- Date: February 13, 2011
- Source: Admin
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Regulations
The Clinical Laboratory Improvements Act of 1988 set certain conditions that medical laboratories must meet in order to perform testing on human specimens. The Act categorizes testing as follows:
- waived complexity, moderate complexity, a subset of moderate complexity testing,
- provider-performed microscopy (PPM) or high complexity testing.
Waived testing is usually associated with physician office laboratories or hospital nursing units. PPM testing is also usually associated with physician office laboratories or hospital units. Moderately and highly complex tests are usually associated with hospital laboratories or reference laboratories. To qualify for either of these certificates, stricter requirements must be met like:
- participating in proficiency testing,
- performing a quality check system and
- meeting personnel testing requirements of the CLIA ’88.
Compliance
Compliance with quality and regulations is a continuous process for the clinical laboratory. Inspections are mandatory. Typically an inspection by an outside source is required every couple of years. Interim self-inspections are required in the off-year. If there are complaints against a laboratory, inspections can be more frequent. Inspections involve maintenance and function checks, calibration and calibration verification procedures, and monitoring of the quality control system.
At the minimum, the laboratory / organization should follow:
- manufacturer instructions or provide documentation to expand beyond manufacturer claims,
- regulatory guidelines, and
- its own policy and procedure.
The laboratory or organization concerned is held to all of these standards and must demonstrate compliance for a successful accreditation outcome.
Sources:
1. https://www.cms.gov/clia/
2. http://www.clinicallabtesting.com/sites/clc.nsf/page/compliance
