set that was
agreed upon by the medical staff, Pharmacy and Therapeutic Committee (P&T), etc.
Scribes or Doctors assistants can enter orders if allowed by law and governing regulations.
However, it is expected that the doctor is nearby when this is occurring so they can react
to rules and alerts. The review team must clearly understand the role of scribes in this
environment. Scribes reacting to best practice alerts intended for doctors is not
acceptable. The review team will check for this in the unit interview process. Drug/drug,
drug/allergy interactions, etc., must be active for all medication orders entered via CPOE.
Hospital should explain how they count the percentage of total orders entered by
clinicians for inpatients; the requirement is (≥50%) average for inpatients.
Note
Stage 6 validation cannot be awarded if less than 50% CPOE and/or no rules firing.
P A
40. The hospital has implemented CPOE.
IP (with or without ED) orders entered by clinicians or licensed
41. % independent practitioner at the computer.
(Std: ≥ 50% - no more than fifty (50) percent can be verbal / written for inpatients).
Clinical Decision Support with alerts or reminders is in use for the following:
42. Drug-drug interaction alerts are active.
43. Drug-allergy interaction alerts are active.
44. Drug-food interaction reminders are active.
45. Drug-lab alerts/reminders are active.
46. Dose range alerts (both high and low where appropriate) are active.
47. Duplicate order alerts are active, including for all diagnostic testing.
48. Cumulative dose alerts are active.
Order Set Build
49. Self-developed or third-party.
Organization-specific evidence based order sets (developed specifically
50.
for this organization).
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Medical Documentation
The structured format of doctors’ documentation should generate discrete data such as
diagnoses, problems, disease scores, risk scores, medication history, or allergies that can
interact with clinical decision support to drive order sets, clinical warnings or that interact
with specific treatment protocols or clinical pathways related to the diagnosis or co-
morbidity of the patient.
The specific documentation we focus on here includes the history and physical (H&P),
history of present illness (HPI), consult notes, progress notes, ED note, discharge note,
problems and diagnoses lists. Typical alerts suggest additional orders or suggest other
diagnostic actions to consider.
Success
Physician documentation has at least one rule firing. The review team will ask for and
verify that at least one rule example is active, and they will expect the rule demonstrated.
They will also expect to see discrete data generated from physician documentation for
interaction by the CDS system.
Note
A Stage 6 validation cannot be granted if medical documentation is delivered
predominantly through a dictation and transcription and/or voice recognition (VR)
capability that results predominantly in text blobs (little to no discrete data is generated).
The only exception to this is with the use of a natural language processing (NLP) capability
that the organization can clearly demonstrate is able to drive CDS alerting. Exclusively,
physician documentation without underlying CDS due to the use of a dictation and
transcription and/or VR process is not acceptable.
P A
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At least one best practice / CDS alert is active.
Provide example:
60.
Doctors access medical imaging reports and images from within the
61.
patient’s EMR either natively or through a context aware link.
62. Front-end speech recognition. (Not required)
63. . Back end speech recognition. (Not required)
Emergency Department
EMRAM Stage 6 does not prescribe a specific percentage requirement for orders that
must be directly entered by a physician via CPOE in the ED environment. The EMRAM
also does not prescribe a percentage requirement for wristbands scanned or medications
and blood products delivered via the technology-enabled closed-loop administration
process in the ED. However, these capabilities must be available in the ED and the
hospital must be prepared to demonstrate this process if requested by the review team.
P A
Doctors use structured templates that generate discrete data to
document care and drive CDS alerts. Explain an active CDS alert:
64.
Discrete data generated from the structured template (or NLP on free
65. text) is normalized to a standard/controlled medical vocabulary (e.g.,
LOINC, SNOMED, ICD-10).
66. Doctors use CPOE.
67. Nurses document in the EMR (e.g., flowsheets, assessments, etc.).
Closed-loop administration process can be used for medications, blood
68.
products, and human milk (if applicable) in the ED.
