Section 450.5  Scope and Applicability

 

a)         This Part provides regulatory oversight of all entities certified pursuant to 42 CFR 493, that perform analysis of human specimens for health assessment or to diagnose, prevent or treat disease.

 

b)         All certified CLIA laboratories will be regulated as set forth in 42 CFR 493 and described in the State Operations Manual (Appendix C – Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services), issued by the Department of Health and Human Services.

 

c)         Licensed Laboratory

 

1)         As set forth in this Part, a "licensed" laboratory is a laboratory licensed by the Department under the standards set forth in CLIA laws and regulations (CLIA Law) to accept and test clinical human specimens from a person, in accordance with Article VII of the Act.

 

2)         The licensed laboratory shall maintain certification status in good standing as required by CLIA Law.

 

d)         Physicians, corporations, individuals, local health authorities, and others that intend to conduct clinical tests on human specimens for health assessments or to diagnose, prevent or treat disease shall obtain certification status by the Department in accordance with CLIA Law. Health screening activities under Section 2-120 of the Act may be conducted by a licensed laboratory at the laboratory location listed on the CLIA certificate; however, health screening events shall be conducted in accordance with Sections 450.1300, 450.1310, and 450.1330.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.10  Definitions

 

"Act" or "Clinical Laboratory Act" − the Illinois Clinical Laboratory and Blood Bank Act.

 

"Approved Clinical Laboratory" − a laboratory certified under the federal Clinical Laboratory Improvement Amendments (CLIA) of 1988.

 

"CLIA Law" – the Clinical Laboratory Improvement Amendments of 1988 (amendments to the Public Health Service Act (42 USC 263a)) and the related federal regulations.  Establishes quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid, and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or of assessment of health.

 

"Clinical Laboratory" or "Laboratory" − a facility which performs laboratory tests or issues reports resulting from tests.  For the purposes of this Part, "Clinical Laboratory" or "Laboratory" does not include forensic laboratories.  (Section 2-103 of the Act)

 

"Controlled Substance" − a drug, substance, or immediate precursor as defined in the Illinois Controlled Substances Act.

 

"Demonstration of Proficiency" − when a laboratory meets the standards for acceptable proficiency testing as stated in Section 450.720(a) by means of on site analysis of specimens sent to the laboratory by agencies approved by the Department for that purpose.

 

"Department" − the Department of Public Health of the State of Illinois.  (Section 2-105 of the Act)

 

"Director" – the Director of the Department of Public Health.

 

"Director of Clinical Laboratory" or "Laboratory Director" – an individual who administers the technical and scientific operation of a clinical laboratory, including the reporting of the findings of clinical laboratory tests.  (Section 2-104 of the Act)

 

"FDA" − Food and Drug Administration within the United States Department of Health and Human Services (HHS).

 

"Full-time Experience" − experience in the field being referred to consisting of at least 35 hours per week conducting activities required by the specific position or field such as conducting the tests referred to in Section 2-103 of the Act.

 

"Health Screening" – tests or categories of tests set forth in the Act and this Part that are performed for the purpose of assessing a phase of the general state of health of human subjects  (Section 2-120 of the Act).

 

"HHS" – the United States Department of Health and Human Services.

 

"Licensed Clinical Laboratory" – a laboratory licensed by DPH based on certification by the Centers for Medicare & Medicaid Services (CMMS) in accordance with CLIA.

 

"Physician" − unless otherwise indicated in the Act and this Part, a person licensed by the Department of Professional Regulation, pursuant to the requirements of the Medical Practice Act of 1987; (i.e., a physician licensed to practice medicine in all its branches and a chiropractic physician) or a person licensed as a physician under the laws of another state or territory of the United States. (Section 2-116 of the Act).

 

"Prepackaged Reagent Analyzer" − an automated instrument in which a specimen or a diluted specimen is reacted with reagents contained within individual packet(s) containing all of the measured reagents required for the analysis for a given analyte.

 

"Single Practice" − a medical, dental or podiatric practice, or a partnership, professional service corporation, or medical corporation of one or more licensed practitioners who share facilities, personnel, income and expenses for a clinical laboratory that is used solely as an adjunct to the care of patients of the members of the single practice.

 

"Test" − laboratory examinations and issuance of reports resulting from the biological, microbiological, serological, chemical, immunohematological, radioimmunological, hematological, biophysical, cytological, pathological, toxicological or other examination of materials derived from the human body for the purposes of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of, the health of humans including determining drug use by humans. (Section 2-117 of the Act).

 

"Toxicology Laboratory" − a licensed laboratory that performs tests to detect drug abuse in the workplace, among job applicants, or for other similar purposes.

 

"Waived Test" – a test system, assay or examination that HHS has determined meets the CLIA statutory criteria as specified for waiver under Section 353(d)(3) of the Public Health Service Act that has been determined to be so simple as to pose no risk of harm if performed incorrectly.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.20  License Application

 

a)         All applications shall be submitted on forms provided by the Department, shall be notarized, and shall include all information requested on the form.

 

b)         If the licensed provider has a change of owner, location, or name of the laboratory, the Department shall be notified of the change in writing within 30 days following the change by one of the following methods:

 

1)         U.S. Mail to:  Illinois Department of Public Health, Office of Health Care Regulation, Division of Health Care Facilities and Programs, 525 West Jefferson Street, Fourth Floor, Springfield, Illinois 62761; or

 

2)         Facsimile to:  217-782-0382, attention:  Division of Health Care Facilities and Programs.

 

c)         The description of the program shall be provided in sufficient detail to permit the Department to determine the fields of science represented by the services of the laboratory and the tests which may fall within the scope of its program and services.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.30  Laboratories Covered

 

The following are required to be licensed by DPH:

 

a)         All clinical laboratories and blood banks located within the State of Illinois.  This includes facilities that issue reports resulting from laboratory examinations, but do not perform laboratory examinations at that facility. (See Section 2-103 of the Act.)

 

b)         Laboratories located in hospitals licensed under the Hospital Licensing Act that are not operated by the governing authority of the hospital, including laboratories operating under a lease arrangement with another person or entity.

 

c)         Laboratories outside of Illinois receiving specimens referred from laboratories located in Illinois shall be certified under CLIA Law, or certified by, and in good standing with, their state laboratory program.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.35  Testing Limitations for Exempt, Permit and Licensed Laboratories (Repealed)

 

(Source:  Repealed at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.40  Penalties and Fines

 

a)         The Department may deny, revoke, or refuse to renew a license or permit for the reasons set forth in Article VIII of the Act. All hearings and appeals shall be conducted in accordance with the procedures set forth in that Article and this Part. Any person holding 5% or more of the ownership in a clinical laboratory who was convicted of violation of Section 8-101(b), (c) or (g) of the Act, shall constitute grounds for denial or revocation of license or permit.

 

b)         In addition to other actions authorized by the Act and this Part, the Department may assess penalties or fines against a licensee or permit holder for violation of any provision of the Act or rules. The Department shall review each inspection report according to criteria provided by this section to determine whether a fine will be assessed, the amount of such fine, and whether each day of violation shall constitute a separate violation for purposes of fine assessment.

 

1)         The Department shall consider the following criteria independently and aggregately to determine whether a fine shall be assessed.

