DEPARTMENT OF HEALTH AND HUMAN SERVICES  
DIVISION OF ENVIRONMENTAL HEALTH  
BLOOD LEAD ANALYSIS REPORTING  
Filed with the secretary of state on February 7, 2020  
These rules take effect immediately upon filing with the secretary of state unless  
adopted under section 33, 44, or 45a(6) of the administrative procedures act of 1969,  
1969 PA 306, MCL 24.233, 24.244, or 24.245a. Rules adopted under these sections  
become effective 7 days after filing with the secretary of state.  
(By authority conferred on the department of community health by sections 5111(1)  
and (2)(f), 5474(1)(c), and 20531 of the public health code, 1978 PA 368, MCL  
333.5111, 333.5474, and 333.20531; and Executive Reorganization Order No. 2015-1,  
MCL 400.227.)  
R 325.9081, R 325.9082, R 325.9083, R 325.9084. R 325.9085, and R 325.9086 of the  
Michigan Administrative Code are amended, as follows:  
R 325.9081 Definitions.  
Rule 1. (1) As used in these rules:  
(a) “Department” means the department of health and human services.  
(b) “Limit of detection” means the lowest quantity of a substance that can be detected  
with reasonable certainty for a given laboratory analytical procedure.  
(c)"Physician/provider" means a licensed professional who provides health care  
services and who is authorized to request the analysis of blood specimens. For this  
purpose, provider may also mean the local health department.  
(d) “Portable blood lead analyzer” means a point-of-care blood lead testing instrument  
or similar device used to determine blood lead levels.  
(e) “User” means a physician/provider, local health department, Head Start agency,  
community action agency, and any other agency or individuals who utilizes portable  
blood lead analyzers.  
(2) The term "local health department," as defined in section 1105 of the public health  
code, 1978 PA 368, MCL 333.1105, has the same meaning when used in these rules.  
R 325.9082 Reportable information.  
Rule 2. (1) Reportable information pertains to the analysis of blood samples submitted  
to clinical laboratories and the results from portable blood lead analyzers.  
(2) Upon initiating a request for blood lead analysis, the physician/provider or user  
ordering the blood lead analysis shall collect the following information:  
(a) All of the following information with respect to the individual tested:  
(i) Name.  
(ii) Sex.  
(iii) The individual’s ethnic origin.  
July 11, 2019  
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(iv) The individual’s race.  
(v) Birthdate.  
(vi) Address, including county.  
(vii) Telephone number.  
(viii) Social security number and Medicaid number, if applicable.  
(ix) If the individual is a minor, the name of a parent or guardian.  
(x) If the individual is an adult, the name of his or her employer.  
(xi) A secondary contact for the individual tested or, if the individual is a minor, a  
secondary contact for the individual’s parent or guardian, including, to the extent  
available, name and phone number of the secondary contact.  
(b) The date of the sample collection.  
(c) The type of sample, either (capillary or venous).  
(d) The physician’s/provider’s or user’s name, name of practice or agency, (if  
applicable), telephone number, fax number, email address, and mailing address.  
(3) The information collected in subrule (2) of this rule must be submitted with the  
sample for analysis to a clinical laboratory that performs blood lead analysis or a user of a  
portable blood lead analyzer.  
(4) Upon receipt of the blood sample for lead analysis, the clinical laboratory or user of  
a portable blood lead analyzer shall collect the following additional information:  
(a) The name, address, and phone number of the laboratory or testing entity.  
(b) The date of analysis.  
(c) The specimen number.  
(d) The results of the blood lead analysis in micrograms of lead per deciliter of whole  
blood. If the result is below the limit of detection, report as less than the laboratory’s limit  
of detection for that analytical procedure.  
R 325.9083 Reporting responsibilities.  
Rule 3. (1) All clinical laboratories and users of portable blood lead analyzers doing  
business in this state that analyze blood samples for lead shall report all blood lead  
results for adults and children to the department electronically consistent with rule (4). If  
a result and required reportable information under rule (2) cannot be reported  
electronically within the time frame specified by this rule, then the results must be  
submitted to the Michigan Department of Health and Human Services, Childhood Lead  
Poisoning Prevention Program (CLPPP), P.O. Box 30037, Lansing, MI 48909, or by fax  
to (517) 335-8509. Reports must be made to the department within 5 working days after  
test completion. Nothing in these rules prevents a person or entity required to report  
under these rules from reporting results to the department sooner than 5 working days.  
(2) Nothing in this rule relieves a clinical laboratory or a user of a portable blood lead  
analyzer from reporting results of a blood lead analysis to the physician or other health  
care provider who ordered the test or to any other entity as required by state, federal, or  
local statutes or regulations or in accordance with accepted standard of practice, except  
that reporting in compliance with this rule satisfies the blood lead reporting requirements  
of section 5474(1)(c) of the public health code, 1978 PA 368, MCL 333.5474.  
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R 325.9084 Electronic communications.  
Rule 4. (1) A clinical laboratory or user of a portable blood lead analyzer shall submit  
the data required in Rules 2 and 3 electronically to the department.  
(2) Reporting must utilize the data format specifications provided by the department.  
R 325.9085 Quality assurance.  
Rule 5. For purposes of assuring the quality of submitted data, each clinical laboratory  
or user of a portable blood lead analyzer shall allow the department to inspect copies of  
the medical records or laboratory test results that will be submitted by the clinical  
laboratory or user of a portable blood lead analyzer to verify the accuracy of the  
submitted data. Only the portion of the medical record that pertains to the blood lead  
testing must be submitted. The department shall protect the medical records submitted  
using reasonably appropriate privacy and security safeguards regardless of whether the  
medical records are received by the department in electronic or hard copy form.  
R 325.9086 Confidentiality of reports.  
Rule 6. (1) Except as provided in subrule (2) of this rule, the department shall  
maintain the confidentiality of all reports of blood lead tests submitted to the  
department and shall not release reports or information that may be used to directly link  
the information to a particular individual.  
(2) The department may release reports or information, otherwise protected under  
subrule (1) of this rule, under any of the following conditions:  
(a) If the department has received written consent from the individual, or from the  
individual's parent or legal guardian, requesting the release of information.  
(b) If necessary for law enforcement investigation or prosecution of a property  
manager, housing commission, or owner of a rental unit under section 5475a of the public  
health code, 2004 PA 434, MCL 333.5475a.  
(c) If the director of the department determines that release is crucial to protect the  
public health against imminent threat or danger.  
(d) As necessary for the department to carry out its duties under the public health code,  
1978 PA 368, MCL 333.1101 to 333.25211.  
(e) If necessary for the purpose of research designed to develop or contribute to  
generalizable knowledge, with documented approval by the department’s institutional  
review board.  
(f) If necessary for the purpose of public health activities designed to prevent or  
mitigate lead poisoning within a community.  
(3) Medical and epidemiological information that is released to a legislative body must  
not contain information that identifies a specific individual.  
(4) Aggregate epidemiological information concerning the public health that is released  
to the public for informational purposes only must not contain information that identifies  
a specific individual.  
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