Clinical Laboratory Biohazard Risk Assessment

Special Laboratories

Laboratory Categories: Non-Malignant Leukocyte Immunophenotyping, Clinical Chemistry, Diagnostic Immunology, Diagnostic Services Serology, Hematology Laboratory Location(s): L8 Brief Description of Processes Conducted within Laboratory

1. Sample Receipt and Processing (manual) 2. Special Coagulation (Chrono-Log 700, ACL TOP 750) 3. Special Hematology (Inova DSX) 4. Phlebotomy 5. Electrophoresis (Sebia Hydrasys, Sebia Capillaris Tera 3) 6. Immunochemistry (Optilite) 7. Serology (Genius) 8. Infectious Disease testing (Diasorin Liason XL) 9. Routine maintenance, cleaning and troubleshooting of analyzers 10. Microscopy 11. Automated Instrument reader 12. Mikro 220 Incubated centrifuge

Name, Routes of Exposure, and Biological Safety Categories of Specimens or Agents Used

Specimen Type or Agent

Possible Routes of Transmission of Laboratory Infection

Biosafety Containment

Level Patient Parenteral Mucosal Inhalation Ingestion

Blood X X X 2

Serum X X X 2

Plasma X X X 2

Urine X X X 2

Body Fluids X X X 2

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Specimen/Sample Type/Agent Characteristics

List Each Agent or Specimen/Sample Type worked with within the Laboratory

Culture or Patient Material

Maximum volume worked with

Infectious Dose (if known)

Susceptibility to Disinfectants**

Immunization or Treatment Available***

Blood* Patient 8 ml N/A Yes** Partial***

Serum* Patient 8 ml N/A Yes** Partial***

Plasma* Patient 8 ml N/A Yes** Partial***

Urine Patient 4 liters N/A Yes** Partial***

Body Fluids Patient 8 ml N/A Yes** Partial***

*Assumes potential for bloodborne pathogens. Patient specimens, urine and body fluids, may harbor infectious agents **1:10 Bleach (0.5% sodium hypochlorite) *** Patient specimens can contain any of a number of bloodborne pathogens some of which have immunization, chemoprophylaxis or post-exposure immunization available.

Brief Description of Analytic Procedure(s)

Laboratory procedures and equipment (e.g., automated processor or pipettor) are identified below, for each agent, specimen or sample type, which increases the likelihood of exposure due to either aerosol-generating procedure (centrifuging, vortexing, pouring, pipetting) or the use of sharps (needles, glassware): Aerosols

• Manual removal of sealed caps • Centrifuging • Vortexing or mixing on open bench • Specimen aliquoting , pipetting • Automated analyzers

Sharps • Automated Analyzer Needles • Microscope slides • Pipette tips

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Control Measures

Location(s) Control Measures Required

Room number or area in laboratory where the patient

material or agents will be used

BSL-2

Enhanced BSL-2

precautions

BSL-2 with additional

Engineering Controls

Enhanced BSL-2 additional

Engineering Controls

Required Containment Equipment

L801- Receipt, Processing X X 2, 5, 6, 7, 8

L806 Special Coagulation X X 2, 5, 6, 7, 8

L807 Processing X 2, 5, 6, 7, 8

L808, 810 Special

Hematology

X X 2, 6, 7, 8

L809, 811 Electrophoresis X X 2, 6, 7, 8

L812

Immunochemistry/Serology

X X 6, 7, 8

L814 Immunochemistry/HIV X X 6, 7, 8

L816 Infectious Disease X X 6, 7, 8

Required Containment Equipment

1. Class II Biological Safety Cabinet NA

2. Centrifuge with closed centrifuge safety cups/carriers YES

3. Autoclave NA

4. Chemical Hood NA

5. Engineered Safety Sharps YES

6. Sharps Containers YES

7. Bench-top Biohazard shield YES

8. Biohazardous Waste Container YES

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Responsibilities by Job Function

