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Rules Governing Maine Medical Laboratories And Health Screening Permits


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PART TWO

PERMITS FOR HEALTH SCREENING LABORATORIES
SECTION 12. HEALTH SCREENING LABORATORY (HSL)
12.1 Health screening laboratory (HSL). PART TWO of these rules govern health screening laboratories (HSLs) as defined in Section 1.11 of these rules.
12.1.1 Applicable rules. The purpose, applicable definitions and other provisions in Sections 1 through 11 of these rules apply to HSLs.
12.1.2 CLIA certification. HSLs must be CLIA certified and 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.
12.1.2.1 A violation of any of the federal CLIA standards, certification requirements or conditions of participation constitutes a violation of HSL rules.
12.2 Responsibility for compliance. The HSL applicant and permit-holder must comply with the provisions of these rules.
12.3 Permit required. Except as set out in Section 1.11.1 of these rules, no medical laboratory is authorized to operate as a HSL without a department-issued permit. Prior to securing a department-issued permit, no specimens may be obtained and no testing may be performed.
12.3.1 Term of permit. The issued permit expires 24 months after the date issued. Permits are not renewable. Upon approval of a new HSL application, a new permit is issued.
12.3.2 Valid permit. A permit is valid only for the HSL identified on the issued permit.
12.3.3 Nontransferable. An issued HSL permit is not transferable or assignable.
12.3.4 Permit posted at test site. During the HSL event, the issued permit must be posted at the HSL location where it is visible to the public.
12.4 Exempt from state licensure. HSLs are exempt from state licensure. See 22 M.R.S.A. §2013-A(1)(G).
SECTION 13. HSL PERMIT APPLICATION
13.1 Permit 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.
13.2 Required 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.
13.3 Department 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.
13.3.1 Appeal. The permit applicant may appeal the department’s decision in accordance with Section 19.8 of these rules.
13.4 Information 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.

SECTION 14. HSL OPERATION
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.

SECTION 15. HSL PERFORMANCE STANDARDS AND PERSONNEL
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.
SECTION 16. HSL RECORDS AND POLICIES
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.
SECTION 17. HSL QUALITY CONTROL AND PROFICIENCY TESTING
17.1 Quality Control. Quality control must be practiced and documented as a routine part of the HSLs operation.
17.2 Laboratory instruments. Each HSL instrument must be calibrated for accuracy and linearity according to the manufacturer’s instructions.
17.2.1 Each day (24 hour shift) of operation, each instrument must be checked for proper function according to the manufacturer’s instructions.
17.2.2 Each day (24-hour shift), each instrument must be checked with two different levels of quality control material.
17.2.3 If available, standards and controls must be of the same matrix as client specimen, such as whole blood, serum, and similar specimen.
17.2.4 Acceptable ranges must be established for all aspects of the quality control program. Client test results must not be reported until causes for out of range quality control results have been resolved.
17.3 Repeat test. Client test results that meet the following criteria must be repeated at the same sitting:
17.3.1 Total cholesterol test results on clients that are above 300 mg/dL or below 100 mg/dL.
17.3.2 HDL cholesterol results above 100 mg/dl or below 15 mg/dl.
17.3.3 Triglyceride results above 400 mg/dl.
17.3.4 Glucose results above 350 mg/dl or below 50 mg/dl.
PROFICIENCY TESTING
17.4 Proficiency testing program. HSLs must be enrolled and successfully participate in a CLIA proficiency testing program for each test performed.
17.5 Documentation of enrollment. Documentation of enrollment in a CLIA proficiency testing program and records of the laboratory’s performance must be provided upon request to the department.
17.6 Instrument performance records. HSL records must be maintained on the performance of each instrument.
SECTION 18. HSL SAFETY STANDARDS AND INSPECTIONS
18.1 Safety. HSLs must comply with the rules in this section and applicable standards in Section 9 of these rules.
18.2 Laboratory safety. Applicable OSHA laws must be known and demonstrated by HSL personnel to ensure freedom from unnecessary physical, chemical, biological and electrical hazards.
18.3 Prohibited activity. Smoking, drinking and eating are prohibited in the HSL work area.
18.4 Infectious material and waste. Potentially infectious materials and waste must be handled, stored and disposed in accordance with the Maine Department of Environmental Protection, Biomedical Waste Management Rules, 06-096 C.M.R. Chapter 900.
18.5 Inspection. HSLs are subject to inspection at any time testing is offered at a HSL screening location.
18.5.1 Complaints and suspected violations of rules. HSLs are subject to inspection by the department in response to a complaint or suspected violation of these rules.
18.5.2 Code violations. HSLs are subject to inspection by the department, or another state agency, or a municipality for suspected violations of building codes, fire codes, life safety codes or for other similar purposes.
SECTION 19. HSL ENFORCEMENT PROCEDURES AND APPEALS
19.1 Compliance. HSL permit-applicants and permit-holders must comply with these rules. HSLs that fail to comply with these rules are subject to the enforcement provisions in this section and applicable provisions in Section 11 of these rules.
19.2 Operating a HSL without a permit: fines or imprisonment. A person who operates, maintains, directs or engages in the business of operating a HSL without a department-issued permit is in violation of these rules. The performance of any of the acts set out in this section constitutes a crime punishable, upon conviction, by a fine not less than $50 and not more than $500, or by imprisonment for not more than one year, or both.
19.3 Unsupervised HSL: fines or imprisonment. A person who conducts, maintains or operates a HSL without the direct and responsible supervision and direction of a person possessing the required qualifications is in violation of these rules. The performance of any of the acts set out in this section constitutes a crime punishable, upon conviction, by a fine not less than $50 and not more than $500, or by imprisonment for not more than one year, or both.
19.4 Injunction. The department, through the Office of the Attorney General may, in addition to other available remedies, bring a court action for an injunction to restrain the operation of a HSL that is in violation of these rules or to enjoin the continued operation of a HSL until compliance with these rules is achieved.
19.5 Suspension or revocation of HSL permit. The department may petition the District Court to suspend or revoke a HSL permit.
19.6 Grounds for suspension or revocation of HSL permit. Grounds for the suspension or revocation of a HSL permit include but are not limited to the following:

