Physician

Office
Laboratories

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Introduction
Medical Laboratory
Hospital laboratory

Point of Care Testing (POCT)

Commercial laboratories

Physician Office Laboratories (POLs)

PST

Physician Office Laboratories (POLs)

Define

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Selection of instrumentation
Number of patient specimen
Volume of measurement & examination
Acquisition costs
Operating costs
Technical expertise

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Hematology methodology
Hematology analyzer
electrical impedance - size
- count blood cells
( producing 2-8 parameter)
sufficient capacity (~ volume)
easy to operate
sufficiently reproducible

Coagulation
Prothrombin time monotoring walfarin th/

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Chemistry methodology
Latest technology advantage ?
Multiple applications
Minimal reagent
Adequate capacity
Sensitivity, specificity, accuracy, and precision

not explicit criteria

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Urinalysis
Macroscopic reagen strips color blindness

reflectant photometer

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Microbiology methodology
culture not considere
gram stains

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Immunology methodology
Rapid streptococcal antigen (RSA)
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Urinary Tractus Infections and Sexually
Transmitted Diseases - - -

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Cost accounting
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Personnel and training
Personal record
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In-service Education
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Laboratory Prosedure Manuals
Important laboratory functions
Manual :
- simple
- easy to follow
Should include :
- specimen requirements
- prosedure for specimen collection
- identification and processing
- assay methodology
- reference interval
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 - quality control
- reporting methods

Standard Operating Procedure (SOP)

every test

Professional consultans /
NCCLS
(National Committee for Clinical Laboratory Standards )

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SOP
Specimen collection and identification - - -
methodologies - - -
Reference ranges - - -
Quality control / Quality Assurance - - -
Preventive maintenance - - -

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The Clinical Laboratory Improvement Act (CLIA)
and the Physician's Office Laboratory
Physicians who had managed a
clinical laboratory as part of their
practice

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Quality Assurance Standards: CLIA 88
Assessmentrequired for:
Patient Test Management
Quality Control

Proficiency Testing

Test Comparisons

Relate results to clinical data

Personnel

Communications

Complaints

Staff review

Records

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The Clinical Laboratory Improvement Act (CLIA)
and the Physician's Office Laboratory
Physicians who had managed a
clinical laboratory as part of their
practice

05/13/17 16
Quality Assurance Standards: CLIA 88
Assessmentrequired for:
Patient Test Management
Quality Control

Proficiency Testing

Test Comparisons

Relate results to clinical data

Personnel

Communications

Complaints

Staff review

Records

05/13/17 17
 I. Introduction
Topic Two
Scenario: unsafe practices
Regulatory agencies
II. General Safety Guidelines
Hazard warning signs and labels
Safe work practices
Control of air flow
Training and record-keeping
III. Bloodborne Pathogens
Direct contact
Indirect contact
IV. Universal Precautions
Barriers
Other safe practice rules
V. Tuberculosis Prevention
VI. Communication of Hazards and the Chemical Hygiene Plan
Introduction
Standard operating procedures
NFPA Hazard Identification (Diamond) System
VII. Personal Protective Equipment (PPE)
Laboratory coats
Gloves
Dress code
Safety goggles, glasses, masks or full face shields
Vaccinations
Splash guards or shatter proof shields
First aid kits
Spill kits
Eyewash or facewash stations
Safety showers
Hoods and safety cabinets
Surgical masks
VIII. Fire and Electrical Safety Protection
RACE
Other fire safety precautions
Fire extinguishers
Electrical safety precautions
IX. Ergonomics
Repetitive stress injuries
Lifting

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 Topic Three
Details about this topic
Supporting information and
examples
How it relates to your audience

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 Real Life
Give an example or real life
anecdote
Sympathize with the audiences
situation if appropriate

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 What This Means
Add a strong statement that
summarizes how you feel or think
about this topic
Summarize key points you want
your audience to remember

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 Next Steps
Summarize any actions required
of your audience
Summarize any follow up action
items required of you

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