 

A)        Whether the laboratory has previously been cited in the prior two year period for noncompliance in the same area of laboratory testing (e.g. chemistry, hematology, immunohematology, etc.) as currently cited for noncompliance with the Act or this Part.

 

B)        Whether the laboratory has been cited for a violation of the Act or rules and does not correct the violation within the time frame agreed upon by the laboratory and Department in the plan to correct the violation.

 

C)        Whether the laboratory fails to provide an acceptable plan to correct a violation of the Act or this Part.

 

D)        Whether the violation appears to be the result of any failure to carry out duties and responsibilities set forth in this Part and the Act by the laboratory or the laboratory's agents or employees or by any other person responsible for the control or supervision of the laboratory.

 

E)        Whether the laboratory demonstrated good faith efforts (e.g. taking steps to correct or agreeing to correct the cited violation) to correct the violation upon receipt of oral or written notice of the violation and whether such actions in fact corrected the violation.

 

2)         Criteria to determine the amount of a fine are the following, and all amounts determined pursuant to the criteria shall be added together to determine the total fine.

 

A)        For each repeat finding of noncompliance for the same area of laboratory testing, a fine of $100 per work day until the violations upon which noncompliance in that area of testing are based are corrected.

 

B)        For non-correction of a violation within the time frame agreed upon by the laboratory and Department, a fine of $200 per work day for each day subsequent to the inspection which determined that violations were not corrected.

 

C)        For the laboratory to fail to provide an acceptable plan to correct a violation of the Act or rules, a fine of $100 per work day starting on the tenth day after the laboratory received the notice of violation.

 

3)         Each day a violation exists shall constitute a separate violation.

 

4)         The Department shall serve any notice of assessment of fine on the laboratory in the same manner as any notice of license revocation provided pursuant to the Act and this Part (See Section 8-102 of the Act and Section 450.60 of this Part), and the laboratory shall have the same rights and opportunity for hearing as elsewhere provided pursuant to the Act and this Part.

 

5)         All fine assessments which are upheld in whole or in part by final order of the Department shall be due in full at the conclusion of the time period for filing for administrative review pursuant to the Administrative Review Law (Ill. Rev. Stat. 1987, ch. 110, pars. 3-101 et seq.), unless the laboratory has within that time filed proceedings in administrative review specifically appealing the fine assessment and unless the court has stayed the enforcement of the fine assessment.

 

(Source:  Added at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.50  Incorporated and Referenced Materials

 

The following materials are incorporated or referenced in this Part:

 

a)         The following State of Illinois Statutes are referenced in this Part:

 

1)         Illinois Clinical Laboratory and Blood Bank Act [210 ILCS 25]

 

2)         Illinois Dental Practice Act [225 ILCS 25]

 

3)         Hospital Licensing Act [210 ILCS 85]

 

4)         Medical Practice Act of 1987 [225 ILCS 60]

 

5)         Podiatric Medical Practice Act of 1987 [225 ILCS 100]

 

6)         Code of Civil Procedure, Article III (Administrative Review Law) [735 ILCS 5/Art. III]

 

7)         Illinois Controlled Substances Act [720 ILCS 570]

 

b)         The following State of Illinois Regulations are referenced in this Part:

 

1)         Sewer Discharge Criteria (35 Ill. Adm. Code 307)

 

2)         Standards for Owners and Operators of Hazardous Waste Treatment, Storage, and Disposal Facilities (35 Ill. Adm. Code 724)

 

3)         Solid Waste Disposal: General Provisions (35 Ill. Adm. Code 809)

 

c)         The following federal guidelines, statutes, federal regulations, and other materials are incorporated by reference:

 

1)         Federal Regulations and Statutes:

 

A)        42 CFR 493, Laboratory Requirements (CLIA regulations) (October 1, 2018)

 

B)        21 CFR 600-680, Biologics (April 1, 2018)

 

C)        Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191, Title II – Preventing Health Care Fraud and Abuse; Administrative Simplification; Medical Liability Reform, Section 264 – Recommendations with Respect to Privacy of Certain Health Information (August 21, 1996), Assistant Secretary for Planning and Evaluation, Room 415F, U.S. Department of Health and Human Services, 200 Independence Avenue, SW, Washington DC 20201

Also available online at: https://aspe.hhs.gov/report/health-insurance-portability-and-accountability-act-1996

 

D)        42 USC 263a, Certification of Laboratories (January 12, 2018)

 

2)         Federal Guidelines and Other Materials:

 

A)        GP17-A3 Clinical Laboratory Safety; Approved Guideline – Third Edition, Clinical and Laboratory Standards Institute (CLSI) (June 2012), 950 West Valley Road, Suite 2500, Wayne PA 10987 Also available online at:  https://clsi.org/media/1381/ gp17a3_sample.pdf

 

B)        Public Health Service Act, Subpart 2, Section 353 – Clinical Laboratories, Certification of Laboratories (1997), Public Health Law, CDC, 1600 Clifton Road, Atlanta GA 30329-4027

Also available online at: https://wwwn.cdc.gov/cliac/pdf/ Addenda/cliac0910/Addendum%20C_Yost.pdf

 

C)        Reference Volume for Human Cytogeneticists, Molecular Geneticists, Technicians, and Students for the Interpretation and Communication of Human Cytogenetic and Molecular Cytogenomic Nomenclature: ISCN 2016 − An International System for Human Cytogenetic Nomenclature (2016), S. Karger AG, Medical and Scientific Publishers, P.O. Box CH-4009 Basel, Switzerland

 

d)         All incorporations by reference of federal regulations and the standards of nationally recognized organizations refer to the regulation and standards on the date specified and do not include any additions or deletions subsequent to the date specified.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.60  Administrative Hearings

 

a)         Department decisions concerning exemptions from the Act, permits and licenses may be reviewed in an administrative hearing.

 

b)         All administrative hearings shall be conducted in accordance with the Act and the Department's rules entitled Practice and Procedures in Administrative Hearings (77 Ill. Adm. Code 100).

 

(Source:  Amended at 15 Ill. Reg. 15727, effective October 18, 1991)

 

Section 450.210  Qualifications of the Director of a Clinical Laboratory

 

A director candidate shall meet one or more of the qualification requirements in 42 CFR 493, Subpart M.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.220  Operational Participation of the Director

 

a)         The laboratory director is responsible for the operation and administration of the laboratory, including the employment of personnel who are qualified and competent to perform test procedures, maintain records, and report test results promptly, accurately and proficiently to assure compliance with applicable CLIA Law.

 

b)         The laboratory director, if qualified, may perform the duties of the technical supervisor, technical or clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications.

 

c)         The laboratory director shall be accessible to the laboratory to provide onsite, telephone or electronic consultation.

 

d)         The laboratory director shall follow the weekly schedule established in accordance with Section 450.1110(d), except for absences due to emergencies, illness, or professional meetings. In case of an absence for vacation or other purposes that does not exceed 30 days, the owner shall ensure director coverage by designating an acting director who is qualified to direct that laboratory.

 

e)         If the laboratory director is absent for more than 30 days, the owner shall designate an acting laboratory director who meets the qualifications in 42 CFR 493, Subpart M.  If the absence of the laboratory director will be permanent, the owner shall immediately submit a request for a laboratory director change to the Department.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.230  Number of Laboratories Permitted to Operate

 

a)         The director of a clinical laboratory shall not direct more than five moderate or high complexity clinical laboratories, as defined in 42 CFR 493. This limitation does not preclude a laboratory director from serving additional laboratories as a technical supervisor, technical or clinical consultant, general supervisor, or testing personnel.

