M1: Lab Safety, QA/QC, and Regulatory Compliance

What is OSHA?

aka Occupational Safety and Health Administration, publishes and enforces health and safety regulations for most industries

What is CDC?

aka Center for Disease Control and Prevention, regulation addresses biosafety

What is EPA?

aka Environmental Protection Agency, regulation addresses infectious waste management

What is HCFA?

aka Health Care Financing Administration, regulation addresses QA/QC policies, procedures, inspection, certification, and personnel requirements

What are some standards that OSHA established?

• Hazard Communication

• PPE

• Lifting/ergonomics

• Fire protection (exits, emergency plans, fire protection)

What is included in OSHA’s hazard communication standard?

• Hazard classification

• Labels

• SDS

• Lab safety info and training

When does lab personnel go through lab safety training?

At the time of initial assignment and annually thereafter

What should lab safety training address?

• Recognition of hazards

• Control of hazards

• Emergency response measures

• Safety information resources

• Clean-up procedures and sterilization/decontamination measure

What is included in a hazard label?

• Harmonized signal word

• Pictogram

• Hazard statement for each hazard class and category

• Precautionary statements

What hazard is shown here? (a human silhouette with a starburst/white shape across the chest)

Health hazard, warns that a substance causes serious, long-term, or chronic health damage

What hazard is shown here? (flame icon)

Flammable hazard, materials that can catch fire easily and burn rapidly

What hazard is shown here? (black gas cylinder icon)

Compressed gas hazard, warns that a container holds compressed, liquefied, refrigerated, or dissolved gas under high internal pressure

What hazard is shown here? (two test tubes pouring liquid onto a metal surface and a hand)

Corrosive hazard, can cause damage/burns to materials or skin upon contact

What hazard is shown here? (exploding bomb icon)

Explosives hazard, substance or product can explode rapidly upon heat, friction, impact, or instability

What hazard is shown here? (flame over a circle)

Oxidizer hazard, substance releases oxygen which can intensify a fire if nearby

What hazard is shown here? (black silhouette showing a dead tree and a fish lying dead on the water)

Aquatic toxicity hazard, substance causes damage to aquatic life and surrounding environments

What hazard is shown here? (skull icon)

Acute toxicity hazard, a substance can cause severe, immediate, or fatal health effects after a single, short exposure

Which organization provided the four-color hazard label?

National Fire Protection Agency (NFPA)

What does each color of the four-color hazard symbol mean?

Red: Fire

Blue: Health

Yellow: Reactivity

White: Specific Hazard

What is an SDS?

A SDS is a document that relays vital information about certain chemicals and biological age

Is it okay to store chemicals in the fume hood?

No, store chemicals on shelves with raised edges, NOT the fume hood

What should be clearly labelled on a chemical’s original container?

Date of receipt and expiration date

Can bases and acids be stored together?

No, reactive materials should not be stored together

Can dry chemicals be stored together?

Yes, but separate organic and inorganic materials

Storing acids should be below or above shoulder height?

Below only, above shoulder height is dangerous

Where should flammables be stored?

Store flammables in an approved fire cabinet away from heat and flames. Flammable chemicals that require cold storage must be stored in refrigerators approved for flammable storage.

Hazardous chemicals used in a cytogenetic lab include (the two main ones)

DAPI and ethidium bromide

Handling chemicals include:

• Using a fume hood

• Using secondary containers for substance transfers

• Primary barriers (BSC, PPE)

• Avoiding contact with eyes and skin

What is a primary barrier + example?

Primary barrier protects people and the immediate laboratory environment from exposure to infectious agents

Ex: BSCs and PPE

What is a secondary barrier + example?

Secondary barriers protect the environment external to the laboratory from exposure to infectious materials

Ex: handwashing, decontamination, separate work/lab areas, special ventilation

What is the major infectious occupational health hazard in the health care industry?

Hepatitis B, can be prevented with vaccines

What is universal precautions?

Developed by CDC, an approach to infection control to treat all human blood and certain human body fluids as if they were known to be infectious for HIV, HBV and other bloodborne pathogens

CDC states that ___ is the single most important measure to prevent acquired infections

Handwashing

PPE includes what?

Gloves, gown, mask, and eyewear

Food and drinks can be stored in the lab?

False, do not store food and drink in the same refrigerators, freezers, or cabinets as specimens, chemicals, or reagents.

Using your mouth to pipette is okay?

False, use a pipette bulb, pipette aid or an automatic pipette.

