Clinical Laboratory (PDF)

1-1: The Clinical Laboratory Clinical/medical laboratory - Labs that perform chemical and microscopic tests on blood, body fluids, and tissues Hopsital laboratories - Private hosptials - Universtiy hospitals - Teaching hsoptials - Government-operated institutions - Small (les...

1-1: The Clinical Laboratory Clinical/medical laboratory - Labs that perform chemical and microscopic tests on blood, body fluids, and tissues Hopsital laboratories - Private hosptials - Universtiy hospitals - Teaching hsoptials - Government-operated institutions - Small (less than 100 beds) - Medium (up to 300 beds) - Big (more htan 300 beds) Nonhosptial Laboratories - Group practices - Physician offices - Nursing homes - Veterinary offices - Government agency - Military installations - Industry 1) Laboratory Director - Usually pathologist 2) Technical Supervior - Laboratory manager, chief technologist 3) Clinical Consultant - consultant 4) Technical consultant/supervisor - Department head, section head, section supervisor, technical spcialist 5) Testing perrsonnel - Medical tehcnolgist, clinical lab scientist, medical lab technician, lab assistant AABB: American Association of Blood Banks - International association that sets blood bank standards, accredits blood banks, and promotes high standards of performace in the practice of transfuion medicine CDC: Centers for Disease Control and Prevention - Central laboratory for the national public health sytem CMS: Centers for Medicare and Mediacaid Services - the agency within the DHHS responsible for implimenting CLIA’88 CLSI: Clinical and Laboratory Standards Institute - An international, non profit organization that establishes standards of best current practicce for clinical laboratories; formerly known as National Committee for Clincal Laboratory Standards (NCCLS) CLIA’88: Clinical Laboratory Improvement Amendmetns of 1988 - Federal act that specifies minimum performance standards for clinical laboratories 1) Waived tests 2) Tests of moderate and high complexity  3) PPMP I) certificate of Waiver - Permits lab to only perform CLIA waived tests II) Registration certificate - Permits lab to conduct moderate or high complexity testing until lab is determined by survey to be in compliance with regulation III) certificate of compliance - Issued to a lab holdning certificate of registration after an inspection finds the lab to be in compliance with regulations IV) certificate of accreditation - Issued to a lab that has been accredited by a CMS approved accrediting org. V) certificate of PPMP - Issued to a lab in which a physician, mid-level practitioner, or dentist performs no tests of complexity other than microscopy procedures (also permits waived tests). CAP: College of American Pathologists - Agency that offers accreditation to clincal laboratories and certification to clinical laboratory personnel COLA: Commission on Office Laboratory Accredidiation DHHS: Department of Health and Human Services - The governmental agency that oversees public health care matters;commonly known as HHS FDA: Food and Drug Administration - The division of the DHHS responsible for protecting the public health by assuring the safety and effacy of foods, drugs, biological prodcuts, medical devices, and cosmetics HCFA: CMS JC: Joint Commission - Independant agency that accredits hospitals and large healthcare facilities (JCAHO) LRN: Labroatory Response Network - Nationwide network of labs coordinated by the CDC wtih te ability for rapid repsonse to threats to public health NCCLS: CLSI POL: Physician office laboratory - Small medical lab located within physician office, group practice, or clinic POCT: Point of care testing - Testing outside the traditional laboratory setting, or bedside testing PT: proficiency testing - program in which lab’s accuracy in performing analysis is evaluated at regular intervals and cinapred to the performance of similar labs PPMP: Provider-performed micrsopcpy procedure - Certificate under CLIA’88 QA: Quality Assessment - In the lab, a program that monitors the total testing process with the aim of providing the hgihest quality patient care 1-2: The Clinical Laboratory Professional AAMA: American Association of MEdical Assistants - Professional socetu and credintialing agency for medical assistance AMT:American Medican Technologist - Professional society and credentialing agency for clinical laboratory personnel ASCLS:American Society for Clincal Lab Science - Professional society and credentialing for laboratory personnel ASCP:American Society for Clincal Pathology - Professional society and credentialing for laboratory personnel and allied health personnel ASPT:American Society of Phlepotomy Technicians - Professional scoeity and credentialing agency for phlebotomists CLS:Clincal Laboratory Scientist (medical technologist) - Baccaluaurete degree - Completed clinal training in accredited clinical lab science program - Passed national exam CLT: Clinical Laboratory Technician (medical laboratory technician) - Minimum of two years completed of training from technician program - Passed national exam CAAHEP: Commission on Accreditaion of Allied Health Education Programs - Agency that accredits edcuation programs for clinical lab personnel (CAHEA) HIPPA: Health Insurance Portibility and Accountability Act - 1996 act that guarentees protection of privacy of an individual’s health information NAACLS:National Accrediting Agency for Clinical Lab Sciences - Agency that accredits educational programs for clinical laboratory personnel NCA: National Credentialing Agency