NEW JERSEY - ENVIRONMENTAL ISSUES

January 1, 2008

New Jersey 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.

D. Record-keeping

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?

A regulated medical waste is any solid 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 biologics, and that is listed in the following table:

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. Pathological Wastes
Human pathological wastes, including tissues, organs, and body parts and body fluids that are removed during surgery or autopsy, or other medical procedures, and specimens of body fluids and their containers.

3. Human Blood and Products
Liquid 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.

4. Sharps
Sharps that have been used in animal or human patient care or treatment or in medical, research, or industrial laboratories, including hypodermic 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.

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.

7. Unused Sharps
The following unused, discarded sharps: hypodermic needles, suture needles, syringes, and scalpel blades.

(N.J.A.C. 7:26-3A.6)

2. What are the major requirements for physicians under the Regulated Medical Waste Act?

Under New Jersey's Comprehensive Regulated Medical Waste Management Act (the "Act") (N.J.S.A. 13: 1E-48.1 et seq.), physicians are defined as "generators" or any person whose act or process produces a regulated medical waste or whose act first causes a medical waste to become subject to regulation. For the purposes of the Act, where more than one person is located in the same building (as is the case when several physicians with separate practices are in the same building), each individual business entity is a separate generator for the purposes of the Act.

A. Generators

The Act more specifically defines a generator by listing the following as examples:
-Ambulatory Surgical or Care Facility
-Community Health Center
-Podiatrist's Office
-Home Health Care Agency
-Health Care Facility
-Medical Clinic
-Morgue
-Nursing Home
-Urgent Care Center
-Veterinary Care Center
-Animal, Biological, Clinical, Medical, Microbiology, Pathology, Diagnostic or Research Laboratory
-Any other Facility identified by NJ Department of Environmental Protection and Energy or the NJ Department of Health that generates medical waste.

B. Registration

Every generator, regardless of the amount of regulated medical waste produced, is required to register with the NJ Department of Environmental Protection and Energy ("NJDEPE" or "DEPE") on forms provided by the DEPE at the following address:

Medical Waste Advisement Unit
Division of Solid Waste Material
New Jersey Department of Environmental Protection and Energy
401 East State Street, CN 414
Trenton, New Jersey 08625

The registration year for generators extends from July 22 through July 21 of each calendar year.

(N.J.A.C. 7:26-3A.8)

C. Fees

The annual generator fee is based on the amount of waste generated per year. Fees are payable by August 20 of each calendar year. The fees are listed as:

Estimate of lbs/year (lbs/month)1............Base Fee for each category2

# 300 (# 25)...................$528.50

300 - 1000 (25-83.3)......$687.14

> 1000 (> 83.3)..............$845.78

(N.J.A.C. 7:26-3A.8)

D. Segregation Requirements

Generators are required to segregate regulated medical waste intended for transport off-site to the extent practicable prior to placement in containers. Regulated medical waste must be segregated into:

1. Sharps, including sharps containing residual fluid;

2. Fluids, quantities greater than 20 cubic centimeters; and

3. Other regulated wastes.

(N.J.A.C. 7:26-3A.10)

E. Packaging Requirements

1Estimates are compared to historical data based on the number of practitioners and type of practice. Accuracy is vital.

2Fees may be adjusted in subsequent years based on NJDEPE's actual costs in providing services to the particular generator category.

Prior to transport, generators must ensure that all of their regulated medical waste is packaged in containers that are:

1. Rigid;

2. Leak-resistant;

3. Impervious to moisture;

4. Have a strength sufficient to prevent tearing and bursting under normal conditions of use and handling; and

5. Sealed to prevent leakage during transport.

In addition, sharps and sharps with residual fluids must be placed in puncture-resistant packaging and fluids must be placed in packaging that is break-resistant and tightly-lidded or stoppered.

(N.J.A.C. 7:26-3A.11)

F. Storage Requirements

Regulated medical waste must be:

1. Stored in a manner and location that maintains the integrity of the packaging and provides protection from water, rain and wind;

2. Maintained in a nonputrescent state, using refrigeration when necessary;

3. Placed in locked storage areas, if it is to be stored outdoors, to prevent unauthorized access;

4. Accessible only to authorized employees; and

5. Stored in a manner that affords protection from animals and does not provide a breeding place or a food source for insects and rodents.

(N.J.A.C. 7:26-3A.12)

G. Decontamination Standards

The following requirements pertain to reusing containers:

1. All non-rigid packaging and inner liners cannot be reused;

2. Any container used for the storage and/or transport of regulated medical waste and designated for reuse once emptied, must be decontaminated if the container shows signs of visible contamination; and

3. If any container used for storage and/or transport of regulated medical waste cannot be treated to remove any visible signs of contamination, the container must be managed (i.e. labeled, marked and treated and/or disposed of) as regulated medical waste.

(N.J.A.C. 7:26-3A.13)

For purposes of tracking, regulated medical wastes are considered regulated medical wastes until they are treated by substantially reducing or eliminating their potential for causing diseases and destroyed so they are no longer recognizable as medical waste.

H. Labeling Requirements

All packages of regulated medical waste must be labeled according to the following requirements:

1. Each package of untreated regulated medical waste must have a water-resistant label affixed to or printed on the outside of the container. The label must include the words "Medical Waste" or "Infectious Waste," or display the universal biohazard symbol. Red plastic bag(s) used as inner packaging need not display a label; and

2. Packages containing treated regulated medical wastes are not required to be labeled but are required to be marked. (See following.)

