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Waived Lab Inspections When the CLIA regulations were published in 1988, physicians doing only basic testing in their offices breathed a sigh of relief. Many others that had been doing more sophisticated testing cut back to waived methods in order to avoid regulatory headaches and a knock on the door from the CLIA inspector. Recent developments may bring that CLIA inspector into your waived laboratory after all.What's Waived? The list of waived methods, originally eight very basic tests, continues to grow. Included are all kits FDA-cleared for home use and some test systems developed in the last decade and specifically aimed at the physician's office market. They are single-step tests requiring no specimen manipulation and little training or technical prowess. All of these tests are viewed as presenting an insignificant chance for error. The US Department of Health and Human Services believes that, should the rare error occur in a waived test procedure, it would not place the patient in imminent danger. Consequently, laboratories that perform only waived methods simply need to obtain a certificate of waiver and pay their fee every two years. No muss, no fuss. Labs adding simple microscopy procedures to their test menus need a higher certification that allows them to perform both waived and provider-performed microscopy procedures. PPM certification involves a slightly higher fee and proficiency testing is required. Still no hassles from the inspector. Random Inspections of Waived Labs Laboratories that hold waived or PPM certifications are bound by one provision that seems very benign: Follow the Manufacturer's Directions. These "simple" tests only work as advertised if attention is paid to the details of the directions. Timing for urine reagent strips, for example, is critical for accurate and reliable results. In 2000, state health agencies in Colorado and Ohio began random inspections of waived laboratories. Looking only at whether or not waived labs were following manufacturer's directions, inspectors found problems in over 50% of the labs they visited. As a result of this pilot program, CMS, then HCFA, enlarged the study and now conducts inspections for waived/PPM labs in virtually every state. Here’s how to be prepared for that knock on the door. First Step: Read the Directions Pull the package inserts out of your newest box of reagent strips, test devices, and disposables boxes. (Following out-of-date directions serves no purpose.) With highlighting pen in hand, read every word. Flag any direction that you are doing differently (however slightly) or not at all. If a direction seems vague, obtuse or utter nonsense, flag that too. If the insert mentions quality control, look for specific guidelines. Yes, flag those as well. Ensure Compliance You perform testing in your office for the convenience of your patients and to increase the efficiency of your practice. Before you turn in your CLIA certificate and uncork the aspirin bottle, be assured that following manufacturer's directions will give you peace of mind and cost very little in terms of time and inventory. If you or someone within the practice has a laboratory background, achieving CLIA compliance will be a simple matter of interpreting and implementing the flagged parts of the manufacturer's directions. If you are not so blessed, seek the assistance of a technical consultant. See Hiring a Consultant. We hope you will call on Knapp·Frazer Consulting to serve your compliance needs. In any case, your consultant will implement the required changes and additions to your laboratory protocols, show your staff how and when to run and document required quality control, and suggest quality assurance steps to make your lab hum. You may choose to bring the consultant back for regular visits to train new staff members, review QC (and PT, if required) and keep your lab humming. After taking these few steps, you'll want to hang out a sign: CLIA Inspectors Welcome. |
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This article may be republished in its entirety on your web site or in your newsletter under the following two conditions: 1) Include the following statement at the beginning or end of the article. "Republished with permission of the author, Margaret A Knapp MT(ASCP) CLS, of Knapp·Frazer Consulting. www.knapp-frazer.com ~ 707.539.6621" 2) Send copy of your publication or URL to Knapp·Frazer Consulting at time of republication. |
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