 

b)         The director of a clinical laboratory shall actively participate in the activities and programs of the clinical laboratory.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.310  Location

 

The location and construction of the laboratory, including plumbing, heating, lighting, ventilation, electrical services and similar features, shall be such as to ensure that the operation of the laboratory will present no hazard to the public health. Each initial license application and each license application for a change of location shall be accompanied by a letter from the laboratory owner indicating that the owner has checked with any zoning authority having jurisdiction and the zoning authority has found that the laboratory location meets local requirements or will meet local requirements within a time frame acceptable to the zoning authority. If no zoning authority has jurisdiction, the letter shall state that fact.

 

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.320  Conformance to Local Ordinances

 

Laboratory quarters and facilities shall conform to all local building, safety, and fire codes or ordinances. Each initial license application and each license application for a change of location, shall be accompanied by a letter from the laboratory owner indicating that the laboratory has been inspected and approved by the local authorities to ensure that the laboratory meets the applicable building safety code; plumbing code, fire code, and ordinances, or by-laws. If there are no local codes, ordinances or by-laws relating to plumbing, the owner shall submit documentation that the laboratory premise has been inspected and approved by a State licensed plumber within the last year.

 

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.330  Safety and Sanitation Manual

 

The laboratory director shall establish a Safety and Sanitation Manual.  This manual shall be consistently implemented throughout the facility and contain signed or initialed documentation that it has been reviewed by the director at least annually to ensure that the requirements of this Part are met. The manual shall include but need not be limited to the following items as they apply to the licensed or permitted laboratory.

 

a)         General Sanitation and Safety with respect to:

 

1)         minimum clearance in passageways to assure that exit from and access to the laboratory is not impeded;

 

2)         the selection of and the schedule for the use of cleaning supplies for floors, walls, ceilings, bench tops, and sinks;

 

3)         hand washing protocol;

 

4)         requiring that all items which are disposed of and which can cut or puncture the skin shall be placed in containers which are impervious to the flow of liquids, rigid to prevent the container from collapsing when handled in the laboratory, and puncture proof to prevent needles from penetrating the container;

 

5)         safe storage, transport, and use of compressed gases, if any, which includes the requirements that each cylinder is shipped with a valve safety cover which shall remain in place when regulators are not attached; that gas cylinders shall be secured at all times; and that empty containers shall be labeled and removed from the laboratory;

 

6)         requiring that smoking, eating, and drinking shall be prohibited in all areas where laboratory work is performed;

 

7)         requiring that mouth pipeting shall be prohibited;

 

8)         requiring that all electrical outlets shall be grounded, electrical equipment be maintained in condition to prevent shock and fire hazards, and protective fuses not be bypassed; and

 

9)         requiring that all blood letting and collection devices shall be both sterile and disposable.

 

b)         Warning signs shall indicate "Hazardous Materials" (radioactive, flammable, poison, irritant, carcinogen, etc.) with required precautions in the use and storage of those materials.

 

c)         Fire prevention and control with respect to:

 

1)         the use of open flames, flammables, safety cans, safety cabinets, etc.;

 

2)         requiring that a fire extinguisher of the CO₂ or dry chemical type shall be in the laboratory;

 

3)         actions to be taken in case of fire; and

 

4)         requiring that provisions for unimpeded egress from the building shall be posted.

 

d)         Chemical hazards with respect to:

 

1)         maintenance of a list of all chemicals used in the laboratory categorized as corrosive, flammable, toxic, carcinogenic, explosive, radioactive, and mutagenic;

 

2)         actions to be taken in the event of an accidental break or spill;

 

3)         ventilation in accordance with the kinds of chemical fumes encountered;

 

4)         storage requirements for chemicals which are caustic, poisonous, flammable, carcinogenic, etc.;

 

5)         requiring that wastes discharged to any sewer shall be in accordance with the general requirements for liquids, solids, or gases as well as specific requirements for mercury and cyanide as established by the Illinois Environmental Protection Agency (35 Ill. Adm. Code 307).

 

6)         safe use of radioactive materials, if used in the laboratory, by having a registration certificate or license from the U.S. Nuclear Regulatory Commission or the agency to which the U.S. Nuclear Regulatory Commission has delegated certification or licensure authority.

 

e)         Biological hazards with respect to:

 

1)         handling of specimens to avoid infection by air, ingestion, direct inoculation, and skin contact;

 

2)         providing biological safety hoods and other appropriate barriers (i.e. plastic gloves) in accordance with the types of organisms encountered; and

 

3)         disposal of cultures, specimens and other potentially infectious materials, which shall be completely incinerated or otherwise sterilized or sealed in a container as indicated below to render the materials innocuous before disposal or removal from the premises.

 

4)         specific procedures to be followed in the event of accidental exposure to a biological hazard.

 

A)        The incineration of materials shall be done in accordance with the requirements of the Illinois Environmental Protection Agency concerning the operation of an incinerator.  (35 Ill. Adm. Code 724).

 

B)        The sterilization of materials shall be done by autoclaving the materials in accordance with the manufacturer's recommendations and the effectiveness of the autoclave shall be verified and documented at least weekly with a biological spore assay containing B. stearothermophilus.

 

C)        The disposal or removal of materials outside of the facility shall be done in the following manner:

 

i)          Incinerated or sterilized materials shall be disposed of through routine waste disposal methods without precautions against possible contamination.

 

ii)         Materials which have not been incinerated or sterilized shall be disposed of by a waste hauler with a proper permit from the Illinois Environmental Protection Agency.  (35 Ill. Adm. Code 809).  These materials must be sealed, transported and stored in biohazard containers. These containers shall be marked "Biohazard," bear the universal biohazard symbol, and be orange, orange and black or red.  The containers shall be rigid and puncture-resistant such as a secondary metal or plastic can with a lid that can be opened by a step-on pedal.  These containers shall be lined with one or two high density polyethylene or polypropylene plastic bags with a total thickness of at least 2.5 mil. or equivalent material. The containers which are marked "Biohazard" shall be sealed before being removed from the laboratory.

 

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.410  General Supervisor

 

In a licensed laboratory, the general supervisor shall be accessible to the laboratory to provide on-site, telephone, or electronic consultation, and shall meet qualification requirements in 42 CFR 493, Subpart M.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.420  Testing Personnel

 

A testing personnel candidate shall meet one or more of the qualification requirements in 42 CFR 493, subpart M.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.430  Cytotechnologist (Repealed)

 

(Source:  Repealed at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.440  Technician (Repealed)

 

(Source:  Repealed at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.450  Laboratory Assistant (Repealed)

 

(Source:  Repealed at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.460  Technical Supervisor

 

In a licensed laboratory, the technical supervisor shall be accessible to the laboratory to provide on-site, telephone or electronic consultation, and shall meet one or more specific qualification requirements under each specialty or subspecialty of service in 42 CFR 493, subpart M.

 

(Source:  Added at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.470  Clinical Consultant

 

A clinical consultant candidate shall meet one or more of the requirements in 42 CFR 493, subpart M.

