Fundamental Concepts in Clinical Laboratory Science | CLS 1113, Lab Reports of Chemistry

Download Fundamental Concepts in Clinical Laboratory Science | CLS 1113 and more Lab Reports Chemistry in PDF only on Docsity! Clinical Laboratory Sciences 1113 Introduction to Clinical Laboratory Practices STUDY GUIDE FOR UNIT 8: FUNDAMENTAL CONCEPTS IN CLINICAL LABORATORY SCIENCE Compiled by Roger C. Nichols In many ways, clinical laboratories are one of the most heavily regulated industries in the U.S. Still significant gaps exist in these regulatory processes allowing laboratory tests to be performed and reported under some horrific conditions, and contribute to the public’s mistrust of laboratory test results. Before we discuss the specifics of laboratory regulatory processes, there are some general definitions that are crucial to understanding these processes. 1. Regulation. A generic term that describes the intervention of government in health care service to control or change the behavior of the participants by invoking and enforcing certain rules. Regulatory rules may include certification, accreditation, and/ or licensure (all discussed below). Regulatory measures may also control costs, standards, personnel, and a host of other parameters. Most regulatory measures are passed by federal, state, and local governments. Examples: Medicare, State Health Department. 2. Certification. The process by which a non-government agency or association grants recognition to an individual or organization that has met predetermined standards specified by the certifying organization. It is voluntary and carries no legal sanctions. Examples: ASCP, NCA. 3. Accreditation. The process by which an agency or organization evaluates and recognizes a program of study or activity in an institution as meeting certain predetermined standards. It does not imply lawful practice, but is an assurance of high quality practices. Example: The WSU Clinical Laboratory Science Programs are accredited through the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS). 4. Licensure. A license is permission granted to an individual or organization by competent authority, usually governmental, to engage in a practice, occupation, or activity defined legally to be otherwise unlawful. Licenses are granted on proof of education and/or examination rather than on measures of performance. Examples: State administered exams in Florida, Tennessee, Montana, and California. Other states by proof of educational background. Governmental Regulatory Forces Federal and/or state governments can mandate inspections and standards programs through their powers to license and/or reimburse health care facilities, including clinical laboratories. Such power is derived from the enactment of laws by various legislative bodies under their duty to protect REGULATION, CERTIFICATION AND ACCREDITATION OF THE CLINICAL LABORATORY public health, safety, and welfare. As an example, the federal government enacted the Social Security Act of 1965 and the resulting Medicare/Medicaid provisions (to be discussed under REIMBURSEMENT). Under Medicare, rules exist that govern personnel standards, record keeping, management, safety, and internal and external quality control systems including proficiency testing. Sufficient inconsistencies between different laboratories were apparent enough to compel Congress to enact the Clinical Laboratory Improvement Act of 1967 (CLIA ‘67). CLIA ‘67 was primarily directed towards laboratories engaged in interstate commerce (accepting more than 100 specimens each year from each category for which they were approved) plus all requirements of the Medicare regulations. Labs approved under CLIA ‘67 had to be licensed by the Center for Disease Control (CDC) and administered through State Health Agencies. So now, the federal government had two different sets of regulations for clinical laboratory standards. In addition, any state regulations had to meet or exceed both Medicare and CLIA standards. With respect to federal regulatory processes, there are several other agencies that are either directly or indirectly involved in these regulatory processes. Among them are: 1. Health Care Financing Administration (HCFA): Administers regulatory, financing (reimbursement) and enforcement requirements of Medicare and Medicaid. HCFA continues to gain power as a federal regulatory agency. 2. Office of Management and Budget OMB): Defines budgetary constraints imposed on health care costs in all federally supported programs. One can quickly see the complexities of administering and enforcing multiple regulatory mechanisms. Last year, spurned by the public’s concern over the proliferation of private testing laboratories (many producing poor results), Congress introduced legislation that emerged as the Clinical Laboratory Improvement Act of 1988 (CLIA ‘88). CLIA ‘88 is a substitute bill for the existing CLIA ‘67 and applies to hospital and independent laboratories, nursing facilities, and HMOs as well as Medicare and non-Medicare, interstate and intrastate laboratories including physician office labs (POLs). Congress is expected to amend existing Medicare rules to the provisions of CLIA ‘88. All labs have been operating under CLIA ‘88 since