New York state laws and regulations that affect your medical practice
I. OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION REGULATIONS
1. How are physicians regulated by the Occupational Safety and Health Act (OSHA)?
Physicians in the clinical practice of medicine are subject to the OSHA regulations which protect employees who come into contact with blood and other potentially infectious agents.
The major requirements are:
A. Universal precautions, free vaccinations and post-exposure treatment.
The regulations require that all health care employers, including physicians, ensure that their employees follow universal precautions and have access to free hepatitis B vaccinations. "Universal precautions" is an approach to infection control where all human blood and certain bodily fluids are treated as if known to be infectious for HIV, and other bloodborne pathogens.
Post-exposure evaluation and treatment must also be provided, free-of-charge. This includes counseling, prophylaxis and AZT should it be recommended by a licensed health professional treating the employee.
B. Written Exposure Control Plan
The regulations require employers to develop a written exposure control plan which must identify the job classifications, procedures and tasks of employees who are exposed to blood and must specify the means used to protect such employees from infection. The plan must also set a schedule for implementing the methods for compliance and a procedure for the evaluation of circumstances surrounding exposure incidents.
Additionally, all exposure control plans must provide for the use of the following: 1) engineering controls, such as puncture-resistant containers for used needles; 2) work practice controls, such as rules that ensure employees are performing procedures in the safest way; 3) housekeeping controls, such as decontamination procedures, procedures for discarding contaminated needles and handling regulated wastes; and 4) use of protective equipment, such as gloves, gowns and masks that must be provided to employees free-of-charge.
The plan must be available to all employees. It must also be reviewed and updated at least annually and whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure and to reflect new employee positions with occupational exposure. (See Appendix for Model Exposure Plan)
C. Employee Education
Employers must ensure that all employees with occupational exposure participate in a training program which must be provided at no cost to the employee and during work hours. Annual training must also be provided within one year of previous training.
Employers must establish and maintain accurate records for each employee with occupational exposure. Records must include employee's name and social security number, copy of all results of examinations, medical testing and follow-up procedures. All medical records must be kept confidential.
3. Are there any penalties for non-compliance?
Yes. Non-compliance is subject to fines of up to $70,000 for a willful violation.
II. REGULATED MEDICAL WASTE
1. What is a regulated medical waste?
Regulated medical waste ("RMW") is any waste, generated in the diagnosis, treatment, (for example, provision of medical services), or immunization of human beings or animals, in research pertaining thereto, or in the production or testing of biologicals, and that is listed below:
REGULATED MEDICAL WASTE
Waste Class Description
1. Cultures and Stocks:
Cultures and stocks of infectious agents and associated biologicals, including: cultures from medical and pathological laboratories; cultures and stocks of infectious agents from research and industrial laboratories; wastes from the production of biologicals; discarded live and attenuated vaccines; and culture dishes and devices used to transfer, inoculate, and mix cultures.
2. Human Pathological Wastes:
Human pathological wastes, including tissues, organs, body parts (except teeth and the contiguous structures of bone and gum), body fluids that are removed during surgery, autopsy, or other medical procedures, and specimens of body fluids and their containers. It does not include urine or fecal materials submitted for other than diagnosis of infectious diseases.
3. Human Blood and Products:
Discarded waste human blood; products of blood; items saturated and/or dripping with human blood; or items that were saturated and/or dripping with human blood that are now caked with dried human blood; including serum, plasma, and other blood components, and their containers, which were used or intended for use in either patient care, testing and laboratory analysis or the development of pharmaceuticals. Intravenous bags are also included in this category.
Sharps that have been used in animal or human patient care or treatment or in medical, research, or industrial laboratories, including hypodermic and intravenous needles, syringes (with or without the attached needle), Pasteur pipettes, scalpel blades, blood vials, needles with attached tubing, and culture dishes (regardless of presence of infectious agents). Also included are other types of broken or unbroken glassware that were in contact with infectious agents, such as used slides and cover slips. This category includes unused, discarded sharps: hypodermic needles, suture needles, syringes, and scalpel blades.
5. Animal Waste:
Contaminated animal carcasses, body parts, and bedding of animals that were known to have been exposed to infectious agents during research (including research in veterinary hospitals), production of biologicals, or testing of pharmaceuticals.