 

(Source:  Added at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.510  Facilities and Equipment

 

The laboratory must document that the physical facilities, equipment, and instruments are adequate for performance of tests for which the laboratory is requesting a license or permit.  (See Subpart C)

 

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.520  Preventive Maintenance of Equipment and Instruments

 

a)         Preventative maintenance program

 

1)         The laboratory must establish a written preventive maintenance program for each piece of equipment.  The program shall be documented and implemented on a regularly scheduled basis.  It shall provide for instrument function verification and equipment maintenance.

 

2)         The preventive maintenance programs shall at minimum coincide with the manufacturer's recommendations.

 

b)         Service Contract

 

1)         A service contract from an outside source for preventive maintenance is acceptable provided there is a description of the services to be performed for each instrument or each piece of equipment and a statement of the frequency of maintenance to be performed.

 

2)         A service contract does not negate the laboratory's responsibility to perform other routine maintenance as may be required.

 

3)         The laboratory must maintain records of preventive maintenance whether performed by the laboratory staff or by an outside source.

 

c)         Specific Laboratory Equipment

 

1)         Automatic dilutors and samplers, except those checked by use of a calibrator or reference material included in each run, shall be checked for accuracy and reproducibility at least once per month.

 

2)         A serum/cell calibration shall be performed on a serofuge when first put into operation and after major adjustments or repairs. Accuracy of the timer and rpm shall be checked at least quarterly.

 

3)         Volumetric glassware (pipets, flasks) that is not designated "class A" by the manufacturer, shall be calibrated to confirm its designated volume.

 

4)         Cuvettes shall be free of scratches and suitable to the procedure in which they are used.  If applicable, the cuvettes should be matched.

 

5)         Specific requirements for checking spectrophotometers and radioactive counting equipment are included in Subpart K.

 

6)         Thermometer readings for temperature controlled spaces and instruments shall be recorded each day of use.  Tolerance limits shall be established.

 

7)         All thermometers in the laboratory shall be checked against a reference thermometer (certified by the National Bureau of Standards or guaranteed by the manufacturer to meet National Bureau of Standards criteria) before being placed into use and annually thereafter.

 

8)         Glassware shall be free from scratches and cloudiness and graduations shall be legible. "To contain" and "to deliver" pipettes shall be separated.

 

9)         Analytical balances shall be checked for accuracy at least annually and accuracy of weights verified by using 'Class A' weights.

 

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.530  Glassware (Repealed)

 

(Source:  Repealed at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.540  Lancets, Needles and Syringes (Repealed)

 

(Source:  Repealed at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.550  Electrical Equipment (Repealed)

 

(Source:  Repealed at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.560  Photometric and Spectrophotometric Equipment (Repealed)

 

(Source:  Repealed at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.570  Analytic Balances and Weights (Repealed)

 

(Source:  Repealed at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.610  Criteria for Licensure

 

Clinical laboratories located outside of Illinois shall be certified, under CLIA Law, or that state's laboratory program, before accepting specimens referred by clinical laboratories located in Illinois.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.710  Inspections

 

a)         All clinical laboratories required to be licensed shall be open to inspection by representatives of the Department at all reasonable times.

 

b)         The Department may submit forms, such as check lists, to be completed by the director of the laboratory in advance of inspection.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.720  Proficiency Survey Program

 

Each laboratory shall enroll in a proficiency testing (PT) program that meets the criteria of 42 CFR 493, Subparts H, I, K and R.  The laboratory shall enroll in an approved program or programs for each of the non-waived specialties and subspecialties for which it seeks certification, and shall test the samples in the same manner as patients' specimens.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.730  Western Blot Assay Testing Procedures

 

All laboratories which conduct the Western blot assay shall comply with the following requirements.

 

a)         Western blot assay Testing Procedures

 

1)         Western blot assay kits licensed by the United States Food and Drug Administration (FDA) shall be performed on specimens which have been found to be repeatably reactive using the enzyme-linked immunosorbent assay (ELISA) test.  The laboratory shall perform a Western blot assay test to determine reactivity with viral polypeptides in accordance with manufacturer's recommendations or package insert.

 

2)         When a Western blot assay kit that is not licensed by the FDA is utilized, the testing procedure must be able to demonstrate and reproduce in a second demonstration at least the viral polypeptides in accordance with recommendations of the Centers for Disease Control, Association of State and Territorial Public Health Laboratory Directors, or American Association of Blood Banks.

 

3)         Western blots must have clear backgrounds and lack non-specific banding; and all banding should be distinct and uniform as well as reproducible.

 

4)         The final blots of non-licensed kits must be examined to determine if the antibodies reacted specifically with HIV polypeptides.  Western blot interpretations shall be consistent with the manufacturer's recommendations or package insert.

 

b)         Laboratory Certification and Quality Control

 

1)         The laboratory prior to using any given lot of a non-licensed Western blot kit, shall test all lot material with control sera consisting of negative (no reaction), weakly positive (some reaction – but not strong), and positive (strong, very noticeable reaction) sera.  The laboratory shall ensure that the reagent lots are correctly identified with the above control sera.  Any and all reagents not meeting the laboratory's specified criteria established in accordance with the quality control system methodologies in Section 450.1150(g) shall not be utilized for testing.

 

2)         The laboratory shall maintain internal viral Western blot quality control for all Western blot assay.  All internal Western blot quality control results shall be maintained by the laboratory for review by the Department.

 

3)         The laboratory shall participate in at least one proficiency testing program for ELISA and Western Blot screening and supplemental testing for viral antibodies offered by the College of American Pathologists, the American Association of Bioanalysts, or the Department.  A copy of all proficiency testing evaluation reports shall be made available for review by the Department.

 

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.810  General

 

Blood banks operating in Illinois shall be licensed by the FDA under 21 CFR 600, 601, 606, 607, 610, 630 and 640.

 

(Source:  Former Section repealed at 13 Ill. Reg. 11573, effective September 1, 1989; new Section added at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.820  Applicability of Other Parts of the Regulations (Repealed)

 

(Source:  Repealed at 13 Ill. Reg. 11573, effective September 1, 1989)

 

Section 450.830  Donors and Donor Blood/Criteria for Donor Selection (Repealed)

 

(Source:  Repealed at 13 Ill. Reg. 11573, effective September 1, 1989)

 

Section 450.835  Directed BLood Donations (Repealed)

 

(Source:  Repealed at 13 Ill. Reg. 11573, effective September 1, 1989)

 

Section 450.840  Donors and Donor Blood/Identification of Donor Blood (Repealed)

 

(Source:  Repealed at 13 Ill. Reg. 11573, effective September 1, 1989)

 

Section 450.845  Donors and Donor Blood/Storage and Transportation (Repealed)

 

(Source:  Repealed at 13 Ill. Reg. 11573, effective September 1, 1989)

 

Section 450.848  Preparation of Blood Components (Repealed)

 

(Source:  Repealed at 13 Ill. Reg. 11573, effective September 1, 1989)

 

Section 450.850  Plasmapheresis (or Plateletpheresis) (Repealed)

 

(Source:  Repealed at 13 Ill. Reg. 11573, effective September 1, 1989)

 

Section 450.860  Autologous Transfusion (Repealed)

 

(Source:  Repealed at 13 Ill. Reg. 11573, effective September 1, 1989)

 

Section 450.870  Transfusion Service Records (Repealed)

 

(Source:  Repealed at 13 Ill. Reg. 11573, effective September 1, 1989)

 

Section 450.910  Prohibition Against Free Trial Tests (Repealed)

 

(Source:  Amended at 9 Ill. Reg. 20709, effective January 3, 1986)

 

Section 450.920  Terms Not to be Used in Names of Laboratories

 

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.