(N.J.A.C. 7:26-3A.14)

H. Marking (Identification) Requirements

Prior to transportation, packages of regulated medical waste must be identified according to the following requirements:

1. The outermost surface of each package prepared for shipment must be marked with a water-resistant identification tag of sufficient dimension to contain the following information:

i. The generator's name;

ii. The generator's address. If the generator is not located in New Jersey, then its state permit or identification number should be used, and if its state does not issue permit or identification numbers, then the generator's out-of-state address should be used;

iii. The transporter's name;

iv. The transporter's NJDEPE solid waste registration number;

v. The date of shipment; and

vi. Identification of contents as medical waste.

2. If inner containers, including sharps and fluid containers, each inner container must be marked with indelible ink or imprinted with water-resistant tags. The marking or the tag must contain the following information:

i. The generator's name; and

ii. The generator's address. If the generator is not located in New Jersey, then its state permit or identification number should be used, and if its state does not issue permit or identification numbers, then the generator's out-of-state address should be used.

(N.J.A.C. 7:26-3A.15)

I. Use of Transporters

Generators of regulated medical wastes must use only transporters who have NJDEPE registration numbers, who have notified the Environmental Protection Agency ("EPA") and who have a certificate of public convenience and necessity issued by the New Jersey Board of Public Utilities or are otherwise exempted. (See following.) A list of NJDEPE registered transporters may be obtained from the NJDEPE using the medical waste help number (609) 530-8599.

(N.J.A.C. 7:26-3A.16)

Exemptions:

1. Generators of less than three cubic feet of regulated medical waste per month who transport only their own regulated medical waste to another generator for storage or disposal are exempt from the above requirements, provided that they meet the following conditions:

i. The regulated medical waste is transported by the generator in a vehicle with a gross weight of less than 8,000 pounds which is owned by the generator;

ii. The original generation point and the storage point or disposal facility are located in New Jersey; and

iii. The generator complies with all necessary requirements.

(N.J.A.C. 7:26-3A.17)

J. Report and Record-keeping Requirements

All shipments of regulated medical wastes must be tracked from the point of generation to the point of disposal on forms provided by the DEPE. The following requirements must be met by all generators.

1. Tracking Form

Generators must:

i. Prepare at least the number of tracking form copies that will provide the generator, each transporter(s), and each intermediate handler with one copy and the owner or operator of the destination facility with two copies.

ii. Sign, by hand, the certification statement on the tracking form.

iii. Obtain the handwritten signature of the initial transporter and date of acceptance on the tracking form; and

iv. Retain the generator copy. (See following.)

Generators who transport their own medical waste must:

i. Sign, by hand, the certification statement on the tracking form.

ii. Sign the transporter section of the tracking form, noting the date the regulated medical waste was transported;

iii. Retain the generator copy (see following);

iv. Ensure that the tracking form accompanies the regulated medical waste while in transit; and

v. Comply with the tracking form requirements for transporters at N.J.A.C. 7:26-3A.31(d).

(N.J.A.C. 7:26-3A.19)

2. Generator Record-keeping

Each generator must:

i. Keep a copy of each tracking form required by the N.J.A.C. 7:26-3A.19 for at least three years from the date the waste was accepted by the initial transporter unless the NJDEPE requires an additional retention period; and

ii. Retain a generator log which shall include, but not be limited to, the following:

a. The date of entry;

b. A description of regulated medical waste generated, segregated by Waste Class;

c. The total quantity in pounds for each Waste Class of regulated medical waste generated each day, or each month for generators of less than 300 pounds per year;

d. The name and NJDEPE solid waste transporter registration number of each transporter who transported regulated medical waste;

e. The EPA regulated medical waste transporter number of each transporter;

f. The date that the regulated medical waste was given to every transporter;

g. The name and address of each intermediate handler or destination facility that received the regulated medical waste, and the quantity in pounds for each Waste Class of regulated medical waste sent to each facility corresponding to the transporter who transported the regulated medical waste to that facility;

h. The method of treatment, destruction or disposal of each Waste Class by quantity in pounds (for example, on-site treatment, on-site incineration, disposal via sanitary sewer) corresponding to the facility; and

i. The generator log must be retained for at least three years from the date that the waste was generated, unless the DEPE specifically requires an additional retention period.

iii. Annual reports must be made to the NJDEPE by July 21 of each calendar year. The generator annual report must include:

a. The date of the report;

b. A description of the regulated medical waste, identified by Waste Class;

c. The total quantity in pounds for the year of each Waste Class of regulated medical waste generated, treated, destroyed, or disposed of;

d. The name and NJDEPE solid waste transporter registration number of every transporter who transported the generator's regulated medical waste;

e. The EPA regulated medical waste transporter number for each transporter;

f. The name and address of each intermediate handler or destination facility and a description of quantity in pounds for each Waste Class of regulated medical waste sent to each facility;

g. The method of treatment, destruction or disposal of each Waste Class by quantity in pounds (for examples, on-site treatment, on-site incineration, disposal via sanitary sewer); and

h. Copies of all generator reports must be retained for at least three years from the date that the report is due, unless the NJDEPE specifically requires an additional retention period.

(N.J.A.C. 7:26-3A.21)

Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.