TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER d: LABORATORIES AND BLOOD BANKS
PART 465 CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES
SECTION 465.420 RECORD MAINTENANCE


 

Section 465.420  Record Maintenance

 

a)         All records that the laboratory is required to maintain shall be recorded in indelible ink with any changes lined through so that the original entry is visible.  Changes shall be initialed and dated. Documentation supporting all corrections on records shall be maintained.  Electronic records and signatures are allowed.  See General Provisions, Electronic Commerce Security Act [5 ILCS 175].

 

b)         A copy of the sample report form shall be maintained by the laboratory for at least 5 years.  If results are entered into a computer storage system, a printout of the data shall be returned to the laboratory for verification with bench sheets. Electronic records shall be made available in hard copy for on-site evaluation.  Electronic data shall always be backed up by protected tape, disk, or hard copy.  If the laboratory changes its computer hardware or software, it shall make a provision for transferring old data to the new system so that it remains retrievable within the time frames specified.  See Good Automated Laboratory Practices, EPA 2185, Office of Information Management, Research Triangle Park NC 27711, August 10, 1995.

 

c)         Records of bacteriological analyses shall be kept for at least 5 years.  Actual laboratory reports may be kept.  However, data may be transferred to tabular summaries, which shall include the following information:

 

1)         Date, place, and time of sampling;

 

2)         Name of person who collected the sample;

 

3)         Identification of the sample origin, such as routine distribution sample, resample, construction sample, raw or process water sample, surface or ground water sample, or other special purpose sample;

 

4)         Date and time of receipt of sample in the laboratory;

 

5)         Records necessary to establish chain-of-custody of the sample;

 

6)         Date and time of sample analysis;

 

7)         Name of the persons and designation of the laboratory responsible for performing the analysis;

 

8)         Designation of the analytical techniques or methods used; and

 

9)         Results of the analysis.

 

d)         The disposal of all records subject to the Local Records Act [50 ILCS 205] shall be in accordance with the provisions of that Act and Section 465.430.

 

(Source:  Amended at 35 Ill. Reg. 14494, effective August 12, 2011)