 

(Source:  Amended at 13 Ill. Reg. 11573, effective September 1, 1989)

 

Section 450.930  Prohibitions in Advertising and Announcements

 

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.

 

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.940  Acceptance of Specimens and Reporting of Results

 

No clinical laboratory shall accept specimens or report results except as provided in Article VII of the Act.

 

(Source:  Amended at 13 Ill. Reg. 11573, effective September 1, 1989)

 

Section 450.950  Referral of Specimens for Examination to Unlicensed Laboratories

 

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.

 

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.1010  Necessary Records

 

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)

 

b)         Reports to be submitted to the Department.

A laboratory shall submit reports containing information and data concerning its technical operations, as may be requested by the Department.  These reports shall be notarized and signed by the owner and director of the laboratory.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.1110  Responsibilities of Director

 

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.

 

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.1120  Reference Materials

 

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.

 

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.1130  Preventative and Corrective Maintenance Program

 

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.

 

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.1140  Procedure Manuals

 

a)         Current procedure manual(s) prepared by each laboratory shall be available for use by technical personnel.  Manufacturer's manuals and textbooks may be used as supplements to the laboratory manual, but not in lieu thereof.

 

b)         Each procedure manual shall contain a table of contents reflecting the name of the test; methodology used; annual review by the director; date and type of change in methodology, instrumentation, reagents, etc., which are approved by the director with cross reference to the actual change in that procedure.  Each procedure shall use the headings below and include, where applicable, all items listed.  The following format is recommended.

 

1)         Principle of the test.

 

Include a brief statement concerning the type of reaction(s) involved.

2)         Specimen.

 

A)        State the conditions for patient preparation.

 

B)        Specify the type of sample with respect to volume of sample required, anticoagulants, preservatives, stability, and requirements for storage.

 

C)        State the criteria for an unacceptable sample.

 

D)        Specify handling conditions with respect to timing, transport or storage conditions, and special equipment.

 

E)        State the criteria for proper specimen identification.

 

3)         Reagent preparation.

 

A)        List specific reagents used in the procedure.

 

B)        State the directions for preparation and labeling of each reagent to include the initials of the person who prepared the material, contents, concentration, lot number, date of preparation, expiration date, and storage requirement.

 

C)        For coagulation reagents, record the time of reconstitution and initial.

 

4)         Procedure calibration

 

A)        Give detailed stepwise instructions including dilutions of working standards (calibrators). List standards used, grade of purity required and storage requirements.

 

B)        State specifications for photometric readings (%T, absorbance, etc.).

 

C)        Where calibration graphs are used, the type shall be specified.

 

D)        Specify acceptable tolerances for standards and corrective actions to be taken if results are outside the tolerance limits.

 

5)         Procedure.

 

A)        Write detailed instructions in a stepwise manner.  A flow chart may be used as an adjunct.

 

B)        Specify the following for photometric measurements.

 

i)          Type of instrument.

 

ii)         Wavelength.

 

iii)        Cuvette size.

 

iv)        Solution used as a blank.

 

v)         Range of linearity.

 

vi)        How the raw data are read (%T, absorbance, etc.).

 

vii)       Stability of the final solution.

 

C)        Clearly indicate safety hazards.

 

6)         Calculations.

 

A)        Give stepwise instructions for calculations.

 

B)        Give the equation.

 

C)        Give a precise example.

 

D)        Describe the common variations in calculations.

 

7)         Quality Control.

 

A)        State the reference materials to be used.

 

B)        Give instructions for preparation of reference materials.

 

C)        State the minimum frequency with which reference materials are to be run.

 

D)        State how action limits for reference materials are to be established.

 

E)        State the corrective actions to be taken when action limits are exceeded.

 

8)         Reporting results.

 

A)        State expected ranges where appropriate.

 

B)        Give information about methodology which may be necessary for interpretation of results.

 

C)        Give guidelines as to acceptable reporting format and units as applicable.

 

D)        A system for handling critical values shall be available.

 

E)        State and laboratory confirmed upper and lower limits of linearity and/or detection limits for the procedure to insure that reported results are within these limits.

 

9)         Procedural notes.

 

A)        List possible sources of error.

 

B)        Describe the plan for an alternate means of specimen handling or analysis in the event the procedure should fail.

 

10)         References.

Document the source(s) of information used in the procedure.

 

11)         Utilization of product package inserts.  Include a system to assure that package inserts are current with and applicable to the kits or reagents actually in use.  Package inserts may not be used as part of the procedure manual unless they comply with all of the provisions enumerated under this Section.

 

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.1150  Quality Control System Methodologies

 

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.

 

2)         Automated Procedures

 

A)        Particle Counting and Hemoglobin

 

i)          Calibration techniques shall follow the manufacturer's specifications.

 

ii)         The director shall establish criteria for high and low counts and determine the policy for verification.  Tolerance limits shall be established for duplicate testing.

 

iii)        Background counts shall be performed daily on diluent and lysing agents.

 

iv)        Reference materials shall be used each, or after each run to assess precision.

 

v)         Each procedure shall be checked or recalibrated each 8 hours, if the instrument is used during the 8 hour period, with standards (calibrators) or reference materials covering the range of expected values.

 

B)        Differential counts

 

i)          The manufacturer's specifications shall be followed with respect to operation, calibration, and the use of reference materials.

 

ii)         The director shall establish a policy for the review of all abnormal differentials that indicate an abnormal cellular, morphology or abnormal platelet enumeration.

 

3)         Coagulation studies

 

A)        Two levels of reference materials for prothrombin and or partial thromboplastin times shall be used during each 8 hours when the instrument is used, Action limits shall be established.

 

B)        If available commercially, two levels of reference materials shall be included in each run for all other coagulation procedures. Patient specimens shall be performed in duplicate and tolerance limits established.

 

b)         Chemistry

See Section 450.1120 for general quality control requirements.  See Section 450.520 for checking dilutors and samplers.

 

1)         Manual-Automated procedures which use a Spectrophotometer or Photometer

 

A)        Calibration of the optical component of each instrument shall be done in accordance with the instrument manufacturer's instructions.

 

B)        Each procedure shall be recalibrated at least every three months or more frequently in accordance with the following:

 

i)          Procedures which are linear shall include at least 3 standard concentrations (calibrator) (unless the instrument manufacturer specifies that 3 calibrators are not necessary to determine procedure in linearity and calibration over the reportable range) including one at the highest level of the reportable range and one near the threshold (cutoff).

 

ii)         Procedures which are non-linear over the reportable range shall include (unless the instrument manufacturer specifies that procedure calibration over the reportable range can be accomplished in another manner) a minimum of 5 standard concentrations (calibrator).

 

iii)        The procedure is recalibrated when major instrument maintenance has been performed.

 

iv)        The procedure is recalibrated in accordance with the manufacturer's recommendations and when a reagent lot number is changed.

