Tuesday, February 18, 2020

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

Monday, February 3, 2020

Auditing Essay Example | Topics and Well Written Essays - 1500 words - 1

Auditing - Essay Example In fact seasonal interruption are routine and regular and even after such interruptions business continue in normal course and thus entities pursuing seasonal business may be called going concern despite periodic seasonal interruption In this write up the issues relating auditors’ responsibility to assess the substantial doubt arising out of normal auditing procedures is considered in order to produce independent and effective reporting to the stakeholders. The assumption under the concept of going concern is continuity in normal course and such â€Å"continuity of entity operations is usually assumed in financial accounting in the absence to contrary† (Michael J Ramos, page 285)ii Auditors assess the going concern concept whenever substantial doubt is created while following regular and normal audit procedures.†If there are no doubt neither directors nor auditor need refer specifically to going concern in the financial statements or audit report. However, the Combines Code states that directors should report that the business is a going concern with supporting assumptions and qualifications as necessary. â€Å"(Lain Gray and Stuart Manson, page 674)iii Going concern concept assumes an atmosphere of normalcy. Under the going concern concept â€Å"the enterprise will continue in operational existence for a foreseeable future.† (Nexia International, page 137)ivWhenever auditors have substantial doubts about the going concern concept it underlies that financial statements have not been prepared under normal circumstances. This is because â€Å"the going concern concept is unlikely to be compatible with the intention or necessity to enter into a scheme of rearrangement with the company’s creditors, or make an application for an administrative order, or place the company in administrative receivership or liquidation.†(Saleem Sheikh and William Rees, page 349)v In other words results or status shown by