FEE STRUCTURE OPTIONS .us



COMPLIANCE ASSISTANCE

CONCEPTS AND OPTIONS

January 5, 2004

BACKGROUND:

The Environmental Laboratory Accreditation Act (27 Pa C.S. §§ 4101 – 4113) provides the Department of Environmental Protection with the power and duty to establish an accreditation program for environmental laboratories. Many of the environmental laboratories affected by this Act and the resulting regulations are new to laboratory accreditation. The Act indicates that the Department has the power and duty to provide technical assistance and advice to persons and environmental laboratories subject to the Act (Section 4104 (7)).

Currently, the Department primarily provides compliance assistance to environmental laboratories during the on-site assessment. The reports provided to the laboratories include a specific reference where the correct procedure may be found and a detailed list of the items that would demonstrate correction of the finding. Department staff is available for answering questions by telephone or e-mail. Upon request, Department staff routinely participates in seminars and training sessions throughout the state. It is anticipated that additional assistance will be required as a result of the adoption of regulations that will affect additional environmental laboratories and will impose additional requirements on currently accredited laboratories.

The Department is therefore exploring options available to provide an expanded compliance assistance effort directed toward regulated environmental laboratories. If the Department’s compliance assistance efforts do not meet the needs of the environmental laboratories, many environmental laboratories will have difficulty complying with new regulations. The Department’s goal is to have all environmental laboratories meet the requirements to produce data of known and documented quality.

Numerous challenges/obstacles exist that hinder the Department’s ability to provide the necessary assistance to the laboratories. Some of these challenges/obstacles are:

• Laboratories have limited staff

• Laboratories have limited funds

• Laboratories have limited ability to travel

• Competition exists among Laboratories

• Laboratory technical people may have other job responsibilities

• Technology (e.g. current PCs, internet access) may not be available to all laboratories

OPTIONS AVAILABLE:

The ultimate goal of any compliance assistance effort should be improving an environmental laboratory’s ability to produce valid and defensible data for use by the Department, the regulated community, and the public. Several areas where compliance assistance is necessary are general laboratory operation, correct performance of specific test procedures, and documentation of laboratory activities. These areas, as well as others yet to be identified, would need to be provided to all environmental laboratories regardless of size or location within the Commonwealth. Several different ways of providing assistance have been identified. Each mechanism is briefly discussed.

1. Compliance Guide: The Department would develop a document or documents to help an environmental laboratory understand the compliance requirements associated with any proposed or newly adopted regulations. Initially, the compliance guide would be tailored to the smallest wastewater and drinking water environmental laboratories. The guide would address the requirements for the basic testing performed by these smaller laboratories. Eventually the compliance guide could be expanded to larger laboratories. Sample document templates could be included for:

A. Quality Manual

B. Method Specific Standard Operating Procedures

C. Record keeping – e.g. temperature records

D. Sample handling and reporting

2. Formal training programs: The Department would develop and provide formal training courses or seminars that would assist environmental laboratories as they prepare for accreditation. The training courses or seminars would be present information that would be applicable to all environmental laboratories, regardless of size and would be presented across the Commonwealth at numerous locations. Possible sites include the Department’s laboratory and regional and district offices, colleges or universities, hotels, and other training facilities. The seminars and courses could be presented in conjunction with existing organizations. Possible topics for inclusion are:

A. Developing a Quality Manual

B. Writing a Standard Operating Procedure

C. Documentation

D. Example or mock on-site evaluation

E. Method specific training

3. Newsletter: A periodic newsletter could be developed to provide updates about the environmental laboratory accreditation program in Pennsylvania. Possible topics for inclusion in the newsletter are:

A. New method approvals

B. Changes to PA code

C. Tips and suggestions

D. Proficiency Test samples – things to do and not do

E. Preparing for an on-site evaluation

F. Responding to an on-site evaluation report

G. Frequently asked questions

H. Highlight positive practices

4. Technology-based solutionS: Expand the use of technology to provide additional mechanisms for asking for and receiving assistance. Once compliance guides or newsletters are published, have these documents readily available on the Department’s Laboratory Accreditation website. Include a question and answer section listing answers given to commonly asked questions. Establish an environmental laboratory accreditation e-mail account (similar to the existing askDEP). A single e-mail address would solve the problem of not knowing the right person to ask. A toll free telephone number may also be a mechanism to provide access to assistance for an environmental laboratory regardless of location or access to the internet.

EVALUATION AND DISCUSSION:

To enhance our compliance assistance efforts, the Department is considering utilizing two full time positions initially. These 2 positions would be filled as soon as possible and the selected individuals would begin working on development of the compliance guide and on some of the other documents. As the regulations move through the approval process, these individuals would be available for assistance as environmental laboratories prepare for accreditation.

As environmental laboratories become more familiar with the requirements, the Department’s personnel requirements would be expected to decrease. Additionally, effective use of external contracts for laboratory consultants or specific training could supplement Departmental staff efforts to continue an effective laboratory compliance assistance program.

The Department is seeking comments on the various options presented. Suggestions for additional areas or topics to include would also be helpful.

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