A clinical science lab may or may not include direct patient care.
A clinical science lab is any area designated for the testing of human bodily specimens. It can be be a specialty lab, a hospital phlebotomy department, or even an area in a physician's office where a medical assistant conducts urinalysis testing. All clinical science labs operate under the jurisdiction of the U.S. Department of Health and Human Services, and the local State Department of Health. The lab must also meet the criteria of the United States Department of Labor to begin operation.
Instructions
1. Go to the Occupational Safety and Health Administration, or OSHA website, and carefully read their guidelines. Prepare your clinical science lab for OSHA inspection by ensuring such things as materials storage, machinery, fire code specifications and personal protective equipment meet all OSHA standards. Schedule a free on-site consultation by contacting OSHA (see resources).
2. Be sure the lab you choose is well ventilated and well lit.
Research the requirements for a clinical laboratory according to the regulations in your state by going to the website of the state department of health. Ensure your clinical laboratory meets all specifications during the purchase of equipment and during equipment setup. Contact your state department of health to apply for a Clinical Laboratory Improvement Amendment or CLIA compliance inspection.
3. Some clinical science labs do patient testing in the office.
Buy your clinical laboratory equipment such as an autoclave, a laboratory refrigerator, a urinalysis machine, a centrifuge and disposable testing supplies from a medical supply company in your area. Make sure all equipment meets the criteria of the Department of Health for your state, keeping in mind that each state has different requirements.
4. Urinalysis is one CLIA-waived clinical lab test.
Register with the Food and Drug Administration to be assigned a CLIA category of laboratory complexity from one, the lowest level of complexity to three, the highest level of complexity. Purchase only CLIA-waived testing supplies unless you will be assigned to a higher category of complexity. The seven criteria for CLIA scoring are listed on the FDA website under CLIA Categorization Criteria.
5. Bio-hazardous waste requires special handling.
Contact a bio-hazardous waste company to arrange routine pick-ups and new container deliveries. Find a local bio-hazardous waste company in your area by contacting 3E, a company which supplies approved waste containment in line with federal and state requirements.Contact 3E (see resources) and ask for pricing information, because most containment agencies do charge for this service.
6. Call a local clinical specialty laboratory, and they will help set you up to do business with their office. Contact OSHA and the state department of health once your setup is finalized, and request assistance with authorization to begin operations at your clinical science lab.
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