week 6 chapter 12

The word quality implies a state of excellence, free from defects or deficiencies, that earns the confidence and trust of consumers. Quality is accomplished by adhering to a set of measurable standards adopted by an industry, such as healthcare. Quality in the delivery of healthcare, including laboratory results, ensures patient safety, and customer satisfaction. Laboratory tests are a vital link that assists healthcare providers in identifying a patient's medical diagnosis. Quality performance-starting with the healthcare provider's order and the work of the phlebotomist and continuing until the specimen results are reported-must exist at all stages of the process in order for test results to be accurate. Accuracy is how close a result is to the actual value. For example, if the true result for a patient value is 125 mg/dL, an accurate result measured by a chemistry test is as close as possible to that value. The precision of a test is its ability to give nearly the same result when performed repeatedly. Using the same example, if repeated glucose measurements fall within a close range of 120 to 130 mg/đL, the results are precise.

Total quality management (IQM) is the highest level of quality oversight and is managed at the organizational or institutional level. TQM governs the behavior of a set of individuals, in this case healthcare workers. The purposes of TQM are to identify an organization's internal and external customers and to design operations that produce the highest customer satisfaction. TQM involves all members of the healthcare team creating quality processes to improve customer satisfaction. This satisfaction is achieved as a result of both the healthcare encounter and the accuracy (correctness) of the results.

Quality cost management (QCM) is a system used to measure and manage the cost of quality. Cost of quality is not simply the cost of a procedure or product; it includes the cost of delivering healthcare with the highest level of quality. In the laboratory, this includes the cost of repeating tests when results are in question, the cost of correcting errors in a process (at every phase of testing), and the cost of maintaining customer satisfaction. Quality cost management works closely with total quality management.

A quality management system (QMS), refers to both a set of quality objectives established to achieve the goals identified by TQM and the methods used to monitor the achievement of those objectives. In the medical laboratory, QMS includes the organizational structure of the laboratory as well as the procedures, processes, and resources needed to develop and meet quality objectives. A QMS includes the functions that most directly involve laboratory personnel-quality assurance and quality control.

The Joint Commission defines quality assurance (QA) as a system of planned activities that assess operational processes for the delivery of services or the quality of products provided to consumers, customers, or patients. This system is designed to guarantee quality patient care by continued reassessment of all the processes. The Centers for Disease Control states that Laboratory Quality Assurance (QA) encompasses a range of activities that enable laboratories to achieve and maintain high levels of accuracy and proficiency despite changes in test methods and the volume of specimens tested. Quality assurance refers to examining the performance of a process to ensure that testing is being carried out correctly, results are accurate, and mistakes are found and corrected to avoid adverse outcomes. For example, the overall blood collection and handling process along with all of the individual tests these samples can undergo are frequently evaluated. Quality assurance involves looking at every step in the pre-examination, examination, and post-examination phases of a procedure. L Figure 12-3 shows an example of this ongoing, cyclical process. Quality assurance activities should be in place during the entire testing process-from initial contact with the patient until the results are documented and logged or charted on the patient's medical record. Each activity contributes to the overall assurance of quality. Any step in an activity can fail, so appropriate control measures are used constantly to minimize or eliminate failures.

When a QA program is put in place, standards (rules of practice) are defined and should be followed in order to meet customer safety and satisfaction requirements. Developing, evaluating, and modifying the processes, policies, and procedures used in the medical laboratory are the functions of a QA program. Quality assurance focuses on the overall process used to measure patient outcomes (condition and length of hospital stay), which includes error detection activities (double-checking information) as well as corrective and preventive activities (documentation and training). In the medical laboratory setting, QA is applied to everything involved in producing a quality laboratory test result, including • the ordering and requisitioning of tests • positive patient identification • collection processes • the integrity of the specimen • test analysis processes • the reporting of results • turnaround time the time between placing the order and receiving the results)

A series of indicators (observable events used as evidence) are used to access integrity of the chain. Indicators are measurable, specific, well defined, and essential to the process and are designed to assess areas of care that tend to cause problems or negative outcomes (results). They measure quality, accuracy, timeliness, customer satisfaction, adequacy, and other factors. "Wristband identification errors will be less than 1%" is one common example. To evaluate such an indicator, specific, scheduled evaluations of various documents (such as patient records, incident reports, and lab reports) and direct patient observations may be used.

Quality control (QC) is defined as activities that ensure that specific steps in a process meet acceptable standards or parameters (limitations). QC checks are essential to ensuring reliable results and are mandated by accrediting agencies. Accreditation inspectors periodically review QC documents. Activities such as verifying patient identity, checking reagent expiration dates, testing control material prior to patient samples, and reviewing data recording for errors are all part of quality control. Normal parameters are established for all laboratory tests in order to evaluate the outcomes. Basically, quality control measures ensure that procedural steps are followed and yield consistent results. Quality control focuses on detecting the defects in a process, which are indicated by the presence of variances deviations from the procedure, such as blood collection from an arm with an IV or controls that are out of range).

