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 TWO - PERMITS FOR HEALTH SCREENING LABORATORIES
Section 144-256-TWO-14 - HSL OPERATION

Universal Citation: 10 ME Code Rules ยง 144-256-TWO-14

Current through 2024-38, September 18, 2024

14.1 Itinerary sent to department. Fourteen (14) business days prior to the earliest scheduled screening event, the department must receive an itinerary of planned HSL events from the permit-holder.

14.1.1 Changes in itinerary. Notice of any change that is made to an itinerary must be received by the department at least one business day prior to the changed screening event.

14.1.2 Valid use of permit. The HSL permit is valid only for those HSL events identified on the itinerary and submitted changes received by the department.

14.2 Individuals request testing. Individuals request the screening test and the test results are given to the individual at the time the on-site testing occurs. A physician's referral is not needed for an individual to be tested by a HSL.

14.3 Authorized HSL tests. HSLs may be authorized to perform any of the following health screening tests. All other testing by HSLs is prohibited.

14.3.1 Fecal occult blood testing;

14.3.2 Colon cancer testing;

14.3.3 Testing for total cholesterol, triglycerides, high density lipoprotein cholesterol (HDL); low density lipoprotein cholesterol (LDL); and

14.3.4 Glucose testing.

14.4 Client present during tests. HSL tests must be performed while the client is present.

14.5 Screening purposes only. The results of the testing must not be used for diagnostic purposes. The results of the HSL testing are used for health screening purposes only.

14.6 Specimen referrals prohibited. Referral of specimens to other laboratories is prohibited. Specimens must only be taken for on-site testing of fecal occult blood, colon cancer, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol or glucose.

14.7 Reporting test results to client. The results of the screening tests must be in writing and provided only to the client and, with the client's consent, the client's physician. The department-approved report form must contain at least the following information:

14.7.1 The name of the HSL and contact information;

14.7.2 The date and location of the HSL testing;

14.7.3 Whether the client was fasting at the time of testing, as this affects triglyceride and glucose results;

14.7.4 The HSL test results; and

14.7.5 The name(s), initials or other identification of the person(s) performing the HSL testing and health education for the client.

14.8 Client health education. A qualified HSL educator provides health education information to clients in accordance with HSL policies and procedures. Health education information is provided to help clients maintain or improve their health status.

14.9 Follow-up referral information. Information regarding follow-up options is available to clients, including referral to physicians or other authorized persons if the client does not have a primary care physician.

14.9.1 Referrals must not be made to any physician or authorized person who has a direct financial interest in the HSL.

Disclaimer: These regulations may not be the most recent version. Maine may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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