Fundamentals of the Clinical Laboratory PDF

Chapter 1 Fundamentals of the Clinical Laboratory 1 Preamble PowerPoints are a general overview and are provided to help students take notes over the video lecture ONLY. PowerPoints DO NOT cover the details needed...

Chapter 1 Fundamentals of the Clinical Laboratory 1 Preamble PowerPoints are a general overview and are provided to help students take notes over the video lecture ONLY. PowerPoints DO NOT cover the details needed for the Unit exam Each student is responsible for READING the TEXTBOOK for details to answer the UNIT OBJECTIVES Unit Objectives are your study guide (not this PowerPoint) Test questions cover the details of UNIT OBJECTIVES found only in your Textbook! 1  Chapter Objectives 1. Identify the typical departments of a clinical laboratory and functions of each. 2. List five (5) reasons laboratory tests are used to aid the physician in caring for patients. 3. Differentiate the roles and responsibilities of Clinical Laboratory Technicians and Clinical Laboratory Scientists. 4. Define the term ethics and discuss medical applications. 5. Describe and demonstrate the use of the organizational structure of the laboratory. 6. Name and describe clinical laboratory staffing and functions. 7. Define and discuss accreditation, licensure, and certification. 8. Explain CLIA ’88 and the classification of laboratory testing by complexity of the test 9. Describe the Rules and Regulations for the State of Georgia. 10. List the governmental agencies that regulate laboratories and the non-governmental agencies that accredit hospitals and laboratories. 11. Compare the functions of the laboratory professional organizations. 12. Explain why documentation is important in the clinical laboratory and describe the proper format to document on reports. 13. Describe the proper way to correct errors on paperwork in the laboratory. 14. Identify the legal terms and the legal aspects of the laboratory. 15. Describe the Georgia Good Samaritan Law, HIPAA and the Patient’s Bill of Rights 16. Discuss the types of lawsuits that are common to the healthcare field and ways to prevent them. 3 The Profession Clinical laboratory testing plays a crucial role in the detection, diagnosis, and treatment of disease. After collecting and examining a specimen, laboratory professionals analyze and communicate results to physicians or other primary care providers. 4 2  History of the Profession Original Credentialing and Professional Organizations The American Society for Clinical Pathology (ASCP) created the Board of Registry (BOR) in 1928 to certify laboratory professionals. Individuals who passed the BOR’s registry exam were referred to as “medical technologists,” identified by the acronym “MT (ASCP).” In 1933, the American Society of Clinical Laboratory Technicians (ASCLT) was formed. Today, this organization is known as the American Society for Clinical Laboratory Science (ASCLS). 5 History of the Profession Individual Professional Recognition During the 1960s, new categories of laboratory professionals joined generalist medical technologists in performing the daily work of the clinical laboratory. The category of medical laboratory technician (MLT) was developed as a 2-year associate’s degree program. To help cope with the increased workload. Specialist categories in chemistry, microbiology, hematology, and blood banking were created. Specialists certified in cytotechnology, histotechnology, laboratory safety, and molecular pathology/molecular biology have evolved as well. Technicians certified as donor phlebotomists or phlebotomy technicians are part of the laboratory team. Pathologists’ assistants are another category of specialty certification. Certification as a Diplomat in Laboratory Management is available. 6 3 History of the Profession Additional Individual Professional Certification and Licensure Numerous states and U.S. territories currently require licensure. Individual Licensure California, Florida, Hawaii, Louisiana, Montana, Nevada, New York, North Dakota, Rhode Island, Tennessee and West Virginia Laboratory Licensure- Georgia 7 History of the Profession State of Georgia Licenses LABORATORIES In the State Rules and Regulations it states: No clinical laboratory shall operate without a license Laboratory must have proof of certified personnel to obtain and maintain licensure Current thought is to push state to License all Laboratory workers 8 4  History of the Profession Newest Professional Recognition Generalists are now referred to as medical laboratory scientists (MLSs). The similar technician-level designation continued to be designated as medical laboratory technicians (MLTs). The appropriate professional credentialing is MLS(ASCP) and MLT(ASCP). 9 Health Care personnel structure FIGURE 1-2 Hospital Organizational Chart. Modified from Kaplan LA, Pesce AJ: Clinical chemistry: theory, analysis and correlations, ed 5, St Louis, 2010, Mosby. 