Introduction to the Medical Technology Laboratory PDF

Introduction to the Medical Technology Laboratory Chapter 1: Fundamentals of the Clinical Laboratory  Health Care Organizations Modern health care organizations have many different configurations depending on a number of factors. – Geographic location – Marke...

Introduction to the Medical Technology Laboratory Chapter 1: Fundamentals of the Clinical Laboratory  Health Care Organizations Modern health care organizations have many different configurations depending on a number of factors. – Geographic location – Market – Mix of patients – Size – Affiliations The size of health care organizations range from very large teaching hospitals to freestanding labs or sample collection stations.  Health Care Organizations fig. 1-1  Laboratory Medicine Laboratory medicine or clinical pathology, is the discipline in which clinical laboratory science and technology are applied to patient care. Laboratory medicine comprises several major scientific disciplines: o Clinical Chemistry and Urinalysis o Hematology o Clinical Microbiology o Immunology and Serology o Immunohematology (Blood Banking) o Cytology/Histology  Laboratory Medicine fig. 1-2  Use of the Clinical Laboratory Appropriate use of the med. lab is critical to the practice of lab medicine. o The lab must serve to educate the physician and other health care providers so that the results generated can be used appropriately. o When test are being ordered, the lab must assume its role of leadership and education in assisting the physician to understand the most useful pattern of ordering tests. o Continuing education is also important in  Use of the Clinical Laboratory Hundreds of tests are available in a large lab, however, only a small percentage are routinely ordered. When results of these common tests are used appropriately in the context of the patient’s clinical case, physical examination findings, and the medical history, clinical decision making will be improved. A small number of appropriately chosen tests may be sufficient to confirm or rule  Laboratory Departments Hematology and Hemostasis Hematology- the diagnostic study of blood and its formed elements. o The routine test in this department is the complete blood count (CBC). o This test includes:  RBC count  WBC count and differential  Platelet count  Hemoglobin concentration (Hb or Hgb)  RBC indices  Platelet aggregation and coagulation studies  Laboratory Departments Hematology and Hemostasis CBC results are useful in diagnosing or ruling out hematological conditions such as: o Anemia o Leukemia o Sickle cell disease o Infectious diseases o hemophilia Cell counts are also done on other body fluids such as: o CSF o Synovial fluid  Laboratory Departments Urinalysis Urinalysis is the physical, chemical and microscopic observation of urine. Physical Chemical Microscopic -Color -pH -RBC -Clarity -Blood -WBC -Specific gravity -Glucose -Crystals -Ketones -Casts -Bilirubin -Leukocytes  Laboratory Departments Clinical Chemistry Clinical chemistry is the quantitative analysis of various analytes in body fluids. o The main fluids tested are plasma and serum o Test panels are done to help diagnose and assess the function and drug therapy of organ systems Organand diseases such Systems as: Diseases Liver Cancer Kidney Diabetes Cardiovascular Stroke Thyroid Heart attack Gastric Hormonal imbalances Reproductive  Laboratory Departments Immunohematology (Blood Banking) Immunohematology is the branch of lab medicine which aims to provide quality blood components for safe transfusion. In order to ensure the safety of the components, a number of tests are done on both patient and donor samples. Blood Tests Components Whole blood Blood grouping Plasma Compatibility Platelets testing WBCs Antibody identity Parental testing  Laboratory Departments Immunology and Serology Immunology and serology evaluates infectious diseases and autoimmune conditions through the detection and/or quantification of antibodies and antigens in body fluids. Conditions include: o HIV o syphilis o Rheumatoid fever and arthritis o SLE o Pregnancy  Laboratory Departments Microbiology Microbiology is the study of microorganisms and their interactions with their host in order to culture, identify and treat diseases causes by them. Classes of microorganism studied include: o Bacteria o Fungi o Parasites o Viruses  Laboratory Departments Cytology/Histology Cytology is the study of the structure and function of cells with the aim of detecting and diagnosing abnormalities. Histology is the diagnostic analysis of tissue through a series of protocols in order to aid in the diagnosis of abnormalities.  Laboratory Departments Phlebotomy (Venipuncture) Phlebotomy is the drawing of blood from a patient’s vein for use in diagnostic testing.  External Accreditation and Regulation In the current laboratory setting, many governmental regulations and recommendations from professional, state and federal accreditation agencies and commissions of various types, govern the activities and monitor the standards of the lab. o COLA o CLSI These agencies o CAP include: o OSHA o JCAHO o CDC o AABB o FDA o ASHI o CMS o AOA o HHS o CLIA  CLIA ‘88 The Clinical Laboratory Improvement Amendments of 1988 seek to ensure the laboratory results reported are of high quality regardless of where the testing is done. CLIA ‘88 regulations divide laboratories into categories based on the “complexity” of the test being performed by the laboratory, as follows: Waived tests – tests cleared by the FDA for home use due to fact that results pose little risk of harm to the patient.