 

v)         The procedure is recalibrated when the quality control program reflects an unusual trend or the controls fall outside acceptable limits.

 

C)        At a minimum, one reference material and one calibrator or two reference materials with different concentrations shall be used for each analyte in each run of unknown specimens, except, when prepackaged reagent analyzers are used, one reference material and one calibrator or two reference materials with different concentrations shall be used once in each 24 hour period in which the analyzer is used for that analyte.

 

2)         Atomic Absorption Flame Photometers

 

A)        The atomization rate shall be checked each day of use.

 

B)        Each run of unknown specimens shall include two levels of reference materials.

 

C)        Calibration and operation techniques shall follow the manufacturer's specifications.

 

D)        Each procedure shall be recalibrated each day of use.

 

3)         Chromatography

 

A)        A standard (calibrator) shall be included with each batch of unknown specimens.

 

B)        Calibration and operation techniques shall follow the manufacturer's specifications.

 

C)        Reference materials (spiked samples) shall be included in each batch of unknown specimens and are treated the same as unknowns.

 

4)         Electrophoresis

 

A)        The linearity of a densitometer shall be checked each day of use.

 

B)        Reference materials for comparison of migration patterns and stain intensity shall be included with each run.

 

5)         Ion Selective Electrode

 

A)        The manufacturer's recommendations shall be followed with respect to calibration and control procedures.

 

B)        Reference materials shall be included with each run.

 

6)         Radioimmunoassay

 

A)        The stability of radioisotope counting equipment shall be checked each day of use with an appropriate radioactive reference source.  Tolerance limits shall be established.

 

B)        Background counts shall be performed each day of use and tolerance limits established.

 

C)        Each procedure shall include calibrators (standards) as recommended by the reagent manufacturer.

 

D)        Reference materials shall be included with each run.

 

E)        The duration of the counting times shall follow the recommendations of the instrument manufacturer.

 

7)         Mass Spectrometry

 

A)        Mass spectrometers shall be tuned daily.

 

B)        Procedures for checking air leaks and determining ion ratios shall be available and followed.

 

C)        Ion ratios shall be determined for each instrument and each assay if appropriate for the instrument.

 

D)        If ion ranges are used, criteria shall be available for designating a positive.

 

c)         Urinalysis

 

1)         Specific gravity equipment shall be calibrated with distilled water and one other solution of known refractive index each day of use.

 

2)         Screening or qualitative chemical urinalysis shall be checked daily by use of suitable reference materials.

 

3)         Calibration and the use of reference materials for equipment which utilizes automatic readers shall follow the recommendations of the manufacturer.

 

d)         Bacteriology-mycology

 

1)         Each unit of media shall be properly labeled to indicate identity, date of preparation-receipt and expiration date.

 

2)         Each batch of media shall be tested before use, or concurrently with selected organisms, for selectivity, sterility, enrichment, and biochemical response, as currently required under 42 CFR 493.1256(e)(4).

 

3)         Appropriate ATCC strains shall be available and maintained.

 

4)         All reagents, strips, discs, and antisera shall be properly labeled as to lot number and expiration date and checked each day of testing with organisms that produce positive and negative reactions.

 

5)         An adequate incubation system shall be used and shall be appropriate for the kinds of organisms isolated and volume of work.  CO2 incubators shall be checked daily to insure that CO₂ concentration is maintained within established tolerance limits.

 

6)         Flow charts may be used to indicate all steps to be employed to isolate and identify all organisms.

 

7)         The daily log or worksheet shall reflect all tests and test results which lead to the isolation and identification of all microorganisms.

 

8)         Staining materials shall be checked each day of use against organisms with the expected staining characteristics.

 

9)         A wire loop used for quantitative tests shall be calibrated prior to placing into use and quarterly thereafter.

 

10)        Agar Disc Diffusion methods:

 

A)        The agar disc diffusion test shall be checked with each new batch of media and at least once each seven days with stock cultures of Escherichia coli ATCC 25922, Staphylococcus aureus ATCC 25923, and Pseudomonas aeruginosa ATCC 27853.   Zone sizes shall be recorded for each antimicrobial agent.  Limits shall be established.

 

B)        Petri dishes used shall have a diameter not less than 150 mm and contain no more than 12 discs.

 

C)        Susceptibility tests shall be performed on pure cultures only.

 

D)        A barium sulfate turbidity standard shall be used for the Kirby-Bauer method.

 

11)        Minimum Inhibitory Concentration (MIC) Methods:

 

A)        The MIC test shall be checked with each new batch of media and at least once each seven days with stock cultures of Escherichia coli ATCC 25922, Staphylococcus aureus ATCC 29213, and Pseudomonas aeruginosa ATCC 27853. The MIC values shall be recorded for each antimicrobial agent. Tolerance limits shall be established.

 

B)        When trimethoprim-sulfamethoxazole is included in the battery of antibiotics, Streptococcus faecalis ATCC 29212 shall also be included as a control.

 

12)        Automated susceptibility testing systems shall follow the quality control requirements specified by the manufacturer or at a minimum those specified under item 11 above.

 

e)         Parasitology

 

1)         A calibrated ocular micrometer shall be available for determining the size of ova and parasites when size is a critical factor.

 

2)         The laboratory shall have an atlas and reference collection of prepared slides, transparencies or gross specimens.  The collection shall include organisms which the laboratory encounters and reports from patient specimens.

 

3)         Permanent stains shall be used for the examination of intestinal protozoa and other parasites where internal structure is critical for proper identification.

 

4)         Concentration methods shall be routinely employed on all stool specimens negative for ova and parasites by direct examination methods. Concentration techniques shall be capable of detecting all cases of clinically significant parasites likely to be encountered in the community.

 

f)         Immunology-Serology-Immunochemistry

Kits purchased for serological testing shall be used in accordance with the manufacturer's instructions.

 

1)         VDRL/RPR

 

A)        Non-reactive, minimally reactive, and reactive reference materials shall be included with each run.

 

B)        The needle delivery shall be verified within plus or minus two drops per ml each time a new needle is used, when control patterns cannot be reproduced, and when the antigen does not drop clearly from the needle.

 

C)        The revolutions per minute of the rotator shall be checked each week of use and be within the recommended tolerance limits.

 

D)        Each new lot of antigen and reference materials shall be checked with non-reactive, weakly reactive and reactive reference materials before being placed into use.

 

E)        Ambient temperature in the test area shall be maintained between 23 degrees Centigrade and 29 degrees Centigrade.

 

F)         The antigen for VDRL testing shall be prepared fresh each day of use.

 

2)         Qualitative tests

Positive and negative controls shall be included in each run.  Each new lot of reagents and reference materials shall be parallel checked with one of known reactivity before being placed into use.

 

3)         Quantitative tests

Each quantitative test shall include with each run a negative control, where applicable, a positive control of known titer or controls of graded reactivity.  Each new lot of reagents and reference materials shall be parallel checked with one of unknown reactivity before being placed into use.

 

g)         Immunohematology

 

1)         ABO grouping reagents and Rh typing sera shall conform to the requirements of licensure under 21 CFR 600-680. Any facility which produces their own products shall adhere to these same requirements.

 

2)         All antisera, ABO reagent red cells, anti-human globulin (Coombs) shall be tested each day of use with a positive control.