Job Title or Function Responsibilities Contact with Specimens

Technologist Specimen processing Direct

Lab Assistant Specimen delivery, aliquoting Direct

Lab Aide Delivery of supplies None

Supervisory Staff Supervision of technologists Direct

Environmental Services Cleaning, waste removal Indirect

Facilities On-site facilities maintenance None

EHS Audits, risk assessments, spill response Direct

Service Personnel On-site maintenance of lab equipment Indirect

Visitors Observation of lab work None

House staff (MDs) Limited work with specimens Direct

Students Direct work with specimens Direct

Security Facility and personnel security None

Safety Training Requirements

Job Title or Function Biological Safety

Program

Bloodborne Pathogens

Laboratory Safety

Radiation Safety

Shipping IATA/DOT

C14 (LN2)

Job Specific

Technologist X X X X X

Lab Assistant X X X X

Lab Aide X

Supervisory Staff X X X X X

Environmental Services X X

Facilities X

EHS X X

Service Personnel X

House staff (MDs) X X X

Students X X X

Security X

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Personal Protective Equipment Required

Job Title or Function PPE Splash Barrier

Respiratory Protection

Latex or

Nitrile Gloves

Lab Coat, Gown (Disposable or

Cloth)

Full Face Shield

Safety goggles/w

Mask

Bench-top splash shield

N-95 PAPR

Specimen Processing X X X X Special Coagulation X X X X Storage X X Specimen and Waste Disposal

X X X

Special Hematology X X X X Electrophoresis X X X X Immunochemistry X X X X Hepatitis, HIV X X X X Serology X X X X Flow Cytometry X X Infectious Disease X X X X Spill Response X X X Lab Inspection X Visitors X Facilities Environmental Services X Service Personnel X X

Waste Disposal Requirements

Procedures for treatment of waste stream in accordance with the DEP in New York City and New York State regulations

Waste Types Red Bag

Sharps Container

Chemical Disinfection & Red Bag

Chemical Disinfection

& Drain Disposal

Chemical Disinfection

& Collect for EHS

Autoclave Drain Disposal

Specimen & Blood bags X Patient Sample Tubes X Sharps- needles, sticks X Contaminated paper, PPE

X

Contaminated glass/plastics

X

Chemically Contaminated (Biological) material

X

Automatic processor X X

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Employee Occupational Health Exposure Plan

Occupational Health Monitoring Requirements

Baseline physical upon hire:

• Employee medical screening, occupational and medical history • Physical examination • Blood work for measles, mumps, rubella and varicella immunity • Hepatitis - Blood Test (B&C)/B Vaccination • TB screening • Vision screening (near, far, and color) • Respirator clearance, chemo or laser screening as appropriate

• Annual health assessment:

• Medical monitoring questionnaire

• TB screening

Policy to Follow in Case of Accidental Exposure

• Follow the NewYork-Presbyterian Hospital Bloodborne Pathogen Exposure Control Plan.

• In the event of an exposure to bodily fluids, such as a splash or spray to the eyes, nose, mouth, broken skin, or a skin puncture, the employee should:

Immediate wound care

For a percutaneous (needlestick/sharp object) injury or skin exposure

• Wash wound thoroughly with soap and water.

For a mucous membrane exposure (eyes, nose, mouth):

• Flush with tap water or sterile saline/water continuously for 10 minutes.

Report exposure incident to supervisor.

Obtain source patient’s name, location and medical record number.

Report to the Workforce Health and Safety as soon as possible during regular business hours, or the Emergency Department at all other times for immediate evaluation and treatment, with follow-up in WHS on the next business day to complete the full medical evaluation.

Complete an Employee Accident/Incident Report after evaluation and treatment has been initiated.

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Procedures for Investigating Accidents/Exposures and Documentation of the Incident

and Implementation of Corrective Action

• Follow the NYP Reporting Events Policy: Complete an ‘Employee Accident / Incident Report’ with the Supervisor. If immediate

treatment is needed, the form may be initiated by WHS or NYP Emergency Department.

All accidents and exposures which occur during the course of employment must be reported in writing to Human Recourses within 24 hours of the incident.

A copy of the report should be brought to the laboratory for inclusion in the Quality Management Program.

The supervisor will follow-up with corrective actions and training as needed.

Containment Breach Protocol

• Procedures for handling spill/decontamination (e.g., in BSC, centrifuge, water bath, counter, tube system)

Follow NYP Clinical Laboratories Exposure Control Plan, Section VIII.

