Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart K - QUALITY CONTROL › Section 450.1140 - Procedure Manuals

Current through Register Vol. 48, No. 28, July 12, 2024
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.