What containers should be used to transport blood, body fluids, and tissues?

Leak‐proof containers labeled with proper handling and storage information

Why do we cover the stopper of an evacuated tube containing blood with gauze or paper?

To avoid infectious aerosols

What is considered biohazard waste?

Any material contaminated with blood, bodily fluids, or other infectious agents

What are typical uses of a Class I BSC?

Personnel protection only

Typical uses: toxic powder weight, necropsy

What are typical uses of a Class II BSC?

Personnel AND product protection

Typical uses: tissue culture, bacteria

Most commonly used cabinet in cytogenetic lab

What are typical uses of a Class III BSC?

Personnel AND product protection

Typical uses: extremely dangerous material like ebola virus, toxic powder, etc

Should needles be okay to recap?

No, needles should never be recapped and should be placed immediately in these special sharps containers after use.

Where should scalpels and broken glass be placed?

Designated punch resistant containers

How do you dispose cell culture media and blood waste?

1. Add 10% bleach by volume to the flask

2. Wait approximately 20-30 minutes for deactivation

3. Flush the materials down the sink

How do you dispose chemical liquids?

1. Dump in biosafety Can

2. Notify environment specialist to pick up

Two most used generic disinfectants are:

1. 10% household bleach (sodium hypochlorite)

2. 70% alcohol

Warning with 10% household bleach

Corrosive and irritant, should be wiped off a metal surface with water or alcohol after decontamination

What is 70% alcohol less effective on?

Residual organic material, due to its rapid evaporation rate

In events of a surface contamination:

1. Put on the appropriate PPE

2. Isolate contaminated area

3. Disinfect blood or body fluid spills with 10% bleach solution or 70% Ethanol

4. Discard all contaminated material into the appropriate puncture‐proof biohazard containers

What is decontamination?

Renders an item or material safe to handle.

What is sterilization?

Completely free of living microorganisms and viruses, using autoclave, ozone, or radiation.

What is disinfection?

Eliminates most pathogens but not necessarily all types of microbes.

What do you do in the case of a direct skin contact with a carcinogen or reactive material?

Immediately flush the affected area with plenty of water and use a good lather of soap to aid in physical removal

What is a Class A fire?

Ordinary combustibles or fibrous material, such as wood, paper, cloth, rubber, and some plastics.

What is a Class B fire?

Flammable or combustible liquids such as gasoline, kerosene, paint, paint thinners and propane.

What is a Class C fire?

Energized electrical equipment, such as appliances, switches, panel boxes and power tools.

What is a Class D fire?

Certain combustible metals, such as magnesium, titanium, potassium, and sodium.

What is the PASS method?

Pull the pin

Aim at base of fire

Squeeze the top handle or lever

Sweep from side to side

What is RACE?

R-Rescue patients, visitors and employees from immediate danger

A-alarm using pull stations or phone (911)

C-confine fire or smoke by closing all doors, including corridor doors

E- extinguish, if capable, or evacuate the area as directed

What is the function of flammable storage cabinets?

To keep fire away from flammable substances (EtOH, MeOH, Giemsa), do not keep combustibles such as paper or cardboard inside

What is considered a BSL1 lab?

Handling microorganisms that do not consistently cause disease in health adults

What is considered a BSL 2 lab?

Agents associated with human disease (HepB and measles). General required for any human-derived blood, bodily fluids, tissues in which infectious agent may be unknown.

(Cytogenetics lab falls into this category)

What is considered a BSL 3 lab?

Includes work on microbes that are either indigenous or exotic, and can cause serious or potentially lethal disease through inhalation (yellow fever, West Nile virus, TB)

What is considered a BSL 4 lab?

Very rare, but consists of work with highly dangerous and exotic microbes (Ebola and Marburg virus)

What is QC?

Quality control, a set of procedures used by clinical laboratories to maintain standard of quality and designed to minimize, detect, and evaluate errors.

QC Examples

This is accomplished by focusing on the equipment and reagents used, the methods employed in the testing.

• Specimen/Equipment logs and Culture Worksheet

• Reagent labeling

• Procedure Manual

• Validation of protocol and FISH probes

• 2 readers are necessary for 1 FISH case

What is QA?

Quality Assurance, the planned and systematic activities implemented in a quality system so that quality requirements for a product or service will be fulfilled.

