reglab/statecodes huggingface dataset:
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart H - SPECIAL REQUIREMENTS PERTAINING TO BLOOD BANKS › Section 450.810 - General

Current through Register Vol. 48, No. 28, July 12, 2024
Blood banks operating in Illinois shall be licensed by the
				  FDA under 21 CFR 600, 601, 606, 607, 610, 630 and 640.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart I - PROHIBITED PRACTICE › Section 450.920 - Terms Not to be Used in Names of Laboratories

Current through Register Vol. 48, No. 28, July 12, 2024
The term "certified", "approved", "qualified", or like terms
				  shall not be incorporated in the name of any laboratory, nor shall such terms
				  be used in connection with any laboratory.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart I - PROHIBITED PRACTICE › Section 450.930 - Prohibitions in Advertising and Announcements

Current through Register Vol. 48, No. 28, July 12, 2024
Since permitting and licensing under the provisions of the
				  Act does not imply approval but serves merely as notice to the Department of
				  the location of facilities and the character of program and services, there
				  shall be no reference in any advertisement or announcements expressing or
				  implying approval by the Department.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart I - PROHIBITED PRACTICE › Section 450.950 - Referral of Specimens for Examination to Unlicensed Laboratories

Current through Register Vol. 48, No. 28, July 12, 2024
No clinical laboratory shall refer specimens for examinations
				  to unlicensed laboratories, except that referral of laboratory examinations to
				  the laboratory or blood bank of a hospital licensed under the Hospital
				  Licensing Act is not considered a violation of the Act and this
				  Part.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart J - RECORDS AND REPORTS › Section 450.1010 - Necessary Records

Current through Register Vol. 48, No. 28, July 12, 2024
a)
				Complete records in regard to each specimen examined shall be kept on file in
				the laboratory for not less than five years. The records shall contain:
1) Laboratory number or other identification
				of the specimen.
2) The name of the
				person from whom the specimen was taken, except in cases of anonymous HIV
				testing or of anonymous or coded premarital syphilis testing. The names and
				addresses of persons who have chosen to have HIV testing done anonymously may
				not be recorded in the files, except that any existing records referring to
				testing done before anonymity was chosen may be retained without linkage to the
				anonymous testing.
3) The name of
				the licensed physician or other authorized person, clinical laboratory, or
				blood bank submitting the specimen.
4) The date the specimen was collected and
				the date the specimen was received in the laboratory.
5) When a specimen is forwarded to another
				clinical laboratory for tests, the name, the date when the specimen was
				forwarded to the laboratory, the date it was tested, and the date the report of
				the findings of the test was received from the laboratory.
6) In case the specimen is an unsatisfactory
				specimen, the condition of the specimen when received.
7) The types and numbers of tests performed
				annually.
8) The results of the
				test conducted by the laboratory, the method used, the signature of the
				examiner.
9)
Clinical
				laboratory test results may be reported or transmitted to
:
A)
The licensed physician,
the patient if requested,
or other authorized person who requested the
				test, their designee, or both;
B)
Any health care provider who is
				providing treatment to the patient
; or
C)
An electronic health information
				exchange for the purposes of transmitting, using, or disclosing clinical
				laboratory test results in any manner required or permitted by
				HIPAA.
10)
No interpretation, diagnosis, prognosis, or suggested treatment shall
				appear on the laboratory report form, except that a report made by a physician
				licensed to practice medicine in Illinois, a dentist licensed in Illinois, or
				an optometrist licensed in Illinois may include that
				information.
11)
Nothing in this
Part
prohibits the sharing of
				information as authorized in Section 2.1 of the Department of Public Health
				Act.
(Section 7-102 of the Act)
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart K - QUALITY CONTROL › Section 450.1110 - Responsibilities of Director

Current through Register Vol. 48, No. 28, July 12, 2024
The director(s) of a clinical laboratory shall:
a) Establish, implement, monitor, and
				document a quality control program which at a minimum meets the requirements of
				this Subpart. This quality control program shall include documentation of
				corrective actions taken.
b)
				Determine the laboratory procedures which will be performed and the instruments
				and methodologies that will be used.
c) Establish a program to validate new
				procedures before laboratory results are reported. The validation procedure for
				quantitative methods must have provisions to determine accuracy and
				precision.
d) In accordance with
				the weekly schedule established by the Director, assess the activities of the
				laboratory by personal observation, evaluation, and review of reports of
				laboratory findings. The director shall establish a policy for review of all
				abnormal findings.
e) Determine the
				format of laboratory report forms and decide what information is to be
				contained on the report forms.
f)
				In accordance with the weekly schedule established by the Director, consult
				with supervisors and other staff members and review the adequacy of the quality
				control program.
g) Confer with
				those served by the laboratory on matters that relate to test performance and
				determine the nature and scope of technical and administrative information to
				be released by the laboratory staff.
h) Ensure that proper personnel
				qualifications are met. (See Subpart D)
i) Ensure that all reagents used in the
				laboratory are not beyond their expiration date.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart K - QUALITY CONTROL › Section 450.1120 - Reference Materials

