Laboratory Certification Program Overview
- Background
- Program Structure
- Lab Audits and Certification
- Technical Strengths
- Reciprocity
- Fiscal Responsibility
- Enforcement
- Continuous Quality Improvement
Background
The Wisconsin Department of Natural Resources (WDNR) Laboratory Certification Program was created in 1986 to help insure that laboratories submit reliable and consistent data to the Department's various environmental programs. The program currently offers certifications and registrations designed to accommodate the needs of many DNR programs including testing under the Clean Water Act, Resource Conservation and Recovery Act and the Safe Drinking Water Act. The program is unique because it offers two levels of accreditation; certification for large, commercial laboratories or registration for smaller municipal or industrial laboratories required to perform compliance monitoring by their permit.
The program has grown significantly since its inception and currently certifies or registers about 410 laboratories in 17 states. It is one of the most sought after certifications in the nation.
Program Structure
The program operates under Chapter NR 149 of the Wisconsin Administrative Code, which sets very specific requirements for certified and registered laboratories. Ch. NR 149 sets the scope of the available fields of accreditation and the fees for each. Available fields of accreditation are defined by Matrix-Technology-Analyte(group) for aqueous and solid matrices and Matrix-Method-Analyte(group) for the drinking water matrix. This allows a laboratory some flexibility in choosing which types of analyses and which approved technoloigies/methods they wish to be certified or registered for, thereby limiting their certification costs. The fees charged to laboratories participating in the program are considerably lower than similar programs in many other states.
Laboratory audit responsibility is shared between the Central Office and several Regional offices. The Central Office consists of four full time auditors, a Program Coordinator, and a Program Chemist. The Department's West Central and South Central Regional offices are staffed by auditors primarily responsible for smaller, registered laboratories. The Central Office and Regional staff meet regularly to discuss relevant certification issues and to maintain program consistency.
The program is sufficiently decentralized to allow small in-state laboratories to receive audits and inspections in a timely manner from a knowledgeable DNR employee located close to their facility. These facilities are typically registered, which means that they analyze only their own samples for compliance purposes. Most auditors have also succesfully completed the EMSL- Cincinnati Drinking Water Laboratory Certification Course. All audit staff have been trained by a mentoring program that assures technical competence and good auditing skills. This allows the auditors to spend time helping laboratories understand the current state and federal regulations and to suggest ways to improve their laboratories as well as fulfilling the requirements.
The program's performance is overseen by an advisory council mandated by state statute. The Certification Standards Review Council consists of representatives from the laboratory community and other related environmental interests. The Council meets with the program at least annually, and has input when the program proposes new regulations. The program also has a limited partnership with the Wisconsin State Laboratory of Hygiene, a public health laboratory located within the University of Wisconsin System. This special relationship allows the Department to stay abreast with the changing analytical chemistry field and to regulate laboratories with the needs of the environmental community in mind. The State Laboratory of Hygiene serves as a provider of reference samples, is the state's primacy laboratory and is the laboratory of choice for many internal agency projects, including split samples for enforcement cases.
Laboratory Audits and the Certification Process
Laboratory audits are the cornerstone of the Laboratory Certification Program. A laboratory seeking certification in Wisconsin is required to maintain a strict Quality System which is verified through the on-site evaluation. All new laboratories applying for certification or registration in Wisconsin are required to pass an on-site evaluation before entering the program and certified or registered labs are required to pass an on-site inspection every three years. Through the audits, the program emphasizes quality systems, proper method execution and traceability of analytical results. The on-site evaluations consist of intensive surveys that examine laboratory facilities, sample receipt and handling, performance of analytical procedures, quality assurance, records and data reporting. One of the ways the audits evaluate a laboratory's performance in these areas is to track a sample analyzed by the laboratory from the point of entry to the final report. An audit report detailing laboratory deficiencies and areas for improvement is issued within 30 days after the on-site inspection for the benefit of the laboratory. These reports may be issued in conjunction with an enforcement action in severe cases of non-compliance.
In reality, the audit is an on-going evaluation of a certified laboratory's performance, which begins as soon as the laboratory applies for certification or registration. Laboratories applying for Safe Drinking Water (SDWA) analyses and Underground Storage Tank (LUST) analyses are required to submit initial demonstrations of capability and method detection limit data. All laboratories applying for certification are required to pass the appropriate reference samples available from a variety of providers. Initial on-site inspections are not scheduled until all of the necessary information is in order.
A laboratory's certification status is reviewed annually, and the certification period is for one year. The certification or registration period runs from September 1 to August 31 of the following year. All labs are billed in May for the upcoming certification period. Each year, laboratories are required to pass the necessary reference samples and pay the appropriate annual fee prior to being renewed. Laboratories which do not meet the criteria for renewal are contacted by program staff, and a resolution is usually quickly achieved.
The program's computer database is one of the highlights of the Wisconsin program. This database allows in-depth laboratory tracking, and is capable of maintaining records of applications, certification status, audits, reference samples and method citations used by a particular laboratory. The database is searchable, and specialized lists of laboratories for a particular project are readily available.
Technical Strengths
In addition to the in-depth audit process, the Laboratory Certification
Program staff participate in a wide variety of activities related to environmental
laboratories. These activities range from method development (e.g. the
Wisconsin Modified Diesel and Gasoline Range Organics Methods) to data
review and validation. The Laboratory Certification Program has developed
guidance in several areas of analytical interest, including preparing laboratory
quality assurance manuals and determining the limit of detection for a
specific analyses.
The program's staff are also very knowledgeable about a wide range of environmental regulations on both the state and federal level, and are willing to share knowledge will the laboratory community through a variety of forums including conferences, meetings and newsletters.
Reciprocity
By statute, the program is required to enter into reciprocity agreements with other states that have comparable accreditation programs. Currently, the program recognizes the accreditation of eight states. Reciprocity agreements are beneficial to the program because they reduce the number of out-of-state laboratories that require on-site evaluations. Reciprocity agreements mean cost sharing and information sharing, and unfortunately many states are unwilling to give up their share of the pie to participate in them.
Fiscal Responsibility
The Laboratory Certification Program is entirely supported by program revenue generated through annual and application fees. The fees charged to laboratories are designed to recover the actual costs of administering the program, and cannot exceed the Department of Administration-approved spending authority allocated through the state's biennial budget process.
Enforcement
Laboratories found to be deficient either during an on-site evaluation or through the annual performance criteria are given several opportunities to comply with the regulations. The program follows a stepped enforcement process that escalates as deficiencies remain unresolved. The enforcement process can be very time consuming and tedious, going from a Notice of Noncompliance to a Notice of Violation and finally to Suspension or Revocation of certification, but it is fair. The stepped enforcement allows laboratories to work with program staff to become a fully compliant, high quality laboratory.
Continuous Quality Improvement
The Laboratory Certification Program was chosen as a model program for the Department's Continuous Quality Improvement (CQI) Initiatives and has made several strides in improving efficiency. Through the CQI process, the program has developed a streamlined application- audit process which has considerably reduced the amount of time it takes for a laboratory to become certified. Applications are processed in the Central Office according to a Standard Operating Procedure and on-site evaluations are scheduled within 90 days of completing the application. The phrase "90-day clock" has been incorporated into the program as a statement of the desire to provide rapid service to its customers, from the time that the application is received to the time that certification is granted.
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