Evolution of Laboratory Quality Management Systems - Assignment Example

A high percentage of clinical decision-making depends on the laboratory test results. Therefore, there is a need for laboratory results that are accurate, reliable, and timely (Sewell and Maclowry 1). The poor laboratory practices in the past led to increased errors that gave misleading results despite the vital role they play in the patient treatment outcomes. In addition, they resulted in waste of time and personnel effort. So as to prevent these undesirable consequences, the quality practices through Quality Management Systems were introduced in the laboratories. The origin of Quality Management Systems (QMS) as coordinated activities aimed at directing and controlling an organization about quality can be traced back to 1920s. During this period, Walter Shewhart developed a statistical process control (SPC) as a method of controlling quality in the manufacturing process. With time, quality has become an issue for only not the manufacturing sector, but also to the service delivery players such as laboratories. The concept of quality has gone numerous transformations with the input of different people like Edwards Deming (1940s) who developed Continuous Quality Improvement (CQI) and Phillip Crosby (1970s) with his Quality by Requirement. The theoretical constructs of QMS included the Continuous Quality Improvement, the Six Sigma, and the Lean methods. In 1980s, many laboratories adopted the laboratory information systems (LIS) with the necessary QC Softwares. Quality Control (QC) formed the basis of the first models of ensuring quality in these facilities. It depended on the statistical information and trend analysis of the of the QC results of the instrument used for the testing process. In addition, the performance measurement of the test method was critical to this course. Since QC depended only on the results, it could not meet the objective of quality management of detecting errors that may occur and preventing them from reoccurring rather than guaranteeing an error-free laboratory. As a result, the second model (Quality Assurance, QA) of quality management that involves the systems and processes was introduced. QA as a quality measurement system identifies the key components of the testing process as well as the established laboratory systems. These first two models formed the basis upon which other quality management systems such as cost quality management and total quality management were developed. With a push for more reliable systems, Six Sigma Quality Management was introduced into the laboratories by the end of 90s. The current medical laboratory quality involves the public, lab technicians, the accreditation bodies such as the Clinical and Laboratory Standards Institute (CLSI), and standards development organizations (International Organization for Standardization, ISO). Other stakeholders in the health sector including the World Health Organization (WHO) and Center for Disease Control (CDC) also play a significant role in ensuring laboratory quality. ISO provides guidance for quality in production and service delivery, and laboratory practice was ISO certified in 2000. On the other hand, the CLSI provides guidelines, standards and best laboratory practices for quality in laboratory testing. Despite the fact, that research laboratories are not also subjected to strict regulations as the clinical laboratories; these quality changes in the clinical lab practice have significantly influenced their operations. The good laboratory practices that ensure quality are the same in both facility setups, thus resulting in quality research that is accurate and reproducible. Despite the day to day work of collecting samples, testing and presenting results, other activities such as ordering reagents, dealing with other employees and leadership are also involved in the laboratory. Being the head of a laboratory is the most daunting task. Therefore, as a lab manager, you must have appropriate management skills because they give the managers the ability to organize their work as well as supervising the junior staff. In the early Laboratory, a lab manager used a directive style of management where he would order the lab technicians to perform tests as per the directions. He had close controls on employees and motivated them by threats and discipline. Though effective in cases of crisis and risk deviations, it can result in employee underdevelopment due to little learning process. In addition, the frustrated and resentful highly skilled employees can leave resulting in high employee turnover. Authoritative style was also common in the laboratories in late 1920s in order to provide long-term direction for the employees. It was necessary because the laboratory practice of that time was still under development and required long-term plans. The manager gives clear direction to the employees and motivates by persuasion and feedback on performance. On the other hand, the advanced and complicated laboratory practice in the present encourages leadership styles that promote values that would increase efficiency and quality of test results. Some of these values include harmony, teamwork and information sharing between the manager and employees as well as among the employees themselves. As a consequence, the laboratory leaders of the 2015 have adopted affiliative style of management that is useful in performing routine tasks and ensuring adequate performance. In addition, an all-inclusive decision-making and team effort requires the present managers to use participative or democratic style of management. It provides commitment, team building, and consensus among patients. The 2015 laboratory managers also practice a coaching style where they promote professional development of the employees. In addition to providing the career development opportunities, they help and encourage them to develop their strengths and improve their performance. On the contrary, the traditional managers provided little or no opportunities for employee growth. Regardless of the differences in management styles of the past and the present, pacesetting style is common to both of them. It