| Question | Answer |
| 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 |
