Biomedical subjects
Publications and source records attributed to K Voldish.
Any physician's office can pass a CLIA inspection if it is prepared and knows what to expect. Offices that pass an inspection feel a great sense of pride knowing the laboratory meets the same standards of quality as a hospital or clinical laboratory.
On January 1, 1994, enrollment in an accredited proficiency testing program became mandatory under the CLIA regulations for physicians performing moderate and high complexity tests in their offices. Physicians not enrolled in programs are in violation of the standard.
The newest additions to the Clinical Laboratory Improvement Amendment (CLIA)-88 regulations are in the physician's interest. It is hoped this trend will continue as the Health Care Financing Administration (HCFA) reviews physician comments on the regulations.
Safety practices are a necessary part of the physician office laboratory operation. The Occupational Safety and Health Administration (OSHA) inspects office laboratories constantly and a physician must be aware of the condition of the laboratory at all times.
Physicians performing laboratory tests must have a registration certificate as of September 1, 1992. To continue testing without this certificate could lead to large fines and possible prosecution. This article covers quality assurance, quality control, and maintenance of instruments.
Physicians performing moderate or high complexity tests will need to prepare their office laboratories to meet CLIA-88 government standards. Doctors who have not applied for their registration certificate should do so immediately. This is the second in a three-part series.
The final rules implementing the Clinical Laboratory Improvement Act (CLIA) of 1988 were published. Physicians will see their office laboratories fall under control of the federal government as of September 1, 1992. Physicians need to understand the regulations.
New Jersey physicians who have office staff giving injections, performing venipuncture, analyzing body fluids, or assisting with minor surgical procedures must comply with OSHA's bloodborne Standard. The Standard became effective on March 6, 1992.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) regulations will require physician office laboratories (POLs) to participate in proficiency testing (PT) for all nonwaivered tests performed in private offices. PT will enhance the quality of the testing performed in a POL.
Documented personnel files will be a requirement of the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) regulations. This documentation will help reduce laboratory errors and liability by clearly and completely defining the employee's duties and responsibilities.
Urinalysis is the most frequently ordered test performed in the physician office laboratory. Quality control programs must be a part of every urinalysis ordered in the office laboratory. Quality control will assure the test will yield reliable information.