Equipment and work surfaces are decontaminated with an appropriate disinfectant (e.g., a freshly prepared 1/10 solution of bleach):

• After completing procedures.

• When surfaces are overtly contaminated.

• Immediately after any spill of blood or other potentially infectious materials.

• At the end of the work shifts.

• Allow at least 5 minutes of exposure to disinfectant.

Spills involving suspected or confirmed CJD patient sample requires contaminated surfaces to be cleaned with 2N NaOH or undiluted hypochlorite for 1 hr. of contact time.

Supplies for Decontamination

Decontaminant Application

5.25% sodium hypochlorite (as a 1:10 dilution, prepared daily) Countertops, waste bins, floors, liquid waste

Clorox or Super Sani-Cloth Germicidal wipe Countertops, equipment, spills

70% ethanol Countertops, lab equipment

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BSL2 Facility Design Requirements

• Laboratory access must be limited or restricted to protect the public and/or employees.

• Sufficient space exists between benches, cabinets and equipment to allow adequate cleaning.

• Furniture, work surfaces and flooring in the laboratory is impervious to liquids and capable of being easily cleaned and decontaminated. Carpets and rugs are not permitted in laboratories.

• Hand washing sink, eye wash and emergency showers are located within the laboratory work area.

• Biosafety cabinets must be installed so that fluctuations of the room air supply and exhaust do not interfere with proper operations. BSCs should be located away from doors, windows that can be opened, heavily traveled laboratory areas, and other possible airflow disruptions.

• Mechanical ventilation systems should provide an inward flow of air without recirculation to spaces outside of the laboratory.

Hazard Communication Requirements

• Safety Data Sheet (SDS) are available to all staff.

• Biohazard labels on the entrance to the laboratory and on equipment used for storing/holding clinical specimens or other potentially infectious materials.

• Biohazard labels on equipment used to store or process patient samples or agents.

• Biohazard labels on each refrigerator, freezer, incubator or other equipment that is located in a hallway or other type of open access or passage area and is used for storing/holding clinical specimens or other potentially infectious materials.

Required BSL2 Safe Laboratory Practices

• Laboratory personnel must demonstrate proficiency in standard and special microbiological practices before working with BSL-2 agents.

• All procedures involving the manipulation of infectious materials that may generate an aerosol should be conducted within a BSC or other physical containment devices.

• Laboratory work surfaces are on a decontamination schedule and are decontaminated after completion of work and after any spill of potentially infectious material.

• Routinely clean environmental surfaces before setting up work areas and again before leaving work areas.

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o Clean any item (e.g., microscope, timer, pen, telephone, thermometer, key board) touched with used gloves.

o Clean bench surfaces, stationary racks, clay tiles, rockers, slide staining racks, water/heating baths and all trays whenever a spill occurs. Clean all surfaces at the end of each shift.

• Minimizing splatter (e.g., by using lab “diapers” on bench surfaces, covering tubes with gauze when opening)

• When working at open bench workstations and manually removing sealed caps; specimen aliquoting or pipetting

o Minimizing splatter (e.g., by using lab Chux on bench surfaces, covering tubes with gauze when opening).

o Place a gauze pad over the cap, and then slowly pry or push the cap off with an away-from-body motion.

o Always remove caps behind a bench-fixed splash shield, or wear additional PPE appropriate to protect eyes, nose, mouth from splashes and aerosols.

o Routinely decontaminate work surfaces and change gloves frequently to minimize risk of contamination and cross contamination

• A splash barrier capable of protecting the face should be used whenever performing manipulations on blood and body fluids that may produce splashes (e.g. capping/uncapping containers, pipetting/dispensing, vortexing, mixing/diluting, shaking, and pouring). Face protection can be accomplished by using an individual face shield, a bench-top splash shield or a BSC with proper positioning of the worker. Glasses or goggles do not provide adequate protection unless worn with a face mask that covers the mouth and nose.

• Mouth pipetting is prohibited; Use mechanical pipetting devices, automated or semi-automated pipettes and safety transfer devices

• Work with sharps has been evaluated and safety sharps implemented where feasible.

o Policy prohibiting the recapping, purposeful bending, breaking, removing from disposable syringes, or other manual manipulations of needles

o Syringes that re-sheath the needle, needle-less systems, and other safety devices should be used. Only needle-locking syringes or disposable syringe-needle units (i.e., needle is integral to the syringe) should be used for phlebotomy or the aspiration of fluids.

o Non-disposable sharps must be placed in a hard walled container for transport to a processing area for decontamination, preferably by autoclaving.

