QC and QA Flashcards
What are the main principles/disciplines of quality management ?
- quality control
- quality assurance
- quality improvement
laboratory accreditation
additional external tools such as proficiency testing, intra-laboratory comparisons and benchmarking are incorporated
What is quality control?
a program that inspects all aspects of a system and that involves every method utilized in the laboratory to ascertain that all equipment and processes are functioning as required
includes establishing specifications for the following:
1) assessment of procedures used in testing/treatment to determine compliance to the specifications
2) training and assessment of skill of laboratory personnel
3) performance of any corrective actions to bring protocols/procedures into specification
Quality control verifies that procedures/protocols have been suitably implemented and accurate data are collected for analysis for quality assurance.
What is quality assurance?
Quality assurance describes the activities related to the verification and validation of all laboratory functions, services and outcomes to guarantee the following:
1. Errors and problems are detected, corrected, resolved and prevented;
2. Baselines, threshold values, tolerance limits and specifications are established;
3. Results and outcomes meet specifications and thresholds;
4. Laboratory personnel are competent and warrant certification;
5. Laboratory goals are achieved, and services are provided;
6. Patient and clinician users are satisfied with the services and outcomes provided by the laboratory.
What is quality improvement?
Quality improvement describes the goal of continually striving to achieve higher standards in all aspects of service provision within the embryology laboratory and IVF program. As the laboratory and IVF program evolve and mature, a second dimension of quality improvement is to benchmark the laboratory’s performance, services, and clinical outcomes against their competitors or “renowned” programs worldwide.
What are the main distinctions between QA and QI?
QA measures compliance against certain necessary standards. Quality improvement is a continuous improvement process. QA is required and normally focuses on individuals, while QI is a proactive approach to improve processes and systems. Standards and measures developed for quality assurance, however, can inform the quality improvement process. The chart below details and categorizes the distinctions between QA and QI.
List some of the key elements for effective QC program in embryology laboratory
Appropriately educated, trained and certified personnel
Correct operation and calibration of all instruments
Standards for environment, media, reagents, contact materials and equipment
Consistent and proper execution of appropriate techniques and methods
Proper procedure, policy, and safety manuals
Proper documentation and record-keeping
System for patient sample collection and management (i.e., chain of custody)
System for appraisal of test performance, correction of deficiencies, and implementation of advances and improvements
Following manufacturer’s instructions
Having a procedure manual describing processes for testing
Performing calibration procedures periodically
Documenting remedial/corrective action(s)
What is the main goal of quality assurance?
The main goal of a quality assurance program is to monitor and evaluate the ongoing and overall quality of outcomes and services of the laboratory
What are the requirements for a quality assurance plan?
The quality assurance plan should at least follow the CLIA ‘88 requirements that clinical laboratories have written review and appraisal policies for patient test management assessment, quality control assessment, proficiency testing assessment, comparison of test results, relationship of patient information to patient test results, personnel assessment, communication, complaint investigation quality assurance review with staff, and the maintenance of quality assurance records.
The quality assurance plan should be designed to evaluate the effectiveness of policies and procedures, identify and correct problems, assure the accuracy and precision of procedures, and monitor the performance and competency of the laboratory staff. The emphasis of the quality assurance program should be the prevention of errors rather than the detection and correction of errors after they occur. The quality assurance process can be broken down into many areas of observation and evaluation.
What are areas of observation and evaluation for quality assurance in embryology lab?
- Establish culture methods that provide reliable results with expected rates of fertilization, cleavage embryo quality, pregnancy and implantation.
- Establish baselines and threshold values to help establish specifications for overall performance of equipment and personnel as well as determine minimum standards for outcomes and service expectations.
- Prevent error by strict adherence to protocol manuals, preventative maintenance of equipment, equipment calibration, and appropriate personnel training.
- Establish monitoring activities to ensure that testing and procedures are performing as expected. These include the use of standards, controls, quality control review and proficiency testing.
- Institute corrective actions that occur when errors or abnormalities are detected in laboratory functions. Activities include equipment repair or recalibration, troubleshooting, and personnel reassessment or retraining.
What is the purpose of quality assurance program?
A quality assurance program is developed and implemented to assess and improve the reliability and efficiency of the laboratory, to ensure that the highest possible quality of service is provided, and to comply with regulatory requirements.
What is the scope of laboratory quality assurance plan?
Your laboratory quality assurance plan must be comprehensive. The pian must focus on resolving known, identified, or suspected problems that may have a negative effect on the provision of laboratory services. The plan should focus on issues that may improve the testing process. All phases of laboratory operations must be included. The laboratory must establish written policies and procedures detailing the quality assurance process. These procedures should identify the w-10, WHAT, WHERE, WHEN, WHY, and HOW aspects of the plan.
What are the goals of quality assurance?
C. Goals
Ensure that policies and procedures are effective and comply with applicable laboratory laws and regulations.
Ensure accurate, reliable, and efficient performance of tests and test reporting.
Improve the overall quality and efficiency of the laboratory’s service by promoting effective, efficient, and appropriate use of available resources.
Ensure a safe environment for patients and staff.
Meet the needs of physicians in rendering diagnoses and treatment of patients.
What are the objectives of QA desinged to accomplish its goals?
To provide an organized, systematic process designed to accomplish the above goals by:
1. Identifying, prioritizing, monitoring, evaluating, acting on, and resolving issues in the laboratory that impact test management, test performance, and patient care.
2. Evaluating personnel to assess the competence and the maintenance of skill and knowledge levels.
3. Implementing effective solutions to problems through education and necessary change.
4. Communicating findings to staff.
5. Following up on all corrective actions to ensure that improvements have been maintained.
6. Coordinating all laboratory quality assurance activities to promote cooperation and to prevent duplication.
7. To review on an annual basis and to update as necessary the quality assurance plan of the department.
What are critical indicators? What are some categories that should have critical indicators?
“Critical indicators” are processes or events that reveal how well the laboratory is functioning. Monitoring critical indicators results in the identification of problems significant enough to require review, analysis, and implementation of appropriate corrective action.
Indicators are not difficult to establish. Indicators should represent problems that would negatively impact laboratory testing or patient care should they occur. Develop a method of identifying when a critical indicator fails to meet expectations.
Critical indicators should be simple and definitive. An indicator that fails to meet the laboratory’s expectation does not identify what is wrong. It only indicates that something is wrong. Once a problem has been identified, an analysis of what caused the problem must be performed. The cause must be identified, so appropriate corrective action can be implemented to prevent a recurrence of the problem in the future.
Test management and performance, appropriate utilization of services, proficiency testing, user satisfaction, safety, quality control, observed or reported incidents, and competency of personnel.
How is quality assurance achieved?
Quality assurance is achieved by regularly reviewing critical indicators in each of the phases of laboratory testing. Problems identified during the reviews are acted upon to prevent future occurrence. Observations made that could provide opportunities for implementation are acted upon as well.