6. Isolation Wastes:
Biological waste and discarded materials contaminated with blood, excretion, exudates, or secretions from humans who are isolated to protect others from certain highly communicable diseases, or isolated animals known to be infected with highly communicable diseases.
Regulated Medical Waste does not include hazardous waste and household waste. Hazardous waste is waste that is ignitable, corrosive, reactive (explosive) or toxic. Hazardous waste has its own regulations for treatment, transportation, storage and disposal.
(Public Health Law § 1389-AA; Environmental Conservation Law § 27-1501; 6 N.Y.C.R.R. 371.3)
2.What rules and regulations govern the management of Regulated Medical Waste?
Article 27 of New York's Environmental Conservation Law, Article 13 of the Public Health Law and their respective supporting regulations set forth guidelines for the storage, treatment, transportation and disposal of RMW generated or managed in the State of New York. The purpose of these laws is to protect human health and the environment from the infectious agents.
(Public Health Law § 1389-aa; Environmental Conservation Law § 27-1501)
3.To whom do these rules and regulations apply?
Article 13 of the Public Health Law ("Article 13") applies to residential health facilities, hospitals and clinical laboratories.
(Public Health Law § 1389-bb)
Article 27 of New York's Environmental Conservation Law ("Article 27") applies to any person engaged in the storage, containment, treatment, disposal or transfer of RMW off the site of the facility producing such waste.
(Environmental Conservation Law § 27-1503)
While Article 13 and 27 do overlap, the focus of Article 13 is the on-site storage, packaging or disposal of RMW. The focus of Article 27 is the treatment, transportation and tracking of RMW.
4. What are the requirements for the management of RMW?
A. Storage Requirements
Residential health facilities, hospitals and clinical laboratories (hereinafter "Article 13 generators") and any person engaged in the storage, containment, treatment, disposal or transfer of RMW (hereinafter "Article 27 generators") are required to separate medical waste from other waste products as soon as practicable. All RMW is required to be stored in containers marked "biohazard."
Article 13 generators shall not maintain RMW on patient room floors for more than 24 hours or in clinical laboratories for more than 72 hours. RMW shall be stored in rooms or areas used exclusively for waste storage which shall have an appropriate sign, prevent unauthorized access, protect wastes from the elements, prevent access by vermin and be adequately ventilated. RMW shall not be stored on the premises for more than 30 days, except that a site generating under 50 pounds of RMW per month and not accepting RMW for treatment from other facilities may store waste for a period not exceeding 60 days.
Article 13 and 27 generators of RMW shall maintain all RMW, except for discarded sharps, in red bags which are resistant to moisture and breakage. Discarded sharps shall be maintained in leakproof, rigid, puncture resistant containers, which in no case shall be filled above the designated fill line. Such containers shall be red in color or conspicuously labeled "infectious" or "regulated medical waste."
Article 13 and 27 generators of RMW are required to store or handle RMW in disposable or reusable pails, cartons or drums for being transported from the waste generating facility. These containers shall be leakproof and have tight fitting covers and be kept clean and in good repair. Containers shall be conspicuously labeled "infectious" or "regulated medical waste." Trash chutes are not permitted to be used to transfer RMW between locations where such waste is contained.
All generators are required thoroughly to wash and decontaminate reusable containers each time they are emptied, unless their surface is protected by a disposable liner, which is removed with the waste. Reusable containers shall not be used for the containment of waste to be disposed.
Under no circumstances shall RMW be transferred from one container to another in a manner that compromises the health and safety of the persons handling such waste. RMW being moved from one container to another or from one location to another shall be secured in a primary container.
(Public Health Law § 1389-bb; 10 NYCRR 70-1.3, 2.2; Environmental Conservation Law § 27-1505)
B. Treatment and Disposal Requirements
Article 13 and 27 generators are required to dispose of RMW by one of the following methods:
1. Incineration- RMW may be incinerated in an approved facility, which provides complete combustion of the waste into carbonized or mineralized ash. This resulting ash may be disposed in the same manner as nonhazardous waste provided it is not an otherwise hazardous waste as defined by the Environmental Conservation Law;
2. Discharge- liquefied or semi-liquid waste shall be discharged into a sanitary sewerage system connected to a secondary treatment facility, except as specifically prohibited by the commissioner of health;
3. Decontamination- RMW may be decontaminated by autoclaving, a process by which sterilization is achieved by exposing waste to steam under pressure for a specified period of time; or
4. Other- disposal may be accomplished by other means as approved by the commissioner.
RMW shall not be disposed of by burial at a landfill unless first incinerated or decontaminated. All used sharps must be rendered unrecognizable prior to disposal.