• Centrifuges rotors in BSL-2 or higher areas, need aerosol containment (“O-rings”) and gasketed safety cups.

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• Food storage/preparation, eating, drinking, smoking, handling contact lenses, applying cosmetics or lip balm and use of personal electronic devices are prohibited in work areas where chemical or radiologic hazards, or infectious materials are present.

• A plan is in place in the event that an agent suspected of exceeding the labs biosafety level is encountered.

o Immediate notification of supervisor

o Cessation of work until appropriate safety controls are in place and or material is referred to appropriate lab

• An effective pest management program is required.

• Laboratory equipment should be routinely decontaminated, maintained and certified and procedures are in place for equipment decontamination prior to repair, maintenance or removal from the laboratory.

• Automated or manual instrumentation procedures with the potential for producing specimen aerosols and droplets (e.g., stopper removal, vortexing, opening or piercing evacuated tubes, using automatic sample dispensers) require PPE and engineering controls designed to prevent exposure to infectious agents.

o Always use instruments according to manufacturer instructions

o Ensure instrument safety shields and containment devices are in place at time of use.

o Wear PPE to protect from splashes and aerosols when loading unfixed samples into instrument tube racks

• If vacuum service (i.e., central or local) is provided, each service connection should be fitted with liquid disinfectant traps and an in-line HEPA filter placed as near as practicable to each use point or service cock. Aspirator bottles or suction flasks should be connected to an overflow collection flask containing appropriate disinfectant, and to an in-line HEPA or equivalent filter.

• Biological safety cabinets should be used for the initial processing of clinical specimens when the nature of the test requested or other information suggests the likely presence of an agent readily transmissible by infectious aerosols (e.g., M. tuberculosis), or when the use of a BSC (Class II) is indicated to protect the integrity of the specimen.

• Procedures detailing procurement, transportation, and handling of patient specimens (blood, body fluids, tissue)are in place to ensure that all specimens are submitted in an appropriately labeled and well-constructed container with a secure lid to prevent leakage during transport

Transportation Requirements

• The laboratory monitors that specimens/samples have been transported to the laboratory in a manner that ensures safety for the carrier, the general public and the laboratory.

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• All specimens are transported in a leak-proof secondary container (e.g., impervious plastic bag) during handling, processing, storage, transport, or shipping. The container is labeled or color-coded appropriately. If the specimen could cause a puncture, then the secondary container must be puncture-resistant.

• Training is provided for the safe handling and shipping of biological materials and dry ice in compliance with regulatory agencies including the International Air Transport Association (IATA), Department of Transport (DOT), Centers for Disease Control and Prevention (CDC) and U.S. Department of Agriculture (USDA).

Specimen/Sample Storage Details

Nature of Stored Material (e.g. virus,

bacteria on solid/liquid medium,

infected tissue, fluid or cell line,

waste sample)

Volume(s)

of Stored

Materials

Packaging and

Containment

Conditions

Storage Conditions

(8oC, -20, -80, LN2)

Storage

Location

Blood and Body Fluids 1000 tubes Test tubes 4 - 8 o C L807

Blood and Body Fluids Test tubes -70oC L806

Bloodborne Pathogens Exposure Control Plan, Biological Spill Planning and Response Plan, Chemical Hygiene Plan and Radiological Safety Plan Available

• Available to staff and reviewed annually by lab director or designee.

Special Considerations for Environmental Services Staff

• Housekeeping staff receive annual safety training and job specific training.

Special Consideration for Service Personnel

• A brief lab orientation is provided for service personnel and these personnel are always escorted by a knowledgeable supervisor or technologist.

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Prepared by: ____________________________________ Scott W. Finkernagel, CBSP Senior Biosafety Manager Environmental Health & Safety Annual Review and Acceptance- documentation within NYP Electronic Document Management System.

T:\AllEHS\Biosafety\RiskAssessments\NYP\CentralLab.doc

Scott W. Finkernagel, CBSP