10-144-256 Me. Code R. § ONE-6

Current through 2024-51, December 18, 2024

Section 144-256-ONE-6 - LABORATORY OPERATION

6.1Medical laboratory operation. The operation of medical laboratories must comply with applicable provisions set out in these rules.

6.2Performance 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).

6.3Records. 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.

6.4Physician 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).

6.4.1Exception. Without a physician's or authorized person's request, a medical laboratory may examine specimens for a limited number of tests including but not limited to the following:

6.4.1.1 Urine pregnancy testing;

6.4.1.2 Cholesterol testing;

6.4.1.3 Colon cancer testing;

6.4.1.4 Fecal occult blood testing; and

6.4.1.4 Glucose testing for persons previously diagnosed with diabetes. See 22 M.R.S.A. §2030(2).

6.4.2Option. These rules do not require medical laboratories to perform any test without a physician's or authorized person's request, including urine pregnancy testing, cholesterol testing, colon cancer testing, fecal occult blood testing, or glucose testing of persons with diabetes. See 22 M.R.S.A. §2030(3).

6.5Reference 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.

6.6Test 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.

6.7Specimens. 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.

6.8Maternal 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:

6.8.1Test volume. The laboratory must perform a minimum test volume of twenty-five (25) patient tests per week.

6.8.2Reference data. The laboratory must establish its own population-based reference data for each maternal screening test that is performed by the laboratory (maternal AFP, UE3, HCG and DIA) using the method chosen for testing and samples obtained from the population to be screened.

6.8.2.1 Individual test results must be expressed as multiples of the unaffected population median (Multiples of the Median or MoM) which is obtained by dividing the test value by the median value for the relevant gestational week.

6.8.2.2 Since the MoM is a ratio of two concentrations, the MoM value can be readily adjusted to take into account the other variables like maternal weight and ethnicity that affect the interpretation of biochemical markers.

6.8.2.3 Medical laboratories must update their established medians at least annually.

6.8.3Laboratory report. The laboratory report must be simple and clear, presenting the test results in units of assay measurement and in MoM values and a categorization into screen-positive or screen-negative according to pre-assigned criteria.

6.8.3.1 Risk assessment must be given for Down Syndrome (DS) screen-positives and optionally for screen-negatives.

6.8.4Review and follow-up guidelines. The laboratory must establish written guidelines specifying when results need to be reviewed and follow-up recommendations made.

6.8.4.1 The laboratory shall recommend that women who screen positive for a Neural Tube Defect (NTD) or DS whose gestational age was determined by Last Menstrual Period (LMP) should have an ultrasound scan to estimate gestational age.

6.8.4.1.1 The laboratory must revise the gestational age and recalculate the risk only if the difference between the ultrasound estimate of gestational age and the LMP estimate is greater than the laboratory's preset number of days.

6.8.4.2 The laboratory shall recommend that women with an ultrasound dated gestational age who are screen-positive for NTD should consider having a detailed ultrasound to identify the cranial markers of spina bifida and to determine whether spina bifida is present or absent. 6.8.4.3 The laboratory shall recommend that women with an ultrasound dated gestational age who are screen-positive for DS should consider having an amniocentesis performed for a rapid diagnosis of DS using PCR (Polymerase Chain Reaction) or FISH (Fluorescence IN SITU Hybridization) followed by a karyotype.

6.8.4.4 The laboratory shall request outcome information on all pregnancies in order to determine the false-positive and false-negative rates.

6.8.4.5 Information on test results and pregnancy outcomes shall be provided to the department upon request. See 22 M.R.S.A. §2023(5).

6.9Restriction: 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).

6.10Itemized billing statements. A medical laboratory that performs services under these rules shall send an itemized billing statement to the patient.

10-144 C.M.R. ch. 256, § ONE-6