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)

• 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 regulations for quality control in automated hematology– Required procedures

• Calibration

• Control samples

• Proficiency testing

– Check manufacturer’s recommendations for particular piece of equipment

• 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

• 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

• 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

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