Critical laboratory reports

Safe Practice Recommendations ^[1]

1. Identify who should receive the results
   • The primary responsibility for receiving and following up on test results lies with the ordering physician
   • Laboratory results must be reported directly to the physician who can take action, not to an intermediary.
2. Identify who should receive the results when the ordering provider is not available
   • Develop a procedure to link each patient with either a physician or a service at the time of admission
   • Develop a call schedule/system that works to identify whom the results should go to when the ordering physician is not available
   • Role-based coverage models have proven more reliable than traditional call systems.
     → link each patient with a position/service designated at admission and then have an on-call system tied to that position ^[1]
3. Define what test results require timely and reliable communication
   • Maintain a prioritized list of critical test values/interpretations that require accelerated notification systems
   • Ensure the list is segmented into categories that correspond to differentiated notification time requirements
   • Ensure the list is reviewed and verified at least annually and includes a process for adding/dropping tests
   • Reference existing standards and evidence on criticality
   • Limit the number of tests categorized as highest priority (red)
4. Identify when test results should be actively reported to the ordering provider and establish explicit time frames for this process
   • Define appropriate notification time parameters for communicating critical test results according to urgency, e.g. within 1 hour, within the shift (target 6-8 hours), within 3 days. Example (all categories require acknowledgement):
     • Red category — requires stat pager, immediate clinical decision required
     • Orange category — results should be called; clinical decision required within hours.
       • maximize efficiencies of workflow issues
       • avoid unnecessary calls late at night
       • synchronize calls with other existing systems e.g. change of shifts etc.
     • Yellow category — results can be sent passively; clinical decision required within days
   • Describe explicit steps in notification system; describe when laboratories should initiate and follow up on notifying the ordering physician about critical test results
   • Develop a fail-safe plan for communicating critical test results when the ordering physician cannot be contacted within the designated time frame.
   • Hospitals should have fail-safe plans in place for reporting critical findings and to ensure that the patient will receive timely clinical attention!
5. Identify how to notify the responsible provider(s)
   • Identify and utilize the communication techniques that are most appropriate for the particular clinical situation, e.g. active push system for results requiring a prompt clinical response
     • Red category results should be called to the responsible physician; the physician must respond to a page
     • Results should not be left with secretary or nurse or just as emails
   • Ensure acknowledgement of receipt of test results by a physician who can take action for all categories (red, orange, yellow) of critical test values/interpretations
   • Systems should reliably ensure the hand-off to the responsible physician is complete if change of shift occurs
6. Establish a shared policy for uniform communication of all types of test results (laboratory, cardiology, radiology, and other diagnostic tests) to all recipients
   • Make the notification system explicitly clear to all stakeholders
     • Use read-back techniques in the process of acknowledging recipt of results
     • Develop a shared policy with the key elements of the quality improvement monitoring plan
     • Plan for annual review and validation
   • Encourage and foster shared accountability and teamwork across and between clinical disciplines
     • Implement face-to-face interdisciplinary change-of-shift debriefings for the handoff of laboratory, cardiology, radiology, and other relevant clinical information e.g. problem lists, allergies, medications, a to do list
     • Describe relative responsibilities of the laboratory, cardiology, radiology, the ordering physician, the on-duty physician, and the nurse
     • Address the importance of shared responsibility and partnering when facing a red category finding
   • Decide what information should be included as a minimal dataset to be communicated to the responsible person. Examples of a minimal dataset should include:
     • This is a red (orange) category finding
     • Significant comorbidities
     • Prior test results, if available
     • Related medications
     • Other relevant clinical information
7. Design reliability into the system
   • When ordering a test, include a minimal dataset of clinical information to support the interpretation of diagnostic tests
   • Create tracking systems to assure timely and reliable communication of test results. Develop special procedures for situations where delays typically occur:
     • After discharge
     • Ambulatory (cross departmental boundaries)
     • Late arriving
     • Other predictable relevant situations (shift changes, after-hours, surgeon in OR, etc.)
   • The responsibility for tracking and follow-up on positive findings lies with the relevant physician
   • Explore the possibility that laboratory, cardiology, and radiology would monitor the receipt (acknowledgement) and document handoff of findings
8. Support and maintain systems
   • Partner with patients in the communication about test results.
     Nothing about me, without me
   • Include family as appropriate, given consideration to confidentiality and regulatory compliance
   • Provide orientation and ongoing education on procedures for communicating critical test results to all members of the medical team
   • Provide ongoing monitoring of the effectiveness of systems, e.g. weekly failure rates, tests of call systems, response times
9. Support infrastructure development
   • Adopt advanced communication technologies (intranet access, LINE messaging, email to patients with attention to confidentiality issues)
   • Improve laboratory and other test system capabilities. Plan for integrated medical record solutions to link clinical information with laboratory results, as in the following:
     • Drug-drug interactions
     • Previous test results
     • Enable reporting of complex threshold criteria such as renal and pediatric dosing
     • Track trends in patient conditions
     • Link to medical record to identify first diagnosis of cancer or diabetes
     • Link documentation of acknowledgement fields to tracking reports to monitor feedback loop
     • Evaluate the use of Point-of-Care (POC) testing in critical and ambulatory areas; integrate POC results with other test results and make them available to other physicians

① Manage the critical values database

• responsible for data validation/accuracy of laboratory results
  possibly supported by laboratory accreditation such as: CAP ± CLIA.
  CAP: College of American Pathologists
  CLIA: Clinical Laboratory Improvement Act
• design, implement, and manage a hospital database of critical laboratory values:
  • Although hospitals have thresholds about which results to notify, these nearly always include many results that are not truly critical, thus greatly increasing the number of calls and diluting the sense of urgency with which the notifications are received by physicians!
  • start with hospital-wide, reviewed annually
  • progress to specialty-specific
• compile, and store safely, evidence that the process is operational:
  • minutes of meetings discussing management of critical values database
  • up-to-date list of critical values
  • documentation of requests to changes to critical values

② Inform the medical team of items that exceed the specified limit

• responsible for data validation/accuracy of laboratory results
  possibly supported by laboratory accreditation such as: CAP ± CLIA.
  CAP: College of American Pathologists
  CLIA: Clinical Laboratory Improvement Act
• design, implement, and manage a hospital database of critical laboratory values:
  • start with hospital-wide, reviewed annually
  • progress to specialty-specific
• compile, and store safely, evidence that the process is operational:
  • minutes of meetings discussing management of critical values database
  • up-to-date list of critical values
  • documentation of requests to changes to critical values

⑤ Confirm the medical team received and acted

⑦ Audit compliance with standard guidelines

⑧ Develop EBM guidelines and train medical teams to use them

⑨ Indicators for evaluating appropriateness and effectiveness

Project Monitoring Indicators

1. Notification success rate. Documented feedback from doctor that he was notified by the laboratory

   1. Physician directly acknowledges being notified by the laboratory
   2. Physician activates the order system in the digital medical record and confirms sighting of the laboratory warning

2. Appropriate management rate. Physician compliance with standard medical guidelines

   1. Audit results by laboratory item
   2. The number of new hosital guidlines created and implemented

3. Clinical (survival) rate. Patient survival by laboratory item

   1. at 48-hour after the laboratory made the first notification
   2. at the time the patient was discharged from the hospital

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