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Laboratory
The visit to the laboratory is to understand how technology enablement of sample
collection is carried out as it relates to supporting the closed-loop sample collection
process. Sample identification must be supported by technology from the point of
collection through to the testing process in the laboratory at least 50% of the time. The
information on the technology-enabled label must include all the information necessary
to allow the system to match the sample to the right patient throughout the sample
testing and reporting process.
The review team will also visit the hospital’s Blood Bank or the laboratory department
responsible for dispensing blood products to understand how technology enablement of
blood products is carried out as it relates to supporting the closed-loop blood product
administration process. Specifically, the hospital must demonstrate how it associates a
blood product with a patient in the EMR to support the technology-enabled identification
of the blood product at the bedside at the time of administration. HIMSS Analytics
recognizes the variations in blood bank processes that depend on whether the vendor
blood bank solution in use has been approved (e.g., FDA) to connect with the EMR, if
government approval is required, or if the blood bank is outsourced. If government
approval is required and a vendor is approved, or if government approval is not required,
the review team expects the blood bank to fully utilize technology in their processes. If
the blood bank is outsourced, the hospital is still expected to demonstrate how it
associates the blood products it receives to the patient in the EMR.
If government approval is required and the vendor is not approved, the review team will
expect to see a work-around process in place where the blood bank staff use technology
to positively associate (e.g., scan a barcode, QR code, RFID tag, etc.) the selected blood
product directly to the intended patient within the EMR. This should enable the nurse to
use the same identification technology on the blood product (e.g., scan the same barcode,
QR code, RFID tag, etc.) at the bedside with full CDS from the EMR to verify the right
blood product is being administered.
Note:
A Stage 6 validation cannot be granted if a technology-enabled verification process is not
in place 50% of the time to support nurses in verifying the product being administered.
P A
Blood specimens are technology-enabled (e.g., barcoded, QR coded,
69.
RFID tagged, etc.) at the point of collection.
70. Technology is used to match the specimen with the patient order.
71. Technology is used to link the patient order to a blood product.
A process is in place to disassociate a blood product from the patient in
72. the EMR when the blood unit is not administered and returned to the
blood bank or laboratory.
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Medical Imaging
The visit to medical imaging is conducted to verify that the hospital is indeed filmless for
radiologic and cardiologic exams. The review team will spend time with a radiologist in a
reporting room to review the findings documentation process, throughput and queue
management, and the initial and final results documentation and availability as well as
how the ED is supported by the medical imaging department.
The review team will expect to see the use of structured templates in the system (e.g., cut
and paste from templates developed in MS Word is not acceptable). The team will also
inquire about the capture of discrete data, if any (e.g., the size of a mass, length of a lesion,
radiation dosing, etc.) and what, if any, technology improves availability of findings to the
medical staff. If medical imaging services are not available in house 24 hours per day,
seven days per week, the review team will want to know what out-of-hours medical
imaging support is available to the organization.
Finally, the review team will want to know the hospital’s policy and associated capability
for digitizing film or ingesting images from CD/DVD received from patients or other
external sources and storing the images in the hospital’s EMR environment and making
them accessible by clinicians through the EMR. Conversely, the review team will want to
know that the hospital can print film or produce a CD/DVD upon request by the patient
or external entity.
Ideally, a hospital team member will be able to login using the role of a Cardiologist in
order to quickly show worklist management, image access and reporting capabilities from
this perspective. A demonstration of how this works would be sufficient, for EMRAM
Stage 6 HIMSS does not require a Cardiologist to be available or to visit the Cardiology
department.
Success
The hospital’s Medical Imaging department (radiology and cardiology) must be filmless
and PACS images are available for viewing remotely unless prohibited by hospital policy
or government regulations. The review team will want to understand the average
turnaround times for final reports by Radiologists/Cardiologists. The review team may
ask how the hospital handles images captured and read by the emergency department
during an evening / night ED visit when the day Radiologist/Cardiologist makes a change
to the diagnosis documented by the ED physician. For example, how and when is the ED
physician informed of the change?
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Note
A Stage 6 validation cannot be granted if Medical Imaging services are not filmless or if
diagnostic images and/or reports are not available outside of the imaging departments.
P A
Medical Imaging is filmless. If not, what modalities are still on film?
73.
