New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-1 - Clinical Laboratories › Section 58-1.11 - Reports and records

Current through Register Vol. 46, No. 28, July 10, 2024
(a) When
					 requested, a laboratory shall submit reports containing such information and
					 data concerning its technical operation as may be specified by the department.
					 Such reports shall be signed both by the owner and director of the
					 laboratory.
(b) Each clinical
					 laboratory or blood bank shall have records indicating the daily accession of
					 specimens and containing the following information:
(1) The laboratory shall have an accession
					 system which may be a computerized accession system. It shall include:
(i) the accession number or other
					 identification of the specimen;
(ii) the name or other identification of the
					 person from whom the specimen was taken;
(iii) the date the specimen was received in
					 the laboratory;
(iv) the test or
					 tests requested for that specimen;
(v) if the request for the test was oral and,
					 contrary to the requirements of subdivision (b) of section
					 58-1.7  of
					 this Subpart, the request was not followed by a written request, a statement to
					 that effect, provided that, in the case of a computerized accession system,
					 such a statement may be recorded in a separate accession log;
(vi) in the event a specimen is forwarded to
					 another clinical laboratory for tests, the name of such other laboratory, the
					 date upon which the specimen was forwarded, the date it was tested or the
					 result or results were reported, and the date the report of findings was
					 received from such laboratory, provided that, in the case of a computerized
					 accession system, such information may be recorded in a separate accession
					 log;
(vii) a brief description of
					 the condition of unsatisfactory specimens when received, for example, broken,
					 leaked, hemolyzed, turbid, etc. 'ovided that, in the case of a computerized
					 accession system such information may be recorded in the laboratory report
					 required by paragraph (2) of this subdivision;
(viii) if the specimen is not received from
					 another laboratory either:
(a) the date the
					 specimen was tested; or
(b) the
					 date the result was reported, provided that the testing date or dates are
					 available upon the request of the originating physician for the same period of
					 time specified in subdivision (c) of this section for the retention of the
					 report, unless the information required by clause (a) or (b) is recorded in the
					 laboratory report required by paragraph (2) of this subdivision;
(ix) the hour, if required, when
					 the specimen was received in the laboratory, unless such information is
					 recorded in the laboratory report required by paragraph (2) of this
					 subdivision;
(x) the name of the
					 licensed physician or other authorized person or clinical laboratory or blood
					 bank submitting the specimen, unless such information is recorded in the
					 laboratory report required by paragraph (2) of this subdivision;
(xi) where a computerized accession system is
					 in use, hard copy (computer generated) accession records shall be available to
					 the laboratory staff or other authorized person in the laboratory for three
					 months from the receipt of the specimen and shall contain all information
					 required by paragraph (1) of this subdivision to be recorded in a computerized
					 accession system.