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Office Lab Start-up Chances are good that your practice is already involved in laboratory testing. At minimum, you might dip a urine, spin a crit, or check a saline prep. If that is the extent of your test menu, you have probably been approached by a sales representative and tempted to trade in your waived or PPM certificate for full CLIA certification.The sales rep in question my have shown you glossy photos of a chemistry analyzer or, depending on the breadth of his/her company's offerings, a family grouping of chemistry and hematology instruments with a third analyzer for immunoassays. Who could resist giving them all a good home, especially with the tempting promise of increased revenue for your practice? Do the Math While it is in the sales rep's best interest to sell his/her wares as a package deal, you would serve your own interests best by taking a step back. Take a critical look at the rep's estimate of your test volume, his cost analyses, and proposed lease agreements before beginning or expanding in-office laboratory testing. Use your send-out log or your copies of reference lab order forms to tally what lab work you referred in a representative time period. Make sure none of your providers were on vacation during the sample period. Unless you plan to negotiate fee-for-service contracts with managed care organizations, subtract patients whose testing must be referred by existing contracts. Your sales rep will show you a cost analysis for the proposed test system(s) that Itemize(s) lease payments, labor costs, calibrators, controls, reagents, and even waste. It will probably arrive at an average cost per test, which will be balanced against a reimbursement figure. Very attractive. Ask your friendly sales rep for the cost per patient result. This number gives a more realistic look at the total cost of getting a patient report to the chart. This cost will be higher than cost per test because no one is reimbursing you for performing calibration, quality control, or proficiency testing. Next add your annual proficiency testing subscription costs and your biannual CLIA and/or state license fees. Also add the cost of a technical consultant, and begin getting his/her advice as you select instrumentation and other equipment. Making the right choices now will save headaches (and dollars) later. Remember that the sales rep works for the vendor; the consultant works for you. More on this later. Go Easy A consultant worth his/her fee might suggest beginning with one instrument to test the waters of laboratory testing. An internal medicine, oncology, or family practice might choose to get its feet wet with a hematology analyzer. An ob-gyn or urology practice may opt for an immunoassay instrument to test for hormone levels or PSA. While not taking full advantage of your new CLIA certification, these two classes of instruments are less expensive and easier to use than general chemistry analyzers. After a few months of operation, you will be able to make a more informed decision on whether or not to expand your menu and acquire additional instrumentation. Before finalizing negotiations, take a careful look at the lease agreement(s) you will be signing. Should reimbursement take a turn south, can you escape from five full years of payments by transferring the lease? Is there a buy-out clause so that, if all goes well, you can purchase the instrument(s) at the end of the lease term at current (used) value? If not and you want to continue testing, you'll have to start again from square one. Procedure and Safety Manuals Instrument manuals and product inserts contain some of the information required in a good laboratory manual. They will not contain the site-specific details of policies and protocols that your consultant will develop to your specifications. General policies, specialty-specific procedures and examples of laboratory charts, logs, and report forms will be assembled into a manual that serves both to appease the CLIA inspector and train and guide your laboratory staff. Your practice may already have a general safety manual. Again, it must be site-specific. A manual written to show you how to write a manual is not enough. Make sure your manual contains sections on bloodborne pathogens and chemical hygiene, both OSHA requirements. Recent additions to safety regulations include a requirement to evaluate and use sharps safety devices and disposal containers. If your manual is lacking any of these items, get your consultant on the job. Staffing Your New Laboratory Laboratory personnel requirements vary by state, your test menu, and the size of your practice. CLIA allows high school graduates with "appropriate training" to perform most testing. If you decide to use nursing staff to perform testing, look for an analytical technophile among your employees. The personality that enjoys consumer electronics, clears paper jams in the printer or copier as a matter of course, and "plays" with new equipment to learn it -- without breaking it -- is your best candidate. If you must or choose to hire a medical technologist or other experienced laboratorian, post an advertisement at www.knapp-frazer.com. Have your consultant perform technical screening interviews on all applicants. CLIA Certification and State License If you hold a CLIA certificate of any kind, you already have a CLIA number. Include that number on any correspondence with CMS (formerly HCFA) or your state agency. To upgrade your CLIA certification, simply notify CMS through your state agency. Request a state information packet at the same time. Readers who have not had the pleasure of dealing with their state can arrange an introduction by visiting www.astho.org. If you do not hold the appropriate CLIA certificate and/or state license or if you’re not sure, your consultant will be able to advise you and guide you through the application process. Enroll in Proficiency Testing Consult articles under the “Proficiency Testing” heading for discussions on the why and how of proficiency testing. Briefly, PT is the traditional means of laboratory self-assessment and improvement. Enrollment in an approved PT program is required by CLIA for all regulated analytes. A list of approved PT services will come with your state information packet. The following PT services are widely used by physicians' office laboratories. Get their catalogs and ask your consultant to do a cost comparison for your proposed test menu. You will need proof of enrollment to show your CLIA/state inspector. AAFP-PT American Academy of Family Practice 800.274.7911 www.aafp.org/pt American Proficiency Institute 800.333.0958 www.api-pt.com Excel or CAP College of American Pathologists 800.323.4040 www.cap.org Medical Laboratory Evaluation ACS-ASIM Services 800.338.2746 www.acponline.org/mle Your annual subscription fee buys three sets of PT samples covering your laboratory's test menu. They are mailed to you at prescribed intervals throughout the year. Your laboratory performs the testing and reports the results back to the PT service. The service compares your results to other labs performing the same testing by the same method(s), compiles the data and provides paper or on-line evaluations. Have your PT service send a copy of the evaluation directly to your consultant to avoid delays in correcting any failure -- or near failure -- that it may contain. One of the common mistakes inexperienced laboratory directors make is looking only at the summary page of the evaluation. Be advised that a score of 100% does not necessarily mean that all of your results are truly A+. Use Your Technical Consultant Although you may be tempted to wear both the lab director and consultant hats yourself, delegating responsibilities to a consultant will save you many hours as you set up your laboratory and many hours more in the months and years thereafter. Your consultant should be experienced in laboratory design and start-up, regulatory compliance, quality assurance, and personnel management. Remember, physicians' office laboratories using licensed clinical laboratory scientists as technical consultants or testing personnel are more than twice as likely to do well on proficiency testing as their counterparts using medical practice staff members alone. (JAMA.1998;279:468-471) Physicians donning the director's hat for the first time should check The Lab Director, which appears under the “Personnel” heading. |
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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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