Regulatory FAQs: Learn about medical practice rules and regulations
By Robin Desrocher, Director, Risk Management andTanya Babitch, Assistant Vice President, Risk Management
What does the Occupational Safety and Health Administration (OSHA) require for medical practices?
OSHA standards require that medical practices develop and comply with safety policies and procedures related to blood-borne pathogens, regulated waste disposal, and chemical hazard communication. Employee training is required initially and annually thereafter. Records of all OSHA training should be maintained for three years. Employers are required to make Hepatitis B vaccination available at no cost to all employees whose job classifications indicate potential exposure. Employees who refuse vaccination must sign a declination form.
Unless another OSHA rule specifically provides a different period of time or exception, employee occupational medical records and exposure records must be kept confidential and retained for at least the duration of employment plus 30 years. More information is available at the OSHA website.
The Texas Medical Association offers additional OSHA resources for physician practices.
Since I perform only a few simple tests in my office, do Clinical Laboratory Improvement Amendments (CLIA) regulations apply to my practice?
Yes, CLIA does apply. However, some simple tests are waived from specific CLIA requirements. They may include:
- urine dipstick or tablet analytes, nonautomated;
- fecal occult blood;
- ovulation test (LH) by visual color comparison;
- urine HCG by visual color comparison tests;
- erythrocyte sedimentation rate, nonautomated;
- hemoglobin by copper sulfate, nonautomated;
- spun microhematocrit; and
- blood glucose using certain devices cleared by the FDA specifically for home use.
A complete list of CLIA-waived tests is available at the FDA's CLIA website. If you perform only these tests, a CLIA certificate of waiver is required.
What are the requirements for medical waste management?
Chapter 326 of the Texas Administrative Code defines the requirements for medical waste management, disposal, transportation, collection, and storage. In general, generators of medical waste shall obtain a signed manifest from the transporter and are required to maintain these manifests for a period of three years. More information is available from the Texas Commission on Environmental Quality.
What does the law require for physicians to sign death certificates?
Texas physicians, physician assistants or advanced practice registered nurses who are asked to sign a death certificate must do so electronically or face fines of up to $500 per violation.
A medical certifier on a death certificate must submit the medical certification and attest to its validity electronically. Physicians must register with the Texas Electronic Vital Events Registrar (TxEVER) before signing a death certificate. Any physician who signs a death certificate and is not registered with TxEVER may be fined up to $500 by the TMB.
Physicians who have not yet registered can do so by clicking on “User Enrollment” at the TxEVER website. If you need assistance, send an email or call the TxEVER at 888-963-7111.
Chapter 193 of the Texas Health and Safety Code provides additional regulations regarding certification of death.