Each year, new products, technological advancements, and government activity impact our laboratory businesses and patient care. 2015 will be no exception. The challenge will be to stay up-to-date on the issues. No one can keep tabs on everything; even with regular conference attendance and the best print and online resources, it’s easy to become overwhelmed and fall behind. The intent of this article is to provide a snapshot of five trends lab leaders will be tracking in 2015: IQCP, test utilization, molecular/next generation sequencing, laboratory developed tests, and test harmonization. Whether you work in a small physician office lab or a large reference center, successfully adapting to the changes will allow you to be efficient without sacrificing quality and improve the service you provide to clinicians and their patients.
Individualized Quality Control Plan (IQCP)
Of the changes that will affect your lab in 2015, this may be the one that places the greatest strain on lab resources. The Center for Medicare and Medicaid Services (CMS) introduced IQCP in 2013 as a quality control option based on risk management. By January 2016, CLIA QC compliance will require either the current daily minimum QC or implementing an IQCP. For most labs, the key 2015 activity will be to replace Equivalent Quality Control (EQC) procedures with an IQCP to allow them to continue to run QC less frequently than the CLIA daily minimums.
It’s important to note that COLA has already adopted IQCP as it stands; however, Joint Commission and CAP are developing their own requirements for IQCP, which are expected to be released mid-year.
An IQCP must include three components; Risk Assessment, Quality Control Plan, and Quality Assessment. The Risk Assessment must note areas where errors or failures could occur in the complete path of workflow and assess the potential risk for harm to a patient if an erroneous result were to be reported. It must also take into account the test assay and its clinical use. For example, an incorrect cardiac marker result will likely have a greater impact on patient care than an incorrect calcium result. Once the risks are determined, the Quality Control Plan (QCP) defines the control mechanisms for detecting or preventing errors, as well as the methodology for periodic Quality Assessments designed to ensure QCP effectiveness.
CMS reminds us that IQCP is optional and a lab may avoid the extra work that the new regulations require by reverting back to the CLIA minimum. This option may be preferred by labs with fewer instruments, where the cost of the IQCP’s increased workload may outweigh the cost savings of potentially reduced QC testing. Labs with many instruments, however, may find the potential cost savings opportunity is greater than the costs of implementing an IQCP.
The primary resource for risk-based quality control planning is the Clinical and Laboratory Standards Institute (CLSI) guideline EP23, Laboratory Quality Control Based on Risk Management (http://clsi.org/), from which the IQCP guidance was developed. Specific guidance and reference material on IQCP can be found at http://www.cms.hhs.gov/clia.
In 2015, expect to see more print and online resources and presentations focused on managing physician test ordering. Clinician orders drive the biggest variable cost for labs: test reagents. Labs are frequently frustrated by their lack of control over this significant cost and feel that they are at the mercy of clinicians who may order unnecessary tests, or order repeats too often.
There have been a number of powerful examples in the past year demonstrating how labs have realized significant cost savings by actively managing physician ordering. Johns Hopkins reported $1 million in potential savings over a twelve-month period for cardiac testing alone—just through physician education and changes in their CPOE (Computerized Physician Order Entry).1 Broward Health System (Fort Lauderdale, FL) reported saving $800,000 by creating a test formulary and instituting additional approval measures for expensive esoteric tests and send-outs.2
Henry Ford Health System (Detroit, MI) adopted a formulary approach and created a multi-disciplinary committee to review new or unusual test requests. This team approach took the onus off the laboratory and focused the group on a shared goal of determining whether the tests ordered met the clinical needs of the referring physician. The estimated cost avoidance for non-reimbursed tests ranged from $110,000 to over $3 million per year.3
In last October’s issue of MLO, Thomas Daly, Medical Director at Cleveland Clinic Laboratories, focused on the lab’s role: “The laboratory should provide mechanisms to help support clinicians in the selection, utilization, and interpretation of laboratory testing, particularly for uncommonly used tests that clinicians will have little experience with from prior use.”4 As reimbursement changes ramp up, it will become increasingly important for labs to investigate collaborative solutions for test utilization, including formularies, ordering algorithms, and CPOEs.
Molecular and next generation sequencing
Clinical laboratories must be prepared for the continuing trend toward personalized medicine and companion diagnostics. Education, in the rapidly growing areas of molecular and genetic testing, will be critical not just for the lab but for clinicians and patients as well.
