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Bloodborne pathogens
Infectious agent spread through blood-blood (or similar) transmission
• EX: HIV, HBV
Occupational exposure: Needlestick or cut with a contaminated sharp object or contact with blood, tissues, blood-containing body fluids, body fluids to which Standard Precautions apply, or a concentrated virus.
Exposures may involve:
• Mucous membranes or nonintact skin
• Skin affected with dermatitis
• Prolonged contact
• Contact involving an extensive area
Most exposures do not result in infection
• Likelihood: Depends on several factors
• Concentration of virus in blood or sample
• Duration of contact (longer → more likely)
• Worker: Cuts or abrasions, breaks in skin
• Worker: Immune status (vaccinations)
Antiseptics
Used on living tissues
Exs: Soaps, iodine, chlorhexidine, mouthwash
Disinfection
Kills most organisms on surfaces
• 99.9% of viruses, bacteria
• 30-60 second contact with bleach, lysol
Sterilization
Kills all organisms including spores
• Mycobacterium, fungal spores
• Autoclaves: High temps and pressure
• Steam sterilizers: 30m, 121C & 15psi
• Pre-vacuum: 10m, 133c, 30psi
Decontamination
Eliminates many/most pathogenic microorganisms, except spores, on inanimate objects
Engineering control
Work practice control
Class A fuel
Ordinary combustibles such as trash, paper, wood and textiles
Class B fuel
Flammable liquids
Class C fuel
Electrical equipment
Class D fuel
Combustible metal
1. Identification
2. Hazard Identification
3. Ingredient information
4. First-Aid measures
5. Fire Fighting Measures
6. Accidental Release (Clean-up)
7. Handling & Storage
8. Exposure control / PPE
9. Physical & Chemical Properties
10. Stability & Reactivity
11. Toxicological Information
What information is included in the SDS?
Ecological Information
Disposal considerations
Transport Information
Regulatory Information
Other Information
What SDS information is optional?
Quality control
• Statistical measures used to predict the reliability and validity of test results
• Based on use of samples with known values run in parallel with patient samples
• If results are not within acceptable limits, patient results are not reported
Proficiency testing
• Program to monitor & evaluate accuracy & reliability of the analytical testing process
• Includes written quality control procedures
• Required under clia 88
• Not required for waived test category
PHI
Licensure
Mandatory for practice
Certification
Voluntary to prove competency
Regulatory agency
Legislation
Accreditation
Professional organization
CMS
• Federal agency within the US Dept of Health & Human Services (HHS)
• Administers Medicare, works with states for Medicaid & CHIP
• Oversight of related legislation (ex: HIPPA & CLIA’88)
CLIA 88
Established requirements for certification of laboratories & personnel
Regulation covers ALL diagnostic testing labs, including Physician’s Office Labs (POLs)
• Exempt: Research & Educational labs
Established Minimum educational standards for Laboratory Technicians
• Established the associate’s degree as the minimum entry-level technician
• Other personnel requirements (EX: Laboratory must be overseen by M.D.)
Proficiency testing, QC & QA Program minimum standards
Organizational Requirements
• Must be certified by CMS, OR a private certifying or state regulatory agency approved by CMS
• GA: State Dept of Community Health (GADCH)
Lab classification criteria
• Performed test complexity (Method)
• Risk of harm of an erroneous result
• Amount of interpretation / judgement needed
• Availability for home use
HIPAA
Patient Bill of Rights
CDC
Establishes Infection Control Standards for OSHA, supports lab standards through research, innovations, & monitoring
FDA
Monitors testing and administration of all Blood Products (Regulation of all Blood Banks: Non-profit, Private, & Corporate)
CAP
a primary laboratory accrediting organization and an internationally recognized program that utilizes
teams of practicing laboratory professionals as
inspectors
JC or TJC
evaluating and accrediting hospital laboratory services since 1979 and freestanding laboratories since 1995
COLA
NAACLS
the premier agency for international accreditation and
approval of educational programs in the clinical
laboratory sciences and related disciplines
OSHA
Establishes Safety Standards for business & industries operating within the US
Hazard communication standard
Requires that the chemical manufacturer, distributor, or
importer provide SDSs, formerly material safety data sheets
(MSDSs), for each hazardous chemical to downstream users
to communicate information on these hazards
Chemical hygiene plan
Exposure control plan
GA Department of Community Health
ASCP
AMT
AABB
• PATIENT ID (Full Name and DOB or MRN)
• IMPROVE COMMUNICATION
• INFECTION PREVENTION
Joint Commission Natl. Patient Safety Goals – What are the 3 goals in the lab?
Regulatory agency
Responsible for implementation of Legislation and oversight and Guidance
• Signal word
• Hazard pictograms
• Hazard statement
• Precautionary statement for each category / class
What’s on manufacturer labels?
Inhalation
Percutaneous inoculation
Mucus membranes
Ingestion
What are the routes of transmission in Lab infections
Inhalation
Aspiration of aerosols
Percutaneous inoculation
Needlesticks, cuts, or abrasions
Mucus membranes
Contact with contaminated surfaces (rubbing eyes)
Ingestion
Eating, applying cosmetics
Patient Identification
Phlebotomy-associated negative effects
Specimen Identification
Order Entry
Specimen Integrity
Effective use of laboratory
Preanalytical
Verification of accuracy of results
Abnormal Results
Analytical
Communication of results
Timely Manner
Way RAV for Critical results
Effective use of test results
Outcomes of lab testing
Postanalytical