Transcript HITPOTHACOAM14_Presentation - The American Health Lawyers

Health Information
Technology—Advancing the
Value and Safety of Care
June 30, 2014 | 12:30-1:45 pm
This luncheon is brought to you by the
Health Information and Technology, Physician
Organizations, and Teaching Hospitals and
Academic Medical Centers Practice Groups, and
the Accountable Care Organization Task Force.
Faculty :
Kathy Kenyon, JD, MA
Office of the National Coordinator
U.S. Department of Health & Human Services
Washington, DC
[email protected]
Disclaimer: These materials and any opinions
expressed are mine and do not necessarily reflect
the official policy of ONC or of any other agency of
the U.S. government.
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What I’ll Cover
 Electronic health record-(EHR-)enabled hospitals have the attention of
surveyors from the Centers for Medicare & Medicaid Services (CMS)
and Accrediting Organizations (AOs) (e.g., The Joint Commission);
 Today’s focus—CMS Surveys and Hospital Conditions of Participation
(CoPs);
 Safety Assurance Factors for EHR Resilience (SAFER) Guides; and
 Examples of EHR problems, fixes, relevant CoPs, and helpful SAFER
Guides.
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Health IT Safety and CMS
 Hospitals must satisfy the CMS CoPs for Medicare participation.
 CMS surveyors conduct certification, recertification, complaint and validation
surveys:
 Hospitals accredited by AOs with CMS “deemed status,” such as The Joint
Commission, meet CMS certification and recertification requirement
through accreditation surveys.
 The U.S. Department of Health and Human Services’ (HHS’) Health IT Safety
Plan, July 2013, recognized CMS surveys as playing an important role in
ensuring health information technology (IT) and EHR safety.
 CoP “deficiencies” typically lead to “plans of correction,” but can lead to path
toward termination from Medicare for uncorrected “condition level”
deficiencies.
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CMS Surveys
 CMS surveyors report seeing more and more EHR-related issues and
expect this to be an area of increasing concern:
 CMS memo to state agencies on use of EHR “navigators” during
surveys (memo 14-31, posed 5-16-2014).
 CMS’ Survey and Certification group and the Office of the National
Coordinator (ONC) have conducted webinars for surveyors to help
with surveys in EHR-enabled settings.
 CoPs are technology neutral; none specifically on EHRs.
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Resource on EHR Safety
 For hospitals, avoiding deficiencies associated with EHR use should be
part of preparation for a survey.
 Hospitals are responsible for plans of correction that specifically and
quickly mitigate identified deficiencies.
 ONC resource on EHR safety that should help health care organizations
assess, avoid, and mitigate potential problems during surveys—SAFER
Guides.
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ONC’s SAFER Guides
 Nine self-assessment guides in known risk areas;
 158 Recommended Practices;
 Worksheets, examples, references, and citations to relevant Health
Insurance Portability and Accountability Act, meaningful use, and EHR
certification regulations; and
 Based on best evidence available by top health IT safety experts and field
tested.
“SAFER Guides” in your browser will take you to:
www.healthit.gov/safer/
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SAFER Guides
Foundational
 High Priority Practices
 Organizational Responsibility
Clinical Processes
 Patient Identification
 CPOE with Decision Support
 Test Results Review and Follow-up
 Clinician Communication
Infrastructure Support
 Contingency Planning (for Downtimes)
 System Interfaces
 System Configuration
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Root Cause Analysis of Deficiencies in
EHR-enabled Hospitals
 Plans of corrections must address the underlying causes of deficiencies
cited under CoPs.
 Problems related to EHR implementation and use almost always involve
both technical and social factors.
 Eight “sociotechnical” factors hospitals should consider as part of their
analysis of the problem and corrective action:
 Built into SAFER Guides.
Adapted from Sittig, Singh, “Defining Health Information Technology–related
Errors: New Developments Since To Err Is Human.” Archives of Internal
Medicine 2011;171:1281-4.
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Sociotechnical Factors
 Hardware and software;
 Clinical content—built into EHR systems;
 Human-computer interfaces;
 People;
 Workflow and communication;
 Internal organizational issues—P&P, culture, leadership;
 External rules and regulations; and
 Measurement and monitoring.
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EHR Problem Examples
 Drawn from real life—facts have been combined or altered slightly.
 For more examples and parts of the ones used here, see ECRI
Institute, Deep Dive: Health Information Technology (2012). Study
of 171 health IT-related events.
