Hello! Welcome to the Improov Weekly Blog where we will discuss all issues related to the laboratory profession, from initiating testing to accreditation preparation; from automation to customer service; from personnel competency to inventory control; from quality assessment to competency assessment. Every issue related to achieving and maintaining a successful laboratory operation will be discussed. All suggestions for blogs are welcomed!

The roles and responsibilities of the clinical laboratory have never been more prominently on display than during the COVID19 pandemic. Much of the coverage has focused on pre-and post-exposure antigen and antibody testing, monitoring treatments provided to COVID patients, and following post-infection syndromes.

Our laboratories have been able to meet these and other challenges due to a combination of dramatic advances in diagnostic laboratory technology, including PCR (Polymerase Chain Reaction) testing, as well as advances in digital technology, reducing the turnaround time for reporting laboratory results, and enabling physicians to provide the level of care demanded.

Even before the pandemic, the laboratory had already become “information central” within the greater healthcare environment. Accurate and timely laboratory results are integral to making informed clinical decisions on disease prevention, diagnosis, treatment, and management. Clinical information provided by the laboratory also plays a critical role in the determination of public health policies.

The laboratory profession will continue to grow in importance and provide timely clinical information by embracing the new challenges and opportunities presented by these rapid technological advances. Laboratories will also have to adapt to new demands by the public for access to personal information, and the increased expectations of clinicians for new testing capabilities.

Challenges for Clinical Laboratories

Management and Operational:

· Meeting the demand for new diagnostic services from the laboratory that may require changes in laboratory organization and communication, including workflow, scheduling, reporting policies, data generation, transmission, and storage

· New personnel requirements to ensure a competent trained workforce to meet these challenges

· Integration with HR on personnel policies affecting recruitment and retention, including expectations of hybrid or work from home accommodations when possible

· Expanded relationships with other healthcare providers and support personnel

· Increased direct interaction with an empowered public

· Keeping up with Federal and State regulatory changes

· Supply chain issues affecting inventory

Technological

· Investing in Systemic Automation: The integration of new testing methodologies, advanced laboratory information systems, and digital reporting to create the “data central” model for integrated healthcare organizations.

· Monitoring Point of Care Testing: Emerging technological innovations in healthcare, including smartphone apps, biosensors, lab-on-a chip, and wearable devices, have made Point-of-Care Testing (POCT) part of the transformation of the healthcare landscape. Personnel training is a special challenge as POCT errors occur primarily in the analytic phase of testing. This means that all Point of Care Testing personnel must be properly trained, and have their competency periodically assessed, even if all their testing is waived.

· Adopting Molecular Diagnostic Testing: Rapid advances in the areas of molecular-level and genetic testing are dramatically changing clinical practice. New testing techniques are more sensitive and specific, allowing clinicians to detect, diagnose, and manage disease more effectively than ever before. Technologies that analyze DNA, RNA, and protein composition evaluate disease at the molecular level, permitting earlier detection and a more personalized approach to patient care.

Opportunities for Laboratories as Data Central for Healthcare

Within integrated healthcare network organizations, such as ACO and PCMH

Through the deployment of a robust connectivity system, laboratories have the ability to streamline physician office workflow, receive test orders and return results to a variety of EMR systems in real time, and play an essential role in building physician relationships. Benefits include enhanced laboratory order accuracy, more complete patient and billing information, improved revenue collections, and better patient outcomes.

Expanded opportunities for consultation by laboratory professionals

Pathologists and laboratory professionals are recognized as qualified to assist in the development of clinical pathways and clinical decision support software to guide physicians in test selection. The effective use of such resources is essential to the achievement of quality patient outcomes. It is critical that laboratory directors, and other laboratory professionals promote the value of their laboratory services and the key role of the laboratory in ensuring that an accurate diagnosis is established early in the continuum of care, and that timely clinical information is available to coordinate the course and cost of care.

Expanded Roles for Clinical Consultants

While laboratories have always provided guidance and interpretations of test results when requested by ordering physicians, the growing complexity of laboratory medicine has now created the need for a more proactive role, properly filled by Clinical Consultants. It is the Clinical Consultants who combine the expertise of a laboratory professional with the knowledge and experience of a clinician to assist the ordering physician with the most appropriate interpretation and application of the test results for specific patients.

Conclusion

The practice of laboratory medicine and the ability to deliver quality patient care is being transformed by the intersection of technological, societal, and economic changes. At the center of this is the clinical laboratory professional, whose work environment is changing at dizzying speeds: always new tests, new instruments, new methodologies, new information systems, new performance requirements, new workplace rules, and new expectations. Often, these are followed by revised regulatory standards.

Laboratory professionals, accustomed to rapid change in terms of the test menu and instrumentation, are now seeing rapid changes in how test results are handled. This includes not only the reporting, storage and transmission of test data, but also the increased use of mobile technology that gets these results to physicians and patients at their convenience, anytime, anywhere. Laboratories are also impacted by the increasing variety of tests that are offered in non-laboratory (“Retail”) settings, such as pharmacies, airports and malls; and the issues of ensuring competent testing. Changing concepts of patient rights means increased demand for patient ordered testing, and test result interpretation.

The role of laboratories as data central for patient diagnosis and care elevates laboratory professionals to equal partnership in patient care alongside the medical professionals who have direct patient contact.

Improov blog is written by Irwin Z. Rothenberg