Current through Register Vol. 48, No. 28, July 12, 2024
a)
				Reference materials shall be used for each test procedure.
b) Statistical methods, using at least 20
				measurements, shall be used to calculate the mean value and standard deviation
				and set action limits for at least one reference material for each quantitative
				test.
c) The results of the
				analysis of the reference material(s) for each day of testing shall be recorded
				and shall be clearly displayed. Action limits shall be clearly displayed and
				used to detect problems. Results and action limits shall be available for
				inspection.
d) Each test procedure
				shall have a plan for remedial action to be taken in response to detected
				problems as soon as discovered.
e)
				When lot numbers (batches) of reference materials are changed, the old and new
				lots shall be tested in parallel until suitable action limits are obtained for
				the new lot.
f) All methods which
				do not have reference materials shall be controlled by duplicate testing with
				established tolerance limits.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart K - QUALITY CONTROL › Section 450.1130 - Preventative and Corrective Maintenance Program

Current through Register Vol. 48, No. 28, July 12, 2024
A preventive and corrective maintenance program shall be
				  established which includes appropriate periodic inspection and testing of
				  laboratory equipment. The requirements are given in Subpart
				  E.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart K - QUALITY CONTROL › Section 450.1150 - Quality Control System Methodologies

Current through Register Vol. 48, No. 28, July 12, 2024
a) Hematology
1) Manual Procedures
A) Each procedure shall be checked or
				recalibrated each day of use with standards (calibrators) or reference
				materials covering the range of expected values. See Section
				450.520
				for checking dilutors and samplers.
B) Hemoglobin - methodology shall be
				calibrated monthly with standards that cover at least three concentrations and
				a zero point.
C) Hematocrit -
				Optimum packing time of microhematocrit centrifuges shall be determined before
				being placed into use and after major adjustments or repairs. The speed of the
				microhematocrit centrifuge shall be checked monthly. Tolerance limits shall be
				established. Timer checks shall be performed monthly. Tolerance limits shall be
				established.
D) Red and White cell
				counts - The hemocytometer counting chamber and coverslip shall be maintained
				in a condition that does not interfere with cell recognition or the volume of
				the chamber. Coverslips certified by the Bureau of Biological Standards shall
				be used. Counts shall be performed with certified pipettes or pipettors whose
				accuracy has been determined by the manufacturer.
E) Platelet counts - Manual platelet counts
				shall be performed by counting both sides of the chamber. Tolerance limits
				shall be established. A procedure to compare platelet results with the
				differential blood film shall be established.
F) Differential Leukocyte count - Blood
				smears shall be prepared and stained by a method which produces smears in which
				morphologic cell features can be evaluated. Cellular morphology shall be
				examined and platelets estimated routinely with the differential
				count.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart K - QUALITY CONTROL › Section 450.1155 - Cytology

Current through Register Vol. 48, No. 28, July 12, 2024
Cytology services at all clinical laboratories shall comply
				  with the following requirements:
a)
				Personnel
1) Director of the clinical
				laboratory shall meet the requirements set forth in Section
				450.210
				of this Part.
2) Supervisor of
				clinical laboratory personnel shall meet the requirements set forth in Section
				450.410 of
				this Part.
3) Cytotechnologist
				shall meet the requirements set forth in Section
				450.430 of this
				Part.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart L - HIV CONTAMINATED BLOOD AND HUMAN TISSUE › Section 450.1200 - Handling and Disposal of HIV Contaminated Blood and Human Tissue

