| Monday, January 01, 0001
Many factors should be considered when deciding whether to implement a new test or change testing methodologies in your medical practice.
Streamlining operations while maintaining the highest quality of services provided will result in a more efficient practice, whether the operational task is laboratory testing or patient examination. The difficulty is trying to decide what to minimize, improve, and/or replace. However, it may be easier if the process is an ongoing one, where optimizing quality in laboratory operations is a constant process.
The Clinical Laboratory Improvement Amendments (CLIA) define a laboratory as a facility where testing is performed "for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of, the health of human beings."1 Thus, if patient testing of any kind is performed in your medical office, it is considered a laboratory. You have to obtain the proper CLIA certificate and abide by the appropriate regulations.
This leads to the first efficiency consideration – type of testing and test menu.
Type of Testing / Test Menu
Many screening kits, point-of-care hand-held instruments, and small table-top analyzers have been categorized by the Food and Drug Administration (FDA) as waived tests under CLIA, and may be adequate for the type of testing performed in your office laboratory. If you only perform waived testing, a Certificate of Waiver is required and you must adhere to the CLIA regulations that relate to waived testing. These regulations state that waived laboratories must follow all manufacturer's instructions, and must permit the Centers for Medicare and Medicaid Services (CMS) to complete announced or unannounced inspections. Annually, CMS inspects approximately 2% of waived labs.
If any testing is categorized as non-waived, a different CLIA certificate2 is required. Non-waived laboratories must comply with all applicable CLIA regulations. CLIA regulates testing facilities and testing personnel, quality control and quality assessment, proficiency testing, and routine periodic on-site inspections.
Testing facilities can vary as much as practices vary. A single provider who performs limited testing may be able to perform all testing within patient examination rooms,; whereas, it may be more beneficial for a multi-physician group to have a central laboratory location to perform a wider variety of tests. Each practice should conduct their own assessment to determine what best satisfies their requirements.
Although the location of testing will depend on the type and amount of testing performed, there are some common parameters to consider, including among others:
- The physical size of the facility (is there room to allocate space to a laboratory?)
- Ease of staff and patient access (work flow)
- Timing of test performance (before, during, or after the examination)
Regardless of the location, the testing area must:
- Have appropriate equipment and supplies (including proper utilities and ventilation)
- Be free of contamination (of specimens, equipment, and supplies)
- Provide a safe environment for testing personnel
Test kits, reagents, and other supplies will have to be properly stored under appropriate conditions (correct temperature, humidity, lighting, etc.). Test results and other records will also have to be retained. Written records may be stored off-site as long as they are available for review during an onsite inspection. Much of the information can be maintained through the use of an electronic Laboratory Information System (LIS), if testing volume warrants. Interfacing the LIS with an electronic medical record (EMR) will improve overall efficiency by decreasing transcription errors and turn-around time.
It may seem best to task current personnel with performing laboratory testing; however, this may be neither suitable nor possible. The CLIA regulations define specific personnel positions that must be filled by qualified personnel. Depending on the type of testing performed, current personnel may not be qualified under CLIA to fill the positions or perform the testing.
Most likely, current personnel are "patient-care" professionals, not laboratory professionals; therefore, current personnel may not know the laboratory concepts and practices required to perform quality testing leading to accurate test results. Simply hiring one laboratory professional3 may be sufficient to achieve the desired outcome of a smoothly running laboratory that efficiently produces quality results.
In assessing the financial benefits associated with offering in-house laboratory testing, Tim Dumas, owner of Tim "The Lab Guy" Consulting and a frequent speaker at COLA's Symposium for Clinical Laboratories, recommends the "TIC-TOC" method. "TIC" represents Total InCome and "TOC" denotes Total Operating Costs.
In a recent presentation, Tim defined "TIC" as test volume (number of tests performed) multiplied by reimbursement, and stated that "TOC" has many parameters, including:
- Instrument / analyzer
- Replacement parts
- Service contract
- Reagents (cost per test)
- Calibrators, controls, proficiency testing specimens
- Disposables (pipettes, cuvettes, tips, swabs, etc.)
The instrument manufacturer may be able to provide an estimated TOC per year, but actual TOC will vary based on negotiated contract parameters (e.g., extend service contract to reduce reagent cost) and different acquisition methods (e.g., lease instead of purchase).
The "TIC-TOC" concept can also be applied when considering test kits. The key points are the same whether testing is performed using a kit or an instrument: number of tests performed, cost per test, and amount of reimbursement to expect.
Streamlining laboratory operations while maintaining the highest quality of services provided will result in a more efficient practice; therefore, make operational decisions that will positively impact your practice, staff, and patients.
COLA accredits nearly 8,000 medical laboratories and provides the clinical laboratory with a program of education, consultation, and accreditation. The organization is an independent, non-profit accreditor whose education program and standards enable clinical laboratories and staff to meet U.S. CLIA and other regulatory requirements. COLA's program is endorsed by the American Medical Association (AMA), the American Academy of Family Practitioners (AAFP), the American College of Physicians (ACP), and is recognized by the Joint Commission on Accreditation of Healthcare Organizations (TJC). For more information about COLA accreditation services and educational products, and online educational opportunities, please call 800-981-9883 or visit COLA's web site at www.cola.org orwww.colainsider.org
1Clinical Laboratory Improvement Amendments, subpart A, section 493.2, Definitions,http://wwwn.cdc.gov/clia/regs/subpart_a.aspx#493.2 (last accessed April 2013)
2CLIA certification includes Registration Certificate, Certificate for Provider-performed Microscopy Procedures, Certificate of Compliance, and Certificate of Accreditation in addition to the Certificate of Waiver. Each certification has specific requirements.
3Laboratory professionals can have several different credentials including among others: MLS – Medical Laboratory Scientist, MT – Medical Technologist, CLS – Clinical Laboratory Scientist, MLT – Medical Laboratory Technician, CLT – Clinical Laboratory Technician, HTL – Histotechnologist, HT – Histology Technician, PBT/RPT – Phlebotomy Technician