Healthcare facilities have instruction manuals that describe these special and often mandatory preparations and collection Page 325 procedures. The laboratory user or procedure manual contains the standard operating procedure (SOP) for each test performed in the laboratory. Each procedure's SOP explains its purpose, specimen requirements, step-by-step instructions, limitations, normal and critica values, and interpretation. Each procedure is developed using guidelines from The Joint Commission, Clinical and Laboratory Standards Institute (CLSI), Food and Drug Administration (FDA), and other regulatory agencies. This reference manual must be available to all healthcare personnel involved in the specimen collection process. Procedures performed at laboratories that are accredited by the College of American Pathologists (CAP) are observed during inspections to ensure compliance with the laboratory's SOP. Failure to adhere to the SOP can adversely affect the quality of the specimen obtained and may therefore alter the results. Quality control activities help ensure that • tests are performed on the correct patient • specimen collection procedures are performed correctly and safely • specimens are handled, transported, and processed properly • tests are performed accurately

A control material is a liquid, a serum, or freeze-dried material that has been prepared and tested by the manufacturer and that has a known value, such as a serum with a known glucose value of 125 mg/dL. This substance is used on a device when doing a system check. ff the readings from the control checks are not within the acceptable parameters, the equipment will not yield accurate results. For example, a glucometer test system may have both a high control and a low control with an acceptable range for each. Values obtained during a system check of the glucometer that fall outside the established parameters indicate that corrective action is required. If the values fall out of range when control materials are run, first double-check their expiration dates. The expiration date and lot number should be written down before testing. If they are past the expiration date, replace them and repeat the control check. If the control material has not passed its expiration date, you may repeat the control test. However, a repeat failure warrants immediate calibration, repair, or replacement of the system and should be reported immediately. Follow your facility's procedures to report or correct the problem. Do not use the equipment until the problem has been corrected.

Calibration is a procedure used to ensure that equipment is providing accurate results. In most cases, a standards sample is run to validate accuracy. For example, if the control sample results yield 80 mg/dL, but the correct concentration is known to be 90 mg/dL, the equipment may not be reading accurately. A second control sample may be run to make sure that the equipment, rather than the sample, was the reason for the inaccuracy.

The operators of the equipment enter the results of quality control (QC) performed daily and compare this to acceptable limits prior to testing patient samples. L" Figure 12-5 also shows a Levey-Jen nings chart (a graph showing acceptable limits), which is used to visualize whether results fall within the acceptable parameters or if there is a trend (results showing an upward or downward progression) or shift (a sudden jump in results that continue at the higher or lower level). These log records are usually maintained for at least two years. Trends and shifts are known as systematic errors and may be due to aging reagents or control material, deterioration of light sources, or changes in temperature. Errors that occur with no predictable pattern are random errors and may have several causes. These errors tend to be harder to find and include things such as the following:

• Operator procedural error

• Equipment failure

• Outdated reagents

• Clerical errors

When performing quality control checks on multiple instruments of the same type, be sure to record data on the appropriate log sheet. Each instrument may measure the same control material differently and must have its own log sheet. If control values are outside acceptable limits, you must investigate and correct the source of the error. For example, imagine that you are testing two glucose meters. After testing the first one, you notice that the result is much lower than those of the previous several days. You first must double-check that you are recording the control data on the correct log sheet. Double-check the expiration dates on the control material and test strips. Finally, review your standard operating procedure (SOP) to ensure that you are performing the procedure correctly. Was the reagent prepared properly and stored at the appropriate temperature? If no apparent cause for the error is revealed, repeat the control test; if the meter still reads out of control, do not use it for patient testing. Consult the manufacturer's information for the appropriate action in correcting the readings on the meter.

Quality assessment and process improvement (QAPI) is the review of documentation to discover weaknesses in a process, so that they can be eliminated and the quality of patient outcomes improved. This process is also called continuous quality improvement (CQL). An assessment, or audit (review of records), is performed to discover any weaknesses in a process. Improvements to the process are implemented and the results are monitored to see if process problems are eliminated and future errors are prevented. QAPT is also used to make a process easier to perform. L Table 12-3 summarizes the steps in quality assessment and process improvement. Each of these steps helps ensure that a laboratory is providing quality patient care.

Competency assessment is a method of documenting an employee's ability to perform assigned tasks correctly. These tasks can include any step in the laboratory testing process, from patient identification all the way through to the reporting of test results (pre-examination, examination, and post-examination processes). Competency assessment documents are kept in employee files and may reveal the need for additional training. Also, documentation of individual competency is often required of laboratories during institutional or laboratory-specific inspections. Proficiency testing.(PT) is a means of evaluating the performance of a laboratory and its personnel in comparison with that of other, similar laboratories. Agencies such as the College of American Pathologists (CAP), Department of Public Health (DPH), Centers for Disease Control and Prevention (CDC), and Clinical Laboratory Improvement Amendments (CLIA) provide samples to be tested, such as cell identification, chemistry analysis, or other routine and specialized tests a lab may perform. Laboratories perform the required tests and return the results to the agency. An analysis of the results is given to the laboratory, along with suggestions for improving performance if the results are out of range. Laboratory inspectors require documentation of proficiency testing, along with documentation of corrective actions taken if performance deficiencies are identified. Continued errors on proficiency testing may result in a laboratory no longer being allowed to provide the affected test or service.

Health Resources and Services Administration quality improvement tools- A toolbox of clinical quality and performance measurements webinars. 

provided by the U.S. Department of Health and Human Services, including tools for data collection and performance measurement webinars. 

The Joint Commission quality improvement tools- A suite of tools and resources for healthcare organizations to help them meet TJC standards and National Patient Safety Goals. These tools are available only to TJC-accredited organizations. 

Root Cause Analysis (Six Sigma)- A commercial quality improvement program that provides methodologies for improving quality and reducing variation in any new or existing process. The steps of analysis for new processes include define, measure, analyze, design, and verify. The steps of analysis for existing processes include define, measure, analyze, improve, and control.

 Failure Mode Effects Analysis (FMEA)-  Step-by-step method to identify all of the possible causes of failure in a process or service. These causes are then prioritized according to their seriousness and frequency. Each problem is then analyzed and corrective actions are taken. As each corrective action is completed, the date and results are recorded.