Autoclaving should not be used for treatment of RMW containing hazardous waste, toxic drug waste, radiological medical waste, or recognizable human body parts. Autoclaving should not be used for the treatment of human tissue, organs, animal carcasses or animal body parts unless expressly approved as an alternative treatment technology by the department. All autoclaves that will be used to treat RMW must be validated before use by being tested under certain conditions as specified by the Commissioner of Health.
(Public Health Law § 1389-dd; 10 NYCRR 70-2.3, See 10 NYCRR 70-3.1; Environmental Conservation Law § 27-1507)
C. Transfer Requirements
Article 13 generators of RMW shall transfer custody of RMW only to a transporter who is permitted to transport such waste by the Department of Environmental Conservation. No person shall transport RMW unless permitted as a transporter of such materials by the Department.
RMW shall be transported to an off-site treatment or disposal facility in a leakproof, fully enclosed container or vehicle compartment. RMW is to be kept separate from other waste unless all of the waste is to be treated or disposed of in the same manner as RMW.
(Public Health Law § 1389-ee; Environmental Conservation Law § 27-1509)
D. Recordkeeping Requirements
Article 13 generators shall keep a record of the quantity of RMW generated and the manner in which such wastes are disposed. Article 13 generators are required to submit an annual report to the Commissioner of Environmental Conservation. A copy of such report shall be sent to the Commissioner of Health.
Article 13 generators shall retain the following records for three years: validation testing and challenge testing, including protocols and test results; routine system's monitoring; and department approval of alternative treatment technology. Documentation of each use of the autoclave for decontamination purposes, including residences time, pressure and temperature of each load treated, shall be retained for three years.
Article 13 generators shall document each employee's participation in autoclave training and retain such records for three years. Documentation of corrective actions shall be retained for three years. Documentation of any modification to an approved operation plan shall be retained for three years from the discontinuance of the modified plan.
(10 NYCRR 70-3.4)
E. Operation Plan Requirements
All Article 13 generators are required to develop, document and implement policies and procedures specific to the management of RMW generated on site and/or treated at the facility. At a minimum, such procedures shall include a description of the methods available for treatment and disposal, procedures for safe handling and transport, a description of storage areas and the titles and contact information of the persons responsible for monitoring compliance. Facilities that treat RMW on site shall have a plan for each treatment system employed.
Article 13 generators shall have a response plan to be followed in the event the facility is notified that untreated RMW is suspected to be combined with solid waste. Such response plan and any corrective action taken shall be documented.
Article 13 generators shall have a radiation detection system to screen waste for radiological medical waste and a contingency plan in the event radiation levels above background are detected in waste loads delivered before treatment.
Article 13 generators shall have an plan for the operation of an autoclave which shall be submitted to the department for review and approval prior to using the autoclave to treat RMW. No autoclave shall be used to treat RMW without department approval of such plan and of any modifications to such plan.
(10 NYCRR 70-2.1, 2.3, See 10 NYCRR 70-3.2))
F. Transportation Tracking Requirements
Companies that transport RMW have specific requirements for tracking and shipping such waste.
(See 6 NYCRR 364.9)
5. What are the penalties for failing to comply with these regulations?
Any person who violates Article 13 of the Public Health Law shall be liable for civil penalty not to exceed $2,500 plus an additional penalty of $1,000 per each day during which such violation continues for a first offense, and a civil penalty not to exceed $5,000 plus an additional penalty of $2,500 for each day during which such violation continues for a second offense. An additional penalty may include revocation of permits authorizing the storage, transportation, treatment or disposal of RMW as necessary to protect the public health and safety.
(Public Health Law § 1389-gg; Environmental Conservation Law § 27-1517)
Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.