19.6.1 A violation of these rules and applicable laws;
19.6.2 Permitting, aiding or abetting the commission of any illegal act at the HSL;
19.6.3 Conduct or practices detrimental to the welfare of a HSL client;
19.6.4 A criminal conviction in any jurisdiction of the HSL medical director or the HSL supervisor arising out of or in connection with the operation of a HSL;
19.6.5 Knowingly lending the use of the name of the HSL or the name of its director to a non-permitted HSL;
19.6.6 Incompetent or unprofessional conduct, including but not limited to:
19.6.6.1 Fabricating results;
19.6.6.2 Unauthorized disclosure of confidential information;
19.6.6.3 Willful misrepresentation of results;
19.6.6.4 False or deceptive advertising; or
19.6.7 Making a false or deceptive representation on an application for a department-issued HSL permit.
19.7 Emergency suspension or revocation of HSL permit. When the department finds conditions exist that, in the opinion of the department, immediately endanger the health or safety of clients or otherwise create an emergency, the department may petition the District Court to immediately suspend or revoke the HSL permit.
19.8 Appeal. Any person aggrieved by the final agency action of the department may file an appeal with the District Court pursuant to Title 5, chapter 375 of the Maine Revised Statutes. See 22 M.R.S.A. §2040.


STATUTORY AUTHORITY

22 M.R.S.A. Chapter 411;

22 M.R.S.A. §42;

22-A M.R.S.A. §205; and PL 2011, Ch 531.


REGULATORY HISTORY
EFFECTIVE DATE:

May 7, 1979


AMENDED:

December 27, 1988

May 1, 1990
EFFECTIVE DATE (ELECTRONIC CONVERSION):

May 5, 1996


NON-SUBSTANTIVE CORRECTION:

September 29, 1997 - replaced missing period in (4)(C).


AMENDED:

October 1, 1997

May 25, 1999
REPEALED and REPLACED:

May 9, 2012 – filing 2012-141



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