10 5  Clinical Laboratory Personnel CLIA Requirements for Laboratory Personnel 1. Pathologist, MD Clinical Laboratory Personnel Laboratory Director Department Supervisor or Manager Clinical Laboratory Scientist/ MLS/ MT Medical Laboratory Technician/Clinical Laboratory Technician Clinical Laboratory Assistant Certified Phlebotomist 11 MT (MLS) verses MLT (CLT) Medical Technologist or Medical Lab Scientist (4yr) A person qualified by education, training, and experience to perform clinical laboratory testing requiring the exercise of independent judgment and discretion. Medical Laboratory or Clinical Laboratory Technician (2yr) A person qualified by education, training, and experience to perform clinical laboratory tests requiring a minimal exercise of independent judgment, responsibility, and discretion. * READ OVER THE MLS/MLT JOB DESCRIPTIONS IN YOUR UNIT 1 FOLDER ON BLACKBOARD. 12 6  PROFESSIONALISM What is a professional? An individual who has been extensively trained to render a particular service and is governed by an organized body that regulates continued practice in the field by requiring Certification (or Licensure) Continuing Education Adherence to a code of ethics Ethics – the science of the principles of human morality and duty. The moral philosophy of a group. Assessment of competency 13 Professional Conduct 1. MLT’s are dedicated to serving the health-care needs of the public. 2. MLT’s work with other health care professionals, to provide effective patient care 3. MLT’s shall promote the image and status of their profession by maintaining high standards in their professional practice and through active support of their professional bodies 4. MLT’s shall protect the confidentiality of all patient information 5. MLT’s shall take responsibility for their professional acts 7  Professional Conduct 6. MLT’s shall practice within the scope of their professional competence 7. MLT’s shall endeavor to maintain and improve their skills and knowledge and keep current with scientific advances 8. MLT’s shall share their knowledge with colleagues and promote learning 9. MLT’s shall be aware of the laws and regulations governing medical laboratory technology and shall apply them in the practice of their profession 10. MLT’s shall practice safe work procedures at all times to ensure the safety of patients and co-workers and the protection of the environment Continuing Education Laboratory professionals are expected to maintain their knowledge on the most recent advances in laboratory testing and continuing education programs can address this expectation. Organizations that offer workshop based continuing education include ASCP and ASCLS. Organizations that offer online &/or webinar based continuing education courses include ASCP, LabCE and CDC to name just a few. ASCP – https://www.ascp.org/content/membership/get-involved/access-online-courses LabCE - https://www.labce.com/mls_mt_mlt_lab_continuing_education.aspx CDC - https://www.cdc.gov/labtraining/index.html 8  CLINICAL LABORATORY TECHNOLOGY Why do we use laboratory testing? 1. To confirm or establish a diagnosis 2. To rule out a diagnosis 3. To monitor therapy 4. To establish prognosis 5. To screen for or detect disease 17 Clinical Laboratory Improvement Amendments (CLIA ’88) 1. Waived Tests Designed to employ methodologies so simple and accurate as to render the likelihood of erroneous results negligible. They pose no reasonable risk of harm to the patient if the test is performed incorrectly. Examples: Test kits such as rapid strep antigen, infectious mono, H. pylori and cholesterol testing Moderate and High Complexity Testing Requires quality control, calibration, proficiency testing, some skill in troubleshooting and maintaining equipment, and some skill or judgement in interpretation of results. 2. Moderate Complexity Testing Requires moderate level of skill in troubleshooting and maintaining equipment, and moderate skill or judgement in interpretation of results. Examples: Automated testing such as chemistry, hematology/coagulation and urinalysis 3. High Complexity Testing Requires high level of skill in troubleshooting and maintaining equipment, and skill or judgement in interpretation of results. Examples: Blood Bank and Microbiology testing 18 9  Clinical Laboratory Improvement Amendments (CLIA ’88) 4. Provider-Performed Microscopy (PPM) Test performed by a physician or a mid-level practitioner during the patient visit on a specimen obtained from the provider's patient or a patient of the group practice. The procedure must be in the moderate complexity category and the primary instrument for the test must be a microscope. 19 Phases of Testing Pre-Analytical Phase This first phase includes patient specimen handling prior to testing. Errors can occur during the pre-analytic phase with improper specimen identification, collection &/or specimen handling. Analytical This second phase includes what is usually considered the "actual" laboratory testing or the diagnostic procedures, processes, and products that ultimately provide results. Post-Analytical This final phase culminates in the production of a final value or result. 