for Laboratory Personnel NPA:National Phlebotomy Association - Professional and credentialing agency for phlebotomists Laboratory test professions: - Phlebotomist (technician) - Medical Assistant - Physical office lab technician - Clincal Lab assistant - Biotech Lab technician - Point of care technician 1-3: Introduction to Medical Terminology Prefix: modifying word or syllable placed at the beginning of aword Stem: main part of the word Suffix : modifying word or syllable at the end of a word 1-4: Introduction to the Metric System NIST: National Institute of Standards and Technology - A federal agency that promotes standardization of measurements (National bureau of Standards) 1 mile = 1.6 km 1 yard = 0.9 meters 1 inch = 2.54 cm 1 lb = 0.454 kg 1 oz = 28 g 1 km = 0.6 mile 1 m = 3.3 ft 1 m = 39.37 in 1 cm = 0.4 in 1 g = 0.0022 lb 1 L = 1.06 qt 1mL = 0.03 fl oz 5 C= 9 (F-32) 9 F= 5 (C+32) 1-5: Laboratory Safety: Physical and Chemical Hazards Chemical Hygiene Plan: Comprehensive written safety plan detailing prosper use and storage of hazardous chemicals in workplace MSDS: Material Safety Data Sheet - Written safety information that must be supplied by manufacturers of chemicals and hazardous materials NIOSH: National Institute for Occupational Safety and Health - Federal agency responsible for workplace safety reaserch and that makes recommendations for preventing work-related illness and injury OSH ACT: Occupational Safety and Health Act - Congressional act of 1970 created to help reduce on the job illness, injuries, and deaths, and requiring emplyers to provide safe working conditions OSHA: Occupational Safety and health Administration - The federal agnecy that creates workplace safety regulations and enforced the OSH Act Physical Hazards - Electrical Equipment - Labroatory Instrunments - Glassware Hazard Signs - Blue: health hazards or toxics - Red: Fire hazard - Yellow: Reactive chemicals - White: Reactive with water Caustic Chemicals:strong acids or bases capable of causing severe skin burns - KKOH - NaOH - H2SO4 - HNO3 Serious Hazards - Carcinogens (causes cancer)  - Mutagens (causes birth defects) - Radiosotopes (unstable form of an element that emits radiation) 1-6: Laboratory Safety: Biological Hazards AIDS: Acquired Immonodificency syndrome - Form of severe immunodeficiency caused by infection with the HIV Antiseptic: chemical used on living issues to control growth of infectious agents BBP: blood borne pathogens - Pathogens that can be present in human blood and can cause disease BBP Standard: OSHA guideliens for preventing occupational exposure to pathogens present in human blood and bodily fluids, including, HIV, HBV. HBV: Hepatis B Virus - The virus that causes Hepatitis B infection and is transmitted by contact with infected blood or bodily fluids HCV: Hepatitis C Virus - The virus that causes hepatitis C infection and is transmitted by contact with infected blood or bodily fluids HIV: Human immonodeficiency virus - The retrovirus that has been idenfiied to cause AIDS OPIM: Other potentially infectious materials Transmission-Based Procautions: specific safety practices used in addition to SP when treating patients knwont o be or suspected of being infected with pathogens that can be spreaded by air, droplet, contact Work practice controls - Handwashing before and after glove - Wearing PPE - Removal and disposal of PPE when leaving work area - Using disinfectant such as 10% chlroine bleach to clean work area Disinfection - Dilute Chlorine Belach (hypochlorites) 1:10 dilution - Alcoholes 70-85% - Idophors, y5 parts per million (ppm) or 4.5 ml/L water - Phenols - Quaternary Ammonium Compounds Antiseptics: used on skin or tissue to inhibit growth of microbes - Alcohols - Hydrogen peroxide - Triclosan - Chlorhexine - iodine 1-7: Quality Assessment Coefficient of variation: calculated valuet that compares to the relative variability between sets of data Gaussian Curve: graph plotting distribution of data values around he mean, normal frequency curve Levey-Jennings Chart: quality control chart used to record daily quality control values QC: quality control - System that verifies the reliability of analytical test results through the use of standard controls and analysis GS: quality systems - Comprehensive program in whcih all areas of operation are monitored to ensure quality with the aim of providing the highest quality patient care Westgard’s rules: set of rules used to determine when a method is out of control - Both controls are outside 2 limit - The same control level is outside 2 limit in two successive runs - Controls in four consecutive runs have values greater than 1 all in the same direction - Ten consecutive control values fall on one side of the mean QA Factors - Preanalytical factors - Poor specimen collection - Poor tool handling - Poor storage - Analytical factors and QC methods - Lab Prep of sample - Insturnments maintenance and calibration - Controls - Test procedure - Interfering substances/conditions - Analysis of control results - Postanalytical factors - identification of specimen - Analysizing data 1-8: Laboratory Glassware Flint glass: inexpensive but has low resistance to heat andchemicals. Disposable test tubes are oftem made of flint class Boroscilate Glass: nonreactive with most chemicals, is usually high thermal resistance, and can be heat sterilized. Used for beakers, flasks, and other lab glassware. Quartz Glass: expensive glass that is often used when glass must have excellent light transmission without distortion such as cuvettes Cleaning: rinse with water immediately after using (followed by 2-3 reagent grade waterr rinses and type 1 reagent water. 