reasonable assurance

reasonable assurance

A term used in the context of inspections of a UK hospital trust by the Care Quality Commission (CQC), reasonable assurance is, by definition, neither absolute nor assumed, but based on documentary evidence that can withstand internal and external challenge.

In determining what level of assurance is reasonable, trusts must recognise that the core standards are not optional and describe a level of service that is acceptable and universal. The CQC expects a trust to comply with the core standards, which will be managed through the trust's routine processes for assurance. A Trust’s boards should consider all aspects of their services when judging whether they have reasonable assurance that they are meeting the published criteria for assessment. Where healthcare organisations provide services directly, they have primary responsibility for ensuring that they meet the core standards. However, the Trust’s responsibility also extends to those services that they provide via partnerships or other forms of contractual arrangement—e.g., if human-resource functions are provided through a shared service. If such arrangements are in place, the organisation should have reasonable assurance that those services meet the requirements of the standards.
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References in classic literature ?
Only toward the east, through British East Africa, lay reasonable assurance of freedom.
They would have baffled an ordinary man; but the ape-man, accustomed to climbing, saw several places where he might gain a foothold, precarious possibly; but enough to give him reasonable assurance of escape if Numa would but betake himself to the far end of the gulch for a moment.
The medicine he made was not good medicine, for though Momaya paid him two goats for it, it did not bring back Tibo, nor even indicate where she might search for him with reasonable assurance of finding him.
Anyone investing in the refinery would need reasonable assurance that there will be demand for the economic life of the investment," said Pradhan.
Peter Bucks, who led the review, said a flight protection scheme would create a "level playing field for all UKoriginating passengers, providing reasonable assurance of repatriation protection whether or not they hold an Atol [Air Travel Organiser's Licence Certificate]".
The FDA advised the Company that its PMA supplement lacked information, particularly the clinical evidence and analysis, that would permit the completion of the review and determination of whether there is a reasonable assurance of the device's safety and effectiveness for its intended use.
In addition, petitioners successfully establish traceability and redressability given that we could vacate the board's decision and determine that its decision was not based on a reasonable assurance and instead was arbitrary and capricious.
"I am satisfied that the council has in place a satisfactory framework of governance, risk management and internal control which provides reasonable assurance regarding the economic, efficient and effective achievement of its objectives," she said.
Based on new information, the FDA has found sufficient information exists to establish special controls that, together with general controls, can provide a reasonable assurance of safety and effectiveness for sharps needle destruction devices.
The agency said it became aware that some women were not being fully informed of these risks tied to Essure, "despite previous significant efforts to educate patients and doctors about the risks associated with this device." So, it has decided to "impose additional requirements needed to provide a reasonable assurance of its safety and effectiveness."
Truly high-risk devices, in which insufficient information exists to determine whether general and special controls are sufficient to provide reasonable assurance of the product's safety and effectiveness, follow the PMA pathway.
The misconduct relates to three audit areas, and included failures to obtain reasonable assurance about whether financial statements were free from material misstatement, failures to obtain sufficient appropriate audit evidence and failures to exercise "sufficient professional scepticism".

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