New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter A - Vital Records And Personal Information › Part 34 - Health Care Practitioner Referrals And Laboratory Business Practices › Subpart 34-2 - Laboratory Business Practices › Section 34-2.11 - Recall letters and reporting of test results

Current through Register Vol. 46, No. 28, July 10, 2024
(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 refer- ring 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 refer- ring 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 in- formation 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.