Office Lab testing, QC, Safety, Lab Equipment, Record Keeping, Blood Composition

Specimens for Testing

Whole blood

Anticoagulant

-prevent blood from clotting

-left with RBC and plasma

Plasma

Anticoagulant and centrifuged

Serum

Clotted specimen and centrifuged

-Have clot activator

-Left with serum

Physician Office Lab Testing

Specimen Collection

-Name, DOB, date & time of collection, type of specimen, source of specimen

Tests Performed

-POC: point of care testing

-Glucose

-Cholesterol

-Blood counts

-pregnancy

CLIA '88

-Clinical laboratory improvement amendment

-Goal is to Standardize lab testing

-3 levels of testing

-Waived is most commonly performed in POL

-Moderately complex

-Highly complex

Safety

regulated by the CDC and OSHA

Hazards

Biohazards

-Disease transmission -Pathogens: viruses, bacteria, fungi, protozoa, parasites, proteins

Modes of Transmission

-Contact, vector borne, air borne, droplet, common vehicle

Chain of Infection

-Infectious agent, reservoir host, portal of exit, means of transmission, portal of entry, susceptible host

Bloodborne Pathogens

Biological Specimens

Universal/Standard Precautions

All specimens treated as if infectious

Engineering Controls

-Sharps disposal

-Self-sheathing needles

Personal Protective Equipment

-Gloves

-Lab coat

-Eye protection

-Closed shoes

Biohazard Education

OSHA Mandated

Laboratory Chemicals

-Hazard Communication Standard

-federal law protecting employees' "right to know" about the dangers of all the hazardous chemicals to which they may be exposed under normal working conditions

SDS

-safety data sheet

-Label Requirements

1. Brand name of the chemical

2. Common or chemical name

3. Amount of the contents

4. Signal words such as danger (if flammable, corrosive, or highly reactive with other substances), poison (if toxic when ingested or inhaled), warning, or caution (if any other hazardous condition is present)

5. Instructions for the safe use of the chemical (storage, usage, and disposal)

6. Manufacturer information

7. Description of possible hazards such as physical hazards (ability of material to explode, ignite, or react with other chemicals), health hazards (whether material can irritate tissue or cause cancer), toxicity (whether material is toxic if

swallowed or inhaled), and safety precautions (whether material requires protective clothing, gloves, or eye protection)

8. First-aid instructions if necessary

NFP Standard Labels

-National fire protection association

Laboratory Equipment

Centrifuge

-wear proper PPE

-Never open when in operation- wait 30 min to open

-Proper balancing

-Cleaning

-lab disinfectant

-1:10 bleach

-clean inside and outside daily

-Tube breaking

Incubator

Microbiology specimens on agar

-37 degrees

Refrigerator/Freezer

-Temperature must be recorded each day

- 2-8 degrees

-No food or drink allowed

Quality Control

· Used to ensure that test system is working properly.

· Allows for the reporting of patient results.

· Process in which known manufactured samples are routinely tested to establish the reliability, accuracy, and precision of specific test system product

· Series of analytical measurements used to assess the quality of the analytical data (tools)

· Product oriented

Quality Assurance

· Overall process to aid in improving the reliability, efficiency, and quality of laboratory testing in general; process oriented

· Overall management plan to guarantee the integrity of data (system)

· Process oriented

CLIA '88 part 2

· Clinical Laboratory Improvement Amendment

Waived Testing

-Simple lab examinations and procedures

-Pose no reasonable risk if performed incorrectly

-Competency testing must be performed annually

QC for waived testing

-Provides assurance that test performs as expected and alerts the user when problem occur

-Detect problems that. Might arise because of operator error, reagent or test kit deterioration, instrument malfunction or improper environmental conditions

Performing Tests

-Follow package insert

-Pay attention to timing

Reagent Management

-Chemicals used to perform the test

-Check lot numbers and record them

-Date and initial when opening

-Do not mix reagents from different kits

Record Keeping on POL

Specimen Logs

a detailed record used to track and manage samples (like blood, tissue, or other materials)

Requisition

-Patient information

-Test request

-Name of ordering physician

-Diagnosis codes

Laboratory Manuals

General Policy Manuals

-Management policies

-Job descriptions

-Dress code

-Salary review

-Vacation and holiday policies

-Employee reviews

Procedure Manual

follow what the instructions say

Safety Manual

-Biological & chemical hazards

-PPE

-Proper disposal practices

-Training for Biological hazards

-Exposure control plan

-Fire safety

-Evacuation plans

Specimen Collection Manual

-Online and paper

-Test name with alternate names

-Patient preparation

-Nature of specimen

-Specimen timing for collection

-Preservative or anticoagulant

-Special handling between collection time and delivery to lab

-Labeling requirements

-Required requisition

-Criteria for unacceptable specimens

-Performing laboratory's phone number and hours of operations

Quality Control Manual

-How and when to perform QC

-How and where to log QC result

-Logs are kept

-Inspectors see every 3 years

-What is acceptable QC

-What to do if QC is unacceptable

-Temperature charts

Patient Test Results

-Critical lab results must be given to healthcare provider ASAP

-Results go to EMR

Quality Control

Used to ensure that test system is working properly.

Allows for the reporting of patient results.

CLIA '88

Clinical Laboratory Improvement Amendment

regulations that ensure the quality of clinical laboratory testing by establishing standards for all laboratories testing

Internal OC

Verify that test system is working properly

External QC

Mimic patient samples

Frequency QC

Follow manufacturer's instructions

Blood Composition

Whole Blood

Plasma, red blood cells, white blood cells, and platelets

Plasma

-Unclotted blood

-Mostly water with proteins and dissolved chemicals

Serum

Clotted Blood