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This request for information seeks public comment regarding several items related to Clinical Laboratory Improvement Amendments(CLIA) personnel requirements and histocompatibility requirements, which, with minor exception, have not been updated since 1992. We are also seeking public comment regarding the flexibility to impose alternative sanctions for laboratories issued a Certificate of Waiver (CoW) determined to have participated in proficiency testing (PT) referral. In addition, we are seeking public comment related to appropriate sanctions in situations where we determine that a laboratory has referred its proficiency testing samples to another laboratory and has reported the other laboratory’s result as their own.

This request for information also seeks public comment regarding the updating of fees for determination of program compliance and additional fees for laboratories established under the CLIA regulations. We are also seeking public comment regarding the collection of other fees we are authorized to collect such as fees for revised certificates, post survey follow-up visits, complaint investigations, and activities related to imposition of sanctions.

We intend to consider public comments received in response to this request for information when we draft proposals to update the existing CLIA regulations through future rulemaking. We are also soliciting public comment on other areas of CLIA which should be reviewed and potentially updated.