N.Y. Comp. Codes R. & Regs. Tit. 10 § 58-1.11 - Reports and records
(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.
(2)
Each clinical laboratory or blood bank shall produce a laboratory report and
shall supply the original of said report to the physician or other authorized
person submitting each specimen for analysis. Each laboratory shall retain a
duplicate copy of the report. Pathology reports shall utilize an accepted
system of disease nomenclature. Each report shall contain the following
information:
(i) patient name or other
identification and the name of the person or institution referring the
specimen;
(ii) the result of the
laboratory test or tests;
(iii) the
date, and hour if required, when the specimen was originally collected by the
physician or other authorized person;
(iv) the name under which the laboratory has
been issued a permit and its address;
(v) any information required to be recorded
by paragraph (1) of this subdivision;
(vi) reports including numerical results
shall include normal values, reference intervals, or similar method for
identifying abnormal values. Alternative procedures other than reporting these
values on the report may be approved by the department; and
(vii) if the specimen is received from
another laboratory, either the date the specimen was tested or the date the
result was reported, provided that the testing date or dates are available upon
request of the originating physician or forwarding laboratory for the same
period of time specified in subdivision (c) of this section.
(c) All records and
reports of tests performed including the original or duplicates of original
reports received from another laboratory shall be kept on the premises of both
laboratories and shall be exhibited to representatives of the department on
request. Records listed below shall be retained by the laboratory for at least
the period specified. If other New York State or Federal regulations or
statutes require retention for different periods of time, the laboratory shall
retain the appropriate record for the longest period applicable. Records shall
be retained in their original form for a period of three months and may
thereafter be stored on microfilm, microfiche, or other photographic record, or
as magnetic tapes or other media in an electronic data processing system. Such
records shall be adequately protected against destruction, either by archival
storage of duplicated photographic or electronic medium or by other suitable
means providing equivalent protection. Records which are required to be
retained for more than two years may, after two years, be stored off the
immediate laboratory premises, provided they can be available to the laboratory
staff or other authorized person in the laboratory within 24 hours of a request
for records.
(1) Requests for tests shall be
retained for the same period of time as required for the test results or seven
years, whichever is less, except that referral information for cytogenetic
cases shall be retained for six years.
(2) Accession records shall be retained for
seven years.
(3) Records of quality
control results shall be retained for two years.
(4) Preventative maintenance, service and
repair records shall be retained for as long as the instrument remains in use,
except that records of monitoring of temperature-controlled spaces shall be
kept for one year.
(5) The
following types of laboratory reports shall be retained for at least the period
specified:
(i) tissue pathology including
exfoliative cytology--20 years;
(ii) syphilis serology--negative report--two
years;
(iii) cytogenetics--25
years; and
(iv) all others--7
years.
(6) Worksheets
containing instrument readings and/or personal observations upon which the
outcome is based shall be retained for one year.
(d) The following requirements shall apply to
the retention and disposition of specimens:
(1) Specimens shall be retained so as to be
accessible to the laboratory within 24 hours for at least the period set forth
below:
(i) blood film--other than routine--1
year;
(ii) blood film--routine--6
months;
(iii) bacteriology slide on
which a diagnosis depends--1 year;
(iv) cytology slide showing any
abnormality--7 years;
(v) cytology
slide showing no abnormality--3 years;
(vi) tissue block--20 years;
(vii) histopathology block--20
years;
(viii) histopathology
slide--20 years;
(ix) bone marrow
biopsy--20 years;
(x) cytogenetic
slide--6 years;
(xi) photographic
slide of cytogenetic karyotype--25 years; and
(xii) recipient blood specimens--1 week
stoppered at 6° C.
(2)
All specimens shall be disposed of in a manner designed to minimize the
likelihood of causing infection to any member of the public or laboratory
staff. The laboratory shall have a written protocol which shall be available to
the department for inspection, describing its procedures for the disposal of
specimens.
Notes
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