Current through Register Vol. 48, No. 28, July 12, 2024
a) Any blood or
				components, organs, semen or other human tissue showing exposure to HIV as
				evidenced by two of three reactive ELISA test results (according to the package
				insert - product circular) or any other identified causative agent of AIDS or
				originating from a patient diagnosed with AIDS or AIDS-Related Complex (ARC) as
				defined in 77 Ill. Adm. Code
				693.20,
				shall be disposed of in accordance with the provisions of this Section, unless
				a research facility licensed by the State requests, in writing, the use of such
				blood for AIDS research. (Section 3.1 of the Blood Labeling Act.) Any such
				blood or human tissue shall be disposed of in accordance with Section
				450.1200(b)
				when no longer being used for research purposes.
1) A research facility, for the purposes of
				this Section, shall mean any clinical laboratory licensed under the Act, any
				blood bank licensed under the Blood Bank Act or any hospital licensed under the
				Hospital Licensing Act.
2) Any
				person delivering such blood or blood components, organs, semen or other human
				tissue to research facilities pursuant to such a request shall file with the
				Department a report which shall include at least the following information:
A) a copy of the request for blood or human
				tissue:
B) the quality of blood or
				human tissue delivered:
C) the name
				and location of the research facility to which the blood or human tissue was
				delivered; and
D) the date and time
				of delivery. (Section 620-3.1 of the Act.)
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart M - HEALTH SCREENING › Section 450.1300 - Health Screening and Approved Health Screening Tests

Current through Register Vol. 48, No. 28, July 12, 2024
a)
All health screenings shall be
				conducted under a protocol approved by a physician licensed to practice
				medicine in all its branches that includes, but is not limited to, provisions
				concerning disclosure of the purpose and limitations of the screening tests to
				test subjects, proper collection of samples, and administration of tests,
				including staffing, staff training and equipment monitoring, adequate
				procedures for protecting the confidentiality of test subjects and test
				results, and appropriate referrals for medical attention. (Section 2-120(a) of
				the Act):
b)
Health screening protocols in this Part shall be exempt from the
				provisions of Sections 7-101 and 7-102 of the Act. (Section 2-120(b) of the
				Act):
c) Health screening
				tests shall not be used as diagnostic tests.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart M - HEALTH SCREENING › Section 450.1330 - Reporting and Notification

Current through Register Vol. 48, No. 28, July 12, 2024
a) All
				health screening entities shall file a protocol with the Department in
				accordance with Subpart M.
b) All
				health screening entities shall notify the Department of all health screening
				sites , including street address, city, zip code and any other identifying data
				that are available , at least seven days prior to any health screening
				event.
c) All health screening
				entities shall notify the Department of all personnel anticipated to conduct
				any health screening event at least seven days prior to any health screening
				event.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart A - GENERAL PROVISIONS › Section 465.110 - Scope and Applicability

Current through Register Vol. 48, No. 28, July 12, 2024
a)
				This Subpart A establishes general provisions applicable to the certification
				program for environmental laboratories administered under this Part.
b) Nothing in this Part shall prevent
				uncertified laboratories from performing any quality control or other tests
				when the State has not required such tests to be performed by a certified
				laboratory.
c) Principal State
				Laboratory is exempt from administration under this Part.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart A - GENERAL PROVISIONS › Section 465.130 - Certification Procedure

Current through Register Vol. 48, No. 28, July 12, 2024
a) An
				environmental laboratory that meets or exceeds the minimum criteria for
				certification may receive certification from the Department for any
				microbiological parameter for which a methodology has been specified in this
				Part or for which an alternative methodology has been approved in accordance
				with the provisions of this Part.
b) The operational aspects of an
				environmental laboratory that will be evaluated in considering a request for
				certification are:
1) laboratory
				facilities,
2) personnel,
3) methodology and instrumentation,
4) data handling, and
5) quality assurance program.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart A - GENERAL PROVISIONS › Section 465.140 - Conditions Governing the Use of Certificates

Current through Register Vol. 48, No. 28, July 12, 2024
a) Certification of environmental
				laboratories shall be effective for a two-year period from the date of issue,
				unless modified or revoked by the Department. Renewal certification will be
				granted after successfully passing a biennial audit.
b) Certification shall be limited to those
				parameters for which an environmental laboratory has been approved and that are
				listed on the certificate of approval.
c) The certificate of approval shall be
				posted or displayed in a prominent place in the laboratory facility.
d) Information related to the certification
				of an environmental laboratory shall be accurately represented if used in any
				advertising and shall prominently include the statement that, "Certification by
				the State of Illinois is not an endorsement or a guarantee of the validity of
				the data generated." This information shall also specify the parameters for
				which the environmental laboratory has been certified. The advertising shall
				not include any representation that the environmental laboratory is certified
				to perform a type of analysis for which it lacks proper
				certification.
e) An environmental
				laboratory may surrender its certification voluntarily by notifying the
				Department in writing.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart A - GENERAL PROVISIONS › Section 465.150 - Provisional Certification

Current through Register Vol. 48, No. 28, July 12, 2024
a)
				Whenever a deficiency is found, a certified environmental laboratory may be
				placed on provisional certification. Provisional certification may be imposed
				for the following periods:
1) From 7 to 30
				days if the deficiency could compromise the quality of analytical data
				generated by the environmental laboratory; or
2) From 90 days to one year in the case of
				any other type of deficiency.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart A - GENERAL PROVISIONS › Section 465.170 - Changes in Ownership or Operations

