Clinical Laboratory Improvement Act (CLIA)
When Does a Laboratory Require a CLIA Certificate?
| If it performs clinical laboratory tests | Yes | |||
| If it bills (for example, Medicare, Medicaid, Private Insurance, or the patient) for the test | Yes | |||
| If it does not charge for the test | Yes | |||
| If the test is part of the physical exam and does not charge for the test | Yes | |||
| If it functions only as a collection and processing site | No | |||
| If it only plates cultures on media, refers the specimen out for identification, & does not read and/or report out plates prior to referral. | No | |||
| If it performs only tests using a patient's breath sample (i.e., H. pylori, alcohol breath tests) | No | |||
| If it performs only physiological tests: i.e., stress tests, pulse oximetry, EKG, EEG. |
No | |||
| If it performs tests for legal / law enforcement purposes. | No | |||
| If the facility is a "hospital within a hospital". | Yes | |||
| If the facility performs grossing of a tissue specimen and the reading of the smear. The grossing and reading of a smear are considered a test if performed by a physician, pathologist, or equivalently trained individual. | Yes | |||
| If the facility screens PAP Smears (performed by a physician, pathologist, or cytotechnologist). | Yes | |||
Laboratories |
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| Forensic Laboratory | No | |||
| If individual test results are reported to either the patient and/or physician for treatment, assessment, or diagnosis of the patient. | Yes | |||
| If individual test results are not reported for treatment, assessment, or diagnosis of patient, but are used as findings of a research. | No | |||
Drugs of Abuse Testing Laboratory: |
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| SAMHSA Certified: | ||||
| If performing only the tests certified by SAMHSA: | No | |||
| If performing more than the SAMHSA certified tests: | No | |||
| If for forensic/legal purposes, pre-employment, firing. | No | |||
| If the patient is sent for counseling/treatment. | Yes | |||
If the patient is returned to jail; parole revoked. |
No | |||
List of SAMHSA Drugs: |
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Initial Tests Screening
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Phencyclidine, Amphetamines |
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Federal Facility: |
No |
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| Department of Defense |
No | |||
| Veterans Administration | Yes | |||
| Indian Health Services/Public Health Services | Yes | |||
| Non-Federal Indian Tribe Laboratories (State) |
Yes | |||
| U.S. Coast Guard | Yes | |||
Plasma Centers/Blood Banks: |
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