20 10 Laboratory Departments or Divisions Major Lab Departments: 1. Hematology 2. Hemostasis/ Coagulation 3. Urinalysis 4. Clinical Chemistry 5. Blood Bank (Immunohematology) 6. Immunology and Serology 7. Microbiology 21 Hematology Tests Study of the formed elements in the blood Common tests include the Complete Blood Count (CBC) MCH WBC MCV RBC MCHC Hct RDW Hgb Plt Ct Diff 22 11 Coagulation Tests Study on bleeding and clotting properties of blood Common Tests include: Activated partial thromboplastin time Bleeding time (BT) D-dimer test Fibrin degradation products (FDP) Fibrinogen Prothrombin time 23 Urinalysis Testing Study of the Urine which includes the following: Physical evaluation Assesses color, clarity, & specific gravity Chemical evaluation Screens for chemical substances, e.g., sugar Microscopic evaluation Identifies the presence of blood cells, bacteria, etc. 24 12  Chemistry Tests Study of chemical properties of blood and body fluids Ammonia Glycosylated Hgb Panels: Amylase GGT 1. Basic Metabolic BMP Bilirubin LD 2. Comprehensive ABG Lipase Metabolic CMP BUN PSA 3. Cardiac CEA Total Protein 4. Liver Triglycerides Calcium Uric acid Cholesterol Vitamin B12 Cortisol Folate CK Creatinine Drug Analysis Electrolytes 25 Immunohematology (Blood Bank) Study of immune responses relating to blood cell antigen/antibody reactions for transfusion medicine AB Screen DAT Type & Rh Type & Crossmatch Compatibility Testing 26 13 Immunology Study of the immune system to protect the body from pathogens. Bacterial ANA, ASO, Cold Agglutinins studies FTA-ABS, RPR RF Viral Anti-HIV, CMV studies EBV, HBs Ag General CRP studies HCG 27 Microbiology Study of microorganisms the cause disease Common Tests include: AFB Blood culture CLO test C&S Fungus culture & ID Gram stain Occult blood Ova & parasites 28 14 Laboratory External Accreditation Accreditation gives permission to run a clinical laboratory. Three primary laboratory accrediting organizations: 1. Commission on Office Laboratory Accreditation (COLA) 2. College of American Pathologists (CAP) 3. The Joint Commission (TJC) Benefits of Accreditation 1. Identifies a laboratory institution as meeting established standards of quality 2. Stimulates improvement of standards by involving staff in self- evaluation, research and planning 3. Promotes better understanding of the goals of professional education in the field 4. Provides reasonable assurance that practitioners meet minimum educational standards upon entry into the profession 29 Laboratory External Regulation Regulation (setting the standards) agencies include: Governmental and Professional agencies set standards for the clinical laboratory Federal include: Centers for Medicare and Medicaid Services (CMS) - Clinical Laboratory Improvement Amendments of 1988 (CLIA88) Department of Health and Human Services (HHS) Occupational Safety and Health Administration (OSHA) Centers for Disease Control and Prevention (CDC) Food and Drug Administration (FDA) Professional include: Clinical Laboratory Standards Institute (CLSI) 30 15 Clinical Laboratory Improvement Amendments (CLIA ’88) One of the most important regulations set forth for clinical laboratories was CLIA in 1988. CLIA set standards to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. Hospital Physicians Office Laboratory Reference Laboratory 31 Laboratory EXTERNAL Certification Certification agencies are given the task to verify that laboratories follow the set guidelines and standards set forth by the federal government. These include: 1. College of American Pathologists (CAP) 2. The Joint Commission (TJC) 32 16  Professional Certification Individual Certification or Professional Certification ASCP = American Society of Clinical Pathologist (Most recognized) AMT = American Medical Technologist Completion of the CLT program makes students eligible to take the certification exams  The State of Georgia requires laboratory technicians and technologists to obtain certification within 18 months of graduation to work in the state. 33 Professional Certification Purpose of professional certification To provide and measure a standard of knowledge desirable for a given profession Encourage professional growth Recognize individuals who fulfill certification requirements Encourage professionalism 34 17  Professional Organizations Organizations: ASCP American Society of Clinical Pathologists Both AMT Certification American Medical Agencies and Technologist Organizations ASCLS American Society of Clinical Laboratory Scientists 35 BENEFITS of Professional Organizations Receive a journal Offer Continuing Education Help students find jobs Scholarships Provides information about certification exams Keep awareness of current issues Networking Interaction Involvement – ASCLS_GA Meeting in March/April 36 18  Medical Ethics Ethics also encompasses the principles of conduct of a group or individual, such as professional ethics. ASCLS endorses a professional Code of Ethics, which states that all laboratory professionals have a responsibility for proper conduct toward the patient, colleagues and the profession, and society. In addition, ASCLS has a Pledge to the Profession. 37 Medical and Professional Ethics Medical and professional ethics encompass the moral principles of conduct of a group or individual. Examples of these medical and professional ethics are: Work always under the supervision of a qualified physician Under no circumstances and on their own initiative, render written or oral diagnosis, other than those on reports prepared by the physician Under no circumstances, advise physicians or others in the treatment of disease It is considered ethical to perform laboratory work on a commission basis, when such work is supervised by a physician. 