Current through Register Vol. 48, No. 28, July 12, 2024
a) Certification shall not be transferable.
				In the event of a change of ownership, director, supervisor, or analyst, or
				relocation or major remodeling of the physical plant of an environmental
				laboratory, the Department shall be notified in writing within 15
				days.
b) After receiving
				notification of any of the changes listed in subsection (a), unless otherwise
				specified in this Part for a specific parameter, the Department may, as
				applicable, require the analysis of PTs by any new analyst, or make an on-site
				visit. However, the Department may waive any of these actions if it finds the
				actions to be unwarranted in a specific case. Examples of when the waivers
				would be appropriate include the following circumstances:
1) Waiver of submittal of a summary of
				education and experience when personnel transferring from one certified
				laboratory to another are responsible for dealing with the same analytical
				methods and equivalent equipment; and
2) Waiver of an on-site visit if the
				pertinent test procedures involve simple techniques and equipment. Supervisor
				must provide training documentation approved by the Department to be eligible
				for the waiver.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart A - GENERAL PROVISIONS › Section 465.180 - Revocation of Certification

Current through Register Vol. 48, No. 28, July 12, 2024
a) The
				Department may revoke all or any part of an environmental laboratory's
				certification. Any of the following shall be cause for partial or total
				revocation of certification:
1) Expiration of
				a period of provisional certification, provided the laboratory has not
				corrected the deficiencies after being placed on provisional certification in
				accordance with the provisions of Section
				465.150;
2) Unsatisfactory analyses of PTs as
				specified in Section
				465.200;
3) Failure to notify the Department within 15
				days after any of the changes listed in Section
				465.170
				have occurred;
4) Failure to comply
				with the requirements regarding advertising as specified in Section
				465.140(d);
5) Failure to use the analytical methodology
				specified in this Part or approved in accordance with this Part;
6) Failure to provide notice in accordance
				with Section
				465.150(b)
				of its status as a provisionally certified environmental laboratory;
7) Falsification of results of testing PTs or
				any other information material to the certification; or
8) When conducting PTs analysis in accordance
				with Section 465.200, failure to provide results proving satisfactory precision
				and accuracy in two successive samples shall be cause for revocation of
				certification for the parameter or method that is not within satisfactory
				limits.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart A - GENERAL PROVISIONS › Section 465.190 - Subcontracting by Certified Laboratories

Current through Register Vol. 48, No. 28, July 12, 2024
a) The name of the laboratory actually
				performing the analysis shall be specified on all reports of analytical
				results.
b) For those tests that
				are required to be performed under certification, any laboratory with which a
				certified environmental laboratory subcontracts shall also be a certified
				environmental laboratory.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart A - GENERAL PROVISIONS › Section 465.200 - Proficiency Testing Samples (PTs)

Current through Register Vol. 48, No. 28, July 12, 2024
a) An environmental laboratory is required to
				participate in proficiency testing samples (PTs) analyses for each analytical
				parameter or method for which it seeks or wishes to maintain certification in
				accordance with the certification procedures of Section
				465.130(c),
				the certification renewal procedures of Section
				465.140(a),
				and the quality assurance requirements contained in Subpart B of this
				Part.
b) Heterotrophic plate count
				and coliform Microbiological Water Supply (WS) PT samples shall be analyzed
				annually (every 12 months). Cryptosporidium PT samples shall be analyzed every
				four to six months. PT samples shall be analyzed in the same manner as routine
				samples. The laboratory shall document that the analyst analyzing any PT sample
				is a laboratory employee who routinely analyzes drinking water compliance
				samples.
c) Laboratories shall
				acquire the PT sample from a provider acceptable to TNI.
d) For methods used to test the presence or
				absence of an organism in a sample, each set shall contain 10 samples, all
				shipped at the same time in a lyophilized, dehydrated or aqueous state. The set
				shall include samples, in various combinations, that contain total coliforms,
				fecal coliforms, E. coli, non-coliforms, and at least one blank. Each set shall
				be used only with a single analytical method. For a PT result to be acceptable,
				the laboratory shall have no false negative results and no more than one false
				positive result for each set.
e)
				For quantitative methods, each set shall contain one sample. For a PT to be
				acceptable, the laboratory result shall be statistically acceptable as
				determined by the PT provider.
f)
				PT samples must be analyzed and reported within the PT provider's deadline. The
				PT provider shall submit the laboratory's results and acceptable ranges to the
				Department. No fee shall be charged to the Department for the
				analyses.
g) In the event of a
				failed or unacceptable PT set as defined in 465.200(d), the laboratory must
				request a quick turn-around PT from the provider.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart A - GENERAL PROVISIONS › Section 465.210 - Authority of Certification Officers