May 1991. CLIA ‘88 differs dramatically from preceding federal regulations in as much as it dictates standards of practice on a national level that apply to all facilities where material derived from the human body is tested for medical purposes. The new CLIA mandates proficiency testing for all labs, but is unclear as what basic personnel standards are acceptable. This has been left up to the Secretary of Health and Human Services. Needless to say, it will be difficult to expect laboratories to achieve high marks on proficiency tests without qualified people performing the testing. A summary of CLIA ‘88 is included in this Study Guide. Laboratory Regulation and Accreditation by Private Agencies 1. College of American Pathologists (CAP). The Laboratory Accreditation Program (LAP) of the CAP began in 1961. Laboratories in compliance with regulations imposed by the CAP do so on a voluntary basis. CAP maintains stringent standards in Second, in many cases health care services (including laboratory services) are selected by the physician rather than the patient. Patients also do not choose which service provider or vendor from which to buy the service; these also are selected by the patient’s physician. Third, most hospitals in this country are not-for-profit, meaning that no profit or earnings are distributed to the owners of the hospital (although they earn salaries and benefits). As a result of these factors, health care facilities have not been as profit conscious as a typical corporation, and their success or failure has been judged on other factors. As a result, the costs of health care services have continued to rise, tripling and quad-tripling each year, reaching astronomic proportions by the mid 1980s. Medicare In July 1966, the U.S. government enacted Medicare and it’s supplemental component Medicaid. The legislation is also known as Title XVIII and Title XIX of the Social Security Act. Managed by the Department of Health and Human Services, it was primarily designed to finance the health care costs of the elderly and poor. In all, federal and state agencies pay for 50-60 percent of all health care costs incurred by the U.S. population. Medicare is split into two parts: Part A provides payment for inpatient services in hospitals and approved nursing facilities or to a home health agency after discharge. Part A also pays for laboratory tests along with a long list of other peripheral services. Part B helps pay for bills from physicians, hospital outpatient visits, and certain other medical services not provided for under Part A. In 1983, the costs to the government for health care reached record highs. Prior to 1983, all Part A payments to health care facilities were made based on the hospital’s actual accrued costs. Under such a payment system, there were strong incentives for facilities to sacrifice cost-containment efforts in order to provide the highest quality patient care through ample staffing, ancillary services, and technology. This system without built-in cost- containment mechanisms drove the costs of health care continuously upward, which the federal government, either directly or indirectly, paid most of the bills. In response to the public outcry on the rising health care costs in general and hospitals in particular (remember these are paid for by the U.S. taxpayer), Medicare devised a totally new approach to payment called the prospective payment system (PPS). The PPS was primarily directed toward Medicare’s Part A payments for inpatient services (including lab fees). The new PPS established 468 diagnosis related groups (DRGs); that is, patient diagnoses were grouped according to the disease affecting body organ systems. The basis of payment was the discharge, which was classified into one of the DRGs. Each DRG had a fixed dollar amount that was paid to the health care facility. The amount was based on the average historical amount paid by Medicare for that diagnosis. The effects of the change from a retrospective, cost-based reimbursement system to a prospective cost-based payment system were immediate. Devastating initially, in effect, it introduced competitive principles into a once monopolistic health care market. For example, prior to the PPS system, if the hospital costs for a particular discharge were $5,000, these costs would have been reimbursed in full by Medicare. By contrast, under PPS, Medicare may have set the DRG at $4,000, regardless of the hospital’s actual accrued costs. In this example the hospital would lose $1,000 for each one of these discharges unless the hospital could reduce the cost of delivering care to the patient. If the hospital could reduce the cost to $3,000, it would realize a gain of $1,000. Under PPS, hospitals had to define and control the costs of delivering services. The laboratory, once a revenue generating service, became a true cost control center when DRGs defined the amount of dollars Medicare would pay. Many services decentralized, including laboratories, from the traditional hospital setting. Outpatient surgery center sprang up as did alternate care services not based on the discharge diagnosis applicable to hospitals. Laboratories in hospitals are becoming more oriented toward serving inpatients and/ or are soliciting laboratory testing from private physicians. Referral laboratories are a booming business and operate on volume testing which rely on newer, more sophisticated and automated technology. Despite the initial chaos following PPS, the need for laboratory services flourish and is expected to do so into the year 2000. Private Health Insurance About 30 percent of non-governmental health care expenditures are provided by private health insurers. the best known is the non-profit Blue Cross and Blue Shield. Blue Cross essentially pays for inpatient services, and Blue Shield for physician fees. Commonly quoted together, they are separate entities with separate missions. Private health insurance operates in much the same way as Medicare before Medicare’s shift to PPS reimbursement. The insurer negotiates and reimburses actual cost with individual hospitals. Private insurers have been slow to respond to following the competitive forces initiated by Medicare. Many have began to establish some alternative payment and delivery systems in the past few years. These include negotiated discount price contracts with physicians and hospitals; the creation of preferred provider organizations (PPOs) which contract on a discounted basis with low cost providers and include certain restrictions to keep costs down; and health maintenance organizations (HMOs) which are really health care membership organizations paid by member “dues” to provide total health care on a per-member basis. The latter limits patients to physicians and services subscribed to by the health care carrier. Other health care providers are for-profit organizations and align themselves with for-profit hospital chains (Humana and HCA) and similar organizations which operate under consolidated management and services. This corporate approach to health care is relatively new, and as such, the “jury is still out” on their long term success. From the previous decades of quality at any cost philosophy, the challenges for the future will be one of providing low cost, easy access health care away from the traditionally costly inpatient facilities while maintaining quality patient care. Clinical laboratory testing has one or more desired outcomes: test results are integral to confirming medical diagnoses, or to the “ruling out” process. They also are of vital importance in monitoring physiological THE NATURE OF LABORATORY TESTING integrity during therapeutic processes. In this age of health consciousness, laboratory tests are used as screening tools to assure the individual is maintaining good health. It is important to remember the fact that physicians are ultimately responsible for the patients. Diagnoses are made by the physician based upon many parameters of which only one may be the result of a laboratory test. The laboratory is not in the business of making diagnoses! Its mission, at all levels, is to provide appropriate, accurate, and timely laboratory data. Laboratory Divisions (Disciplines) As shown in the organizational charts, larger clinical laboratories are departmentalized according to their functional disciplines. Smaller labs are less departmentalized, or in some instances, offer limited services. 1. Phlebotomy. As described earlier, phlebotomists are personnel engage in obtaining blood samples directly from the patient. Phlebotomy has gained some status in recent years (as evidenced by the Phlebotomy Handbook). In most labs, phlebotomy is administered through the hematology department or specimen procurement services. CLS 1113 provides a unit in phlebotomy. 2. Microscopy. Microscopy is really not a specific discipline, but rather a generic term used to describe any process that employs microscopic methods in the test procedure. About 50 percent of diagnostic testing requires some form of microscopy. CLS 1113 introduces basic microscopy skills that will be used in other CLS courses. 3. Hematology. Hematology is the study of the cellular components of blood. These include the leukocytes, or white blood cells; the erythrocytes, or red blood cells; and platelets. Anemias, leukemias and a wide variety of diseases are detected through hematological methods. CLS 1123 and CLS 3313 are courses in hematology. 4. Immunohematology (Blood Banking). Immunohematology is the laboratory process of establishing the compatibility of blood and its components given by donor with the blood of recipients for transfusion purposes. CLS 2215 and 3311 are course in immunohematology. 5. Clinical Chemistry. The clinical chemistry laboratory has evolved from tedious and time consuming manual method to one of sophisticated automated instruments and reagent systems. This evolvement of technology has provided the laboratory with the tools for rapid, accurate chemical analysis of the chemical composition of blood and other body fluids. Clinical chemistry utilized many scientific principles and is generally quantitative in measuring precise amounts of an analyte in a given sample. Substances in human plasma or serum react with specific reagents, which are measurable in the laboratory. CLS 2211, 2213, and 3314 are specific clinical chemistry courses taught through the CLS program. Pre-requisite general chemistry courses are taught in the