The Case for a Laboratory Quality Team

Maintaining a high level of quality is one of the primary goals of U.S. clinical laboratories. Sustaining quality is especially crucial during the often tumultuous and seemingly uncertain times that accompany hospital and healthcare systems mergers. According to an analysis by Kaufman Hall, there were 27 hospital and health systems mergers in the first quarter of 2019, representing revenue of $4.9 billion.  Mergers, acquisitions, and growth can be disruptive activities affecting finances, daily operations, and employee morale.

The majority of hospitals and healthcare delivery organizations have a quality department. However, the department is more often focused on the tasks and activities occurring outside of the laboratory. Furthermore, many hospital quality departments consist mainly of nursing or other clinical staff types and lack laboratory representation.

Often, despite the importance of test data, the laboratory’s role in a hospital’s quality department is usually limited.  If the laboratory is involved, it is frequently because a test result may have been involved in an event. Few hospital quality departments directly employ laboratory professionals.

Clinical laboratories must adapt to healthcare organization changes while simultaneously continuing to meet regulatory and accrediting standards. How can a laboratory ensure the changes do not affect the quality and remain “inspection-ready?” How does a large healthcare system standardize quality across multiple laboratories? The answer is a Laboratory Quality Team.

Laboratories are complex and highly regulated operations that must meet CLIA regulations and specific accrediting standards. A laboratory quality team comprised of seasoned laboratory professionals provides the healthcare organization with in-depth laboratory operations experience, real-world quality control knowledge, and practical understanding of regulatory and accrediting standards.

Another great benefit of a laboratory quality team is that their primary focus is on monitoring and maintaining quality in the laboratory. This benefit includes the ability to conduct root cause analyses (RCAs), reviewing and ensuring validation of new tests and instrumentation, and conducting internal audits.

The value of having a dedicated laboratory quality team is readily apparent in mergers, especially when one of the goals of the merger is to streamline processes, standardize operations, and reduce waste.  A laboratory quality team is a perfect tool to conduct a gap analysis between different laboratories to determine the best and most cost-effective processes and procedures to retain.

A dedicated laboratory quality team is an invaluable asset for a healthcare organization operating multiple labs (particularly those in different states). The team can organize and coordinate quality-related activities and performance improvement initiatives. Assessing the level of compliance across laboratories and preparing compliance-related reports would be a primary responsibility of these individuals. The team would also be directly involved in developing, revising, and validating laboratory quality administrative policies and procedures.

As an outcome of new knowledge and scientific breakthroughs, laboratory accrediting bodies are continuously updating standards governing laboratory operations. A laboratory quality team can research and provide clarity on regulatory mandates and accrediting standards. The team can also be a resource on how changes in standards may affect laboratory operations and evaluate whether current procedures or processes need to be updated or eliminated.

Customer service is an essential aspect of laboratory operations. Beyond patients, laboratories serve physicians, nurses, and other healthcare providers. The laboratory quality team can represent the lab when interfacing and collaborating with leadership, interacting with medical and laboratory staff, and is especially suited to interact with lab inspectors.

The laboratory quality team’s minimum qualification should be a bachelor’s degree in a physical, chemical, biological science or medical technology and at least two years of clinical lab experience. However, a more robust set of qualifications would include experience as a clinical laboratory inspector, additional auditor certification (for example, those offered by the American Society of Quality), and personality and skills geared toward researching, learning, and presenting.

Mergers, consolidations, and acquisitions will continue in the healthcare industry as the marketplace environment challenges organizations’ bottom-line. Laboratories are an integral part of hospitals and other healthcare organizations seeking to deliver high-quality services to the community. Lab administrators and managers need to adapt operations while sustaining a high level of quality. A laboratory quality team composed of seasoned, knowledgeable, and motivated professionals can help laboratories navigate the inevitable regulatory, accrediting, and personnel changes unavoidable in the dynamic healthcare industry.

-Darryl Elzie, PsyD, MHA, MT(ASCP), CQA(ASQ), has been an ASCP Medical Technologist for over 30 years and has been performing CAP inspections for 15+ years. Dr. Elzie provides laboratory quality oversight for four hospitals, one ambulatory care center, and supports laboratory quality initiatives throughout the Sentara Healthcare system.

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