Current through Register Vol. 48, No. 28, July 12, 2024
Certification officers shall have all of the following
				  authority with regard to environmental laboratories:
a) To inspect such laboratories in scheduled
				on-site visits and unannounced on-site visits or remote audits in emergency
				circumstances. Remote audits will be followed up with an on-site visit at a
				later date;
b) To require the
				laboratory to provide information regarding the technical operation of the
				laboratory relevant to certification;
c) To inspect quality assurance records and
				any other records pertinent to certification;
d) To observe and question analysts at work
				on parameters or methods for which certification is sought; and
e) To grant or deny certification based upon
				the completion of the evaluation process.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart A - GENERAL PROVISIONS › Section 465.220 - Hearing, Decision and Appeal

Current through Register Vol. 48, No. 28, July 12, 2024
The following procedures are established for Department
				  certification actions which are required by law to be preceded by notice and
				  opportunity for hearing:
a) Prior to
				revocation or partial revocation, the Department shall give written notice to
				the laboratory director or owner. This notice shall include a description of
				the proposed action, the facts or conduct upon which the Department will rely
				to support its proposed action, and the procedures for requesting a
				hearing.
b) Notice given under
				subsection (a) above and any hearing requested following issuance of such
				notice shall be in accordance with the Department's "Rules of Practice and
				Procedure in Administrative Hearings" (77 Ill. Adm. Code 100).
c) If, however, the Department finds that an
				emergency situation warrants immediate action, summary suspension as provided
				for by Section 10-65(d) of the Illinois Administrative Procedure Act
				[5 ILCS
				100/10-65(d) ] may be ordered pending
				revocation proceedings. An emergency situation warrants immediate action if
				there is substantial risk to public health, safety, or welfare resulting from
				laboratory deficiencies that are compromising or are likely to compromise the
				analytical results obtained.
d) A
				final decision of the Director is appealable to the Circuit Courts under the
				Illinois Administrative Review Law [735 ILCS 5 /Art. III].
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart A - GENERAL PROVISIONS › Section 465.230 - Liability

Current through Register Vol. 48, No. 28, July 12, 2024
Representatives of the Department shall not waive the right
				  to seek recovery for injuries incurred while inspecting an environmental
				  laboratory facility.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart A - GENERAL PROVISIONS › Section 465.240 - Reciprocity Agreements

Current through Register Vol. 48, No. 28, July 12, 2024
Notwithstanding any other provision of this Part, the
				  Certification Program Manager of the Department may elect to enter into
				  agreements with the governments of other states or with federal governmental
				  units for recognition of their environmental laboratory inspections and
				  certifications if such certification program uses equivalent controls over
				  sample collection, data handling, quality control, analytical methods, and
				  personnel as required of environmental laboratories within
				  Illinois.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart B - MICROBIOLOGICAL ANALYSES OF PUBLIC WATER SUPPLY SAMPLES › Section 465.300 - Scope and Applicability

Current through Register Vol. 48, No. 28, July 12, 2024
This Subpart B establishes standards applicable to
				  environmental laboratories involved in microbiological analyses of samples of
				  water from public water supplies and their sources.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart B - MICROBIOLOGICAL ANALYSES OF PUBLIC WATER SUPPLY SAMPLES › Section 465.330 - Laboratory Equipment

Current through Register Vol. 48, No. 28, July 12, 2024
Only those instruments that are needed to analyze for the
				  parameters for which the laboratory is being certified are required, but those
				  instruments shall meet the following minimum specifications. A laboratory
				  performing all of the analyses described in Section
				  465.360 shall have,
				  or have access to, within the same building, all of the equipment listed in
				  this Section with the minimum specifications cited.
a) A top loading or trip pan balance shall be
				clean, not corroded.
1) A torsion or trip pan
				balance used for weighing materials of 2 grams or more shall detect 100 mg of
				weight accurately at a 150 gram load.
2) An analytical balance used for weighing
				quantities of less than 2 grams shall be sensitive to 1 mg at a 10 gram
				load.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart B - MICROBIOLOGICAL ANALYSES OF PUBLIC WATER SUPPLY SAMPLES › Section 465.350 - General Laboratory Practices

