A Healthcare Risk Control (HRC) member recently asked for tools to address risks related to specimen preparation and management in pathology and general laboratories. Specific risk areas identified in the query included:
- Patient preparation
- Specimen collection and labeling
- Specimen storage, preservation, and stability
- Specimen transportation and processing,
- Specimen acceptability and rejection
- Specimen referral
In 2013, ECRI Institute Patient Safety Organization (PSO) conducted an analysis of laboratory events submitted to the PSO's database and found that the top two types of laboratory errors involved specimens (mislabeled specimens and specimens with incomplete or missing labels). Although errors can occur throughout the laboratory testing process, the majority occur in the preanalytic phase of testing, which involves test selection and ordering, specimen collection and handling, and specimen transport. Most of the other errors occurred in the postanalytic phase of testing, which involves results reporting, test interpretation and follow-up, and specimen storage. Only a small portion of the errors happened within the four walls of the laboratory. The report concludes that strategies to reduce errors involving laboratory testing must entail all phases of the laboratory testing process and engage all stakeholders in that process.
A variety of resources available from ECRI Institute and elsewhere discuss specimen-related risks and best practices for preventing them.
For example, the guidance article The Clinical Laboratory Improvement Amendments addresses the Clinical Laboratory Improvement Amendments' major requirements and gives risk managers sufficient background to determine whether the standards are being met. The article also discusses specific issues relating to point-of-care testing, waived testing, and other focus areas for risk managers.
In addition, the guidance article: Cervical Cancer Screening addresses best practices for patient identification to prevent specimen mislabeling.
The guidance article Diagnostic Errors: Monumental Problem or Enormous Opportunity? includes interviews with experts to learn what organizations can do to confront diagnostic errors and improve diagnosis. In one section of the article, a practitioner advocates for laboratory workers to move away from a "factory model" and adopt a model that is more focused on the patient and on clinical effectiveness, rather than strictly operational effectiveness. That includes integrating laboratory staff into patient safety and quality improvement efforts. The laboratory's physical and conceptual remoteness from clinical care may have ramifications for the diagnostic process. To give one example, clinicians may be unsure which tests are best suited to the clinical problem or how to interpret results. One way the laboratory might help is by maintaining a list of laboratory professionals to call with questions and ensure that the lab is prepared to meet the needs of physicians if invited.
Other relevant guidance articles include Failure Mode and Effects Analysis, which describes proactive methods like failure mode and effects analysis [FMEA] to evaluate hazard-prone processes and to minimize their risks. Many laboratory processes, such as specimen labeling, specimen transport, and test results reporting, are good candidates for FMEA. Another, Patient Identification, addresses measures to minimize patient-identification mistakes, including those related to specimen labeling. Staff must label the specimen containers at the time of collection in the presence of the patient and use two acceptable patient identifiers. Organizations should prohibit prelabeling of specimen containers [a practice sometimes referred to as "batch processing"], which is considered an unsafe practice because it can lead to misidentification. Finally, Test Tracking and Follow-Up provides risk management strategies to help healthcare organizations improve practices and processes related to test tracking and follow-up.
The Pennsylvania Patient Safety Authority, a state-run error reporting program, has published several advisories to improve specimen labeling and handling. Among the resources are the following:
Other external resources include the following:
The recommendations contained in Ask HRC do not constitute legal advice. Facilities should consult legal counsel for specific guidance and develop clinical guidance in consultation with their clinical staff.