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Title: Section 405.16 - Laboratory services

Effective Date


405.16 Laboratory services. The hospital shall provide laboratory services that meet the needs of the patients as determined by the medical staff and the hospital.

(a) The hospital shall ensure that all clinical laboratory services provided or arranged for by the hospital comply with article 5, title V of the New York State Public Health Law and with Subpart 58-1 (Clinical Laboratories) of this Title, or for facilities located in New York City, with article 13 of the New York City Health Code. Hospitals shall ensure that all blood banks and transfusion services comply with article 31 of the New York State Public Health Law and Subpart 58-2 (Blood Banks) of this Title.

(b) The hospital shall maintain an adequately organized and supervised clinical laboratory with the necessary staff, space, facilities and equipment to meet the needs of its patients.

(1) Emergency laboratory services shall be available 24 hours a day, seven days a week, including holidays.

(2) For emergency situations, the hospital shall have immediately available a minimum blood supply.

(3) A written description of all laboratory services provided shall be available to the medical staff.

(4) The laboratory shall make provision for the proper receipt and reporting of tissue specimens.

(c) Personnel. The hospital shall provide personnel qualified to direct and staff the laboratory.

(1) The hospital shall ensure that all laboratory services are conducted under the supervision of a director who holds a certificate of qualification issued by the New York State Department of Health or, where applicable, the New York City Department of Health.

(2) The laboratory director shall:

(i) provide technical supervision of all laboratory services, regardless of site;

(ii) assure that all tests, examinations and procedures are properly performed, recorded and reported;

(iii) Assure that all tests for hospital patients are ordered by a practitioner so authorized by the hospital;

(iv) assure that appropriate signatures are on all cytology and histopathology reports and that all reports are filed with the patient's medical record and duplicate copies kept in a manner which permits ready identification and accessibility;

(v) assure that the laboratory staff:

(a) have appropriate education, experience, and training to perform and report laboratory tests promptly and proficiently;

(b) are sufficient in number for the scope and complexity of the services provided; and

(c) receive inservice training appropriate to the type and complexity of the laboratory services offered; and

(vi) assure that there is a documented quality control program in effect for all laboratory services in accordance with the requirements outlined in Part 58 of this Title and in conjunction with the hospital-wide quality assurance program required by section 405.6 of this Part.

(d) Tissue examination. Tissue pathology services shall be provided by and under the direction of a pathologist possessing a certificate of qualification issued by the New York State Department of Health or, where appropriate, the New York City Department of Health. The medical staff and the pathologist shall identify which tissue specimens require a macroscopic examination only and which tissue specimens require both macroscopic and microscopic examinations. Policies and procedures pertaining to the receipt and holding of tissue specimens shall be developed and implemented and shall, at a minimum, include the following:

(1) a pathologist shall be responsible for verifying the receipt of tissues for examinations;

(2) a plan is established in the absence of a pathologist for sending all tissues requiring examination to a qualified patholgist outside the hospital; and

(3) provisions for maintaining a tissue file in the hospital.

(e) Blood, blood products and transfusion services. The hospital shall ensure that there are facilities provided or readily available for the acquisition, safekeeping, transfusion and distribution of blood and that storage and use of blood products is under the direction of a blood bank director possessing a certificate of qualification issued by the New York State Department of Health, or where applicable, the New York City Department of Health.

(1) The hospital shall maintain, as a minimum, proper blood storage facilities under control and supervision of the blood bank director.

(2) In the case of services provided by an outside blood bank, the hospital shall have an agreement governing the acquisition, transfer and availability of blood and blood products, including plasma derivatives, that is reviewed and approved by the blood bank director, transfusion committee and administration.

(3) There shall be provision for prompt blood grouping, antibody detection, and compatibility testing, and for laboratory investigation of tranfusion reactions. (4) Blood storage facilities in the hospital shall have a temperature alarm system that is regularly inspected.

(5) Records shall be kept on file indicating the receipt and disposition of all blood and blood products acquired by the hospital.

(6) Samples of each unit of transfused blood and blood products, including plasma derivatives, shall be retained for further testing the event of reactions. The hospital shall promptly dispose of all blood not retained for further testing that has exceeded its expiration date.

(7) The hospital, according to its established procedure, shall review all transfusions of blood or blood derivatives and promptly investigate and report all transfusion reactions. Procedures shall be established and implemented for ensuring that reports of all acute hemolytic transfusion reactions are made to the hospital-wide quality assurance program and to the department pursuant to section 405.8 of this Part and that, as appropriate, recommedations are made to the medical staff regarding improvements in transfusion procedures and practices.


VOLUME C (Title 10)