Chapter 26, 27 and 32

Chapter 26, 27 and 32 Safety and Regulatory Guidelines In the Medical Laboratory/Introduction to Laboratory

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)

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”

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

CLIA ’88 Overview • Specifies type of test performed, training and education of personnel involved in testing, and quality control

CLIA ’88 Testing Categories • Click to play the video

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

CLIA ‘88 Consequences • Contents of the law • List of analytes on the CLIA ’88 waived list • Types of CLIA certificates

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

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)

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

CLIA ’88 and MAs • Where to find more information regarding CLIA ’88 • Guidelines available from Federal Register and online

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

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

Chemical Hygiene Plan • Core of the OSHA safety standard • Written plan specifies training and information requirements of standard • Describes requirements of standard

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

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

OSHA Regulations and Students • Students do not fall under the OSHA guidelines but should take precautions

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

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

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

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

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

Types of Laboratories • Procurement stations • Satellite laboratories • Hospital-based • Reference laboratories

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

Laboratory Departments • Hematology • Urinalysis • Clinical chemistry • Immunology • Serology • Microbiology

Virology • Parasitology • Cytology • Histology • Toxicology • DNA testing

Laboratory Tests • Panels of laboratory tests • Tests categorized into related groups • Formerly called “profiles” • CMS-approved organ- and disease-oriented panels

Quality Controls/Assurances • Control tests • Have known value/outcome • Proficiency testing • Compare with results of patient’s test • Minimizes human error • Checks reagents/chemicals

Preventive maintenance • Manufacturer’s recommended maintenance • Temperature checks on refrigerators, freezers, and incubators

Instrument validations • Check calibration and accuracy of instruments and machines • Ensure accurate results

The medical assistant’s role • Perform administrative office duties • Prepare patients • Collect specimens • Perform waived tests

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

Lab Requisitions • Preprinted • Computer-generated • Features of requisition • Physician’s information • Patient’s name, address, phone numbers • Patient’s billing information

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

Features of requisition • Medications patient is taking • Clinical diagnosis • Urgency of results • Special collection/patient instructions • Other doctor(s) to receive copies of report

Lab Requisitions andReports and the TPMS

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

Features • Date specimen was received by laboratory • Date and time specimen was collected • Date laboratory reported results • Test name, results, and normal reference ranges

Attach to patient’s chart • Notify physician of abnormal results • Computerized laboratory report >>

Specimen Collection • Proper procurement, storage, and handling • Obtain from independent laboratories • Instruction manual • Guidelines • Patient preparation instructions

Microscopes • One of the most used pieces of equipment in laboratory • Parts • Light source • Eyepiece • Objectives • Condenser • Diaphragm

Types of microscopes • Compound • Phase contrast • Fluorescent • Electron

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

How to care for a microscope • Proper way to handle

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

Questions • ?

Chapter 26, 27 and 32