Environmental Lab Certification F.A.Q.
Bureau of Public Health Laboratories
Dept of Health
Bureau of Public Health Laboratories
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Jacksonville, FL 32202
Environmental Laboratory Certification Program
Frequently Asked Questions about the Contracting of On-site Assessments
1. What has changed with my laboratory's assessments?
The Department of Health has been contracting out all routine on-site assessments since 2013. The process has been as intensive as previous assessments and the standards against which you are assessed are the same. The department is careful to write contracts that ensure the contract assessors are qualified.
2. Under this system, how do I get my assessment done?
The department determines whether or not the requested provider meets the contract's technical specifications. This allows you to choose the provider that best suits your needs. The department has published a list of providers and you will then be responsible for selecting one or multiple providers that can conduct your assessment to meet the requirements of your certification. The department makes every effort to qualify the assessors according to the education, training, and experience necessary to do the job so you receive a high-quality and compliant assessment.
3. So who pays the provider?
Client laboratories pay the provider directly in accordance with costs and terms agreed upon between the two parties.
4. Since I am paying for my assessment, does the department still charge lab certification fees? If so, why?
Yes, there still is a fee associated with your certification. The costs of doing on-site assessments have only accounted for a portion of the fees. Even though we are outsourcing the routine assessments, the department has to maintain sufficient Environmental Laboratory Certification Program (ELCP) staff to oversee the providers, to make certification decisions, and to enforce the applicable regulations. Although the fees may decrease, the remaining costs still need to be recovered.
5. What are the providers' responsibilities?
Providers conduct the biennial on-site assessment of your laboratory, evaluating it against the The NELAC Institute (TNI) 2016 Standards. including all necessary pre- and post-assessment activities. This involves planning, scheduling, assembly of a qualified assessment team, document review, traveling to and from your location, checklist preparation and completion, the actual on-site assessment, reporting, and the corrective action review.
6. Does every provider follow the same procedures?
Each provider has been given the flexibility to conduct assessment activities in a fashion that suits its own business practices while meeting the needs of the client laboratory and the requirements of the department. Although we have provided the requirements for the essentials and guidelines for reporting, it is not our intent to dictate all aspects of the process. However, since DH Form 1137 is incorporated by reference in the certification rules, all providers are required to use this form in their assessment reports.
7. When is my assessment due?
Assessments have to be done at least once every two years (Florida Administrative Rule, Chapter 64E-1.104). If you have questions about your labatory's due date, please contact our office for assistance.
8. Who makes the decisions about my laboratory's certification?
The ELCP continues to be the decision-maker. The department makes any and all determinations to grant, deny, suspend, reduce, limit, or reinstate a laboratory's certification. The department also continues to receive, review, and evaluate results of Proficiency Testing for certified laboratories and to maintain records of the results. Everything the department completed in the past regarding your laboratory's certification, with the exception of routine assessment activities, still is done.
9. Will the ELCP continue to be recognized as a NELAP Accreditation Body?
The National Environmental Laboratory Accreditation Program (NELAP) standards and the standards of the NELAC Institute (TNI) have become the fundamental basis for laboratory certification in Florida. The Department of Health and the Department of Environmental Protection have placed a high value on laboratories meeting the requirements of these standards and the department will make every effort to assure that we maintain NELAP recognition as authorized by state law. It is essential to continue being active in the national accreditation program while ensuring the availability of high-quality environmental testing laboratories. As in the past, the ELCP will strive to be your strongest advocate at TNI and a faithful representative of Florida's interests.
10. What if I need advice about a deficiency cited during an assessment or consultation on a regulatory or technical question?
Although most assessment providers also offer consultation services as a part of their overall businesses and may explain or clarify some points about your assessment, they are prohibited from consulting with you regarding any assessment being conducted for your laboratory. This is a protection against the obvious conflicts of interest that would arise if they were allowed to do so. The good news is that the state is not subject to those restrictions. In the interests of laboratory quality improvement and to promote, protect, and improve the public health, the department will continue to provide technical consultation and assistance to certified and applicant laboratories, as well as to the general public upon request. The department is also be the arbiter of disputes should they arise regarding deficiencies cited during an assessment.
11. Is ELCP doing any on-site assessments or will contractors do them all?
The department, at its discretion, continues to perform assessments of laboratories for contract oversight, quality assurance, enforcement, assessment backlog reduction, and other reasons deemed necessary for the effective operation of the ELCP.
12. In the past, I have usually been able to submit an application for additional certification while the assessors were on site. Is that still be possible?
Yes; however, the providers will not be able to address any application we have not processed first, so the application would still have to be transmitted to us, processed, and then assigned back to the assessment team. Assuming there are enough time and resources to do so, the provider may be able to address the application while the team is still on site. Remember, though, there might be additional costs associated. It is always better to plan ahead and apply in advance for any additional certifications you may need. The difference now is that you have greater control over the speed at which an assessment can be arranged.
13. How do I get more information?
Feel free to contact the Environmental Laboratory Certification Program at (904) 791-1599. The department is committed to assuring the acceptable quality, reliability, and validity of environmental testing data. We are here to answer your questions and to provide assistance.