Pharmacy
The pharmacy is reviewed to observe technology supported processes to ensure
medication orders from clinicians are appropriate and within safe practices. The review
team will want to understand the controls in place intended to ensure medications
received are tracked relative to accuracy of fill and refill processes.
The reviewers will observe the order verification process and any rights the pharmacist
has to modify or conduct a therapeutic substitution. The review team will expect to
understand the communication and documentation processes in place for cases when the
pharmacist intervenes to modify an order (e.g., change a dose, therapeutic substitution).
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Some hospitals do not have a 24x7 pharmacy operation. In such cases, the review team
will expect to understand the process for ensuring medication orders are verified either
through an auto-verify function and/or immediate retrospective review the next day
before nurses administer the next scheduled dose. The hospital must clearly describe how
and when orders are verified, and how communication occurs between the order reviewer
and the ordering clinician when an order may need to be modified. Additionally, the
review team will expect a pharmacist to describe the process for monitoring medication
administration overrides by nursing, including overrides associated with any ADM/ADC
that may be in use on the wards.
In cases where the medication order verification is not performed by the pharmacy, but
by other physicians or other qualified and authorized professional, this process must be
demonstrated on the ward. If this is the case, the role of the pharmacy related to any sort
of medication order review, drug compounding or ward stock delivery should still be
clearly described by a pharmacy staff member.
Order Verification
P A
81. Orders transmitted to pharmacy system for verification / dispensing.
Medication orders are verified before dispensing and first dose. The
pharmacy has a 24-hour coverage process or has a process in place to
82.
ensure all orders are verified (e.g., auto-verify, timely retrospective
review, etc.).
Medication profiles are automated / managed from transaction updates
83.
captured from ordering and medication administration processes.
Modified orders or recommendations to modify orders are
84.
communicated and documented in the EMR.
An override management process is in place in concert with Nursing
85.
reviews and addresses any trends in overrides.
Order verification CDS with alerts or reminders in use for the following:
86. Drug-drug interaction alerts are active.
87. Drug-allergy interaction alerts are active.
88. Drug-food interaction alerts are active.
89. Drug-lab alerts are active.
90. Dose range alerts (both high and low where appropriate) are active.
91. Duplicate orders alerts are active, including for all diagnostic testing.
92. Cumulative dose alerts are active.
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Medication Management
A review of the processes in place intended to ensure the medications are accurately
received and stored for distribution throughout the hospital. This includes medications
received in unit dose technology enabled packets and those that must be repackaged.
P A
Technology is in use and enables an accuracy checking process for
93.
supply coming in from the loading/receiving dock area.
The packaging process pertaining to those medications the hospital
94. received in bulk and repackages is well defined and supported by some
level of automation.
Once the medications have been packaged for dispensing, they can be
95.
retrieved by the nurse for administration to the patient at the bedside.
If ADMs/ADCs are in use, the stocking and storage process of non-
96.
ADM/ADC medications is supported by automation.
The stocking of the main inventory management system and the use of
97.
technology into and out of stock storage is supported by automation.
Most medications and IV fluids are labeled with technology-enabled
98.
labels.
The organization has a home medication policy, if home meds are
99. allowed to be administered they are both technology enabled and are
documented in the eMAR.
A process is in place to review and remediate any issues caused by
100.
medication mislabeling, wrong bin or other logistical incident.
The review team will also expect to understand how the hospital manages, stores, and
processes non-DICOM images. The hospital is expected to have a process whereby non-
DICOM images are scanned and indexed into the patient’s EMR. This criteria applies to
non-DICOM images created by medical devices, cameras, or other image capture devices
that are not directly interfaced to the EMR.
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Appendix A – EMRAM Stage 6 On-Site Validation (Sample Agenda)
Time Topic
Opening Session
Welcome & Introductions
Organization Overview
8:00 – 10:00 System Overview & Pervasiveness of Use
IT Security
Business Continuity
Technology-Enabled Closed Loop Scanning
10:00 – 10:15 Break
Closing Session
Validation decision
4:30 – 5:00
Review of findings and opportunities for improvement
Discussion (as needed)
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NOTES:
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NOTES:
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