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#1—Critical Lab Results Lost in Poor Interface
 Lab results showing pending organ failure did not reach the hospital’s
transplant surgery database.
 Organ transplant staff knew some labs did not reach their database, so they
reviewed physicians’ inboxes for lab results, manually entered missing labs
in the transplant database, and deleted lab results from the physician’s
inbox.
 In this case, a staff person failed to enter lab results in the transplant
database; no one noticed.
 After release home, patient died as a result of organ transplant rejection.
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#1—EHR Problems
 Incomplete system interface between lab and transplant surgery
components of EHR system led to missing data in medical records
relied upon for clinical care.
 “Workarounds” involving “hybrid” paper/person processes are
subject to failure, much more than electronic interfaces.
 No monitoring to ensure follow-up of abnormal lab results.
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Fixing #1
 Rebuild and test the interface between the lab and transplant
surgery EHR components to ensure complete transfer of lab
results;
 Create monitoring process to ensure critical lab results are, in fact,
followed up; and
 Use the EHR to support the follow-up process, and educate staff on
how to use that functionality.
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SAFER Guides Resources
 Applicable SAFER Guides:
 System Interfaces
 Test Results Review and Follow-up
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CoP Deficiencies
 In each case, surveyors focus on CoPs closely related to the specific facts.
 However, in all cases, other CoPs might be appropriate to investigate
further, depending on the facts, including:
 Governing Body—when problems are systemic and pervasive, they
suggest failure of the governing body to provide appropriate oversight;
 Patient’s Right to Care in a Safe Environment; and
 Quality Assurance and Performance Improvement (QAPI). If the
hospital did not identify the adverse event, analyze it, and take
corrective action, this suggests QAPI program problems.
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#1 CoP Deficiencies
Medical Record deficiencies:
 §482.24(c)(4)(vi)(A-0467)—Each record must contain all orders, nursing notes, reports
of treatment, medication records, radiology, and laboratory reports, and vital signs
and other information necessary to monitor the patient’s condition, by the person
responsible for providing or evaluating the service.
 §482.24(c)(1)(A-0450)—All entries must be legible, complete, dated, timed, and
authenticated.
 §482.24(c) (A-0449)—information to describe the patient’s progress and response to
medications and services.
 §482.24(b) (A-0438)—medical records must be accurately written, promptly
completed.
§482.24 Condition of Participation: Medical Record Services(A-0431)—Due to the
systemic, serious nature of the deficiencies, Condition-level citation appropriate.
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#1 CoP Deficiencies
After further investigation, citation under the following may also be
warranted:
• Discharge Planning - §482.43(c)(5) (A-0820)—As needed, the
patient and family members or interested persons must be
counseled to prepare them for post-hospital care.
• Transplant-specific requirements under §482.72–76.
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Plans of Correction
Related but not identical to “Fixes” above:
POC requires
• Quick implementation
 Although the longer-term solution of rebuilding the interface is
better, the hospital must also use interim measures to come into
compliance; and
• Explicit linkage to specific CoP requirements, e.g., what steps will ensure
medical records are complete, accurate, promptly filed, and accessible?
How and when will discharge planning instructions be improved?
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#2—Confusing eMAR
 Physician uses CPOE to order Morphine 30mg extended-release every 12 hours,
with option of smaller dose of Morphine 5mg immediate-release morphine for
breakthrough pain in between.
 eMAR dosing information displayed in a way RNs could not easily see.
 Patient complained of intense pain; RN checked eMAR and saw 2 orders:
Morphine 30 mg extended-release Q12 hours
Morphine 5 mg immediate-release as needed
 RN gave Morphine 30mg immediate-release instead of Morphine 30 mg
extended-release, causing respiratory arrest.
 Patient was successfully revived.
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#2—EHR Problems
 The eMAR system used by the nurses at the point of care did not display
dosing information received from the CPOE in a usable format:.
 Configuration decision at human-computer interface by the hospital or
eMAR developer. Should be caught by testing before clinical use.
 Clinical decision support (CDS) did not alert potential overdose of
morphine.
 Clinical judgment. Staff must question what they see in EHR systems.
 Failure to report hazardous situation. Had other nurses seen this problem in
the eMAR but not reported it?
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Fixing #2
 Fix eMAR display of dosing information—may require cooperation of health
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IT developer;
Test interfaces to ensure accurate and complete dosing information reaches
eMAR;
Improved CDS alerts prior to administration of medications with high risk
for overdosing;
User training on eMAR use, including exercise of clinical judgment and
questioning;
Report hazards related to eMAR usability; and
Monitor and follow up on complaints and events associated with
medications, including CPOE, CDS, pharmacy systems, and eMAR.