 

3)         Antibody screening reagent red cells shall be tested each day of use with at least one known antibody.

 

4)         All antisera except ABO antisera shall be tested each day of use with a negative control.

 

5)         The reagent manufacturer's protocol for testing shall be followed.

 

6)         An autologous cell control is required when samples are being tested for Rh type.  An autologous cell control is not required to accompany the Rh type when testing donor samples.

 

h)         Histopathology

 

1)         All special stains shall be controlled by use of positive tissues.

 

2)         All tissue specimens shall be kept in a preservative until microscopic examination and diagnosis have been completed by the pathologist.

 

3)         All stains shall be filtered prior to each day of use.

 

4)         All tissue processing solutions shall be changed or rotated on a regularly scheduled basis.

 

5)         The quality of stains shall be evaluated daily by the director and suboptimal stains corrected immediately.

 

6)         All gross tissue specimens received shall be properly labeled and securely packaged so as to maintain absolute certainty of identification throughout processing, recording and storage.

 

7)         Slides shall be identified with permanent labels and stored so they are readily accessible.  Paraffin blocks shall be adequately identified, indexed, stored in a cool place and protected against damage by heat for at least 2 years.  Wet tissue specimens shall be retained until a diagnosis has been made. The slide and a copy of the report shall be filed for at least 10 years.

 

8)         The laboratory shall request that the tissue request shall contain the name, birthdate, name of the surgeon, clinical information and the date of surgery.

 

i)          Cytogenetics

 

1)         Special Equipment

 

A)        Incubators shall be on special emergency lines.

 

B)        Laminar Flow Hoods shall be used.

 

C)        Karyotyping facilities shall be available with the production of hard copies.

 

2)         Culture Initiation of Specimens

 

A)        At least two (2) containers for each patient

 

B)        Maximum of 1% patient failure (i.e. failure to provide a report as defined in Section 450.1150(j)(3)), for blood, amniotic fluid and chorionic villus samples in a period not to exceed 30 calendar days. If in excess of 1%, the laboratory director shall contact the Department and stop performing the tests until the laboratory can demonstrate a patient failure rate of less than one percent.

 

C)        For other tissues higher patient failure rates are acceptable.

 

i)          Skin and products of conceptions:  maximum of 20% failure in a period not to exceed 30 calendar days. If in excess of 20%, the laboratory director shall contact the Department and stop performing the tests until corrective action is demonstrated.

 

ii)         Bone Marrow:  maximum of 5-10% failure in a period not to exceed 30 calendar days. If in excess of 5-10%, the laboratory director shall contact the Department and stop performing the tests until corrective action is demonstrated.

 

3)         Analysis and Interpretation

 

A)        Counting Chromosomes

 

i)          At least 11-20 metaphases from the two containers shall be counted for routine blood, amniotic fluid, skin, products of conception, and chorionic villus specimens.

 

ii)         For the Fragile-X chromosome, a minimum of 100 metaphases is required before reporting a negative result. Control values for Fragile-X shall be maintained.

 

iii)        If a clinically significant hypermodal metaphase or a structurally abnormal chromosome is detected, 20 additional cells (or 10 additional centers) in each of the two cultures shall be analyzed.

 

iv)        If 2 clinically significant hypomodal metaphases are detected, repeat steps in subsection (3)(A)(iii).

 

B)        Karyotypes

 

i)          A 400 band resolution is minimum.

 

ii)         At least two banded karyotypes (hard copies) shall be prepared for routine bloods, amniotic fluids, chorionic villus specimens, skins, and products of conception.

 

iii)        For bone marrows, at least 25 metaphases shall be photographed and analyzed. A minimum of 20 cells shall be analyzed for the presence of the Philadelphia chromosome and other markers for chronic myelogenous leukemia.

 

C)        Reporting and Interpretation

 

i)          All reports shall adhere to the current International System of Cytogenetic Nomenclature.

 

ii)         All abnormal findings should be accompanied by a recommendation to consult a Geneticist.

 

D)        Documentation

            In addition to other documentation required for any laboratory, documentation of power failure, failure rate, contamination, labeling discrepancy, poor or no growth, poor slide quality, interpretive dilemmas, and diagnostic errors shall be maintained.

 

4)         Archives

Retention of adequate slides, films, hard copies and reports in order to re-analyze any cases challenged, shall be in accordance with the State statute of limitations.

 

j)          Toxicology – Controlled Substances (Drugs of Abuse)

Laboratories which perform tests for controlled substances shall meet all pertinent requirements of the Act and regulations. In addition, the following items shall apply to toxicology laboratories.

 

1)         The laboratory shall demonstrate proficiency as required under Section 450.720, except, the laboratory shall discontinue providing confirmatory testing if for two consecutive testing periods the laboratory either fails to report results for confirmatory testing or for two consecutive testing periods the laboratory fails to confirm the presence of any substance in any proficiency testing specimen or on one occasion falsely confirms and reports the presence of substances not in the test specimen. Reinstatement to offer confirmatory testing shall require errorless performance in two subsequent proficiency testing surveys.

 

2)         The director shall provide confirmatory testing of specimens whenever initial screening shows the presence of controlled substances. The confirmatory testing shall use different principles of chemistry and be at least as sensitive as the testing used for screening purposes. Drug screening may be performed on-site with confirmatory testing at a licensed laboratory or licensed toxicology laboratory.

 

3)         Reports from the laboratory shall include limits of detection (LOD) for methods utilized and identify the method used to confirm positive screening results. Only specimens confirmed positive shall be reported positive for a specific drug or metabolites.

 

4)         Each analytical run of specimens shall have at least three reference specimens including:  a specimen containing no drug or metabolites; a specimen with a known amount of standard at or near the threshold (cutoff), and one additional reference specimen. Documentation that currently used methodology does not allow carryover to contaminate the testing of a subject's specimen, shall be maintained. A minimum of 10 percent of all test samples analyzed per batch shall be a mixture of reference specimens indicated in this subsection (j)(4).

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.1155  Cytology

 

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.

 

b)         Specimens

 

1)         The laboratory order form shall include last menstrual period, age of patient, previous pap smear history and previous history of carcinoma, including if the patient is at high risk for developing cervical cancer or its precursors in the judgment of the physician.

 

2)         If the laboratory order form does not include the information required in subsection (b), the laboratory must request this information prior to the issuance of the report. If the information is not received within 5 working days the report may be issued and the laboratory record noted that the history was not received. In no event should a positive specimen report be delayed. The laboratory shall have in place a program for improvement of client compliance with this requirement.

 

c)         Preparation

 

1)         The quality of stains shall be evaluated daily by the director and suboptimal stains corrected immediately.

 

2)         All solutions shall be filtered and/or replaced at least once each day of use.

 

3)         Gynecologic and non-gynecologic specimens shall be stained separately.

 

4)         All staining and subsequent preparation of cytopathologic specimens shall be done at the laboratory or adjacent site locations under the same ownership and management and quality assurance procedures, where the slides are examined.

 

5)         All automated equipment used in the preparation of specimens shall be used in accordance with manufacturer's recommendations.

 

6)         Each cytologic slide shall be clearly labeled with the name of the patient prior to receipt in the laboratory. In the laboratory, it shall be labeled with a permanent label which may utilize a unique identification system notation. The label shall withstand long term storage.