Current through Register Vol. 48, No. 28, July 12, 2024
a) The following requirements shall apply to
				sterilization procedures:
1) Autoclaving of
				the following items shall be carried out at 121°
										± 1° C for the
				durations specified below:
Item
Minimum duration of
autoclaving at 121°
															± 1° C
Membrane filters and pads
10 minutes
Carbohydrate-containing media (lauryl tryptose,
							 brilliant green lactose bile broth, etc.)
12-15 minutes
Contaminated materials and discarded tests
30 minutes
Membrane filter assemblies (wrapped), sample
							 collection bottles (empty), and individual glassware items
15 minutes
Rinse water volumes of 500 mL to 1000 mL
45 minutes
Rinse water volumes in excess of 1000 mL
Time adjusted for volume; check for sterility
Dilution water blanks
15 minutes
2)
				Membrane filters and pads and all media shall be removed from the autoclave
				immediately after completion of the sterilization cycle.
3) The maximum elapsed time for exposure of
				carbohydrate-containing media to any heat (from the time of closing the loaded
				autoclave to unloading) shall be 45 minutes.
4) Membrane filter assemblies shall be
				autoclaved between each sample filtration series. A UV sterilizer or boiling
				water may be used on membrane filter assemblies for at least two minutes to
				prevent bacterial carryover between sample filtrations, but shall not be used
				as a substitute for autoclaving between sample filtration series.
5) Dried glassware to be sterilized in a
				hot-air sterilizing oven shall be kept at 175°
										± 5° C for at
				least 2 hours.
6) Empty sample
				containers shall be moistened with several drops of distilled water before
				autoclaving to prevent an "airlock" sterilization failure.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart B - MICROBIOLOGICAL ANALYSES OF PUBLIC WATER SUPPLY SAMPLES › Section 465.360 - Methodology

Current through Register Vol. 48, No. 28, July 12, 2024
A laboratory shall be certified for all analytical methods
				  listed in subsection (a) that it uses for compliance purposes. At a minimum,
				  the laboratory shall be certified for one total coliform method and one fecal
				  coliform/E. coli method. In addition, for laboratories that may enumerate
				  heterotrophic bacteria (as measured by the Heterotrophic Plate Count) for
				  compliance with the Surface Water Treatment Rule (SWTR), the laboratory shall
				  be certified for either the Pour Plate Method or the SimPlate method for
				  heterotrophic bacteria.
a) The
				following methodology with the exception of 9221D and Chromocult, as specified
				in the listed references, shall be followed for individual parameters:
1) Analytical Methods Approved for Compliance
				Monitoring under the Revised Total Coliform Rule -
				40 CFR
				141.852(a)(5).
https://www.epa.gov/sites/default/files/2017-02/documents/rtcr_approved_methods.pdf
2) Analytical Methods Approved for Compliance
				Monitoring under the Surface Water Treatment Coliform Rule -
				40 CFR
				141.74(a)(1).
https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100WD7G.txt
3) Analytical Methods Approved for Compliance
				Monitoring under the Ground Water Rule -
				40
				CFR 141.402(c)(2).
https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100WD6V.txt
4) Appendix A to Subpart C of Part
				141.
https://ecfr.io/Title-40/Part-141/Appendix-A#40:25.0.1.1.3.3.16.10.5
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart B - MICROBIOLOGICAL ANALYSES OF PUBLIC WATER SUPPLY SAMPLES › Section 465.370 - Sample Collection, Handling and Preservation

Current through Register Vol. 48, No. 28, July 12, 2024
When the laboratory has been delegated responsibility for
				  sample collection, handling, and preservation, there shall be strict adherence
				  to correct sampling procedures, complete identification of the sample, and
				  prompt transfer of the sample to the laboratory as specified in "Standard
				  Methods for the Examination of Water and Wastewater." In addition, the
				  following standards for sample collection, handling, and preservation of
				  potable water samples shall be met:
a)
				For the sample to be representative of the potable water system, the sampling
				program shall include examination of the finished water at selected sites that
				systematically cover the distribution network.
b) Minimum sampling frequency shall be as
				specified in Revised Total Coliform Rule, 40 CFR 141.
c) Water shall be sampled from cold water
				taps that are free of aerators, strainers, hose attachments, and water
				purification devices. Prior to sampling, a steady flow of water shall be
				maintained from the tap for two to three minutes to clear the service
				line.
d) The sample bottle shall be
				filled allowing at least 1 inch of air space from the top to provide space for
				mixing. A minimum sample volume of 100 mL shall be collected. If a sample
				bottle is filled too full to allow for proper mixing, rather than pouring off
				and discarding a portion of the sample, the entire sample shall be poured into
				a larger sterile container and mixed properly, and the analysis shall
				proceed.
e) The sample report form
				shall be completed in indelible ink immediately after collecting the sample and
				shall contain the following information: name of system (public water system
				site identification number, if available); sample identification (if any); date
				and time of collection; sample site location; sample collector's name and
				organization (if not the water system); persons transporting the samples from
				the system to the laboratory (if not the sampler); sample type (e.g., routine,
				repeat); and total/free chlorine residual (if applicable).
f) When sample containers are prepared within
				the laboratory, the dechlorinating agent, 0.1 mL of a 3% solution of sodium
				thiosulfate shall be added to a 120 mL bottle to neutralize up to 5 mg/L.
				Volume added to larger bottles shall be adjusted to provide the same level of
				neutralization. Stock sodium thiosulfate solution shall be free of
				turbidity.
g) When the sample is
				delivered to the laboratory:
1) The following
				information shall be added to the sample report form:
A) Date and time of sample arrival;
				and
B) Name of the person receiving
				the sample for the laboratory; and
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart B - MICROBIOLOGICAL ANALYSES OF PUBLIC WATER SUPPLY SAMPLES › Section 465.380 - Standards for Laboratory Pure Water

