- The laboratory director must ensure that the POCT program has adequately considered all aspects of safety in the design and execution of the program.
- We have discussed many of the key elements of POCT safety elsewhere within the Technical Consultant duties.
- A key patient safety goal is to prevent patient harm from inaccurate or misleading results that do not reflect the patient’s true condition and may lead to misdiagnosis and inappropriate over or under treatment.
- Some key points to consider in insuring patient safety are:
- Adequate training and competency program
- Availability of instructions and/or standard operating procedures (SOPs) at all sites of testing
- A system for ensuring that all operators are familiar with limitations in POCT devices (for example, screening, diagnosis, monitoring patients) and know when to obtain another sample or method for confirmation of results (e.g., hematocrit limitations of glucose meters, verification of very high POC INR results).
- POC directors should put themselves in the shoes of an inspector: Are you confident that if you went out to a given area in your institution and asked any operator what to do to resolve a misleading or unlikely POCT result that you would receive an informed answer?
- POCT errors are often thought of in terms of the phase of testing that errors can occur. Here errors are defined as failure of a planned course of action or incorrect course of action that leads to a preventable adverse event for the patient.
- The total laboratory testing process is classically divided into three phases. It is helpful to think of the unique elements of each phase when trying to create a safe and effective laboratory testing program, whether at the POC or in the central laboratory.
- A complete list of all the potential steps in each phase is extensive and beyond the current scope of this discussion, but each POCT program should recognize the key steps involved in any testing process.
- Errors or risks to patient safety are usually most common in the pre and post analytic phases for central laboratories, because processes are frequently less controlled then.
- Central laboratories, while not perfect, usually have very tight organization and oversight of their testing or analytical phases. However, because of many of the reasons discussed previously in this Tool Kit, for POCT the analytical phase is usually also at risk for significant numbers of errors.
- As Laboratory Directors, POCT Coordinators, and clinical and administrative partners create safety or quality programs to minimize errors and enhance patient safety, they should define the steps in their testing processes, consider which steps pose the highest risk for error, and devise tools to create good systems, educate operators, monitor results, and correct or modify systems that lead to errors.
- Some considerations for risk and error reduction are included below.
- Pre-analytical phase of testing:
- Patient/specimen identification: Testing wrong patient or specimen, not labeling specimens, entering wrong information on the wrong patient
- Specimen collection: Inappropriate specimen type or volume, inadequate application to device
- Specimen attributes: Patient-related (anemia, leukocytosis) or collection-related (hemolysis, microclot)
- Analytic phase
- Method calibration: Mis-entered calibration data, calibration not done
- Specimen/reagent interaction: Patient-related interference (e.g., cold agglutinins), outdated or improperly stored reagents
- Result reliability: QC not performed or acted upon, device performance monitors not checked
- Result generation: Outside validated range, wrong patient population tested
- Post-analytical phase
- Result generation: Transcription mistake, no units or reference range reported
- Critical value reporting: Critical result not recognized or brought to caregiver’s attention
- Other result reporting: Reports not communicated or communication delayed
- Report verification: Failure to document in medical record, recorded result does not match result initially generated
- Result interpretation: Significance of result not understood. Inappropriate or no action taken.
- All other required elements of laboratory safety also need to be considered as part of the POCT testing program.
- A commitment to safety must run throughout the laboratory, championed by its leaders, facilitated by its policies, and embraced by all. POCT sites may have separate safety committees and/or participate in laboratory or institutional safety committees. They may designate a separate or share a safety officer with other sites.
- Whatever your structure, a safety program (see table sample below) should be in place and supported by written safety policies, protocols, and procedures.
Traditional Components of a Laboratory or Institutional Safety Program
The following lists the usual elements of an institutional safety program for employees or staff. Details of these elements at the POC will be discussed in future editions.
Management structure and responsibilities
Safe work practices
- Personal protective equipment
- Procedure for handling sharps
- Hand washing
- Provide alternatives for individuals with latex allergies
- Ergonomic controls
Standard precautions, bloodborne pathogens, and infection control
Chemical hygiene plan
Protection from harm from excessive noise, UV light, radiation
written policies and procedures, reviewed annually
CLSI POCT1-A2 Point-of-Care Connectivity; Approved Standard
Kost GJ: Preventing problems, medical errors, and biohazards in point-of-care testing. Point of Care 2003;2:78-88.)
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