Massachusetts state laws and regulations that affect your medical practice
1. Are physicians subject to the CLIA regulations?
Yes. Physicians are subject to CLIA regulations, but only if they have a laboratory as part of their offices. The CLIA amendments were enacted to extend the regulation by the U.S. Department of Health and Human Services (HHS) from the 13,000 laboratories previously regulated by HHS to an estimated 200,000 lab sites, including those located in physicians' offices. Generally, CLIA changed the focus of clinical lab regulation from regulation based on the type of laboratory site to regulation based on the complexity of the tests performed by a particular laboratory.
All laboratories performing tests on human specimens must register with the Health Care Financing Administration (HCFA). Registration requires a fee ranging from $100 to $600. All laboratories must also submit to a federal inspection every two years, which will result in an additional fee ranging between $300 and $3,100. Laboratories are also subject to a proficiency test three times a year in which their analyses of test specimens will be verified for accuracy. Registration certificates are valid for a maximum of two years or until such time as an inspection can be conducted to determine program compliance, whichever is shorter.
Yes. CLIA regulations apply to all laboratory testing used for the assessment of health or for the diagnosis, prevention, or treatment of disease. CLIA applies to every laboratory and testing site in the United States, even if only a few basic tests are performed as part of physical examinations.
Certain laboratories, however, may obtain a certificate of waiver for a fee of $100 if they can prove that the tests they perform are exempt from specific CLIA requirements. (See following.) These laboratories are nonetheless required to register with HCFA when applying for a certificate of waiver.
3. Which tests are exempt from CLIA requirements?
Eight tests have been designated as exempt from CLIA standards and a laboratory that performs only these tests can obtain a certificate of waiver from CLIA requirements. The eight tests are:
A. Dipstick or tablet urinalysis (non-automated);
B. Fecal occult blood;
C. Ovulation tests using visual color comparisons;
D. Urine pregnancy tests using visual color comparisons;
E. Erythrocyte sedimentation rate (non-automated);
F. Hemoglobin by copper sulfate method (non-automated);
G. Spun microhematocrit;
H. Blood glucose using certain devices cleared by the Food and Drug Administration (FDA) specifically for home use.
Laboratories with certificates of waivers will not be inspected routinely but will still be subject to inspections as part of complaint investigations and on a random basis to determine whether only the waived tests are being performed.
In 1992, HCFA created a new category of procedures which are not subject to routine inspections. The tests include:
A. Physician-performed microscopy procedures including wet mounts; including preparations of vaginal, cervical or skin specimens;
B. All potassium hydroxide preparations;
C. Pinworm examinations;
D. Fern tests;
E. Post-coital direct, qualitative examinations of vaginal or cervical mucous; and
F. Urine sediment examinations.
4. How are laboratories which perform tests not listed on the exempt list regulated?
All tests not listed as waived are divided into one of two categories, moderate complexity or high complexity, based on the complexity of the testing procedure. For these categories, the regulations list specific requirements for proficiency testing, patient test management, quality control, quality assurance, personnel, and inspections.
Some examples of moderate complexity tests are microscopic analysis of urinary sediment, throat cultures, gram stains, and hematology and chemistry tests conducted on fully automated instruments that do not require operator intervention during the analytic process.
5. What are the major differences between the requirements for laboratories performing tests of moderate and high complexity?
The major differences concern quality control and personnel standards. Personnel standards for facilities doing high complexity testing will require more education and experience than for those doing only moderate complexity testing. The Moderate Complexity classification has requirements for the laboratory director, clinical consultant, technical consultant and testing personnel while the High Complexity classification has requirements for the laboratory director, clinical consultant, technical supervisor, general supervisor and testing personnel.
42 CFR 493.1403-1425; 42 CFR 493.1441-1495
6. How do Massachusetts's regulations on the operation of clinical laboratories differ from the Federal CLIA regulations?
Massachusetts General Law 111D defines a laboratory and identifies those testing facilities require clinical laboratory licensure and/or approval. It is similar to CLIA. The regulations relating to clinical laboratory licensure can be found at 105 CMR 180.000 Rules and Regulations Relating to the Operation, Approval, and Licensing of Laboratories. Massachusetts is one of the states with a federally-approved licensure program. Because of this program a laboratory may obtain a state license in lieu of a federal certificate. Laboratories with a federal Certificate of Waiver will not be subject to Massachusetts' regulations.
Additionally, Massachusetts law requires qualification of personnel, certification the laboratory, proper facilities, maintenance of laboratory procedure manuals, calibration and evaluation of equipment, and quality control assurance.
Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.