Current through 2024-38, September 18, 2024
15.1
Performance standards. HSLs
must comply with applicable performance standards in Section 6 of these rules
and those set out in this section. Performance standards are essential for the
achievement of accurate, reliable results and the protection of public
health.
15.2
Federal CLIA
standards. HSLs must comply with the federal CLIA standards,
certification requirements and conditions of participation in accordance with
Sections 2.1 and 2.2 of these rules.
15.2.1 A
violation of any of the federal CLIA standards, certification requirements or
conditions of participation constitutes a violation of HSL
rules.
15.3
On-site
HSL area. The on-site HSL testing area must be in an enclosed area
separate from other activities.
15.3.1 If a
separate room is not available, suitable partitions must be used to limit the
risk of potential blood borne pathogen exposure and to provide patient
confidentiality.
15.4
Laboratory equipment. HSL test equipment must be calibrated for
accuracy and linearity according to the manufacturer's instructions. The HSL
testing equipment must produce linear results throughout the range at which
results will be reported and have a digital readout and a printed result.
15.4.1 Only instruments or methods capable of
direct measurement are authorized for HDL cholesterol testing.
15.4.2 LDL cholesterol levels may be
calculated.
PERSONNEL
15.5
Qualified personnel. Only
qualified personnel may perform testing and health education at on-site HSL
events.
15.5.1
Multiple roles.
HSL personnel may fulfill multiple roles provided they meet the
qualifications for each role. This rule regarding multiple roles applies only
to HSLs.
15.6
HSL
medical director. A HSL medical director is responsible for providing
oversight for the HSL, including establishing and implementing written policies
and procedures that cover all phases of the health screening process.
15.6.1 The HSL medical director determines
which tests shall be performed and provides guidance as to the focus and
content of the health education provided based on the test results.
15.6.2 The HSL medical director establishes
written protocols for referrals and suggested follow-up information given to
clients.
15.6.3 The HSL medical
director does not have to be on-site during a HSL event.
15.6.4 The HSL medical director may delegate
technical oversight of the HSL testing to the CLIA Laboratory Director or a
designee. See Section 1.8.
15.6.5
An individual who meets one of the following minimum qualifications may be a
HSL medical director:
15.6.5.1 A physician
licensed to practice medicine in the State of Maine.
15.6.5.2 A midlevel practitioner authorized
to practice in the State of Maine.
15.6.5.3 Other person with credentials
acceptable to the department.
15.7
New HSL Medical Director.
Prior notification and approval of the department must be obtained prior
to hiring a new HSL medical director for the health screening
laboratory.
15.8
HSL
supervisor. A HSL supervisor is responsible for the day-to-day operation
of the HSL and must be present on-site whenever testing is performed.
15.8.1 The HSL supervisor is responsible for
supervising the personnel that perform testing and health education.
15.8.2 The HSL supervisor must coordinate and
monitor the screening and personnel to ensure that all protocols are followed
and personnel are properly trained.
15.8.3 The HSL supervisor must possess the
following minimum qualifications:
15.8.3.1
Qualify as a HSL technician as described in Section 15.9 of these
rules.
15.8.3.2 Possess at least an
associate level degree in one of the health or science disciplines or other
credentials acceptable to the department, and documentation of at least three
months experience in a health care setting or HSL laboratory.
15.8.3.3 Possess knowledge of basic first
aid.
15.8.3.4 Possess knowledge of
applicable federal Occupational Safety and Health Administration laws
(OSHA).
15.8.3.5 Have documentation
of six months of laboratory or supervisory experience in a health care setting
or HSL laboratory.
15.9
HSL technician. A HSL
technician is responsible for following all laboratory procedures and protocols
including procedures and protocols for obtaining specimens, performing the
tests and recording results.
15.9.1 The HSL
technician must possess the following minimum qualifications:
15.9.1.1 A high school diploma or a general
educational development (GED) certificate.
15.9.1.2 Training, including instruction and
direct hands-on experience, conducted by qualified trainers on the same type of
instrument used by the laboratory. Training must include but is not limited to
equipment calibration, maintenance, and operation, quality control testing,
detecting errors and troubleshooting problems.
15.9.1.3 Training on pertinent OSHA
laws.
15.9.1.4 Documentation of
orientation under direct supervision covering such aspects of the laboratory's
operation as specimen collection, safety, client relations, testing, reporting
and confidentiality.
15.10
HSL educator. A HSL
educator is responsible for reviewing the test results with the client and
providing health education to the client.
15.10.1 Clients receive pertinent information
from the HSL educator based on the HSLs established protocols and the pertinent
recommendations of established authorities such as the Maine Cardiovascular
Health Council's guidelines for blood pressure screening, the Adult Treatment
Panel of the National Cholesterol Education Program, and the American Diabetes
Association's Clinical Practice Recommendations.
15.10.2 The HSL educator must possess the
following minimum qualifications:
15.10.2.1
An associate level degree in one of the health or science disciplines or other
credentials acceptable to the department.
15.10.2.2 Documentation of training on the
clinical guidelines and health education curriculum of the Maine Cardiovascular
Health Council guidelines for blood pressure screening or its equivalent, the
Adult Treatment Panel of the National Cholesterol Education Program or its
equivalent, and the American Diabetes Association's Clinical Practice
Recommendations or its equivalent.
15.10.2.3 Documentation of orientation under
direct supervision covering such aspects of health education as the testing
process, the interpretation of test results, the provision of health education
material to clients, appropriate actions when a client's results warrant
immediate intervention, and confidentiality
requirements.
