Evaluating the Effects of Regulatory Agencies on the LIMS ( Laboratory Essay

Evaluating the Effects of Regulatory Agencies on the LIMS ( Laboratory Information Management System ) - Essay Example tion, meets the standards set, notably CMS Regulations Part 493 Sub-part K, Clinical Laboratory Improvement Amendments of 1988 (CLIA), and OSE Manual of Policies and Procedures (MAPP) 6700.2. In terms of information security, both agencies will be expecting to be satisfied that the requirements of CMS Regulations Part 170, regarding Information Security, have been met. In practice, Part 170 simply reflects ICT industry standard practice, so providing that the laboratory meets these industry standards, both agencies will be satisfied. In areas specifically involving pathology, a given LIMS implementation will also need to be approved by the College of American Pathologists (CAP). CAP regulators will expect that the LIMS implementation will meet their approval in four key areas: discipline, equipment manufacturer, specimen type and method of analysis. CAP inspections must be regarded as additional to the CMS and OSE inspections and compliance defined below. When examining the exchange of electronic health data, the Federal Regulators will be looking for the use of logical observation identifiers names and codes (LOINC) naming conventions. In order to facilitate the exchange of electronic clinical data between the LIMS being examined and other LIMS implementations, the Regulators will be checking for the use of systematized nomenclature of medicine clinical terms (SNOMED), as defined for specific U.S. applications by the CMS, FDA and, where relevant, CAP. All LIMS Implementations must meet the Centers for Medicare and Medicaid Services (CMS) Regulations Part 493 Subpart K - Quality System for Nonwaived Testing. This means each LIMS implementation must include as a minimum the following. Establishing and following policies and procedures for monitoring, assessing, and, when indicated, correcting problems identified in the general laboratory systems requirements specified in CMS Regulations Part 493 Subpart K that apply to the laboratory in