Physicians may not be prepared to use the sequencing information they receive. For example, one cancer institute has offered full tumor sequencing to its oncologists for several years; however, less than one quarter of the physicians actually use this service, as they don’t fully understand the utility or interpretation of the results. Many labs adopting next generation sequencing (NGS) are finding that they need specialists in bioinformatics to help them manage and interpret the data.
The cost of NGS, and some nucleic acid-based tests, has been rapidly declining over the past decade. Given the level of capital investment and specialized staffing required, many smaller labs are preferring to wait to see if the price drops and automation improves, leaving larger labs to work out the measurement and data interpretation issues related to the new testing.
One innovative approach used by multi-lab institutions is to develop labs that specialize in a particular test methodology or test portfolio. Rather than placing new instrumentation in every lab, new instruments and tests are assigned to a single, specialized facility, thus reducing the burden of getting new tests up and running. This model could be applied in a community by collaborating to support a specialized lab to adopt new technology and provide services to other partners.
Laboratory developed tests
The Food and Drug Administration (FDA) has announced plans to increase oversight of laboratory developed tests (LDTs) and has released draft guidance for public comment. The FDA has always had legal responsibility for LDT regulation but has used enforcement discretion to limit direct oversight in the past. Now the agency has proposed that the increased regulation be phased in over a nine-year period and initially focus on tests, such as those based on genetic assessment, with the greatest risk for adverse effects on patients if erroneous results were produced. It appears that early focus may be on tests that are commercially available from referral laboratories or are being marketed outside the traditional healthcare system.
The first phase will require labs to provide the FDA with a list of current LDTs, and subsequent phases will require reporting of adverse events, documentation of quality systems and LDT performance characteristics. This proposed oversight and the ramifications of the potential policy change have already resulted in considerable political debate. While it’s unlikely that labs will see any impact in 2015, lab leaders should be following the discussion and the responses of a number of professional associations, which are using the 120-day comment period to challenge the FDA’s plans in their current form.
Patient care has become less centralized. Individuals may now receive care through multiple channels, such as their primary care physician, a specialty clinic, or urgent care. Laboratory testing can occur at any of these locations. Even within the same healthcare institution, tests may not be run in the same lab or on the same instruments. It’s easy to see how test results can vary widely, even if the patient’s state of health is consistent.
Results from different clinical laboratories should be equivalent, within clinically meaningful limits, to enable optimal use of clinical guidelines for disease diagnosis and patient management. Unfortunately, results for many laboratory methods are not adequately standardized, and this can cause decisions based on clinical guidelines to be incorrect and patients to receive incorrect diagnosis or treatment.
The International Consortium for Harmonization of Clinical Laboratory Results, organized by the American Association for Clinical Chemistry, is working to address these issues. The Consortium identifies analytes in need of harmonization and works with existing institutions to develop harmonization processes that can be used by manufacturers to harmonize their test methods. See www.harmonization.net for further information.
These are only five of the many important issues facing our profession and businesses. By monitoring these topics and others through professional societies and media resources written by qualified professionals, laboratory leaders can stay informed and be prepared for queries from clinicians or administrators. As the products, technologies, regulations, and reimbursement policies continue to evolve, the well-informed lab will be seen as a resource that adds value to the healthcare system, rather than as a cost center.
- Wike K. Johns Hopkins saves over $1 Million using CPOE. Health IT outcomes. July 9, 2014. http://www.healthitoutcomes.com/doc/john-hopkins-saves-over-million-using-cpoe-0001. Accessed December 5, 2014.
- Serrano L. Combining Test Formularies, Algorithms, and CPOE to Significantly Reduce Lab Test Utilization. Broward Health Fort Lauderdale, FL. Presentation- slide.28. http://www.labqualityconfab.com/wp-content/uploads/Serrano.Combining-Test-Formularies.pdf. Accessed December 5, 2014.
- Zarbo R, Sharma G. Coordinating clinical laboratory and anatomic pathology services in today’s integrated clinical care continuum. Henry Ford health system, pathology and laboratory medicine 2014. Presentaion-slide.39. http://www.labqualityconfab.com/wp-content/uploads/ZARBO-SHARMA.tue_.9.30am.FINAL-V3.pdf. Accessed December 5, 2014.
- Lenhoff A. Cleveland Clinic Laboratories provides a wide variety of tests to meet labs’ reference needs. MLO. 2014;46(10):48.