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Fam Pract Manag. 2001 Oct;8(9):55.

Notifying patients of test results

Q

Should patients be notified of all test results? What’s the best way to do this?

The Clinical Laboratory Improvement Amendments (CLIA) program requires labs to report all results to the physician who ordered the tests, but there is no law that requires the physician to report all test results to the patient. However, ethical and legal considerations indicate that patients should at least be notified of abnormal results, and all practices should have a policy to that effect. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) will require all health care providers to ensure the privacy of personally identifiable health information, which may affect how patients are notified of test results; however, specific instructions have not yet been released.

In the meantime, practices can use whatever method they prefer to notify patients of their results. For most practices, a phone call works best when immediate action is needed, although this can be time-consuming and costly. For less immediate needs, test results can be mailed. Some practices notify patients of normal test results with a simple postcard bearing a pre-determined symbol (e.g., a “smiley face”), rather than actual results, to preserve confidentiality. Other practices transfer this responsibility to patients, asking them to contact the office for their test results. However, this can be frustrating for staff and patients alike, as patients frequently call before the results have arrived or when the person authorized to release the results is unavailable.

Technology can make this kind of physician-patient communication easier. One option is a telephone system that allows staff members to record patients’ test results in private voice-mail boxes that only the patient can access via a personal identification number. Another option is for the practice to post test results on a secure Web site that the patient can access with a password.

Physician office labs

Q

In my new practice, I would like to include a small, on-site lab. How do I get started?

There are basically six steps involved in starting a physician office lab (POL):

1. Determine the kinds of tests you’d like to do. The CLIA program divides laboratory tests into three categories: waived (e.g., fecal occult blood tests), moderate complexity (e.g., throat cultures) and high complexity (e.g., antibiotic susceptibility tests), each with its own requirements for proficiency testing, patient test management, quality control, personnel, quality assurance and inspections. For specifics about the test categories, go to www.phppo.cdc.gov/clia/testcat.asp.

2. Decide who the lab director and staff will be. Although waived labs don’t have personnel requirements, moderate- and high-complexity labs have very detailed requirements. For example, in moderate-complexity labs, the staff performing the testing must have, at a minimum, their high school diplomas or GEDs and documented training for the test(s) they will perform. In addition, the lab director, who is in most cases one of the practice’s physicians, must have 20 hours of laboratory-related CME (or equivalent training in residency) or a minimum of one year’s experience as director of a similar lab.

3. Enroll in a proficiency testing (PT) program. This is required for labs that perform certain moderate- and high-complexity tests (regulated analytes). A list of approved PT providers and contact information is available on the CLIA home page, http://www.cms.hhs.gov/CLIA/.

4. Get lab certification or accreditation. You can get certification for your POL through the Center for Medicare and Medicaid Services (CMS) or accreditation through a private accrediting agency, such as COLA. In either case, you need to apply for a CLIA certificate of registration by filling out the HCFA-116 form, which can be found online at http://www.cms.hhs.gov/CLIA/06_How_to_Apply_for_a_CLIA_Certificate_International_Laboratories.asp#TopOfPage or by contacting CMS or your state agency.

5. Write procedures for the tests that will be performed. The procedures should include all phases of testing: pre-analytic (e.g., ordering, specimen collection and preparation), analytic (e.g., quality control, proficiency testing, test procedure) and post-analytic (e.g., results recorded and reported, interpretation of results). Be sure the procedures address all of the regulatory requirements.

6. Develop a quality assurance plan. Again, the plan should address all phases of testing. Waived labs are not routinely inspected, but moderate-and high-complexity labs are inspected every two years by CMS or their private accrediting agencies.

The AAFP-PT staff may be of assistance in addressing all of these issues. You can contact them at 800-274-7911, pt@aafp.org or www.aafp.org/pt.


* Denotes member of FP Assist, the AAFP’s online clearinghouse for consultants and attorneys.


 

Copyright © 2001 by the American Academy of Family Physicians.
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