Section 58-1.11 - Reports and records

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.; provided 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.
 

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