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Evaluating the Effects of Regulatory Agencies on the LIMS ( Laboratory Information Management System ) - Essay Example

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A LIMS Application being implemented within a given Laboratory must first and foremost, throughout all the medical specialisms practised by that Laboratory, must meet the Centers for Medicare and Medicaid Services (CMS) Regulations Part 493 Subpart K - Quality System for…
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Extract of sample "Evaluating the Effects of Regulatory Agencies on the LIMS ( Laboratory Information Management System )"

Download file to see previous pages ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified in all relevant Paragraphs within CMS Regulations Part 493 Subpart K that apply to the laboratory in question. This means that the LIMS implementation will need to provide a Quality Assessment (QA) module that provides functions, that must, when requested by the CMS and other U.S. Federal Medical Regulators, provide Verifiable Demonstrable Evidence (VDS) in the following areas.
An ongoing review process that encompasses all facets of the laboratory’s technical and non-technical functions and all locations/sites where testing is performed. QA also extends to the laboratory’s interactions with responsibilities to patients, physicians, and other laboratories ordering tests, and the other non-laboratory areas or departments of the facility of which it is a part.
When the laboratory discovers an error or identifies a potential problem, LIMS must allow strong remedial actions to be taken to correct the situation. This correction process must involve identification and resolution of the problem, and development of policies that will prevent recurrence. Policies for preventing problems that have been identified must be formally recorded as well as communicated to the laboratory personnel and other staff, clients, etc., as appropriate.
The LIMS implementation should (that is to say, good practice, but not a legal requirement) provide a facility to monitor the type and number of complaints received by the laboratory such as, for example, a particular client continuously complaining about the laboratory’s failure to promptly respond to STAT test requests. The laboratory must possess and be able to demonstrate to CMS etc, inspectors
A facility to review of the effectiveness of corrective actions taken to resolve problems, revision of policies ...Download file to see next pagesRead More
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