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 34-2.7 - Employees

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Except as
					 provided in subdivision (b) of this section, employees, agents or other
					 fiduciaries of any clinical laboratory, when supplied by the clinical
					 laboratory to a referring health services purveyor to perform functions and
					 duties in the facility of the health services purveyor, shall be deemed
					 consideration given for referral of specimens for performance of clinical
					 laboratory services, and is prohibited.
(b) Nothing in Public Health Law, section
					 587 or in this Subpart shall be construed as
					 prohibiting a hospital or an HMO and a clinical laboratory from entering into a
					 contract for laboratory management services, including provision of technical
					 services and employees for the performance of functions directly related to
					 clinical laboratory operations.
(c)
					 Payment or reimbursement by a clinical laboratory to a health services purveyor
					 for clinical laboratory services and/or directly related services, which had
					 been rendered by the health services purveyor or such purveyor's employees,
					 agents or fiduciaries, shall be deemed consideration given for referral of
					 specimens for performance of clinical laboratory services, and is prohibited.
					 However, a clinical laboratory may enter into a written contract with a
					 hospital, HMO or another clinical laboratory for the provision of phlebotomy
					 services, clinical laboratory services, or directly related services to the
					 contracting clinical laboratory, provided such services are rendered at fair
					 market value and not in connection with individuals who are patients or clients
					 of the hospital, HMO or other clinical laboratory.
(d) Nothing in this Subpart shall prohibit
					 the employees, agents or fiduciaries of a clinical laboratory from visiting a
					 residence for the purpose of drawing blood, or otherwise obtaining or
					 collecting specimens, provided that:
(1) such
					 visits shall not result in a substantially permanent presence and shall be
					 established according to a schedule, available in the laboratory, or upon
					 specific request of the health care provider or other authorized person
					 responsible for care of the patient, and documented by the
					 laboratory;
(2) while at the
					 residence, the employees, agents or fiduciaries of the laboratory do not
					 provide any supplies, services or assistance, directly or indirectly, to the
					 operators, nursing or medical staff or other individuals other than as stated
					 in this Subpart; and
(3) during
					 such visits, the activities of the employees, agents or fiduciaries of the
					 laboratory are limited to:
(i) reviewing the
					 orders for laboratory tests from the patient's health services purveyor,
					 without reviewing the patient's chart;
(ii) scheduling the collection of specimens
					 for future tests, without reviewing the patient's chart;
(iii) collecting specimens;
(iv) labeling the collected
					 specimens;
(v) recording the number
					 and kinds of specimens collected;
(vi) taking steps necessary to ensure that
					 the test requisition forms are properly completed pursuant to orders from the
					 patient's health care provider;
(vii) centrifuging blood specimens;
(viii) causing adequate and sanitary
					 equipment and supplies to be maintained, when appropriate, at a residence,
					 solely for the collection, preservation and transport of specimens;
					 and
(ix) taking steps necessary to
					 ensure the integrity of specimens which are stored, when appropriate, at a
					 residence awaiting transport to the clinical laboratory; and
(4) no rent is paid by the
					 clinical laboratory for the storage of equipment and supplies or specimens, or
					 for any other purpose.