Health and Human Services - Population Health and Community Services - Blood Lead Analysis Reporting


Published: 1997

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

DIVISION OF ENVIRONMENTAL HEALTH

BLOOD LEAD ANALYSIS REPORTING (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 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.

History: 1997 AACS; 2015 AACS; 2020 MR 3, Eff. Feb. 7, 2020.

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. (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.

Page 1 Courtesy of Michigan Administrative Rules

(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.

History: 1997 AACS; 2015 AACS; 2020 MR 3, Eff. Feb. 7, 2020.

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.

History: 1997 AACS; 2015 AACS; 2020 MR 3, Eff. Feb. 7, 2020.

R 325.9084 Electronic communications.

Page 2 Courtesy of Michigan Administrative Rules

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.

History: 1997 AACS; 2015 AACS; 2020 MR 3, Eff. Feb. 7, 2020.

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.

History: 1997 AACS; 2015 AACS; 2020 MR 3, Eff. Feb. 7, 2020.

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.

Page 3 Courtesy of Michigan Administrative Rules

History: 1997 AACS; 2015 AACS; 2020 MR 3, Eff. Feb. 7, 2020.

R 325.9087 Rescinded. History: 1997 AACS; 2015 AACS.

Page 4 Courtesy of Michigan Administrative Rules