Code of Maine Rules
10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES
144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL
Chapter 256 - MAINE MEDICAL LABORATORY RULES
Part ONE - CLIA CERTIFICATION AND STATE-ISSUED LICENSE
Section 144-256-ONE-6 - LABORATORY OPERATION
Current through 2025-13, March 26, 2025
6.1 Medical laboratory operation. The operation of medical laboratories must comply with applicable provisions set out in these rules.
6.2 Performance standards. Medical laboratories are subject to performance standards in accordance with these rules. Performance standards are essential for the achievement of accurate, reliable results and the protection of public health. See 22 M.R.S.A. §2023(5).
6.3 Records. Medical laboratories must maintain laboratory records, including but not limited to reports of laboratory tests. Upon request, laboratory records must be available at all times for inspection by the department. Laboratory records must be retained for 6 years, except when the CLIA record retention requirements establish a lesser or greater time period. See 22 M.R.S.A. §2034.
6.4 Physician requested tests. A medical laboratory shall perform patient testing only at the request of a licensed physician or person authorized by Maine law to request and use the findings of laboratory testing. See 22 M.R.S.A. §2030(1).
6.5 Reference laboratory testing. A medical laboratory that does not perform a specific test may make a referral to have the test performed by a reference laboratory that is CLIA certified to perform the test. The test report shall identify the reference laboratory and shall bear or be accompanied by a clear statement that the findings were obtained by the reference laboratory. See 22 M.R.S.A. §2015.
6.6 Test results. Test results are reported directly to the licensed physician or authorized person who requested the test, or to their designee. A report of test results issued by a medical laboratory must clearly identify that medical laboratory and the director. See 22 M.R.S.A. §2031.
6.7 Specimens. The following persons may collect or process specimens: licensed health care professionals; designees of licensed health care professionals acting within their scope of practice; and qualified medical laboratory personnel who are authorized by the director of the medical laboratory. See 22 M.R.S.A. §2032.
6.8 Maternal AFP testing standards. Medical laboratories performing maternal AFP testing, including AFP4 testing (AFP), unconjugated Estriol (UE3), Human Chorionic Gonadotrophin (HCG) and dimeric Inhibin A (DIA) must at a minimum adhere to the following standards of performance:
6.9 Restriction: pathologic anatomy examinations. A medical laboratory may not perform examinations in the field of pathologic anatomy, including exfoliative cytology, unless the director or an employee of the laboratory is a diplomat of the American Board of Pathology certified in pathologic anatomy or the American Osteopathic Board of Pathology certified in pathologic anatomy, or unless the director is a physician licensed to practice medicine in the State of Maine who possesses special qualifications acceptable to the department, or unless the director is a dentist licensed in Maine and is certified by the American Board of Oral Pathology. See 22 M.R.S.A. §2029(3).
6.10 Itemized billing statements. A medical laboratory that performs services under these rules shall send an itemized billing statement to the patient.