Current through Register Vol. 46, No. 39, September 25, 2024
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
pathologist 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 transfusion 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, recommendations are made to the medical staff regarding
improvements in transfusion procedures and practices.
