Section 144-256-TWO-15 - HSL PERFORMANCE STANDARDS AND PERSONNEL15.1Performance 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.15.2Federal 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.15.3On-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.15.4Laboratory 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
15.5Qualified personnel. Only qualified personnel may perform testing and health education at on-site HSL events. 15.5.1Multiple roles. HSL personnel may fulfill multiple roles provided they meet the qualifications for each role. This rule regarding multiple roles applies only to HSLs.15.6HSL 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.15.7New 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.15.8HSL 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.15.9HSL 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.15.10HSL 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.10-144 C.M.R. ch. 256, § TWO-15