Chapter 26, 27 and 32
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Transcript of Chapter 26, 27 and 32
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Chapter 26, 27 and 32
Safety and Regulatory Guidelines In the Medical Laboratory/Introduction
to Laboratory
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CLIA ‘88
• Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) – Federal regulations designed to set safety policies and
procedures that protect patients
– 1967—misread Pap smears caused Congress to become more involved with regulating laboratories (CLIA ’88)
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CLIA ‘88
• Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) – States can seek exemptions from CLIA standards and
have state standards apply instead
– Accrediting bodies granted “deemed status”
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CLIA ’88 Overview
• Is designed to protect public by regulating all laboratory tests performed on humans
• Is based on complexity of tests performed
• Affects all aspects of the laboratory
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CLIA ’88 Overview
• Specifies type of test performed, training and education of personnel involved in testing, and quality control
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CLIA ’88 Testing Categories
• Click to play the video
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CLIA ’88 Testing Categories
• Waived tests– Simple, unvarying, and require minimum of judgment
and interpretation
• Moderate-complexity tests – Physician-performed microscopy procedures (PPMP)
tests
• High-complexity tests
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CLIA ‘88 Consequences
• Contents of the law– List of analytes on the CLIA ’88 waived list
– Types of CLIA certificates
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CLIA ‘88 Consequences
• CLIA ’88 regulations for quality control in automated hematology– Required procedures
• Calibration
• Control samples
• Proficiency testing
– Check manufacturer’s recommendations for particular piece of equipment
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CLIA ‘88 Consequences
• Aftermath of CLIA ’88– Has led to concerns about overload of paperwork it
produces
– Developments regarding postponements and funding problems
– Recent findings of errors, gaps in quality in physician’s office laboratories (POLs)
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CLIA ’88 and MAs
• Covers all laboratories even if they perform a few basic tests
• Documentation by medical assistants is important
• Responsibility of medical assistants to teach and assist others who may not be trained
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CLIA ’88 and MAs
• Where to find more information regarding CLIA ’88– Guidelines available from Federal Register and online
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OSHA Regulations
• Occupational Safety and Health Administration (OSHA) – Intend for employees to have safe and healthful work
environment
– Present requirements employer must follow to ensure employee safety and health
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OSHA Regulations
• Two standards comprise the regulations– The Bloodborne Pathogen Standard
– Standards for Occupational Exposure to Hazardous Chemicals in the Laboratory
• Purpose is to heighten employee awareness of risks linked with chemical dangers
• Involves employee training and identification of hazardous chemicals
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Chemical Hygiene Plan
• Core of the OSHA safety standard
• Written plan specifies training and information requirements of standard
• Describes requirements of standard
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Chemical Hygiene Plan
• Written CHP and program must be operational if chemicals are stored in facility and handled by employees
• Describes three primary goals an employer must accomplish to be in compliance with OSHA standard for chemical exposure
• Requirements of CHP
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Chemical Hygiene Plan
• Importance of chemical standards to medical assistants– All employees must comply or face penalties
– All employees have right to know about hazards at work site and how to handle, store, and dispose of hazardous substances
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OSHA Regulations and Students
• Students do not fall under the OSHA guidelines but should take precautions
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The Laboratory
• POL collects and tests specimen
• Specimen collected at POL and transported from physician’s office to separate lab for testing
• Collected and tested at separate lab
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Purposes of Lab Testing
• To record an individual’s state of health– Routine physical examination
– Provides reference values for comparison
• To satisfy employment, insurance, and legal requirements– Employment-required drug and alcohol testing
• Research statistics and clinical trials
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• To detect asymptomatic conditions or diseases– Routine screening in another area reveals disorder
– No symptoms associated with disease process
• To confirm a clinical diagnosis– Diagnosis determined through subjective and objective
information
– Tests given to confirm diagnosis
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• To differentiate between two or more diseases– Perform simplest and least invasive test
– Rule out a disease
• To diagnose– If symptoms are vague
– Profile ordered
– Narrows field for diagnosis
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• To determine the effectiveness of treatments
• To prevent diseases/disorders
• To prevent the exacerbation of diseases– Patients with chronic conditions
– May need to adjust diet or medication
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Types of Laboratories
• Procurement stations
• Satellite laboratories
• Hospital-based
• Reference laboratories
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• Point-of-care testing (POCT)– Bedside testing
– Rapid, accurate results
• POLs– Types of tests commonly performed
– Use of self-contained tests
– At-home test kits
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Laboratory Departments
• Hematology
• Urinalysis
• Clinical chemistry
• Immunology
• Serology
• Microbiology
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• Virology
• Parasitology
• Cytology
• Histology
• Toxicology
• DNA testing
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Laboratory Tests
• Panels of laboratory tests– Tests categorized into related groups
– Formerly called “profiles”
– CMS-approved organ- and disease-oriented panels
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Quality Controls/Assurances
• Control tests– Have known value/outcome
– Proficiency testing
– Compare with results of patient’s test
– Minimizes human error
– Checks reagents/chemicals
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• Preventive maintenance– Manufacturer’s recommended maintenance
– Temperature checks on refrigerators, freezers, and incubators
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• Instrument validations– Check calibration and accuracy of instruments and
machines
– Ensure accurate results
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• The medical assistant’s role– Perform administrative office duties
– Prepare patients
– Collect specimens
– Perform waived tests
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• The medical assistant’s role– Four aspects of quality laboratory testing for accurate
results• Prepare patient properly
• Obtain specimen as expertly as possible
• Reagents and equipment in best condition and calibration possible
• Test performed by trained professional
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Lab Requisitions
• Preprinted
• Computer-generated
• Features of requisition– Physician’s information
– Patient’s name, address, phone numbers
– Patient’s billing information
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• Features of requisition– Unique patient identifier
– Patient’s age/date of birth and gender
– Source of specimen
– Time and date of specimen collection
– Test requested
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• Features of requisition– Medications patient is taking
– Clinical diagnosis
– Urgency of results
– Special collection/patient instructions
– Other doctor(s) to receive copies of report
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Lab Requisitions andReports and the TPMS
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Lab Written Reports
• Features:– Laboratory name, address, and phone numbers
– Referring physician’s name and identification numbers
– Patient’s name, ID number, age, and gender
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• Features– Date specimen was received by laboratory
– Date and time specimen was collected
– Date laboratory reported results
– Test name, results, and normal reference ranges
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• Attach to patient’s chart
• Notify physician of abnormal results
• Computerized laboratory report >>
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Specimen Collection
• Proper procurement, storage, and handling– Obtain from independent laboratories
– Instruction manual
– Guidelines
– Patient preparation instructions
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Microscopes
• One of the most used pieces of equipment in laboratory
• Parts– Light source
– Eyepiece
– Objectives
– Condenser
– Diaphragm
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• Types of microscopes– Compound
– Phase contrast
– Fluorescent
– Electron
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• How to use a microscope– Adjusting focus with coarse and fine adjustments
– Raising and lowering of platform while viewing slide from the side
– Control intensity of light with condenser and iris diaphragm
– Oil-immersion lens
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• How to care for a microscope– Proper way to handle
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• How to care for a microscope– Follow manufacturer’s and clinic’s rules
– Cover microscope when not in use
– Clean lenses with special lens paper after each use
– Always focus away from lens to prevent lens from coming into contact with slide
– Use oil only with oil-immersion lens
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Questions
•?