Save
Busy. Please wait.
Log in with Clever
or

show password
Forgot Password?

Don't have an account?  Sign up 
Sign up using Clever
or

Username is available taken
show password


Make sure to remember your password. If you forget it there is no way for StudyStack to send you a reset link. You would need to create a new account.
Your email address is only used to allow you to reset your password. See our Privacy Policy and Terms of Service.


Already a StudyStack user? Log In

Reset Password
Enter the associated with your account, and we'll email you a link to reset your password.
focusNode
Didn't know it?
click below
 
Knew it?
click below
Don't know
Remaining cards (0)
Know
0:00
share
Embed Code - If you would like this activity on your web page, copy the script below and paste it into your web page.

  Normal Size     Small Size show me how

labopsintrotoclinica

Introduction To Clinical Laboratory

QuestionAnswer
List 7 Lab Departments or Divisions Lab Departments or Divisions Hematology Hemostasis (Coagulation) Urinalysis Clinical Chemistry (Biochemistry) Blood Bank (Immunohematology, Transfusion Services) Immunology and Serology Molecular Diagnostics Microbiology
Clinical Laboratory Sciences Professional Team Clinical Laboratory Sciences Professional Team Medical laboratory scientists (MLS) Medical laboratory technicians (MLT) Phlebotomists Medical laboratory aides
Federal Regulatory Standards for Laboratories Federal Regulatory Standards for Laboratories CLIA (quality and proficiency regulations) OSHA (safety regulations) HIPAA (privacy regulations)
Regulatory Agencies (list 4) CAP-certifies proficiency of clinical laboratories FDA-Rates the laboratory Testing OSHA-safety and inspections TJC-The joint Commission (every 2 yrs)
CLIA Clinical Laboratory Improvement Amendments (CLIA'88) 1988 Provides regulations for ALL laboratories All labs must have a CLIA certificate to perform testing and receive federal reimbursement. Includes a certificate fee and biennial inspection fee
Two ways to get CLIA Certified There are two ways to be CLIA certified: Accreditation by Health Care Financing Administration (HCFA) Accreditation by a private organization i.e. TJC,CAP,AAB,ISO APPROVED STATE LAB PROGRAMS
Four Levels of test Complexity Four levels of test complexity Waived testing (doesn't require lab professional status to perform/interpret) PPM - Provider (physician) performed microscopy Moderately complex testing Highly complex testing
Each test is rated as to its level as determined by FDA according to the test complexity and potential risk to public health Risk of harm to the patient Risk of erroneous result Level of personnel training Level of test complexity Knowledge and amount of interpretation required to evaluate test results Availability of test for home use
CLIA/FDA 3 Levels of Complexity 1.Waived (FDA level 1) 2.PPM-Preffered Provider Microscopy (FDA level 1) 3.Moderately complex testing (FDA level 2) 4.Highly complex testing (FDA level 3)
CLIA Regulation Requirement 1.Qualified Personell 2.QC Program 3.Proficiency Testing PT 4.Procedure Manuals 5.Quality Assurance Plans 6.Inspections 7.Medicare Coverage-compliance
OSHA Occupational Safety and Health Administration
OSHA Regulation: (5) 1.Universal Precautions-treat all to be infectious 2.PPE(personnel protective equipment) 3.Universal Precaution Workplace Practices 4.HBV Vaccination Program-for all personnel 5.Annual Inspections
Other OSHA Regulation Other OSHA Lab Regulations 1.Occupational Exposures to Hazardous Chemicals – chemical hygiene plan (CHP) must be put in place 2.Occupational Exposure to Formaldehyde 3.Prevention of the Transmission of Mycobacterium tuberculosis
HIPAA Health Insurance Portability and Accountability Act
HIPAA established in ____ and issued by _____ 1996 and Issued by Dept. of Health and Human Services (HHS)
(OSHA Regulations) 3. Universal Precaution Workplace Practices must include:(7) 1.handwashing 2.no recapping of contaminated needles 3.disposable of sharp objects in sharp containers 4.no food and drink in laboratory 5.no mouth pipetting 6.biohazard and appropriate warning labels and biosafety bags 7.dress code for safety
(OSHA Regulations) 1. Universal Precautions lab personnel must treat all body fluid specimens as if they were infectious
(OSHA Regulations) 2.PPE ...give example gloves lab coats eye protection (mask or face shields)
MLT Medical Laboratory Technician (MLT) Complete training in basic laboratory sciences Entry-level education = an associate degree (AS) Credientials = MLT
MLS Must be educated in the basic sciences (biology, chemistry, physics, etc.), management, and education Complete training in basic laboratory sciences and special testing Entry-level education = BS Formerly CLS or Medical Technologist MT
Regulatory Agencies that certifies the proficiency of clinical laboratories,testing and inspection program CAP
Regulatory Agencies that rates the laboratory testing according to their potential risk to public health FDA
Regulatory Agencies that oversea the safety inspection (schedule or unschedule) (safety regulations) OSHA
Regulatory Agencies that accredits healthcare organizations and programs in the US TJC
LAW that ensure privacy regulation HIPAA
NATIONAL ACCREDITING AGENCY FOR CLS (laboratory education program accreditation) NAACLS
TJC is surveyed inspection every 2 years
CLIA Clinical Laboratory Improvement Amendments
Laboratory could received how many challenge specimens for each analyte (proficiency testing) and how many times a year 3-5 challenge 3 times per year
proficiency testing requirement, labs must score_____and bloodbank must score_____ labs must score 80 % or higher bloodbank must score 100%
Who monitors proficiency testing (pt)> TJC The Joint Commission
FDA Level 1 PPM Preferred Provider Microscopy
FDA Level 2 Moderately complex testing
FDA Level 3 Highly complex testing
Waived Level 1(FDA) simple labs cleared for home used by FDA (pregnancy test)
HIPPA is issued by US Department of Health and Human Service (HHS) 1996
Created by: kclaire03
Popular Science sets

 

 



Voices

Use these flashcards to help memorize information. Look at the large card and try to recall what is on the other side. Then click the card to flip it. If you knew the answer, click the green Know box. Otherwise, click the red Don't know box.

When you've placed seven or more cards in the Don't know box, click "retry" to try those cards again.

If you've accidentally put the card in the wrong box, just click on the card to take it out of the box.

You can also use your keyboard to move the cards as follows:

If you are logged in to your account, this website will remember which cards you know and don't know so that they are in the same box the next time you log in.

When you need a break, try one of the other activities listed below the flashcards like Matching, Snowman, or Hungry Bug. Although it may feel like you're playing a game, your brain is still making more connections with the information to help you out.

To see how well you know the information, try the Quiz or Test activity.

Pass complete!
"Know" box contains:
Time elapsed:
Retries:
restart all cards