1-9: General Laboratory Equipment Distilled Water: the condenaste collected from steam after water has been boiled Reverse Osmosis: purification of water by forcing water through semi permeable membrane Rotor: part of centrifuge that holds tubes and rotates during the operation Serological centrifuge: centrifuge that spins small tubes such as those used in blood banking Autoclave: uses steam under pressure to sterilize items such as dental and surgical isntrunments, solutions, and material to be used in microbiology - Typical autoclave conditions are 121 Celsius for 15-20 minutes at 15 psi.  - Open instrument when reading is 0 psi pH: measurements of the hydrogen ion concentration of a solution - If pH is too low, it can be made more alkaline by adding drops of concentrated alkaline solution like NaOH - If pH is too high, concentrated acid such as HCl or HC2H3O2 can be added Temperature control instrunments - Ovens for drying - Microbiology incubators - 36±1 celsius - Water baths - 36±1 celsius - Refrigerators - 6± 2 Celsius - Freezers - -20±5 celsius - Ultracold freezer - -70±5 Celsius - microwaves Type I Water - From reverse osmosis water (the water is passed through high quality resin to remove remaining ions. - Can also be obtained by processing deionized water using membrane filters - Purest grade of water - Used to prepare standard and control solutions - Used to bring freeze-dried (lyphosized) material into solution. - Must be used right after its prepared to avoid absorption of gases such as carbon dioxide Type II Water - Can be used when presence of small numbers of bacterial (≤ 100 per liter) will not affect results - Used for most procedures in hematology, immunology, qualitative chem Type III Water - Used for laboratory analyses such as urinalysis - Source to prepare type I and II water. Only type I and II should be used to rinse glassware 1-10: The Microscope Electron microscope: microscope that uses an electron beam to create images from a specimen and that is capable of much greater magnification and resolving power than a light microscope - Objects as small as 0.001 um can be viewed - SEM: scanning eelctron microscope - Beam is directed to specimen, but it bounces back and is inteprerated by the microscope  - TEM: transmission electron microscope - Electron beam is beamed through the specimen and the inside of the cell can be seen by the microscope Kohler illumination: alignment of illuminating lught for microscopy Resolving Power: the ability of microscope to produce separate images of two closely spaced objects Clinical Microscopes: light microscopes where specimens are viewed using light sources such as Tungsten,Halogen , Mercury. - Bright-field microscope - Common - Phase-contrast microscope - Better for stained cell viewing since background becomes gray - Epi-florescence micrscope - Combines with dyes and antibodies to identify specific areas where things are located. 1-11: Laboratory calculations and Reagent Preparations Formula Weight: weight of entity represented by a chemical formula (molecular weight) Physiological saline: 85% (0.15M) sodium chloride solution Stock solutions = concentrated solutions 1-12: Blood Collection:Capillary Puncture Heparin : anti-coagulent Lancet: steril pointed blade used to perform puncture Lateral: toward the side Capillary blood has been used only in special situations because of how small the sample size is. Adult/Children puncture site: fingertip Younger aged puncture site: heel Lancets - Blue: 1.9 mm blade (POCT) - Yellow: Heel stick - Red: glucose monitoring - Green: 1.4mm blade (POCT) Capillary tube is about 7 cm long and 1 cm wide. 1-13: Blood Collection: Routine Venipuncture Basalic Vein: large vein on inner side (Pinlky side) of arm Cephalic Vein:: superficial vein of the arm (thumb side) commonly used for venipuncture Hematoma : swelling of tissue around vessel due to leakage of blood into tissue Hemoconcentration: Increase in the concentration of cellular elements in blood Hemolysis : rupture or destruction of red blood cells resulting in the relase of hemologobin Median cubital Vein: superficial vein located in the bend of the elbow (cubital fossa) that connects the cephalic vein to the basilic vein Palpate: to examine by touch Hypodermic needle: needle that is hollow to collect nutrients - Can be ¾ in to 1.5 in in length.  - Routine, 21 guage x 1 in needles are used Tubes - Red - No anticoagulant in tube - Used when serum is required or for bloo dchemistries and serology tests - Red/gray - No anticoagulant in tube - Serum-separator tube, used for tests that require serum - Lavender - EDTA anticoagulant - Most hematological tests, blood tests - Green - Herapin anticoagulant - Special chemiistry tests and lymphocyte studies need - Light Blue - Sodium citrate anticoagulant - Most coagulation studies - Gray - Potassium Oxalate anticoagulant - Certain glucose tests, legal alcohol - Black - Buffered sodium citrate - Western ESR Torunaquet - Tie 3-4 inch above the below, and thet wo ends are stretchd and corossed over the top of the arm. - Should be left in place for no more than 1-2 minutes Venupuncture Procedure - Forearm - Mediam cubital vein - Cephalic vein - Basalic vein Clean in circular motion with 70% alcohol swab. Dry. Needle should be hedl 15-25 degrees angle. Tubes with red stopper should be filled first Tubes that contain anticoagulants are filled last Patient should be instructed to press gauze on site for 2-5 minutes to ensure bleeding stops and no hematoma starts.