Title: Section 34-2.11 - Recall letters and reporting of test results

Effective Date

11/22/2017

34-2.11 Recall letters and reporting of test results. 

(a) A clinical laboratory shall not communicate to a patient of a referring health services purveyor that a clinical laboratory test, including, but not limited to a Pap smear, is or will be due to be performed, or that a visit to the health services purveyor for diagnosis or treatment is or will be due. A clinical laboratory shall not prepare such communication for the health services purveyor to send, or otherwise facilitate the preparation or sending of such communication by the health services purveyor. Such communication or its facilitation shall be deemed consideration given for referral of specimens for performance of clinical laboratory services, and is prohibited.

(b) A clinical laboratory shall not communicate to a patient of a referring health services purveyor the results of a clinical laboratory test, including, but not limited to, a Pap smear. A clinical laboratory shall not prepare such communication for the health services purveyor to send, or otherwise facilitate the preparation or sending of such communication by the health services purveyor. Such communication or its facilitation shall be deemed consideration given for referral of specimens for performance of clinical laboratory services and is prohibited, except that:

(1) a clinical laboratory may communicate in writing to the patient (by mail or electronically) an accurate and complete account of the result of the laboratory test along with information required to be included in a report of test results pursuant to Subpart 58-1 of this Title under the following circumstances:

(i) the laboratory test results have already been, or are simultaneously being communicated to the referring health services purveyor authorized by law to order and use the results of laboratory tests;

(ii) the clinical laboratory advises the patient that the referring health services purveyor authorized by law to order and use the results of laboratory tests has received or is receiving the test results;

(iii) the clinical laboratory shall include, in the communication to the patient, a clear statement, presented in a prominent manner, to the effect that the communication should not be viewed as medical advice and is not meant to replace direct communication with a physician or other health service purveyor; 

(iv) the clinical laboratory directs the patient's inquiries regarding the meaning or interpretation of the test results to the referring health services purveyor; and

(v) the communication to the patient does not include any information which would be consideration given for referral of specimens, including, but not limited to, medical advice specifically directed at the patient concerning the patient’s condition, including diagnosis or treatment of the patient’s condition. 

(2) nothing in this subdivision shall prohibit a licensed physician from communicating with a patient:

(i) when requested by the referring health services purveyor;

(ii) when requested by the patient; or

(iii) when the referring health services purveyor, or other health services purveyor responsible for using the test results, cannot be reached and a critical value needs to be communicated to the patient.

Volume

VOLUME A-1 (Title 10)

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