Section 34-2.7 - Employees

34-2.7 Employees.

(a) Except as provided in subdivision (b) below, 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; and

(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;

(vi) centrifuging blood specimens;

(vii) 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

(viii) 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.

Effective Date: 
Wednesday, December 26, 2001
Doc Status: 
Complete