DOT Hazardous Materials Regulated Medical Waste Nathan Douglas, R.S., M.S. Chemical & Biological Safety Officer Marshall University
Why are we here? “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
Training Outline General awareness / familiarization Function-specific training Safety training Personal Protection Accident Avoidance Emergency Response Security awareness and in-depth training 49 CFR 172.704
Regulations 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
Hazardous Material Employee A person who is employed, and in the course of such employment directly affects hazardous materials transportation safety Includes all employees that Load, unload, or handle hazardous materials; Prepare hazardous materials for transportation; Sign waste transport manifest papers You are a hazmat employee when you put waste into the shipping containers or sign the waste manifest. 49 CFR 171.8
Training Requirements 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 You can have other employees do the work of packaging the waste, provided that you supervise them. However, you cannot allow untrained personnel to sign the waste manifest, as this is an official record of our waste activities. 49 CFR 172 subpart H
What is a Hazardous Material (HAZMAT) 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. The DOT training requires employees who interact in any way with hazardous materials to be able to recognize and identify those hazardous materials. First we must understand what a hazardous material is in general. Then we must learn specific information about our hazardous materials, have knowledge of emergency response information, self-protection measures and accident prevention methods and procedures. 49 CFR 171.8
Hazardous Materials 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
Note 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
Hazardous Material Packaging 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 packaging PG II – medium danger PG III – least danger, least protective packaging 49 CFR 171.8
Our Hazardous Materials Class 2 – Poisonous / Toxic Division 6.2, Infectious Substances Category B Biological Products Cultures Patient Specimens Regulated Medical Wastes 6.2 are Infectious Substances - materials known or reasonably expected to contain a pathogen. Category A - capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals Cannot be shipped as RMW, must be assigned UN 2814 (human) or UN 2900 (animal) Category B - generally not capable of causing such a disability or disease Biological Products – substances used in the prevention, treatment, or cure of a disease (virus, therapeutic serum, antitoxin, vaccine, blood) Culture – an infectious substance containing a pathogen that is intentionally propagated, does not include a human or animal patient specimen. Patient Specimen - human or animal material directly collected and transported for research, diagnosis, investigational activities, or disease treatment or prevention 49 CFR 173.134(a)(1)-(4)
DOT Hazardous Materials Table Designates specific materials as hazardous for the purpose of transportation. The shipper is responsible for determining the shipping name, the hazard class, United Nations Identification number (if required), labels, packaging requirements, and quantity limitations. We use the table to obtain the proper shipping name, to classify the material and get specific requirements pertaining to its packaging, labeling, and transportation. Hazard communication consists of documentation and identification of packaging and vehicles, and is communicated through Shipping papers, Package marking & labeling, and Vehicle placarding 49 CFR 172.101
DOT Hazardous Materials Table 1. Symbols: None 2. 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: 6.2 4. Identification Numbers: UN3291 5. Packing Group (PG): II Symbols indicate limitations or restrictions on the mode of transportation Proper Shipping Name must be consistent with DOT regulations (the table), can use N.O.S., or Not Otherwise Specified when material is not in the table Hazard Class or Division tells the main hazard. 6.2 is Infectious Substance Identification Numbers are assigned to each proper shipping name, UN means the package can be shipped nationally and internationally. Other is NA Packing Group indicates the degree of danger presented by the hazardous material, II is medium 49 CFR 172.101
Regulated Medical Waste 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. This training covers only Regulated Medical Waste, a Division 6.2 hazardous material. RMW can include waste Category B infectious substances, biological products, cultures, and specimens. If you ship non-waste patient specimens or Category A materials you require additional training. 49 CFR 173.134(a)(5)
OSHA – Regulated Waste 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. OPIM The following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids; (2) Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and (3) HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV. 29 CFR 1910.1030(b)
WVDHHR – Infectious Medical Waste 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. 3.9.b. For the purposes of this rule, infectious medical waste includes the following materials: 3.9.b.1. Cultures and stock of microorganisms and biologicals; 3.9.b.2. Blood and blood products; 3.9.b.3. Pathological wastes; 3.9.b.4. Sharps; 3.9.b.5. Animal carcasses, body parts, bedding and related wastes; 3.9.b.6. Isolation wastes; 3.9.b.7. Any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill of any infectious medical waste; and 3.9.b.8. Waste contaminated by or mixed with infectious medical waste. 3.9.c. For the purposes of this rule, infectious medical waste does not include the following materials: 3.9.c.1. Human remains and body parts being used or examined for medical purposes which are under the control of a licensed physician or dentist and are not abandoned materials; 3.9.c.2. Human remains lawfully interred in a cemetery or in preparation by a licensed mortician for interment or cremation; 3.9.c.3. Used personal hygiene products, such as diapers, facial tissues and sanitary napkins; 3.9.c.4. Gauze and dressing material, containing small amounts of blood or other body secretions with no free flowing or unabsorbed liquid; 3.9.c.5. Hair, nails, and extracted teeth; 3.9.c.6. Waste generated by veterinary hospitals, except for waste meeting the criteria found in Sections 3.9.b.1, 3.9.b.4, or 3.9.b.5 of this rule; and 3.9.c.7. Medical tubing and devices with a signed and dated certification by the facility which states: "I hereby certify under penalty of law that this waste has not been contaminated with infectious medical waste, as defined in Infectious Medical Waste, 64 CSR 56." 64 CSR 56.3.9.
Sharps 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. Includes needles, syringes, scalpels, broken glass, culture slides, culture dishes, broken capillary tubes, broken rigid plastic, and exposed ends of dental wires. Sharps are a component of our Regulated Medical Waste and must be handled with caution. Sharps containers MUST be closed before they are placed into the transport container. They should be closed before they are removed from the wall boxes. 49 CFR 173.134(a)(6)
Package the Material 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 When RMW is transported by a private or contract carrier it is excepted from requirements for placarding as Division 6.2 Infectious Substance, provided it is labeled with the biohazard sign per OSHA And excepted from Packing Group II requirements, provided it meets general requirements. 49 CFR 172.312 / 49 CFR 173.197
Packaging Requirements 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
Packaging Requirements 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 packaging 49 CFR 173.24
Additional Requirements 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
Package Markings General marking requirements: Markings must be: 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
Biohazard Labeling in the Bloodborne Pathogens Std. 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)
Pathologic Waste 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.
Manifest - Shipping Papers 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
Manifest – Shipping Papers 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
Completing the Manifest 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
Safety 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
Personal Protection 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
Accident Avoidance 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
Emergency Response 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
Emergency Response 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
Emergency Response 2nd – Spill of blood or OPIM For 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.
Emergency Response 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
Emergency Response 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.
Emergency Response 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.
Security 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).
Security Potential Threats Prevention Techniques 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
Compliance Checklist 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.
Conclusion 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