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The Lab Director In the physician's office setting, the person designated as laboratory director is likely to wear many hats: clinician, business manager, safety officer, etc. In the sole practitioner's office there is only one man/woman for the job. A member of a group practice or clinic may be the willing -- or unwilling -- volunteer to wear the director's hat. In either case, the laboratory director's hat may not get dusted off very often and, quite frankly, may not fit very well.The Basics Make that hat fit a little better by taking advantage of CME opportunities offered through the AMA, COLA, and other organizations. Laboratory medicine organizations offer courses and seminars suitable for the new or experienced lab director. Many of these educational opportunities may be accessed via the Internet. The director oversees laboratory services and has final responsibility for what occurs in and comes out of the laboratory. Learn to take the pulse of the laboratory. A well-written and fully implemented Quality Assurance program is perhaps the best tool for assessing overall operation of the lab. If your current QA program does not measure up to the task, rewrite it. Provide a safe and adequate environment for the testing performed in your lab. As new test systems are brought on board, reevaluate the environment and make necessary changes. When building or remodeling a lab, remember that counter space and electrical outlets are worth their weight in gold. Adequate ventilation is often overlooked until staff and equipment begin to overheat and fume clouds begin to gather. Laboratory instruments and refrigerators produce heat. Hire competent testing personnel and provide any necessary training as new analytes and/or test systems are brought on line. Assess competency after training and annually thereafter. Last but not least, poke your head into the lab on a regular basis. Observe the physical plant for safety hazards and general clutter. Gauge the chaos level of the laboratory. The number of laboratory errors and safety incidents is directly proportional to the stress level of testing personnel. Talk to the lab staff. Ask questions about the procedure that you are watching staff perform. Your question may trigger a response worth a dozen QA reports. Delegate There are specific responsibilities assigned to laboratory directors by CLIA. The director may delegate many of these responsibilities to qualified staff members and/or contracted consultants. Responsibilities that may be delegated to a technical consultant: ˇ Select test methodologies appropriate for the laboratory ˇ Verify performance characteristics of test systems ˇ Establish and implement a proficiency testing program ˇ Establish and maintain acceptable levels of analytical performance of test systems ˇ Establish and monitor quality control and quality assurance programs appropriate for testing systems in use ˇ Direct resolution of technical problems beyond the expertise of testing personnel and assure that patient results are not reported unless test systems are functioning properly ˇ Evaluate competency of personnel performing all aspects of testing ˇ Identify training needs of testing personnel and assure that appropriate training is received ˇ Provide a procedure manual describing all aspects of testing Please note that physicians' office laboratories using licensed clinical laboratory scientists/medical technologists as technical consultants or testing personnel are more than twice as likely to do well on proficiency testing as their counterparts using medical practice staff members alone. (JAMA.1998;279:468-471) Responsibilities that may be delegated to a physician consultant: ˇ Ensure that test reports contain information necessary for interpretation of results ˇ Ensure that consultation is available regarding quality of test results and their interpretation The following director's responsibilities may not be delegated: ˇ Ensure quality laboratory services for all aspects of testing performed ˇ Ensure that the physical plant is appropriate and safe ˇ Employ a sufficient number of personnel with appropriate education to perform their duties and provide training as necessary ˇ Specify in writing the duties of laboratory personnel, including consultants ˇ If responsibilities are delegated, do so in writing and ensure that all duties are properly performed The QA Meeting Schedule regular meetings with your laboratory staff to review QA activities, spot-check quality control, and examine proficiency testing evaluations. If you use a technical consultant, read monthly summaries carefully and ask questions. It's your hat. |
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This article may be republished in its entirety on your web site or in your newsletter under the following two conditions: 1) Include the following statement at the beginning or end of the article. "Republished with permission of the author, Margaret A Knapp MT(ASCP) CLS, of KnappˇFrazer Consulting. www.knapp-frazer.com ~ 707.539.6621" 2) Send copy of your publication or URL to KnappˇFrazer Consulting at time of republication. |
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