348 UNIT 7 Quality Assurance and Regulatory Issues

other examination of materials derived from the

human body for the purpose of providing information
for the diagnosis, prevention, or treatment of any disease
or impairment of, or the assessment of the health
of, human beings. These examinations also include
procedures to determine, measure, or otherwise describe
the presence or absence of various substances
or organisms in the body. Facilities only collecting or
preparing specimens (or both) or only serving as a
mailing service and not performing testing are not
considered laboratories.
CLIA and Donor Centers
The CLIA regulations require accurate and reliable
laboratory testing to include
All donor testing (ABO group, Rh type, antibody
screen, human immunodeficiency virus,
hepatitis, rapid plasma reagin, total serum
solids)
All applicable requirements for
personnel
quality control
quality assurance
patient test management
proficiency testing
The regulations do not cover the following:
Quality control procedures performed for the
purpose of ensuring proper function of equipment
being used to manufacture blood products
once they have been procured from the
donor and appropriately tested.
Quality control procedures used to verify viability
of the product.
Proper performance of irradiation chambers to
irradiate blood components.
Sterility of blood components.
All counts to assess components manufactured
to meet requirements for viability determined
by the FDA.
CLIA Inspection Process
Routine inspections are conducted biennially and are
announced visits. Return visits may be made to determine
the progress made in correcting cited deficiencies.
In addition, a complaint may be made against a
laboratory that could require an unscheduled inspection.
Inspections are performed by trained surveyors
under the CMS.
Enforcement
The CMS may impose sanctions against laboratories
that are found not to meet CLIA requirements. CMS
may impose the intermediate sanctions of a directed
plan of correction, civil money penalties of up to
$10,000 per violation or per day of noncompliance,
and payment for the cost of state on-site monitoring of
a laboratory that is noncompliant with CLIA condition

level requirements. In addition, for any laboratory

that participates in Medicare or Medicaid, CMS
may suspend all or part of Medicare or Medicaid
payment.
The CMS may also impose the principal sanctions
of suspension, limitation, or revocation of a laboratorys
CLIA certificate.
Civil actions may also be taken by CMS. The
agency may enjoin a laboratory from continuing any
activity that constitutes a significant hazard to the
public health. CMS may also prohibit any person who
had owned or operated a laboratory that had its