Statutes, codes, and regulations
Maine Administrative Code
Department 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICESDivision 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERALChapter 256 - MAINE MEDICAL LABORATORY RULES
Part TWO - PERMITS FOR HEALTH SCREENING LABORATORIES
Section 144-256-TWO-13 - HSL PERMIT APPLICATION

10-144-256 Me. Code R. § TWO-13

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Current through 2024-51, December 18, 2024
Section 144-256-TWO-13 - HSL PERMIT APPLICATION
13.1Permit application. Application for a permit must be made on a department-approved form. A permit application is not considered complete until the department receives the application form, required documents, and the application fee, set out in Section 5.6 of these rules.
13.2Required information. An application for a permit must include at least the following information:
13.2.1 The HSL owner's name, address and contact information;
13.2.2 Location (street and city address) of the HSL event(s);
13.2.3 The HSL's CLIA certification information;
13.2.4 Health screening tests that will be performed;
13.2.5 Name and credentials of personnel who will perform health screening tests and client education;
13.2.6 Identification of each piece of equipment that will be used at the health screening location, including equipment serial number or similar identification;
13.2.7 Written policies and practices to ensure safety during the HSL event including but not limited policies regarding contamination, fire prevention and infection control precautions;
13.2.8 The HSLs health education protocols;
13.2.9 Copies of health education information to be distributed to clients during the HSL event; and
13.2.10 Other information required by the department.
13.3Department decision. After a review of the application and required documentation, the department shall issue the HSL permit, or send the applicant a written decision that the permit application is denied, the basis for the decision, and the right to appeal.
13.3.1Appeal. The permit applicant may appeal the department's decision in accordance with Section 19.8 of these rules.
13.4Information on a permit. The issued permit must contain at least the following information:
13.4.1 The name, address and contact information of the legal owner(s) of the HSL;
13.4.2 The health screening tests the HSL is authorized to perform;
13.4.3 The effective date and the expiration date of the issued permit; and
13.4.4 Other information required by the department.

10-144 C.M.R. ch. 256, § TWO-13