VALIDATION STANDARDS
pharmacy and pathology services need to be prepared. ‘Inspection-ready’ is the mantra used within the blood transfusion service. Therein lies a common problem. Many hospitals have not maintained sufficient validation evidence to demonstrate to the MHRA that the hospital services have addressed all patient safety concerns. Indirect patient harm also presents a huge risk to accountable healthcare providers. I will give you an example. If an order communications solution (OCS) goes live after minimal validation is undertaken at the testing stage, and following the launch a messaging error is identified, then the healthcare provider is exposed to potentially huge errors. In the case of LIMS messaging, the wrong test result could be assigned to the wrong patient, misinforming the clinician of the patient’s condition, which could lead to an ill-informed course of treatment. In theory that should never have been allowed to happen because it should have been identified through testing. But if testing has been compromised and shortened, then the likelihood of identifying these errors increase.
Lack of validation also affects the patient experience. In the example above the patient could have been unnecessarily admitted into hospital disrupting their daily lives. Despite the driver for the introduction of many IT systems being to achieve service efficiencies, errors such as these undoubtedly cost the NHS far more in resources.
My fear is that there are so many competing priorities and pressures when working on digital transformation that not enough time, focus and preparation is afforded to ensuring that systems meet the highest level of scrutiny for safety.
Ensuring clinical standards through digital transformation
Anyone looking to raise the standards of CSV across their services should start to apply these five actions into their organisations immediately.
1. Better manage validation during IT implementations. The best way to achieve successful validation is to get advanced agreement from project teams on the gateways and milestones which must be validated before moving on to the next stage of the project. Some IT suppliers manage the process really well because it is within their interest to ensure that they receive full sign off by the healthcare provider before proceeding to the next stage, but I have seen instances where the supplier has not been candid enough to insist that validation is complete before advancing.
2. Take a proactive approach to validation. Prevention rather than cure - a sentiment
of the NHS Long Term Plan – also applies to CSV. They’re already so many pressures on our under-resourced health service that trying to retrospectively validate system safety, in the face of an impending regulatory inspection, only wastes more precious NHS time and money. With the additional (and unnecessary) stress, tension and pressures on healthcare teams it is also not good for morale. To ensure compliance is maintained and risk is managed, we strongly recommend you review the current CSV evidence of your systems. I understand that is easier said than done, but there are some useful tools openly available such as the GaMP (prescribed methodology) and V-Model frameworks (validation framework) which will help to put in place a risk-based approach to validation with documented justification for decision influencing validation.
35 YRS LEAK TEST AND MANUAL PRE-CLEANING TRANSPORT
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