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SAFER Guides Resources
 Applicable SAFER Guides:
 System Configuration
 System Interfaces
 CPOE with Clinical Decision Support
 Organizational Responsibility
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#2 CoP Deficiencies
Medical record deficiencies:
 §482.24(c)(1)(A-0450)—All entries must be legible, complete, dated, timed,
and authenticated.
 §482.24(c)(4)(vi)(A-0467)—Each record must contain all orders . . .
medication records . . . and vital signs and other information necessary to
monitor the patient’s condition, by the person responsible for providing or
evaluating the service.
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#2 CoP Deficiencies
Other likely deficiencies:
 §482.23(c) (A-0405) Medication Administration—Drugs must be
prepared and administered in accordance with . . . the orders of the
practitioner responsible for the patient’s care, and accepted standards
of practice.
 §482.25 Pharmacy (A-0490)-pharmaceutical services meet the needs
of the patients . . . developing policies and procedures that minimize
drug errors.
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#2 Plan of Correction
 Dosing information in EHR should be configured to show all
information needed for safe clinical use.
 Immediate—Implement policy and procedure on administration of
high-risk medications that does not rely on EHR, with education.
 Other?
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#3—Down, Slow, Too Far Away
 Nurses and physicians given laptop computers to document, order, and
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review medical records.
In some units, the wireless internet is not reliably available; staff forced
to make notes on paper and wait in line to get access to a desktop
computer.
They’ve complained to management.
Clinicians report “wrong patient” documentation and orders and
untimely care due to delays for time-critical medications and diagnostic
studies.
Record often does not accurately reflect time care is delivered because
documentation does not happen at the time of care.
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#3—EHR Problems
 Ordering and documentation systems are not reasonably accessible or
available:
 “System configuration" problem. The hospital is not providing enough
hardware or internet access to allow for timely orders, documentation, or
access to records;
 Security contingency planning problem re: system availability. Lack of
reliable internet is not acceptable;
 Exacerbates “wrong patient” problems;
 Failure of leadership to address known problems; and
 Policies and procedures should be in place to prevent downtimes/
slowdowns, and, when they occur to have clear processes to "drop to paper"
and to promptly recover complete and accurate electronic record systems.
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Fixing #3
 Wireless internet access always available in all clinical areas;
 More computer access points, close to patient care, to enable prompt
documentation and ordering in EHR;
 Stronger EHR mechanisms to avoid “wrong patient” identification;
 Policies and procedures are in place for “dropping to paper” during a
downtime and for ensuring information during the use of paper is
recovered in EHR; and
 Governing body and leadership oversight and follow-up of reporting EHRrelated hazards is improved.
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SAFER Resources
 Applicable SAFER Guides:
 Contingency Planning
 System Configuration
 Patient Identification
 Organizational Responsibility
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#3 CoP Deficiencies
Medical Record Deficiencies:
 §482.24(b) (A-0438)—Medical records must be accurately written, promptly
completed, properly filed and retained, and accessible.
 §482.24(c)(1) (A-0450)—All patient medical record entries must be legible,
complete, dated, timed, and authenticated in written or electronic form by
the person responsible for providing or evaluating the service provided.
 §482.24(c)(4)(vi)(A-0467)—Each record must contain all orders, nursing notes,
reports of treatment, medication records, radiology, and laboratory reports,
and vital signs and other information necessary to monitor the patient’s
condition, by the person responsible for providing or evaluating the service.
 §482.24(c) ( A-0449)—The medical record must contain information to
describe the patient’s progress & response to medications and services.
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#3 CoP Deficiencies
Possible other deficiencies:
 Governing Body
 Quality Assurance and Performance Improvement
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#3 Plan of Correction
Immediate:
 Create more computer access points;
 Improve downtime procedures and educate all staff;
 Establish effective monitoring and follow-up; and
 Policies/procedures for system maintenance to ensure access to and
availability of medical records and ordering functionality.
Long Term:
 Remedy wireless access issues.
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#3 Plan of Correction
Specifics needed for the immediate solution:
 Timeframe for purchase/install of computers?
 How many computers will be purchased?
 Timeframe for all other fixes?
 How will downtime procedures be tested?
 Do fixes address completing records promptly, ensuring all necessary
information available?
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