has been adopted over time by managers to ensure that laboratory tasks are accomplished with the high standard required. The managers set high standards and expect employees to meet them. If the existing laboratory testing procedures fail to achieve the desired results, they can be modified, or new ones can be developed. Some of the factors that this failure might be attributed include inefficiencies, high costs, and unskilled testing personnel. Therefore, during development of a new test or procedure, it is imperative to consider its financial, as well as utilization aspects. The method should be relatively affordable to implement and maintain. Usually, a costly process is associated with increased cost of laboratory testing, thus passing the financial burden to the customers. The expensive testing services deny the majority of the poor patients to access the much-needed quality care by resorting to low quality services. The high cost of testing can be due to the expensive instruments and reagents required to carry out the necessary test. A more complicated machine for the test or the test itself can require highly skilled personnel with increased costs in terms of wages and salaries. More time and money can also be involved in training the laboratory technicians to accomplish the complex tests. In order to avoid this scenario where there is increased the cost due to the testing method, a test that ensures the provision of laboratory services at a minimum possible cost without compromising quality should be developed. On the basis of utilization, the test should be simple to use, effective and efficient in producing results. Its concepts and processes should be easily understood by the technicians as it will not only enable them perform accurate tests, but also identify the areas of improvement. The procedure should be efficient and take the shortest time possible to produce results in order to avoid the adverse effects that may arise due to late test results. Effectiveness of the test is the key to guarantee of quality results that meet customers’ satisfaction. Therefore, it should be accurate, precise, and reliable. It should also meet safety requirements to reduce harm to the patient and the technician. The daily volumes, mode and place of use are also significant considerations during test development. It can be used for routine testing or single testing in a main laboratory or at a point of care (POCT). In addition to the above factors, its utilization patterns should be easily monitored, analyzed, interpreted, and such information disseminated appropriately. Some of the usage patterns include physicians’ orders, epidemiological and demographic information, data on specific tests, and outcome indicators. In summary, a newly-developed test should meet the above conditions if it is going to an economic value and enhance the effectiveness and efficiency of clinical outcomes. Fraud billing in clinical laboratories is one of the most significant factors responsible for the spiraling health care costs. The facilities increase the testing bills in order to obtain more money fraudulently from the health financiers such as government and the third-party payers. The high costs resulting from these malpractices scare away the sponsors from allocating more resources to the health care system with the patients bearing the ultimate consequences. However, with appropriate management controls in place, incorrect billing can be prevented by preparing accurate charge description master – electronic or paper information of price for billable supplies and procedures. It will reduce the unnecessary health care costs and improves the quality of services offered. In order to prevent fraud cases in billing, case-costing systems based on costing methodology in MIS guidelines. They allocate lab costs to specific tests, thus enable recovery of all costs against the tests rather than using unclear method known as a relative value unit (RVU) of charging all tests. RVU is associated with gaps that allow for manipulation of cost entries. The case costing systems integrate patient, financial, and statistical information. The databases of these systems contain information related to patient admission, discharge, transfer, lab, nursing, pharmacy, payroll, general ledger and other feeder systems. Fraud billing can also be prevented by using systems with fraud alerts. They would be able to detect a broad range of inappropriate billings such as billing incorrect test, unperformed test, medically unnecessary test, and bills sent for payment by unlicensed or unaccredited laboratories among others. Billing regulations also play a significant role in the billing processes such as ensuring strict adherence to claim reporting requirements. These conditions include the coding systems, coding system rules and medical record documentation. Some of the coding systems are International Classification of Disease (ICD) and Health Care Common Procedure Coding System (HCPCS. The correctly filled charge master with the necessary information including cost code, item description, department number, charge price, revenue code, and level I and II HCPCS code can help in reducing fraud. In addition, use of other codings such as Static Coding that cannot be edited on the charge, master prevents manipulation of financial data. Keeping accurate and up to date medical record documentation can help in reducing fraud billing since they can easily be tracked and verified. The reimburse providers such as the federal governments and private health insurers must also ensure that they pay for the correct bills. They should have appropriate payment systems that would facilitate their reimbursements to the laboratory facilities. In conclusions, the use of appropriate systems that can detect billing errors and full implementation of standards and guidelines for patient billing would significantly reduce billing fraud in clinical laboratories. Work Cited Sewell, D. L., & Maclowry, J. D. (1999). Laboratory management. Murray PR, Baron EJ, Jorgensen JH, Pfaller MA, Yolken RH. Manual of Clinical Microbiology, 8th ed., American Society for Microbiology, Washington DC, USA Read More