Can you relate to this story that you are about to read? Has your laboratory experienced anything similar, or your employees struggled the same way as Sam? Food for thought...
Sam is a long-standing laboratory director with over 20 years of experience. He prides himself on creating a culture of continuous improvement that sustains high quality, reliable and timely patient care. While his position is very demanding, he remains calm under pressure and worry-free while being approachable and happy to assist at all times. However, it wasn’t always this way…
A day in the life of Sam…
Several years ago, Sam found himself stretched to the limit every day, continuously stressed and constantly worried about the effectiveness and quality provided by his laboratory. He’d lay awake at night burdened by endless questions:
Had he successfully assessed all risks, the potential for harm and how to avoid it?
- Was he routinely reviewing quality control and quality assessment activities to ensure that problems were identified, corrected and monitored for effectiveness and timeliness?
- Could he be sure that the quality assessment activities had a mechanism for complaint resolutions whether from the staff or customers?
- Were accreditation protocols being followed?
- Was there a mechanism in place for effective communication between management and all personnel?
- Was the staffing level adequate and were they reading new documents and up to date with competency training?
- Were non-conformities being reported?
- Was there any unresolved CAPAs? How many?
- Did he check the papers on his desk that had been there for the last 3 days? Was there anything related to quality compliance there? How about unchecked emails?
And many more…
The day that changed it all for Sam…
It was a day like any other day for Sam, except that a single error in judgement had occurred and unfolded into a catastrophic event. This error evolved into a series of events that would lead to a major threat to the laboratory business and compromise the integrity and trust held for the organization.
It all began with the laboratory receiving five samples from one of its Patient Service Centres, requiring testing for Gastrin. As per standard operating procedures (SOP’s), the specimens were required to be shipped, transported and arrive frozen. Unfortunately, upon receipt by the laboratory they were still cold but not frozen. As directed by the supervisor, the specimen handlers were instructed to re-freeze the cold samples and proceed with processing and testing, despite the obvious non-conformance with the SOP’s.
One of the physicians who ordered the gastrin test questioned the result she received. While the Laboratory Manager scrambled to try to find out what may have gone wrong with this test, a staff technologist who knew what had happened, reported the incident to the regulatory authorities. And so, Sam’s spiral of stress and concern about the laboratory’s risk management and quality control programs came full circle.
The next day, just after Sam received the employee incident report, a team of inspectors from the accreditation body arrived at the laboratory unannounced to perform a spot inspection. For three days they scrupulously examined all laboratory processes and documentation, including full inspections at several Patient Service Centres. Their non-conformity findings were catastrophic, eye-opening and numerous, 200 to be exact.
As the Laboratory Director, Sam was given five days to take corrective action on 76 major non-conformances, which would result in the laboratory's accreditation to be withdrawn if not corrected.
The change that made the difference…
The first thing that Sam did was to commit to taking immediate action. The entire organization pulled together to immediately correct the major non-conformances within the 5-day deadline and prevent the loss of their accreditation.
The effort and stress to meet this threat took its toll on Sam and his staff. How could he prevent future events such as this and sustain the corrective actions necessary to protect the organization? Sam decided to contact Omnitech Innovations to discover how the Omni-Assistant software could assist them with solutions for the many challenges they faced and manage going forward to sustain a high level of Quality, Compliance and Risk Management.
Bolstered by the Omni-Assistant software solutions and benefits, Sam convinced his team to begin the quality management digital journey with him.
Today, Sam is always up-to-date and in-the-know reassured that they are proactively evaluating risk and implementing necessary precautions to reduce the potential for harm. Not only are they exceeding standards, but also solving problems proactively, enjoying their digital journey and implementing processes for analyzing workflow and continuously improving upon them.
Sam, his staff and the laboratory benefited immediately from the many features of the Omni-Assistant software including:
- Digitalization and automation of all their clinical documentation – allowing for anytime, anywhere secure access and significant reduction in paper process.
- Super-efficient Risk Management Assessment tools
- Greater uniformity and extraordinary quality with automated “Big 6”
- Major time savings and improved resource utilization management
- Complete control over department compliance processes and staff training
- A more effective correction and prevention system
- Increased process improvement efficiencies
- Enhanced quality and reduced errors
- Full transparency knowing what’s going on in the lab, including tracking of all samples from point of collection to disposal
- Enhanced vendor management to service the needs of the laboratory with suppliers and service providers
- Planning and prioritizing projects utilizing information based on the CoPQ (Cost of Poor Quality) to achieve potential cost savings immediately along with 12 months projection
… and as for Sam – no paper on his desk
Most importantly, Sam knows they are Inspection Ready @ All times.
… And you…. What type of director are you? One of those who are content with the status quo or one of those like Sam, who realizes the potential and benefits that can be realized and contacts Omnitech Innovations.