Return to CAP Home
Printable Version

  CAP Laboratory Patient Safety Plan

title
 

Updated August 10, 2009

I. Overview

Over the past decade there has been increased focus on preventing errors and improving patient safety in all areas of medicine. The patient safety movement began in the early 1990s with the formation of the National Patient Safety Foundation and the Institute for Healthcare Improvement (IHI) and gained considerable momentum after late 1999 with the publication of the Institute of Medicine (IOM) report on medical errors, To Err Is Human. Subsequently, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) embraced improving patient safety as one of its core principles, and it revised all of its Standards to that end in mid-2001.

All areas in medicine have been involved with improving patient safety, including the laboratory. Several salient adverse medical incidents directly related to the laboratory and anatomic pathology practices have occurred in the last three years and they have been heavily reported in the media. The reports have underscored the sometimes devastating nature of outcomes from laboratory errors and the crucial role that the laboratory plays in the delivery of healthcare.

The College of American Pathologists (CAP) through the Laboratory Accreditation Program (LAP) has developed numerous quality standards and guidelines to assure high quality practice that contribute to patient safety. While these efforts have provided a level of safety and reliability in pathology practice and laboratory medicine, recommendations from published IOM reports presented the College with the opportunity to establish laboratory patient safety goals founded on medical error reduction and continuous patient safety improvement.

Over the past six years the CAP has become increasingly focused on patient safety issues and has asked some of its standing and ad hoc committees to make recommendations about the subject. Currently, the primary CAP standing committee charged with developing an integrated approach to improving patient safety with respect to laboratory medicine is the Patient Safety and Performance Measures Committee. This Committee has developed an initial core set of Laboratory Patient Safety Goals (LPSG) for laboratories to use in their efforts to improve patient safety and reduce laboratory medical errors. The goals focus on the pre- and post analytic phases of laboratory testing with the objective of improving patient test management processes, including patient identification, test ordering, and critical results reporting and interpretation. The goals also reinforce the pathologist’s and the laboratory’s roles in patient safety with the objective of improving identification, communication and correction of medical errors. The goals highlight the laboratory’s integral role in ensuring patient safety within health care organizations.

Laboratory Director’s Role in Patient Safety

Pathologists are uniquely qualified and positioned to facilitate this cooperation between the laboratory and its patient care partners.

Laboratory medical directors must ensure not only that the laboratory staff follows appropriate procedures and provides reliable results, but also that they thoughtfully communicate with their patient care partners. This includes communicating appropriate pre-analytic requirements and best practices as well as communicating what is learned in the laboratory so that the physician makes fully informed choices about treatment alternatives.

A pathology report may not always have a definitive diagnosis (e.g. ASCUS). The primary physician may benefit from a consultation with the pathologist. Laboratory Directors need to inculcate the post-analytic consultation as an important and potentially critical step when presenting pathologic findings from highly sophisticated diagnostic tools. The post-analytic consultation is increasingly likely to involve alternative interpretations to consider, margin for error associated with the findings, and further tests that could clarify the diagnosis and potentially identify more effective treatment plans.

We recommend that all laboratories create a Patient Safety Plan that addresses each of the LPSG with particular attention to the examples or situations listed in the subheadings. This plan should be reviewed annually and signed by the laboratory director and incorporated into the ongoing QI activities of the pathology department.

The following Template Laboratory Patient Safety Plan is an attempt to assist laboratories in creating a document, recognizing that each laboratory will have unique needs that may not be addressed in this template.

II. Laboratory Patient Safety Goals/Plan

Pre and Post Analytic Phases of Laboratory Testing

Goal 1: Ensure Correct Patient and Sample Identification

  1. At the time of specimen collection
  2. At the time of analysis
  3. At the time of result delivery

Goal 2: Ensure the Verification and Communication of Laboratory Results Requiring Action on the Part of Treating Clinicians, examples may include:

  1. New malignancies
  2. Infectious disease diagnosis requiring immediate treatment or patient isolation
  3. Critical laboratory values

Goal 3: Ensure Time Outs are performed prior to starting procedures

  1. Correct test preparation
  2. Correct patient position
  3. Safety precautions based on patient history or medication use

Operationalization

Goal 4: Ensure the Identification, Communication and Correction of Errors

  1. Timeliness of identification of errors
  2. Revised reports
    1. All inaccuracies in the medical record should be documented and communicated at the time the inaccuracy becomes known. The correct test result or diagnosis should be made clear in an amended or corrected 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.
    2. 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 corrected result to the patient.

