What happens if you get inspected and found to be non-compliant? Is it just that you have to correct the problem? Are you decertified or have to pay a fine? Hospital Ratings Medical Resource Group, LLC
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Re:CLIA Compliance and the Physician Lab Director – More Than a Title
Date: 2007/03/10 21:46
By: cellcounter
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Non-compliance can be in the eye of the inspector. If your inspector finds things wrong that are not considered patient-related, you usually will be given a time-frame for correcting the problems. If anything is found that the inspector considers to be harming patients, you can be shut down. Worst case, if the inspector finds problems that are endangering patients through willful neglect of regulations, you can be fined and criminally prosecuted.
Th best plan is to have a plan. A structured QA and QC plan can eliminate the worry about upcoming inspections and keep you in a state of readiness at all times.
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Re:CLIA Compliance and the Physician Lab Director – More Than a Title
Date: 2007/03/11 14:08
By: ohiomd
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I worked in a clinical laboratory at UCLA medical center and helped the person responsible for quality assurance/control in the lab. I learned from that experience the key is to be extremely organized so you are aware of when controls were tested, the results of calibrations, documentation of recalibrating of lab machines, any maintenance done on a particular laboratory instrument, etc.
She set up excel worksheets where date and times of calibrations and other information such as lot numbers of received lab reagents and their expiration date were recorded in an easily accessible format for any member of the staff to view. Another procedure done was to record any action done in a notebook with a date and signature so that staff was aware of most recent calibration date, what lot number was in current use, etc.
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Re:CLIA Compliance and the Physician Lab Director – More Than a Title
Date: 2007/03/14 21:14
By: cellcounter
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You are absolutely right. Organization is the key to success. Using a system to record information, training, etc. Standardization of practices and proper training of employees is essential.
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