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ISO 15189:2022 Medical Laboratories Requirements for quality and competence Clause 5.5 is Objectives and policies. The standard requires that "The laboratory shall establish quality indicators to evaluate performance throughout key aspects of pre-examination, examination and post-examination processes and monitor performance in relation to objectives" Quality indicators are measurable parameters that are used to assess the performance and effectiveness of the laboratory processes. What is the importance of quality indicators in clinical laboratories? *Improve realibility and confidence of the laboratory *Improves patient safety *Encourages continuous improvement *Increase efficiency by cost saving *Compliance to standards and accreditation requirement Some of the key quality indicators in the laboratory include 1. Turnaround time (TAT) 2. Quality Control (IQC/EQA) performance 3. Sample rejection due to haemolysis, wrong tube, inadequate sample, unlabeled/mislabeled samples 4. Critical value reporting 5. Corrected/amended reports Remember 😊 The laboratory should come up with quality indicators that are specific and measurable and can evaluate all the three phases of testing. Timely review of the quality indicators helps the laboratory to come up with corrections and corrective actions to improve performance.

🔬 Excellence in Every Test: Mastering Accuracy and Reliability Through Quality Control🔬 In the world of diagnostic testing, precision is critical. At Unitas Diagnostics, we implement rigorous quality control measures to guarantee the accuracy and reliability of every test result. From detailed Standard Operating Procedures (SOPs) and internal quality controls to regular equipment calibration and adherence to regulatory standards, our commitment to excellence drives every aspect of our operations. 📈 Key Practices We Follow: Rigorous Testing Procedures: Standardizing methods and validating new tests. Regular Calibration: Ensuring equipment accuracy and preventing drift. Compliance with Regulations: Meeting and exceeding industry standards. By maintaining these high standards, we not only uphold the integrity of our results but also support exceptional patient care. Discover how these practices make a difference in our latest blog post. https://lnkd.in/gTHwYCg2 #DiagnosticTesting #QualityControl #HealthcareExcellence #LabStandards #PatientCare

Have you ever wondered about the likelihood of receiving a 483 Observation (aka finding/nonconformance) during an FDA Inspection? I recently came across this question and decided to dig into the data to find some hard facts. According to data from datadashboard.fda.gov (Inspections), the probability of receiving a 483 observation at the end of an FDA Inspection for Medical Device companies is approximately 50%. (higher or lower than you anticipated?) The reasons for receiving a 483 observation during an FDA Inspection can vary depending on the effectiveness of your people, processes, and systems. Typically, these observations can be categorized into two main areas: (1) inadequate translation of requirements into procedures and (2) lack of adequate evidence to demonstrate compliance with established procedures. Ensuring that you have qualified resources in place and fostering a strong quality culture within your facility can help promote compliance and reduce the chances of receiving 483 observations during FDA Inspections. Now, here's a question for you: How do your company's results compare to the industry average? #dataanalytics #fdainspection #483Observations

Internal Quality Control (IQC) has long been a cornerstone of laboratory quality strategies, yet it comes with limitations and costs. A recent study by Yan Zhang, Hua-Li Wang, et al. explored the potential of Patient Data-Based Quality Control (PDB-QC) using serum potassium concentrations as a benchmark. 🔍 Incorporating PDB-QC into laboratory practices can enhance the detection of systematic errors more efficiently and promptly than traditional IQC methods, although it is less effective for random error detection. ⛔ By leveraging patient data, labs can improve accuracy and reduce costs, ultimately leading to better patient outcomes. 🌟 Full article is available on the following link: https://lnkd.in/dH7qe4ue #QualityControl #Healthcare #PatientData #ClinicalChemistry 

The receiving of a 483 does not directly correlate with noncompliance or nonconformity to regulations. What is on a 483 is an observation from the investigator. It can or cannot be a deviation from regulation. Yes supported by compliance review or not supported. Depending on the investigator experience and knowledge which can and does vary to the point of writing it on a 483 and that’s where it stays. If an error or non compliance supportable observation is written on a 483 Noice of observation rarely is there a retraction done by the agency unless there is a written follow-up which again rarely happens especially in a VAI classification on the particularly iffy item. . That said getting a 483 especially "low hanging” fruit is not that bad. At times getting a multi page with minor deviations given by a a-retentive soul because he/she likes to make a federal case out of everything and prefers the imortalization on the 483 vs. the EIR. In fact it is preferred over one single citation that is high risk regulatory and consumer high risk that can result in a Warning Letter plus recall etc. The approximate 50 percent chance is average in just getting a 483, again interpreted by issues that you have many investigators who do not like walking out of an inspection without issuing a 483 and many supervisory investigators who don’t like to see one of there own spend multiple days at a site and not "even issue” a 483. Bottom line not all 483s are created equal just like the creators.

Valuable insight!

Having trouble with your medical device technical documentation? LFH Regulatory identified the most common mistakes companies make that delay market access. As regulatory experts, we see these issues all too often – disorganised files, outdated information, unclear intended use, insufficient clinical data and more. These problems lead to longer review times, additional questions from notified bodies, and ultimately delayed patient access. We've put together a straightforward blog post outlining the top pitfalls and how to avoid them. It covers: ✅ Structuring your technical file in a clear, logical way ✅ Maintaining and updating documentation throughout the product lifecycle ✅ Defining the intended use and indications for use ✅ Ensuring robust clinical evaluation data ✅ Following current risk management standards ✅ Meeting post-market surveillance obligations Take the guesswork out of creating compliant, effective technical documentation. Read the full article: https://lnkd.in/eaFf-e32 #Invitro #Regulatory #Consultancy #MedicalDevice #InvitroDiagnostics #YorkshireBusiness

What is the impact of having non conformances? Non-conformances (NCs) and reports (NCRs) are critical for medical device manufacturers. They affect CE marking, costs, penalties, and potential recalls. These issues directly impact the Quality Management System (QMS), potentially risking patient safety and care quality. ✴️ Identify, Manage, and Improve ✴️ Effectively identifying and managing non-conformances is essential for preventing faulty devices and ensuring continuous improvement. Establishing robust procedures and efficient handling/reporting mechanisms is paramount to minimising disruptions and enhancing product quality. https://lnkd.in/e4GrtB-q #MedicalDeviceQuality #ContinuousImprovement #PatientSafety #medicaldevice #continuousimprovement #devicemanufacturers #cemarking #ncr #qualitymanagement #managementsystem #qualitymanagementsystem #mdr #technicaldocumentation

#ISOLATORS: #QUALIFICATIONS AND #MAINTENANCE #CLEANROOMS, CONTROLLED ENVIRONMENTS & #CONTAINMENT LABORATORIES Download this Valuable guide free in pharma and medical resources courses and events group 👇👇👇👇 😎 https://lnkd.in/eUXFKGY2