TBD Application Package for Assessment of Crypto Lab QA

Application Package for Assessment of
Cryptosporidium Laboratory Quality Assurance
Submit electronic package to:
Submit any necessary hard copies to:

[Cert Officer email]
[Cert Officer Name]
[Address]
[Phone]

Step 1: Submit all requested information
Please submit all requested elements in one package organized as follows. Your application will be evaluated for
completeness.
1. Completed Audit Application Form
2. Up to date Standard Operating Procedures (SOPs) for the following:
a. Performance of each Method step including: sample spiking, filtration, elution, concentration, purification, slide
preparation, sample staining and examination (for each method version, where applicable)
b. Reagent preparation
c. Cleaning practices
d. Corrective action procedures for failing to meet OPR, method blank, staining controls, sample acceptance and
analyst verification criteria
e. Sampling procedures to be followed by field or utility personnel
f. Procedures for data recording, checking manual calculations, and checking accuracy of all data transcriptions
g. Procedures for data recording and electronic storage of data, including checking for accuracy of data entry and
backup of stored data
3. Training records for all analysts/technicians
4. OPR control chart including at a minimum the last 20 OPR samples processed
5. MS control chart including at a minimum the last 20 MS samples processed
6. Submit two data packages from the last 12 months, include a positive result if available. Include all supporting
documentation from the field sample, matrix spike, method blank and positive control slide.
7. NELAP certificate (as applicable)

Step 2: Submit slides for review
An off-site technical auditor will review one recent OPR and associated positive staining control slide. Contact [Cert
Officer Name and email] to schedule evaluation of slides. This review may occur prior to or following the on-site
audit. The slides prepared for the review during the audit in Step 5 may be requested to fulfill this submission.
Step 3: Order on-site audit package
Order an on-site audit package from Wisconsin State Laboratory of Hygiene (608-224-6260), or equivalent vendor.
Each package consists of 2 50 mL blind samples, 2 vials of artificial matrix, 2 IMS control samples, and 2 analyst
verification slides. One slide is required per analyst and a back up slide. Additional slides may be added for a fee.
These will be used in presence of an auditor; therefore, evaluation date should be within product expiration. Bench
sheets and examination forms for the blind samples, and associated method blank and OPR samples should be
submitted to [Cert Officer Name and email]. Submit the analyst verification slides and associated examination forms,
if requested.
Step 4: Schedule internet analyst evaluation
Contact [Cert Officer Name and email] to schedule internet analyst evaluation for each analyst. A computer with

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internet connection is needed to complete the session.
Step 5: Prepare fresh OPR and positive staining control for review during the audit
Step 6: Evaluation
The laboratory will receive a report detailing all audit findings. The laboratory should provide complete written
responses to any deficiencies or recommendations identified in the report within 60 days. Laboratory status for
continued approval will be based on submission of acceptable responses, proficiency test results, the quality of the
positive control and OPR slide, slide counts, on-site evaluation, and recovery values for blind samples initiated during
audit

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