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-16 - HSL RECORDS AND POLICIES
Universal Citation: 10 ME Code Rules ยง 144-256-TWO-16
Current through 2024-38, September 18, 2024
16.1 HSL records. HSL records including but not limited to records of laboratory services and copies of reports of laboratory tests must be kept in accordance with these rules.
16.2 HSL record maintenance and retention. HSLs must maintain and retain at least the following records and, upon request, make them available for inspection by the department:
16.2.1 Copies of laboratory
test reports must be maintained in a confidential manner for a minimum of two
(2) years.
16.2.2 Laboratory
records including quality assurance, equipment maintenance, and personnel
records must be retained for a minimum of two (2) years.
16.2.3 Confidentiality must be maintained
when disposing of records.
16.3 HSL policies and procedures. The HSL must have written policies and procedures that are available to the HSL staff and, upon request, to the department. There must be written policies and procedures at least for the following:
16.3.1 Specimen collection;
16.3.2 Performing tests;
16.3.3 Equipment maintenance;
16.3.4 Quality control;
16.3.5 Safety;
16.3.6 Reporting test results to clients and
providing health education;
16.3.7
Confidentiality of all client information;
16.3.8 Client referral guidelines based on an
individual's test results,clinical protocols, and the HSLs policy;
16.3.9 HSL personnel training guidelines and
required documentation; and
16.3.10
Other policies and procedures to safely operate the on-site
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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