Current through Register Vol. 48, No. 28, July 12, 2024
The following standards shall apply to all laboratory pure
				  water:
a) Laboratory pure water shall
				have these characteristics:
Parameter
Limits
Frequency
Conductivity
>0.5 megohms resistance or <2 micromhos/cm at
							 25° C
Monthly
Cd, Cr, Cu, Pb, Ni, Zn
Not greater than 0.05 mg/L per contaminant.
							 Collectively, no greater than 0.1 mg/L
Annually
Total Chlorine Residual 
							 1
<0.1 mg/L
Monthly
Heterotrophic Plate Count 
							 2
<500 CFU/mL
Monthly
Bacteriological Quality of Reagent Water 
							 3
Ratio of growth rate 0.8 to 3.0
Annually
1 DPD Method shall be used. Not
				  required if source water is not chlorinated.
2 Pour Plate Method. See Standard
				  Methods 9215E. SimPlate method.
3 See Standard Methods, Section
				  9020B, under Laboratory Supplies. This bacteriological quality test is not
				  needed for type II water or better, as defined in Standard Methods. The
				  bacteriological quality test is not needed for water with a conductivity <1
				  micromhos/cm at 25° C or resistivity >1 megohms. Users of purchased
				  bottled water are not exempt from the suitability test.
b) Laboratory pure water shall be analyzed
				initially and annually (every 12 months) thereafter by the test for
				bacteriological quality of distilled water as specified in "Standard Methods
				for the Examination of Water and Wastewater." Purchased laboratory pure water
				shall be sampled in-house; manufacturer's test results shall not be used to
				establish compliance. Only satisfactorily tested water shall be used in
				preparing media, reagents, rinse, and dilution water. If the water tested does
				not meet the testing requirements, the water shall not be used until corrective
				action has been taken and retesting determines that the testing requirements
				have been met.
c) Laboratory pure
				water shall be analyzed monthly for conductance, chlorine residual, and
				heterotrophic plate count. Heterotrophic plate counts shall be performed as
				specified in "Standard Methods for the Examination of Water and Wastewater." If
				the water tested exceeds requirements for these properties, the water shall not
				be used until corrective action has been taken and retesting determines that
				the testing requirements have been met.
d) Laboratory pure water shall not be in
				contact with heavy metals, and shall be analyzed initially and annually (every
				12 months) thereafter for trace metals (especially Pb, Cd, Cr, Cu, Ni, and Zn)
				in the quantities specified in subsection (a) of this Section. If the water
				tested exceeds requirements for trace metals, the water shall not be used until
				corrective action has been taken and retesting determines that the testing
				requirements have been met.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart B - MICROBIOLOGICAL ANALYSES OF PUBLIC WATER SUPPLY SAMPLES › Section 465.410 - Data Handling

Current through Register Vol. 48, No. 28, July 12, 2024
a) All
				records shall be initialed or signed by the person or persons responsible for
				recording all or any part of the data, or performing the various
				tests.
b) Either each unit shall be
				responsible for maintaining its own records, or all records shall be maintained
				in a general laboratory log book.
c) The laboratory shall record arrival time
				and date received in the laboratory, time and date of analysis, direct count,
				membrane filtration verified count, MTF completed count, analyst's name/unique
				initials, and other special information on each sample report form.
d) A careful check shall be made to verify
				that each result is entered accurately from the bench sheet onto the sample
				report form. The sample report form shall be initialed or signed by the person
				who verified the entry of information from the bench sheet.
e) All forms used in the laboratory for both
				sample reporting and quality control shall be approved by the certification
				officer to ensure that data is recorded in a format that is easily interpreted
				and that contains all necessary information.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart B - MICROBIOLOGICAL ANALYSES OF PUBLIC WATER SUPPLY SAMPLES › Section 465.420 - Record Maintenance

