Nathan Douglas, R.S., M.S.Chemical & Biological Safety OfficerMarshall University

Regulated Medical Regulated Medical WasteWaste

“A person who knowingly violates a requirement of the Federal hazardous material transportation law, an order issued thereunder, … is liable for a civil penalty of not more than $50,000 and not less than $250 for each violation, except the maximum civil penalty is $100,000 if the violation results in death, serious illness or severe injury to any person or substantial destruction of property, and a minimum $450 civil penalty applies to a violation relating to training. When the violation is a continuing one, each day of the violation constitutes a separate offense.”

49 CFR 107.329

General awareness / familiarizationFunction-specific trainingSafety training

Personal Protection Accident Avoidance Emergency Response

Security awareness and in-depth training

49 CFR 172.704

Several agencies have regulations that cover Regulated Medical Waste (RMW) also called: biohazard waste, infectious medical

waste, red bag trash, and regulated waste. Department of Transportation

49 CFR, subtitle B, Chapter 1, subchapter C Occupational Safety & Health Administration

29 CFR 1910.1030 West Virginia Department of Health &

Human Resources 64 CSR 56

A person who is employed, and in the course of such employment directly affects hazardous materials transportation safety

49 CFR 171.8

Includes all employees thatLoad, unload, or handle hazardous materials; Prepare hazardous materials for transportation;Sign waste transport manifest papers

Hazmat employees must be trained when performing duties Refresher training is required every 3 years

Must be directly supervised by a trained person until trained Training conducted within 90 days of hire

or assignment of duties

49 CFR 172 subpart H

According to the US DOT:

A substance or material that the Secretary of Transportation has determined is capable of posing an unreasonable risk to health, safety, and property when transported in commerce, and has designated as hazardous.

49 CFR 171.8

Dangerous goods are divided into 9 classes on the basis of the risk they present.They can be assigned more than 1 class if they present additional hazards

Each class has a primary hazard, and can have numerous sub-hazards, called divisions.

Vehicles transporting hazmat are required to display a placard indicating the hazard contained inside.

49 CFR 171.8

US DOT Hazmat Class & Division Placards

There is a DOT exemption to placarding for RMW Division 6.2 materials, but the Bloodborne Pathogens Standard requires the biohazard symbol on containers used to store, transport or ship blood or other potentially infectious materials.

The contractor’s truck will only have a biohazard sticker, not a 6.2 placard.

49 CFR 172.504

Each Class & Division has established Packing Group requirements. Either PG I, II, or III

The Packing Group indicates the degree of danger presented by the Hazmat, and determines the protective packaging required for safe transport

PG I – great danger, most protective packagingPG II – medium dangerPG III – least danger, least protective packaging

49 CFR 171.8

Class 2 – Poisonous / ToxicDivision 6.2, Infectious SubstancesCategory B

Biological Products Cultures Patient Specimens Regulated Medical Wastes

49 CFR 173.134(a)(1)-(4)

49 CFR 172.101

1. Symbols: None2. Description and Regulated medical waste,

n.o.s. Proper Shipping Name: Clinical waste, unspecified, n.o.s.

(BIO)Medical waste, n.o.s., Biomedical waste, n.o.s.

or Medical waste, n.o.s

3. Hazard Class or Division: 6.24. Identification Numbers: UN32915. Packing Group (PG): II

49 CFR 172.101

A waste or reusable material derived from the medical treatment of an animal or human, which includes diagnosis and immunization, or from biomedical research, which includes the production and testing of biological products.

49 CFR 173.134(a)(5)

Liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials.

29 CFR 1910.1030(b)

Medical waste which is capable of producing an infectious disease. Medical waste shall be considered capable of producing an infectious disease if it has been, or is likely to have been, contaminated by an organism likely to be pathogenic to healthy humans, if such organism is not routinely and freely available in the community, and such organism has a significant probability of being present in sufficient quantities and with sufficient virulence to transmit disease.

64 CSR 56.3.9.

Any object contaminated with a pathogen or that may become contaminated with a pathogen through handling or during transportation and also capable of cutting or penetrating skin or a packaging material.

49 CFR 173.134(a)(6)

Includes needles, syringes, scalpels, broken glass, culture slides, culture dishes, broken capillary tubes, broken rigid plastic, and exposed ends of dental wires.

Regulated medical waste must be packaged at the Packing Group II performance level and meet general packaging requirements PG II exception for private/contract carriers

Inner containers must be packed with closures upward if they contain liquid hazardous materials

49 CFR 172.312 / 49 CFR 173.197

Inner bag with minimum thickness of 1.5 mil

Sharps containers must be securely closed to prevent spills or protrusions

Top of bag closed by tying in a knot; or twisting and folding over, then tightly taping

Shipping container snapped closed or cardboard box taped shut on all seams

49 CFR 173.24

Package filled and its contents limited so under normal conditions of transportation there is no: release of hazardous material to the

environment substantial reduction in the effectiveness of

the package chemical reaction with or inside the package breakage, leakage or movement of the inner

packaging49 CFR 173.24

Items like staples do not protrude through the outer packaging in a way that would damage the inner packaging.

The package is not filled to a gross mass greater than the maximum gross mass marked on the packaging (Standard 18 x 18 x 22 boxes are limited to 45 lbs).

No hazardous material may remain on the outside of a package after filling.

A package containing inner packagings of Division 6.2 materials may not contain other hazardous materials.

49 CFR 173.24a

General marking requirements: Proper Shipping Name and Identification Number Package Orientation Arrows Generating Facility’s Name and Address WV Requires the package to be dated once full

Markings must be: Durable, in English, and printed on the surface or

on a label, tag, or sign Displayed on a contrasting background Unobscured by labels or attachments

49 CFR 172.304

Warning labels shall be affixed to containers of regulated waste.

