Clinical Laboratory Improvement Act

CLIA is a list of clinical laboratory standards that apply to ALL testing done on humans (except research).  These rules apply even to practices that do not bill any third parties and even "pure" DPC physicians that have opted out of Medicare.  DPC physicians that plan to offer any type of in-office testing should make an effort to familiarize themselves with CLIA.  

Resources include this comprehensive CMS page, this overview from Dr. Jane Orient of AAPS, and this review from AAFP.  Even if you intend to only perform "waived testing" you still need to pay a fee (file for a waiver), you are subject to audits (to make sure you only do waived tests), and you must maintain extensive documentation (regularly updated) to prove compliance.  Most DPC practices will likely want to go ahead and apply for a waiver though because these waived tests are commonly performed in physician offices. Remember that even if you (meaning the physician) do something as basic as using a microscope to review your own urine samples - then you have "gone too far" and are now operating beyond "waived testing." This action is labeled "Provider Performed Microscopy" and requires approval under 42 CFR 493 meaning that as summarized by AAFP you are "subject to Subparts H (Proficiency Testing), J (Patient test Management), K (Quality Control), M (Personnel), and P (Quality Assurance)." For those that elect to go the "waived testing" route, here is a list of "Good Laboratory Practices" from the CDC and here is a link to contact your appropriate state agency.

One technique worth considering is educating your patients about home testing.  More and more home tests are available (similar to the those on the waived list).  I plan to research these options in greater detail over the next few months.  Patients are able to do home testing for HIV, Hepatitis C, Strep throat, and UTIs among others.  They can also perform lipid panels, TSH, HgA1c, PSA, and Vitamin D levels.  For now here are a few resources to consider:

7 Innovative Home Medical Tests That May Save You a Trip to the Doctor
Home Strep Tests And Other Ways To Stay Out Of The Pediatrician’s Office
DIY Test for Strep

A Few Examples:
HomeAccessHealth (Hep C, HIV, Cholesterol Panel)
Oraquick (HIV)
Home Health Testing (Cholesterol, CRP, HgA1c, Hep C, PSA, TSH, Vitamin D)