Broader in scope than QC, QC is component of QA

QA Examples

The primary purpose of QA : make sure reagents, equipment, procedure AND personnel perform is acceptable

• Personnel qualification and testing

• Procedure for identifying specimen, culture failure, and other QC’s

• Requirements for sample turn around times, minimum band level requirement (for development delay pt), and physical facilies

• Periodically review QC data

What is the purpose of QA/QC program?

Provides checks and balances to prevent and identify clinical and clerical errors.

What is central to any QA/QC program?

Standard Operating Procedure (SOP) Manual includes requirements and policies for facilities, personnel, sample processing, and regulatory requirements

What is QI?

Quality Improvement, a laboratory’s plan to improve quality by increasing efficiency and effectiveness of laboratory procedures.

QI Examples

• Training technologists and their CE’s

• Verification documentation of abnormal prenatal results

• Data/analyses of abnormal vs normal

What is CLIA ‘88?

Clinical Laboratory Improvement Amendments (CLIA) of 1988

Objective: Establish minimum quality standard to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed.

What is CMS?

Centers for Medicare and Medicaid Services has the primary responsibility for the operation of the CLIA Program.

What are the 3 levels of complexity of the CLIA ‘88?

1. Waivered test

2. Moderate complexity test

3. High complexity test

What is a waivered test?

No technologist or pathologist is needed. Ex. OTC tests such as urine tests, fecal occult blood, and pregnancy tests

What is a moderate complexity test?

Some technical intervention is necessary. Ex. gram stains, acid fast smears

What is a high complexity test?

Very manual test requiring technologist experience and physician interpretation. Example: cytogenetic analysis

What is CAP?

College of American Pathologists

• is an approved accrediting organization to carry on survey in clinical cytogenetic laboratory under CLIA “88”

• responsible for creating unknown samples for proficiency testing

• lab inspections

What are examples of internal assessments (CAP lab self-inspection)

Typical quality indicators: Turnaround time for specimens; Success rate; Number of revised reports

What are examples of external assessments (on-site CAP inspection)

Proficiency testing and laboratory accreditation

What is proficiency testing?

Purpose: Ensure the laboratory can generate accurate results, unknown samples are sent to a laboratory by a CMS approved PT program to be tested in the same manner as the patient specimens. The lab’s and PT’s results are compared and assessed for accuracy.

How often are PT’s for labs by CMS standards?

3x a year

All slides from CAP for PT is identified as ___.

CYF i.e. CYF-1 and CYF-2

How often does CAP inspect a lab?

Every 2 years for:

• Evaluate PT results

• Evaluate QC, QA, and QI

• Evaluate procedures and tests

• Evaluate personnel qualification

• Evaluate physical facilities

• Evaluate laboratory safety (General checklist)

What is a Phase I deficiency?

These deficiencies occur in areas essential in the management of a laboratory but they may not seriously affect the quality of patient care or significantly endanger the welfare of a hospital or laboratory worker.

Ex: Space for technical work is not adequate, inaccurate logs, and inaccessibility of lab manuals

What is a corrective action to take for Phase I deficiencies?

A statement as to the corrective action being taken is sufficient. Recurring Phase I deficiencies will be reviewed critically as to the effectiveness of proposed actions.

What is Phase II deficiency?

These deficiencies occur in areas essential in the management of a laboratory. These deficiencies may have a serious effect on the quality of patient care or may affect the health and safety of hospital or laboratory personnel.

Ex: The band level for constitutional cases is lower than 400-band level for resolution and expired reagents

What is a corrective action to take for Phase II deficiencies?

Corrective actions must be accompanied by appropriate documentation. Such as policies or procedures, plus supporting records, such as patient reports, log sheets, , memos or minutes from meetings. These records must demonstrate compliance with the policy or procedure. Failure to provide this documentation will delay your accreditation.

What is HIPAA?

Health Insurance Portability and Accountability Act

Main purpose: Requires the protection and confidential handling of protected health information and patient’s privacy

Other roles include:

• Allowing workers and families to continue health insurance after job loss/change

• Reduces health care fraud and abuse

• Establishes standards for electronic health care billing and information

Who enforces HIPAA?

U.S. Dept of Health and Human Resources (HHS) Office for Civil Rights

How to avoid HIPAA violation?

Follow SOP exactly when releasing results (usually only goes to patient or physician)

What is JCAHO?

Joint Commission on Accreditation of Healthcare Organization, an organization made up of individuals from the private medical sector to develop and maintain standards of quality in medical facilities in the United States.

No ties to the government, but still reliable for accreditation