Current through Register Vol. 48, No. 28, July 12, 2024
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 Uniform Electronic Transactions Act [815 ILCS 333 ].
b) A copy of the sample report form shall be
				maintained by the laboratory for at least 5 years. A change in ownership,
				merger, or closure of a laboratory does not negate this requirement. As results
				are entered into computer storage system, data shall be verified against 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
				(including start and completion);
7) Name or unique initials 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.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 465 - CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES › Subpart B - MICROBIOLOGICAL ANALYSES OF PUBLIC WATER SUPPLY SAMPLES › Section 465.430 - Action Response to Laboratory Results

Current through Register Vol. 48, No. 28, July 12, 2024
a) For laboratory results concerning samples
				from public water supplies and their sources, if any sample is total coliform
				positive or E. coli-positive, the laboratory shall notify the State regulatory
				agency that has jurisdiction over the public water supply and the public water
				supply by the end of the day.
b)
				Presumptive positive microbiological test results are to be reported by the end
				of the day to State regulatory agency that has jurisdiction over the public
				water supply as preliminary without waiting for membrane filter verification or
				multiple tube fermentation (MTF) completion. After membrane filter verification
				or MTF completion or both, the verified results shall be reported. The State
				regulatory agency and the public water supply shall be notified when results
				indicate that non-coliforms may have interfered with the total coliform
				analysis, as defined in
				40 CFR
				141.21(c)(2).
c) A total coliform-positive result is based
				on the following:
1) The confirmed phase if
				the MTF is used; or
2) The verified
				test for the Membrane Filter Technique if M-Endo medium or LES Endo agar is
				used; or
3) The required color
				change - No requirement exists to confirm a total coliform-positive results
				using Colilert, Colisure, MI agar, E*Colite, m-ColiBlue24, Readycult, or
				Colitag test.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 470 - SPERM BANK AND TISSUE BANK CODE › Section 470.10 - Applicability

Current through Register Vol. 48, No. 28, July 12, 2024
This Part applies to all facilities, institutions and entities
				which collect, procure, furnish, process, distribute, or store semen or tissue
				for the purpose of injecting, transfusing or transplanting these into any human
				body.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 470 - SPERM BANK AND TISSUE BANK CODE › Section 470.20 - Definitions

Current through Register Vol. 48, No. 28, July 12, 2024
"Act" means Section
				55.45 of the Civil
				Administrative Code of Illinois (Ill. Rev. Stat. 1987, ch. 127, par.
				55.45).
"Department" means the Illinois Department of Public
				Health.
"Human Tissue" means an aggregation of morphologically and
				functionally similar cells including skin, organs, bone marrow, corneas, bones,
				muscle, oocytes (eggs), semen; except whole blood or its component parts.
				(Section
				55.45(d)
				of the Act.)
"Legally Authorized Representative" means an individual who is
				authorized to consent to HIV testing and/or disclosure of HIV test results for
				an individual who is:
Under the age of twelve (12).
Deceased,
Declared incompetent by a court of law, or
Otherwise not competent to consent (for reasons other than age
				such as the apparent inability to understand or communicate with the health
				care provider) as determined by the health care provider seeking such
				consent.
The following individuals shall be authorized to consent, in
				the stated order of priority:
For a living or deceased child under the age of eighteen
				(18):
Parent, legal guardian or other court-appointed personal
				representative,
Adult next-of-kin
For a living or deceased adult age eighteen (18) or
				over:
Agent authorized by durable power of attorney for health
				care,
Legal guardian or other court-appointed personal
				representative,
Spouse,
Adult children,
Parent,
Adult next-of-kin.
"Sperm bank" means any facility or program such as a person,
				hospital, clinic, corporation, or partnership that is involved in procuring,
				furnishing, donating, processing, storing or distributing human semen for the
				purpose of artifical insemination. (Section
				55.45(d)
				of the Act.)
"Test" or "HIV test" means a test to determine the presence of
				the antibody or antigen to HIV, or of HIV infection.
"Tissue bank" means any facility or program that is involved in
				procuring, furnishing, donating, processing, storing or distributing semen,
				corneas, bones, organs, or other human tissue for the purpose of injecting,
				transfusing or transplanting any of them in the human body. (Section
				55.45(d)
				 of the Act.)