Labels have to have biohazard symbol & wording per OSHA Bloodborne Pathogen Standard:

29 CFR 1910.1030(g)(1)(i)

Stericycle uses a labeling system to differentiate between packages of Regulated Medical Waste that can be autoclaved and those that must be incinerated.

Pathologic and trace chemotherapeutic wastes must be incinerated. We should use incinerator-only for pharmaceuticals.

Our Generator Label is typically white. Yellow labels are used for incinerate-only waste.

All manifests will have the following:

Identification Number (UN 3291) Proper Shipping Name (Regulated Medical Waste,

n.o.s.) Hazard Class or Division (6.2) Packing Group (PG II) Description of the shipping container

The manifest must also include, the total quantity of material shipped.

49 CFR 172.202

Quantity of Materials Shipped Usually report number of containers and

volume in cubic feet▪ Boxes are generally 4.3 cu ft.

Can also be reported by weight per box, and total

You should verify that the total quantity shipped block is the same as the number of boxes removed from the facility

49 CFR 172.202

Manifests also contain “Shipper’s Certification” This is to certify that the above named materials

are properly classified, described, packaged, marked and labeled, and are in proper condition for transportation according to the applicable regulations of the Department of Transportation.

Must be signed legibly by a trained employee.

Indicates that we agree with the volume (number of containers) of waste sent off-site

49 CFR 172.204

OSHA Bloodborne Pathogen Standard Mandates that employers provide a safe

and healthy work environment Provide Hepatitis B vaccination Provide required PPE and ensure it is used Provide training on HBV and HIV and other

bloodborne pathogens annually Have a written Exposure Control Plan,

revised annually, evaluate safer sharps systems and use them where feasible

OSHA Bloodborne Pathogen Standard Requires employees to observe Universal

Precautions▪ Treat all contaminated items like they’re infectious▪ Wear appropriate PPE▪ Handle and dispose properly

Healthcare personnel have 2 main PPE▪ exam gloves and clothing (scrubs).

Face masks used where splashes/sprays are anticipated, must also use safety glasses/goggles

Most common healthcare accident is needlesticks Extra care must be exhibited when

working with children that squirm Sharps containers must be replaced

when contents reach the “full” line, not allowed to overfill

Containers must be securely closed before they’re moved out of the exam room

1st – Needlestick Follow Exposure Control Plan – available on

employee web site ▪ Wash the affected area with soap and water▪ Notify department Collateral Duty Safety Officer ▪ They will identify the source patient for testing, obtain consent,

and have specimen collected

▪ Immediately seek treatment at nearest Emergency Department ▪ Identify yourself as having been exposed to BBP▪ Prophylaxis should be given within 1-2 hours▪ Request a Workers Compensation form be completed, not

insurance

Needlestick, cont▪ Follow up with Internal Medicine Department▪ They will discuss lab reports from source patient and

exposed employee▪ Provide consultation about potential diseases and

recommended testing timeline

▪ Complete a Needlestick Incident Report and submit to Safety Officer▪ Safety Officer will ensure information is

complete and will review incident with post-exposure management team, and maintain records

2nd – Spill of blood or OPIMFor small spill (1 vaccutainer or less, 10 ml

max) Cleanup should only be performed by persons

trained in Bloodborne Pathogens Wear gloves Spray area with disinfectant▪ Fresh bleach 1:10 dilution , or tuberculocidal product

Use tongs or other mechanical means to pick up sharps and broken glass. Dispose in sharps box.

Small Spill of Blood or OPIM, cont. Wipe up liquids with paper towel and dispose

in biohazard bag. Spray the area of the spill with disinfectant

again Allow 15 minutes contact time, or per

instructions on container if duration is different

Wash and disinfect mechanical devices used during cleanup

Dispose gloves in biohazard bag

Spill of Blood or OPIM For large spill (more than 1

vaccutainer, +10 ml) Secure the area from entry by

unauthorized persons Put on appropriate PPE (gown, shoe

covers, mask, etc.) Spray all containers and the entire spill

area with disinfectant and allow 15 minutes contact time.

Large Spill of Blood or OPIM Clean up sharps and liquids similar to

small spill Disinfect area again, allow 15 minutes

contact time, or per label instructions Clean and disinfect equipment Dispose single-use PPE. Biohazard if

soiled, trash if not. Make arrangements to have spill kit

replenished, as necessary.

Marshall University, the Joan C. Edwards School of Medicine, University Physicians & Surgeons, Inc. and the Marshall University Medical Center manage Regulated Medical Waste in a controlled manner where only authorized personnel have access to secured storage areas.

Due to the nature of Regulated Medical Waste generation patients are in areas where waste is initially generated and temporarily stored.

Waste is either treated on-site via autoclave or shipped off-site through a permitted contract service, documented by waste manifests that are retained for 3 years (WV requirement, DOT is 2 years).

Potential Threats Non-secured areas, or unattended points of

entry Unauthorized personnel allowed access

Prevention Techniques Know the driver(s) Look for an official uniform, ask for id when

in doubt Report suspicious behavior

Inner container (bag) is closed. Box is in good condition. Box does not weigh more than 55 lbs. Outside of box is not contaminated. Stericycle barcode sticker is attached, and

date filled in when box/bin taped closed. Total quantity is written on shipping

paper. Shipping manifest is legibly signed by

trained employee.

DOT regulates the transportation of hazardous materials Proper identification Classification Packaging Training of personnel

If you have questions, ask. Nathan Douglas, 696-3461▪ douglas2@marshall.edu