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Laboratory Quality
Assurance Evaluation Program for Analysis of Cryptosporidium under the Safe Drinking Water Act
As of May 2007, EPA estimates that sufficient laboratory capacity exists for the LT2. As a result, EPA is evaluating additional laboratories for participation in this program only as funding and schedule allow.
The purpose of this Laboratory Quality Assurance (Lab QA) Program is to identify laboratories that can reliably measure the occurrence of Cryptosporidium in surface water using EPA Method 1622 and/or EPA Method 1623. This program is voluntary, and any laboratory may participate, provided the laboratory has:
- the equipment required in EPA Method 1622 and/or EPA Method 1623,
- personnel who have the recommended experience to analyze samples, and
- successfully completed an initial demonstration of capability.
The laboratory, personnel, and demonstration criteria are specified in the application cover letter.
Steps for participation:
- Step 1. Application
The EPA will evaluate laboratory applications for sufficient equipment, experience, and demonstration of capability. Any deficiencies can be corrected before proceeding to the next step in the evaluation process.
- Step 2. Initial proficiency test
After an application has been accepted, the laboratory will be sent a set of eight initial proficiency test (IPT) samples consisting of a suspension of oocysts in a concentrated matrix. Laboratories will resuspend these spikes in reagent water to produce simulated source water samples and analyze the samples using the version of Method 1622/1623 that the laboratory plans to use for routine Cryptosporidium analyses. If a laboratory wishes to be evaluated for more than one version of the method, the laboratory will receive a set of eight IPT samples for each version. Laboratory IPT data will be evaluated against mean recovery and precision (as relative standard deviation) criteria for the IPT samples.
- Step 3. On-site evaluation
After a laboratory passes the IPT and has documented the required capability
to participate in the Lab QA Program through the completed application,
an on-site evaluation of the laboratory will be scheduled. The on-site
evaluation will include two separate, but concurrent, assessments: (1)
assessment of the laboratory's sample processing and analysis procedures,
including microscopic examination; and (2) evaluation of the laboratory's
personnel qualifications, quality assurance and quality control, equipment,
and record keeping procedures. After a laboratory has corrected any deficiencies
noted in the audit, they will be granted approval, and then will be listed
with other laboratories that have passed the on-site evaluation on this
site.
- Step 4. On-going Proficiency Test
EPA will evaluate on-going precision and recovery data to determine if the laboratory continues to meet the performance criteria of the Laboratory QA Program. Laboratories in the program will receive a set of three ongoing proficiency test samples approximately every four months that must be analyzed in the same manner as the IPT samples.
All interested laboratories are encouraged to mail their application package to:
Cryptosporidium Laboratory Quality Assurance Coordinator
c/o CSC Biology Studies Group
6101 Stevenson Avenue
Alexandria, VA 22304-3540
For technical inquiries contact:
Carrie Miller, Manager, Cryptosporidium Laboratory Approval Program
U.S. Environmental Protection Agency
Office of Ground Water and Drinking Water, Technical Support Center
26 West Martin Luther King Dr. (MS-140)
Cincinnati, Ohio 45268
fax number, (513) 569-7191
e-mail address: miller.carrie@epa.gov
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List of Laboratories
Approved for the Analysis of Cryptosporidium Under the Safe
Drinking Water Act
The following laboratories have passed the Laboratory Quality Assurance Evaluation
Program for Analysis of Cryptosporidium under the Safe Drinking Water
Act,
and have been granted "Approved" status. The purpose of the
Lab QA Program is to identify laboratories that can reliably measure the occurrence
of Cryptosporidium in surface water using EPA Method 1622 and/or EPA
Method 1623.
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