Pre-analytical errors: working with manufacturers to help improve quality

Feb. 16, 2014

Laboratory medicine is integral to clinical decisions, providing healthcare professionals with information for prevention, diagnosis, treatment, and management of patients’ health. Up to 60% to 70% of all medical decisions are based on laboratory testing results.1-2 But errors occur in clinical laboratories—often in the pre-analytical phase. Laboratory professionals can reduce the frequency of errors by aggressively investigating their causes. In the pre-analytical phase, as in all phases, working with the applicable product or service manufacturer(s) can be an important part of helping to ensure that the error is not repeated.

When an error occurs in the clinical laboratory, a complaint registered with the applicable product or service manufacturer(s) can be an opportunity to gain needed support and information to help resolve the error. This support and information from a manufacturer is a valuable tool for the laboratory in finding the solution to an error that can, in the long run, help contribute to the laboratory’s overall continuous quality improvements.

Handling customer complaints

In the context of the Affordable Care Act, the focus on healthcare providers is the quality of care provided. We are switching from pay-for-volume, paying for each procedure and each test, to paying for value.3 For the clinical laboratory this will result in testing reimbursement as part of a bundle payment that is part of a patient’s care as opposed to payment for the laboratory on every test run, as in the pre-ACA era. This focus on quality places additional and new pressures on clinical laboratories that have seen operating budgets cut and flat reimbursement payment rates.

Though clinical laboratories have new quality-related mandates that they must adjust to in order to help improve patient outcomes and patient care, medical device manufacturers already have the quality-related requirements to handle customer complaints in place. Clinical laboratories should appreciate the processes manufacturers have established over the years as an opportunity to help them with their quality-related errors through the manufacturer’s Handling Customer Complaint processes.

When an error occurs and laboratories are investigating root causes, the product(s) used may be part of the investigation. If the laboratory suspects product performance may have contributed to or caused an error, the laboratory is responsible for contacting the manufacturer.

Product complaints for medical devices are regulated by the Federal Drug Administration (FDA). Manufacturers’ Quality System must be in compliance to address medical device users’ complaints per Code of Federal Regulations, Title 21, Part 820 (Quality System Regulation), Section 198 (Complaint File); cited as 21CFR820.198.

A product complaint is any indication of the failure of a device to meet customer or user expectations for quality or to meet performance specifications. Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications is subject to the provisions of 21CRF820.198.4

After contacting the manufacturer, a laboratory should expect its complaint to be reviewed, evaluated, and investigated if required per established, written operating procedures covering the handling of a customer complaint. The FDA allows manufacturers to decide the method for handling customer complaints that meets the company’s functional and economic resources, and is fully integrated into the Quality System. The FDA does require manufacturers, under their current Good Manufacturing Practices (cGMP), to document, review, evaluate, and file all complaints; formally designate a unit or individual(s) to perform these activities; determine if (after review) an investigation is necessary; record the reason if no investigation is made; assign responsibility for deciding when not to investigate; and determine whether the complaint requires a Medical Device Report (file to the FDA).4

Laboratories should know that their complaints to a manufacturer cannot be ignored and understand that by logging a complaint they are providing manufacturers feedback on possible issues with product use, design, or production. By evaluating and analyzing a complaint, manufacturers can determine if the complaint is valid and, if valid, the cause and corrective actions. Complaints are also a means of trend analysis that help a manufacturer to monitor the performance of its product and manufacturing processes. Complaints reported back to customers as not valid are equally informative for a laboratory in the investigation of its error, providing them with information that can allow for concentration on other possible causes.

Manufacturers are required under 21CFR820.25 to ensure that the designated personnel are adequately trained and have the proper education in handling the laboratory’s complaint.4 Trained personnel are vital to gathering all the information needed from the laboratory in order for the manufacturer to process the complaint. Personnel may ask a series of questions of the laboratory, some of which may at first glance seem trivial and burdensome to answer; but the information gathered will be critical in accomplishing a successful complaint evaluation.

Trained manufacturer personnel need not only understand the environment/application in which the laboratory uses the product but also be versed in the manufacturing processes of the product. This dual understanding allows the manufacturer to work with the laboratory to create a cause-and-effect analysis of an error.

Medical device reporting

A critical component of the manufacturer asking the laboratory questions is to determine, if it is not stated as part of the complaint, whether the event must be filed with the FDA as part of Medical Device Reporting (MDR). Manufacturers are responsible for making sure the designated person(s) or unit is able to recognize what may need to be reported to the FDA.4 Safety and effectiveness are designed, validated, and verified in all medical devices and the processes. When an adverse device-related event occurs, such as patient death or injury, because of potential device malfunction, manufacturers must gather all related information on the event, within a specific time, to complete the necessary evaluation. Upon gathering all information from the laboratory, the manufacturer will evaluate and analyze the information to determine the proper reporting to the FDA.

After the manufacturer has completed its evaluation and, if required, investigation, a response statement to the customer must be recorded. Manufacturers should send a reply to each complaint as a courtesy, but more important to prevent reoccurrence.4 If the manufacturer determines that the complaint is caused by incorrect use of the product, as opposed to product malfunction or a product out of specification, the customer needs to be advised by the manufacturer to help prevent recurrence. The manufacturer should determine if the customer has proper training with respect to the device use per the product labeling (labeling includes all instructions for use and supporting materials relating to product claims). The manufacturer should confirm that the customer has all current product labeling on file for its reference. Manufacturers that maintain their product labeling information on their company website provide customers with an additional tool for access to resources.

The laboratory’s use of a manufacturer’s complaint-handling process is a means to communicate potential product issues for the manufacturer to investigate. Product complaints are data that can help manufacturers to improve. Manufacturers recognize that continuous improvements can lower the probability of complaints. Conversely, laboratories have the opportunity to use the manufacturer’s complaint process to confirm and eliminate potential root causes in their own cause-and-effect analysis of laboratory errors.
One recent case in point involved a laboratory’s input to a manufacturer in addressing hemolyzed serum samples. A European manufacturer with a special 3-in-1 product for its plasma customers heard the clinical laboratory’s hemolysis complaints. Numerous draws were found to be needleless in-line. Literature addresses all potential causes and solutions, but one cause not easily addressed was the blood flow velocity. The laboratory and manufacturer listened to one another and provided information to one another, and this greatly helped to address the complaint. The manufacturer’s 3-in-1 holder system was purposed to help slow the blood velocity, resulting in reduction of hemolyzed serum samples.

Customer service studies show that 88% of companies believe they provide their customers with superior support and service, yet only 8% of customers believe the same companies provide such support and service.5 When laboratory customers communicate their complaints, manufacturers have an opportunity to help them with their continuous quality improvements as they relate to patient care—and to improve their product/services in order to gain customer loyalty.

Greiner Bio-One

Kevin Daugherty has more than 20 years of experience in medical device manufacturing, covering Vascular and Clinical Laboratory product management and product applications. Currently, he serves as the Director of Technical Service for Greiner Bio-One North America, Inc.


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  4. Medical Device Quality Systems Manual: A Small Entity Compliance Guide. Medical Devices, Chapter 15. Complaints. U.S. Food and Drug Administration website.
  5. Help Scout. Infographic: what is bad customer service costing your business? Accessed January 2, 2014.