(POCT) Moderately complex and highly complex tests –  Physicians Office lab vs. Reference Lab (POL). A POL is a lab where the tests performed are limited to those done for the physician’s own patients coming to the practice. The CLIA ‘88 restricts these labs to only waived tests due to concerns of under qualified staff. The reference lab perform more complex and non-routine tests which cannot be done in POLs and are not offered by small central labs due to  Laboratory Personnel Physicians generally do not perform the lab test themselves but rely on trained laboratory personnel to do them. The med lab team is made up of: o The medical director or pathologist o Medical technologist o Med lab technician o Lab assistants o Phlebotomists o Specialists in various lab disciplines such as chemists and hematologists.  Laboratory Personnel Medical Technologist vs. Lab Technician Medical Technologists (MT): o Have earned a BSc. degree in medical technology or clinical laboratory science. o Perform lab assays and supervise other staff o Are trained to understand the science behind the tests so that problems can be recognized and solved. Lab Technicians: o Have less formal education and training than MT o May have associate degrees or certificates o Have limited responsibilities in the lab and are supervised by MTs  Patient Specimens The MT works with many types of specimens including: o Blood and urine (most common) o Synovial fluid o CSF o Peritoneal and pericardial fluid o Pus o Sputum o Aspirates o Tissue o Swabs o Feces Appropriate quality assessment programs must be in place in the laboratory to ensure that each specimen is given the best analysis possible and that the results reported will benefit the patient in  Quality Assessment (QA) QA programs are required by governments and regulatory bodies. QA programs are mandated standards for all labs intended to greatly enhance the medical community’s ability to provide good-quality patient care. These programs require quality control (QC), the use of proficiency testing and for certain level of personnel to perform and supervise the work in the lab. QA activities must be documented and must be a part of the ongoing organization of the lab. QA programs must include all levels of lab staff. It is the responsibility of the lab, to both patient  Quality Assessment (QA) A QA system is divided into two major major component: o Nonanalytical factors o Analytical factors  Quality Assessment (QA) Nonanalytical Factors These include pre- and post-analytical factors that support quality testing and include: 1. Qualified personnel 2. Established lab policies 3. Lab procedure manuals 4. Proper procedures for specimen collection and storage 5. Preventive maintenance for equipment 6. Appropriate methodology 7. Established QC and QA techniques 8. Accuracy in reporting results  Quality Assessment (QA) Analytical Factors These involve statistical analysis of results to ensure that they are of the highest quality. Some terms used in QA are: o Accuracy describes how close a test result is to the true value. o Calibration is the comparison of an instrument measurement to a known physical constant. o Control represents a specimen that is similar to the patient’s sample and has a known value. o Precision describes how close test results are to one another when runs are repeated. o Standards are highly purified solutions of known composition.  Functions of Quantitative QC Programs Assaying control samples and standards along with patient specimens serve several major functions. 1. Provides a guide to the functioning of equipment, reagents, and individual techniques. 2. Confirms the accuracy of testing when compared to reference values 3. Detects an increase in the frequency of both high and low minimally acceptable values. 4. Detects any progressive drift of values to one side of the average value for at least three days.  Proficiency Testing (PT) PT is a means by which quality control between labs is maintained. The CLIA ‘88 require the enrollment in an external PT program for labs performing moderately complex or highly complex tests. Labs enrolled in a particular PT program test specially prepared samples for specific analytes and send results to be tabulated by the program managers. The results are graded for each lab and results are compared with the expected  Medical-Legal Issues Informed Consent- means that is aware of, understand, and agrees to the nature of the testing to be done and what will be done with the results reported. Confidentiality – any results obtained for specimens from patients must be kept strictly confidential. Chain of Custody – Lab results that could potentially be used in a court of law must be handle in a specific manner. For evidence to be admissible , each step of the analysis, beginning with the moment the Next Class Chapter 2: Safety in the Clinical Laboratory