38 19  Personal Code of Ethics Examples of Personal code of ethics include: 1. Discharge duties with accuracy, thoughtfulness, and care 2. Hold in confidence ALL information relating to patients 3. Be reliable, both in attendance and performance 4. Maintain the dignity of the profession by attire, conduct, and attitude 5. Achieve the highest degree of honesty and integrity. 39 Student Code of Ethics Examples of student code of ethics: 1. Adhere to the personal code of ethics 2. Show respect for instructors' knowledge and experience, both during didactics and while in clinical rotations 3. Strive for increased efficiency and quality through organization 4. Accept responsibility for your own work 5. Maintain adaptability in action and attitude 6. Establish a sense of fraternity among fellow students. 7. Strive to have a pleasant manner while at school or hospital (leave your problems at home) 40 20 The Law and You It is prudent for health care professionals to be aware of what occurs in the health care arena concerning legal issues and to be knowledgeable of some basic actions that can be done to help avoid the unpleasantness of litigation. 41 HIPAA Regulations and Communications In 1996 the U.S. Congress responded to the information age by enacting a law specifically directed to the protection of personal health information (PHI): the Health Information Portability and Accessibility Act (HIPAA). Health care providers are required to respect personal privacy and to maintain patient confidentiality. These regulations protect a patient from illegal or inadvertent disclosure of his or her personal information, of particular concern with HIV because of the risk of loss of employment, housing, insurance, and other benefits of society. 21  Documentation EVERY requisition, report, log sheet, and quality control log is a legal document! NEVER write test results on a scrap piece of paper! EVERY report given on the telephone must have the name of the person, date, and time to whom you gave the result to. The documentation should read as: Called to and read back by “name” at “time” on “date” 43 Correcting Mistakes EVERY mistake you make must be corrected in a specific way: Draw a single line through the error Initial the error No scribbling or scratching out! Write the corrected error next to or above the correction Clearly as so it can be read Always use pen – never pencil NEVER, NEVER, NEVER use white-out 44 22  Documentation IF YOU DON’T DOCUMENT IT- YOU DIDN’T DO IT! You must be ready to go to court at any time to defend your paper work such as your worksheets. 45 Legal Terms Appeal request that a case be heard by a high court in order to seek review and a reversal of a lower court’s ruling Battery touching a person against their will or without their consent Breach of duty Duty means a responsibility or obligation to the patient. It is a breach of duty if whatever harm that was done to the patient could have been avoided. 46 23  Legal Terms Chain of Custody An unbroken trail of accountability that ensures the physical security of samples, data, and records in a criminal investigation Compensation compensate the plaintiff for some harm suffered because of action by the defendant. Confidentiality Keep information in strict privacy 1996: Health Insurance Portability and Accountability Act (HIPAA) (see handout for more details) 47 Legal Terms Defendant party accused by the plaintiff of having harmed him/her in some manner Informed Consent Patient is aware and agrees to the nature of testing Interrogatory Pre-trial discovery in which written questions are sent to a witness who makes a reply under oath. No opportunity for cross examination 48 24  Legal Terms Liable being responsible for damages Litigation lawsuit Malpractice when care is given in an unprofessional or unskillful way Negligence when care given to a patient is not given according to acceptable standards of practice 49 Legal Terms Plaintiff party initiating a lawsuit Reasonable Care care that a reasonable person would exercise under the circumstances; the standard for determining legal duty Summary judgment a judgment without the necessity of a trial 50 25  Legal Terms Tort Damage, injury, or a wrongful act done willfully, negligently, or in circumstances involving strict liability, but not involving breach of contract, for which a civil suit can be brought. 51 Preventing Litigation 1. Always be empathetic toward patients 2. Never quickly admit fault 3. Always respect and protect patient’s confidentiality 4. Perform only those procedures that you are trained and approved to do. 5. Meticulously follow the most recent procedure and policy manuals of the hospital where you are employed 52 26 Preventing Litigation 5. Maintain accurate, complete, and up-to-date records, logs, and quality assurance documentation. 6. DOCUMENTATION, DOCUMENTATION 7. Obtain patient confidence by Appearing unhurried, considerate and gentle when handling patient Speak in an authoritative but quiet voice 53 Postamble READ the TEXTBOOK for the details to answer the UNIT OBJECTIVES. USE THE UNIT OBJECTIVES AS A STUDY GUIDE All test questions come from detailed material found in the TEXTBOOK (Not this PowerPoint) and relate back to the Unit Objectives 27