Reduce Medical Laboratory Professional Liability Insurance
Medical laboratories are not prominent in the current debate over healthcare reform, but these facilities process millions of analytical tests annually on human tissue and body fluids to assist in the detection, diagnosis, and treatment of disease. It is a multi-billion dollar business fueled by the so called “defensive medicine” practices of physicians who order numerous tests to defend themselves against medical malpractice claims. For a single laboratory that may be processing hundreds of thousands of specimens a year, the exposure to professional liability claims is equally great. This article will provide the basic steps to build upon for your professional liability loss control program and may help to reduce your insurance costs.
- Develop a written Standard Operations Procedure (SOP) manual for each and every test and procedure you perform. Each SOP should contain, at a minimum, detailed instructions for obtaining specimens; specimen identification, handling, packaging, and labeling; testing and analysis; reporting; record keeping; and communicating with clients.
- Centers for Disease Control and Prevention
CDC Centers for Disease Control and Prevention - Your Online Source for Credible Health Information
- Be sure your procedures include the Center for Disease Control (CDC) Guidelines for the handling of blood and blood products, and other industry standard protocols for specimen management. Make copies of the SOP manual available to the analysts and medical laboratory technicians, and implement oversight and audit provisions to ensure the procedures are followed.
- Ensure the expertise, quality and experience of your professional staff and technicians. Perform background and reference checks on all professional staff and medical laboratory technician employee candidates. Check to ensure that they are in compliance with all local, state, and federal regulations for necessary education, certification, and licensing. Ask to see school transcripts, letters of references and any other pertinent documents that will establish their credentials.
- Train newly hired professional and technical employees thoroughly. Require that they read the SOPs pertaining to their job activities. Provide “hands on” training in specimen collection and handling, analytical methods, instrument use, your quality control program, and any other methods required to do their jobs properly. Require that technical and professional staff demonstrate knowledge of methods by performing practice procedures for their supervisor. Do not assign the new employee to a job until he or she can demonstrate proficiency and accuracy in each of their required tasks. Once employees are assigned to a job, have supervisors observe work methods to see they follow established protocols.
- Establish an internal and external laboratory audit program. All accredited medical laboratories must pass a periodic Federal Drug Administration audit to retain their certifications. Consider an internal or peer review audit schedule as well. All top-quality labs conduct an annual internal system and performance audit to ensure the quality of data production and reporting. For example, reprocess random audit samples to test consistency of results. Compare overall accuracy to industry reference points or peer laboratories. Summarize your findings and distribute them to staff so that any deficiencies discovered are corrected. Conduct follow-up audits until satisfactory results are achieved. Sample internal audit programs and commercial internal audit software products are provided under Resources.
- Implement an instrument inspection, preventive maintenance, and calibration program. Analytical instruments must be calibrated in accordance with FDA approved procedures or with the requirements stated in the particular analytical method being used. Ensure that recommended manufacturer’s instructions are also followed and that your Quality Assurance Manual describes methods to check instrument tune and appropriate calibration curves for each type of instrument used at the lab. See that analysts and technicians conduct routine instrument maintenance according to procedures and frequency recommended by the manufacturer.
- Do not provide a warranty or guarantee beyond a generic industry standard that states testing and reports conform to generally acceptable analytical laboratory principles and practices, and that services are performed in accordance with applicable laws and regulations.
- Do not provide an interpretation or diagnosis of any test either to the patient or to the physician. This is the physician’s job.
- Do not release test results to any person other than the physician.