 

d)         Examination

 

1)         An individual who examines cytologic slides for neoplasms on a full-time or part-time basis, shall not screen more than 100 slides or the number of slides set by the United States Government for a calendar day and no more than 400 slides in one five day work week for a daily average of 80 slides per calendar day.

 

2)         All gynecologic smears interpreted to be suspicious or positive and all non-gynecologic specimens shall be reported by the director. The report shall be signed by a pathologist.

 

3)         All gynecologic smears which are interpreted to be negative and are from patients who are identified as high risk for developing cervical cancer based upon the information provided by the physician who submitted the specimen, shall be rescreened by a second cytotechnologist or a pathologist before reporting patient results.

 

4)         For each abnormal cytology result, the laboratory director shall make available for review all prior cytology specimens, if on file in the laboratory.

 

e)         Reports

 

1)         Diagnostic nomenclature shall be clearly defined in the procedure manual and made available to the physician who requested the cytology examination.

 

2)         The laboratory report shall:  distinguish between a non-diagnostic smear and a negative result; contain narrative descriptions for any abnormal or malignant/pre-malignant results; include the presence of endometrial cells if endometrial cells are present out of cycle; indicate evidence of any infection; and contain provisions for any recommendations.

 

3)         Each screener shall maintain a work log which documents and identifies the number of gynecologic and non-gynecologic slides screened. When a screener works at one or multiple laboratories, that individual shall leave a signed copy of the work log at each laboratory each week that screener works at the laboratory.

 

f)         Storage

Slides showing malignancy or pre-malignancy conditions and, all abnormal slides and reports shall be stored for ten years from the date of examination. All other slides and reports shall be retained for five years before discarding.

 

g)         Quality Control

 

1)         Rescreening

 

A)        For each cytotechnologist supervisor, the director shall, on a regular basis, rescreen at least ten percent of the gynecologic smears interpreted by each supervisor to be negative. This ten percent of slides rescreened may include up to 50% of this total which may be slides double screened because of high-risk status pursuant to subsection (d)(3) of this Section. In no laboratory shall more than 50% of the rescreened (subsection (d)(3)) slides be utilized to fulfill the ten percent rescreen requirement).  The director shall assure that for each cytotechnologist, at least ten percent of the gynecologic smears interpreted to be negative are rescreened by the director or cytotechnologist supervisor on a regular basis. Records of rescreened slides shall be maintained in a manner which allows periodic performance review of each cytotechnologist supervisor and cytotechnologist.

 

B)        The director shall establish a program to compare cytology reports with tissue biopsies and determine the causes of any discrepancies.

 

2)         Evaluation

 

A)        The director shall evaluate each cytotechnologist's slide examination performance to include smears interpreted to be suspicious or positive and rescreened negative cases.

 

B)        At least annually, the laboratory director shall evaluate each cytotechnologist's individual case reviews against the laboratory's overall statistical rates, document any discrepancies, include reasons for deviations, and document any corrective action taken.

 

3)         Statistical Evaluations

Annually, the laboratory shall establish a statistical evaluation of the number of cytology cases examined, number of specimens processed by specimen type, number of patients reported by diagnosis, false-negative (as determined by the rescreening program or biopsy proven) and false-positive rates (biopsy proven), number of unsatisfactory specimens submitted by each physician or laboratory and the number of complaints received from individuals ordering or receiving test reports. All laboratories shall utilize this information to provide assistance and training to physicians on proper preparation and submission of cytology slides upon request of a physician.

 

(Source:  Added at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.1200  Handling and Disposal of HIV Contaminated Blood and Human Tissue

 

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.)

 

b)         Any such blood and blood components or human tissue, or any materials or paraphernalia exposed to or contaminated by such blood and blood components or human tissue shall be disposed of in accordance with the provision of Section 450.330.

 

(Source:  Amended at 13 Ill. Reg. 11573, effective July 1, 1989)

 

Section 450.1300  Health Screening and Approved Health Screening Tests

 

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.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.1310  Protocol for Conducting Health Screening

 

a)         Any entity that performs health screening shall establish a protocol for health screening activities that is approved by a physician licensed to practice medicine in all its branches.  (Section 2-120(a) of the Act)

 

b)         The protocol for conducting the health screening shall:

 

1)         Indicate the tests to be conducted;

 

2)         Indicate the way in which results shall be reported to the test subject, including any available oral counseling and health professional referral program;

 

3)         Indicate how confidentiality will be maintained with provisions that allow testing personnel, test subject, and test subject's representative access to the test results;

 

4)         Include a written quality control program to ensure accurate and precise test values as set by the physician signing the protocol and a description of the steps to be taken if the control values fall outside acceptable limits as set by the physician in the written quality control program;

 

5)         Include the step-by-step instructions for the following:

 

A)        Specimen collection, handling, transport, storage and disposal;

 

B)        Patient preparation;

 

C)        Type and volume of specimen needed and the established rejection criteria;

 

D)        Proper specimen identification;

 

E)        Proper reagent use, such as labeling, proper lot number usage, expiration dates, and storage requirements; and

 

F)         Instrument operation and calibration in accordance with the manufacturer's instructions;

 

6)         Include directions for the use of one reference material and one calibrator or two reference materials with different concentrations once each 24 hour period in which the analyzer is used;

 

7)         Include a description of the training required of all staff conducting specific health screening tests;

 

8)         Include a copy of educational materials for each individual screening test given to each test subject;

 

9)         Be available to all health screening personnel at the test site;

 

10)         Be sent to the Department at least 30 days prior to the initial testing date if more than one health screening event is conducted by that entity in a calendar year.  These protocols shall be effective for one year. An existing protocol may be renewed by submitting to the Department a letter from the physician who signed the protocol specifying that no changes have been made in the protocol and that the protocol will be used for health screenings over the next year.  This letter shall be submitted within 30 days prior to the expiration of the existing protocol;

 

11)         Be signed, dated, and approved by a physician licensed to practice medicine in all its branches no earlier than three months prior to submission date;

 

12)         Include a copy of the document to be given to each test subject which discloses the purpose and limitations of each individual screening test to be conducted;

 

13)         Include copies of any forms used in the course of conducting health screening activities;

 

14)         Indicate how documentation and quality control items are traceable to each individual analyte and instruments used in the health screening process and how records shall be maintained; and

 

15)         Indicate how records of test subject results and documentation of quality control items shall be maintained for two years.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.1320  Application for a Class III Permit to Conduct Health Screening (Repealed)

 

(Source:  Repealed at 44 Ill. Reg. 20004, effective December 9, 2020)

 

Section 450.1330  Reporting and Notification

 

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.

 

(Source:  Amended at 44 Ill. Reg. 20004, effective December 9, 2020)

Section 450.APPENDIX A  Application for Registration, Class I Permit, Class II Permit, and Licensed Laboratory (Repealed)

 

(Source:  Repealed at 14 Ill. Reg. 2360, effective January 26, 1990)

Section 450.APPENDIX B  Application for Class III Permit Laboratory (Repealed)

 

(Source:  Repealed at 14 Ill. Reg. 2360, effective January 26, 1990)

Section 450.APPENDIX C   Exempt, Permit, and License Requirements – An Overview (Repealed)

 

(Source:  Repealed at 44 Ill. Reg. 20004, effective December 9, 2020)