The goal of quality assurance (QA) in the laboratory setting is to recognize and correct problems identified in laboratory testing in order to provide accurate and reliable laboratory results. A quality assurance program must be written and must indicate what QA activities take place and when the laboratory performs those activities. The written quality assurance plan should be measurable and should indicate what the laboratory considers acceptable and unacceptable. For example, is 5 complaints per month acceptable, or does the lab only allow 2 complaints every month? The number of acceptable “issues” or “problems” identified through the quality assurance plan is determined by the laboratory director. Additionally, the QA plan must be ongoing, monitored periodically, able to identify and document problems in the laboratory testing, correct any problems identified, and assure policies and procedures are updated, as necessary, to include any changes in procedure implemented through QA activities. Included in quality assurance reviews should be an assessment of past corrective actions taken to evaluate whether or not problems identified in previous reviews were actually corrected. For example, a laboratory having problems with CBC controls will correct that problem every time it’s identified. However, if the laboratory continues to experience problems with CBC controls, the problem isn’t truly fixed. Through the continual monitoring of the QA program, the laboratory can identify the true cause of the problem and correct it, rather than putting “patches” on it as it occurs. Lastly, problems identified in the quality assurance assessments should be communicated to staff, as appropriate.
A quality assurance plan is required for non-waived laboratories and involves four different systems: 1) General Laboratory Systems; 2) Pre-analytic Systems; 3) Analytic Systems; and 4) Post-analytic Systems. Included in the General Laboratory Systems are:
- Confidentiality of patient information (How is visitor access to the laboratory controlled and are patient records stored securely?)
- Specimen identification and integrity (How are specimens identified from the time of collection, through the processing and testing phases?)
- Complaint investigations (How are complaints reported? This not only involves patient complaints, but may involve complaints from other physician offices, or even a reference laboratory.)
- Personnel competency assessment policies (How is competency evaluated for each person performing laboratory testing? How is competency evaluated for personnel collecting and processing specimens, though they may not actually perform testing?)
- Evaluation of proficiency testing performance (Does the laboratory director review proficiency testing results? Are proficiency testing results acceptable, and if not, does the laboratory investigate why they are not acceptable?)
Pre-analytic Systems quality assurance assessments are a monitor of laboratory processes before the testing is performed. It is believed that most laboratory errors occur during the pre-analytic phase of the testing process. Pre-analytic systems include:
- Test request (Who does the laboratory accept test orders from? What is the protocol for verbal orders? Does the test request contain information needed to process the specimen?)
- Specimen submission, handling, and referral (How are specimens collected, labelled, and transported? Are samples referred to a CLIA certified laboratory and does the reference laboratory supply instructions about specimen handling?
Analytic systems assessments monitor the actual testing process and include:
- Procedure manual (Does the lab have all the required procedures, and are the procedures available to staff at all times?)
- Test systems, equipment, instruments, reagents, materials, and supplies (Are they discarded if expired? How are the stored?)
- Establishment and verification of performance specifications (Are newly installed instruments validated to include: accuracy, precision, reference ranges, and reportable ranges?)
- Maintenance and function checks (Is maintenance performed according to manufacturers’ instructions?)
- Calibration and calibration verification procedures (Are instruments calibrated as required by the manufacturer and are reportable ranges reviewed to ensure they haven’t changed during the calibration?)
- Control procedures (Are controls performed in accordance with CLIA regulations and manufacturers’ instructions?)
- Corrective actions (Are all corrective actions taken to resolve problems documented?)
- Comparison of test results (Does the lab have a system in place to evaluate test results that seem inconsistent with patient information?)
- Test records (Does the lab document the date and time a specimen is received into the lab?)
Post-analytic systems quality assurance assessments are a monitor of laboratory processes after the testing is performed. It mainly involves the test report and reviews things such as:
- Is the report accurate?
- Where is the test report maintained?
- Does it contain all pertinent information needed to interpret the test results?
- Is it only released to authorized persons?
- Has the lab identified life threatening test results and communicated those results to the patient’s physician?
- How are errors reported?
Quality assurance assessments may be performed monthly, quarterly, semi-annually, or even yearly, depending on the laboratory. It is the laboratory director who decides how often QA assessments are performed. Remember, one of the goals of the QA program is to recognize problems in the laboratory testing. If a laboratory has 40 complaints a month, but only performs quality assurance assessments semi-annually, then the quality assurance program is not adequately identifying and correcting problems. However, if the laboratory only has one complaint every month, the laboratory doesn’t have enough data to adequately assess if the correction to the problem was effective. In the later example, a semi-annual assessment would be appropriate.
Quality assurance can be time consuming to perform all the required reviews and prepare the necessary reports. Additionally, the laboratory director must sign all quality assurance assessment reports. Reviewing all of the laboratory systems required by CLIA may lead to less time for staff to perform laboratory testing and decrease time for patient care. ProLab Consulting, LLC offers assistance with quality assurance monitoring. Let us give you more time to spend with patients by performing your QA assessments for you. We will perform assessments in accordance with your policies and procedures, and provide the laboratory director with quality assurance assessment reports.