Goal 5: Improve Integration and Coordination of Laboratory Patient Safety Role within Healthcare Organizations and Operations among the following groups:

  1. Nursing
  2. Administration
  3. Point of care testing personnel
  4. Providers

Goal 6: Provide a standardized list of acceptable abbreviations, acronyms, and symbols to the following groups:

  1. Physicians
  2. Nurses
  3. Laboratory testing personnel

Goal 7: Improve hand-off communication approaches, in high risk clinical situations such as:

  1. Shift changes
  2. Laboratory testing performed during surgical procedure

Goal 8: Reduce the risk of health care associated infections by the following activities:

  1. Reviewing WHO and CDC Hand hygiene guidelines
  2. Implementing best practices
  3. Conducting periodic risk assessments
  4. Ensuring participation of laboratory staff in infection control activities in health care organization

Examples of the Organization of Laboratory Patient Safety Activities

As patient safety is central in the practice of laboratory medicine and anatomic pathology, patient safety activities are primary among medical director duties. Given the variety of laboratory size and complexity, appropriate systems to meet the patient safety needs of the laboratory may vary from one facility to another.

Below are two possible models of organization that may be effective in the oversight of patient safety activities in the laboratory. These models may not be applicable to every practice setting.

Example Model 1

Patient safety activities in the laboratory will be under the overall auspices of the Laboratory Quality Assurance Committee (LQAC). The LQAC will form the Laboratory Patient Safety Committee (LPSC), a standing ad hoc committee that will coordinate patient safety activities for the laboratory. The LPSC shall consist of a Chairperson and representatives from each major division of the laboratory, including Anatomic Pathology, Chemistry, Cytogenetics, Hematology, Histology, Immunology and Serology, Laboratory Support Services, Microbiology, Molecular Biology, Respiratory Chemistry, and the Transfusion Service. The Chairperson of the LQAC shall select the Chairperson of the LPSC and the Chairperson of the LPSC shall choose members of the LPSC. The Chairperson of the LPSC shall sit on the LQAC and report to that committee on the activities of the LPSC.

The LPSC shall meet at regular intervals similar to the LQAC. It shall create Patient Safety Monitors that address the core Laboratory Patient Safety Goals, create thresholds for action, collect data related to these monitors, and make regular recommendations to the LQAC related to the data. The LQAC is ultimately responsible for acceptance or modification of these recommendations, which will then be implemented through the joint efforts of both committees. The LPSC will document improvement or lack thereof and report back to the LQAC on the result of these actions.

Example Model 2

Patient safety activities in the laboratory will be under overall auspices of the Laboratory Quality Assurance Committee (LQAC). It shall create Patient Safety Monitors that address the core Laboratory Patient Safety Goals, create thresholds for action, collect data related to these monitors, implement actions that address areas for improvement that are illuminated by the monitors, assess the effectiveness of the actions, document improvement or lack thereof, and take further action if necessary related to the monitors.

Samples of Patient Safety Quality Monitors

Quality and patient risks worth managing have several characteristics including being closely linked to patient outcome and customer need and associated with a high degree of variation. Quality monitors should be clearly defined, measurable, have a valid causal relationship to patient outcomes, and focused on actionable aspects of the operation. Below are examples of concrete, positive, economical steps that laboratories may take to improve patient safety and limit errors.

Improvement of patient identification at the time of specimen collection.

Aspect of care monitored: Labeling errors at the time of specimen collection.
Threshold for action: To be determined.
Method of evaluation: All labeling errors discovered at the time of specimen collection will be documented. The laboratorian who discovers the error will document it on a form created for this purpose. The form will include the time the error was made, the time the error was discovered, who reported the error, the outcome of the error with regard to the patient, including adverse patient effects, and who was responsible for the error. The data will be tabulated, analyzed for trends and reported to the laboratory medical director and the appropriate patient safety committee.
Corrective action plan for exceeded threshold: To be determined.

Improvement of patient identification at the time of analysis

Aspect of care monitored: Labeling errors at the time of specimen collection.
Threshold for action: To be determined.
Method of evaluation: All errors discovered at the time of analysis will be documented. The laboratory technologist who discovers the error will document it on a form created for this purpose. The form will include the time the error was made, the time the error was discovered, who reported the error, the outcome of the error with regard to the patient, including adverse patient effects, and who was responsible for the error. The data will be tabulated, analyzed for trends and reported to the laboratory medical director and the appropriate patient safety committee.
Corrective action plan for exceeded threshold: To be determined.

Improvement of the identification, communication and correction of errors

Aspect of care monitored: Inaccuracies in surgical pathology reports should be corrected at the time the inaccuracy becomes known. The corrected result should be made clear in an amended or corrected report as well as communicated to the treating physician for any significant corrections.
Threshold for action: To be determined.
Method of evaluation: All amended surgical pathology reports will be audited for the following data: interval between issuance of initial report and issuance of amended report (number of days), reason for correction, type of correction (typographical error, addition of pertinent information [e.g., measurement added that was not previously recorded], change in pertinent information provided, change in diagnosis, clarification in diagnosis, other), how the error was discovered, and any adverse impacts on patient care secondary to the issuance of the incorrect or incomplete report. Results will be reported to the laboratory medical director and the appropriate patient safety committee.
Corrective action plan for exceeded threshold: To be determined.

 

Related Links Related Links