For the purpose of this policy, the term revised will refer to any laboratory or patient report that has been revised, amended, or corrected.

Ongoing Program to Identify and Correct Problems that may Interfere with Patient Care Services,Test Quality, and Laboratory Safety Management 

Each clinical section is responsible for identifying and correcting problems that may interfere with patient care services, test quality, and laboratory safety management and documenting problems involving that laboratory that are identified internally, as well as those identified through outside sources such as complaints from patients, physicians, or nurses. All sections and all shifts must participate. Employees are encouraged to communicate any concerns or complaints. Any problem that could interfere with patient care or safety must be addressed. Clinical rather than business/management issues should be emphasized; however, these issues may also be reported. Investigation and resolution of all problems are documented either by the Section, by the Clinical Manager, or by the Quality Management Committee, as appropriate.

Methods by which LP sections detect and address clerical, analytical or instrument errors:

The LP must perform a root cause analysis of any unexpected event involving death or serious physical or psychological injury, or risk thereof (including "near misses" and sentinel events). Laboratories must be able to demonstrate appropriate risk-reduction activities based on such root cause analyses. To initiate a root-cause analysis, begin by recording the incident following the Occurrence Reporting System (ORS Reporting Policy). The CC is responsible for conducting the root cause analysis with the Deputy Director of Clinical Care. See above for details.

As problems arise, the sections should record deviations and problems on the Quality Improvement and Assessment Logs; QI Tracker; flag the issue in the LIS, report the problem via the Clinical Center ORS System, the Safety Tracking and Reporting System (STARS) ; report the problem to the SAC through the Quality Management Committee. These problems include sentinel events, physician complaints, patient complaints, communication breakdowns, and medical errors.

These issues are summarized and reported to the Quality Management Committee on an ongoing basis, usually monthly, when the committee meets, to identify trends and initiate appropriate corrective/preventive actions when opportunities for improvement are identified. An annual review of all problems and deviations occurs in November each year, after which the Quality Management Committee issues their recommendations to the Clinical Chiefs, so they may disseminate the information to their staff.

Comparison of Test Results

For tests that are performed using different methodologies or instruments or done at different testing sites, the individual sections must define mechanisms to verify the comparability of patient results throughout the clinically appropriate ranges. Such testing must be performed at least twice a year, and cover all methods performed by all testing areas accredited under the Laboratory of Pathology. Each section must assess a patient's test results that appear inconsistent with relevant criteria, when available: patient age, sex, diagnosis or pertinent clinical data, distribution of patient test results, relationship with other test parameters. Each section must document all test result comparison activities.

Correction of Laboratory Records

Revised Patient Reports

All inaccuracies in the medical record should be documented and significant revisions must be communicated at the time the inaccuracy becomes known. The correct test result or diagnosis should be made clear in an amended or revised report with the date of correction as soon as possible. The original inaccurate result should be reported as such in the medical record. The reason that the original result was reported incorrectly (i.e., due to error or other reason) may not be known and need not be reported in the medical record.

  1. For the purpose of this policy, the term revised will refer to any laboratory or patient report that has been revised, amended, or corrected.
  2. During sign out for all cases, the following prompt and instructions will appear: “Is this a revised report”? If there is an affirmative response from the pathologist, the following message will display, “A significant revised report must be communicated with a treating clinician for in-house cases or submitting physician for consult cases. This notification can be via telephone, secure fax, or secure email. The notified physician’s name, date and time notified must be documented in the SoftPath case report when the notification is acknowledged by the treating or submitting physician”.
  3. "Revised" means changes to patient results, accompanying reference intervals and interpretations, or patient identifiers, but not to minor typographical errors of no consequence. As clinical decisions or actions may have been based on the previous report, it is important to replicate previous information (test results, interpretations, reference intervals) for comparison with the revised information. The previous information and the revised information must be identified as such, and the original data must be present in the revised report (for paper reports) or linked electronically or logically to the revised information (in electronic reports).
  4. This requirement applies to electronic reports in the Laboratory Information System (LIS) and to the data systems interfaced to the LIS either directly or through middleware or an interface engine (but not to systems that are further downstream in the interface chain).
  5. The format of revised reports is at the discretion of the laboratory. For extensive interpretive or textual data (e.g., surgical pathology reports), replicating the entire original and revised. pathology reports may be cumbersome and render the revised report format difficult to interpret. In such cases, a comment in the revised report summarizing the previous information and the reason for the correction may be provided.
  6. Displays in an electronic medical record (EMR) downstream from the laboratory should include the original report as well as the revised report. The report elements listed in GEN.41096 should be included in the EMR.
  7. When there are multiple sequential corrections of a previously reported result, it is considered inappropriate to note only the last correction made. All corrections should be referenced in the patient report.
  8. When an incorrect result or diagnosis causes material injury to a patient, the correct result/diagnosis and the fact that the result has been changed must also be reported to the patient. For an inaccuracy caused by or directly involving a pathologist, the pathologist involved in the case should discuss the matter with the physician who ordered the pathology consultation. The two physicians should jointly determine how best to communicate the revised result to the patient.
  9. All revised reports of previously reported, incorrect patient results are identified as revised in a separate "Revised Report" and both the revised and original data are clearly identified in the SoftPath Laboratory Information System. 

How to create a revised report in SoftPath DX

  1. Step-by-step screenshots
  2. Submit ticket to LIS Coordinator: https://service.cancer.gov

When report errors are detected, the LP does the following:

Common situations that may occur in the Laboratory of Pathology requiring corrected reports may include, but are not limited to: clerical errors during accessioning submitted and consultative cases; transcription errors of source and types of material submitted by the operating room or medical/nursing staff; updated information obtained from additional testing such as NGS; and typographical errors by residents or attending pathologists during signout. 

  1. For minor clerical errors, the revised report with the correction must be entered in the SoftPath case number along with the reason for the correction annotated in the report.
  2. For significant revisions to patient report, the attending pathologist:
    1. Must immediately notify the patient's treating clinician via phone call, secure fax, or secure email;
    2. Document the revised report in SoftPath LIS, which clearly identifies the revised and original data;
    3. Document the date and time the treating clinician was notified of the revised report in the SoftPath LIS.
  3. If there are multiple sequential corrections of a single pathology report, all revisions must be referenced in sequential order on subsequent reports so that the treating clinician makes his clinical decision on the correct report.

Verification and documentation requirements for notification of significant revised reports:

  1. Phone Call and Read Back – the preferred method for LP’s pathologists to ensure the treating or submitting physician receives the revised report is to have the reporting attending pathologist directly contact the submitting or treating physician by telephone. Once the report is called, the attending pathologist or designee must document the date, who was notified, and that a readback occurred, in the SoftPath LIS report.
  2. Secure Fax – the attending pathologist must ensure that someone contacts the receiving facility by phone after sending a secure fax. The sender will document the name of the notified individual and date of the receiving physician’s notification when the physician confirms receipt of the revised report. This notification will be entered in the SoftPath LIS.
  3. Secure Email – sender will select ‘read receipt notification’ on all significant revised reports. When the read receipt is returned by email, the program assistant will document the read receipt date/by whom in SoftPath LIS.