Kentucky Administrative Regulations
Title 902 - CABINET FOR HEALTH AND FAMILY SERVICES - DEPARTMENT FOR PUBLIC HEALTH
Chapter 11 - Medical Laboratories
Section 902 KAR 11:050 - Equipment, methods, and samples
Universal Citation: 902 KY Admin Regs Service 11:050
Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO: KRS Chapter 333
NECESSITY, FUNCTION, AND CONFORMITY: KRS Chapter 333 directs that all medical laboratories in Kentucky shall establish a quality control program acceptable to the Cabinet for Human Resources, and authorizes the cabinet to adopt reasonable rules and regulations to effectuate the purposes of KRS Chapter 333, including standards of performance in the examination of specimens. This administrative regulation is to ensure accuracy of test results by control of medical laboratory equipment, methods, and samples.
Section 1. Quality Control; General Practices. Each medical laboratory shall establish a quality control program covering all types of analyses performed by the laboratory for verification and assessment of accuracy, measurement of precision, and detection of error. The program shall provide for the following:
(1)
Preventive maintenance, periodic inspection, and testing for proper operation
of equipment and instruments as may be appropriate; validation of methods;
evaluation of reagents; surveillance of results; and remedial action to be
taken in response to detected defects.
(2) Adequacy of facilities, equipment,
instruments, and methods for performance of the procedures or categories of
procedures for which a license application is filed or granted; proper lighting
for accuracy and precision; monitoring of temperature-controlled spaces and
equipment, including water baths, incubators, sterilizers, and refrigerators,
to ensure proper performance; evaluation of analytical measuring devices, such
as photometers and radioactivity counting equipment, with respect to all
critical operating characteristics.
(3) Labeling of all reagents and solutions to
indicate identity and, if significant, titer, strength or concentration,
recommended storage requirements, preparation or expiration date, and other
pertinent information; assure that material of substandard reactivity or
deteriorated materials are not used.
(4) The availability at all times, in the
immediate bench area in which staff is engaged in examining specimens and
performing related procedure within a category (e.g., clinical chemistry,
hematol-ogy, and pathology) of current laboratory manuals or other complete
written descriptions and instructions relating to:
(a) The analytical methods to be used by the
staff, properly designated and dated to reflect the most recent supervisory
reviews;
(b) Reagents;
(c) Control and calibration procedures;
and
(d) Pertinent literature
references. Textbooks may be used as supplements to the written descriptions
but may not be used in lieu thereof.
(5) Written approval by the director or
supervisor of all changes in laboratory procedures.
(6) Maintenance and availability to
laboratory personnel and to the cabinet of records, reflecting dates and, if
appropriate, the nature of inspection, validation, remedial action, monitoring,
evaluation, and changes and dates of changes in laboratory
procedures.
(7) Solicitation
designed to provide for the collection, preservation, and transportation of
specimens sufficiently stable to provide accurate and precise test results
suitable for clinical interpretation.
Section 2. Quality Control for Particular Specialties and Subspecialties. In addition to the quality control provisions required under Section 1 of this administrative regulation, each medical laboratory shall provide for additional controls which pertain to the particular specialties and subspecialties in which the laboratory is involved. In establishing the controls, the following rules shall apply:
(1) If the laboratory performs tests in the
specialty of microbiology, chemical and biological solutions, reagents, and
antisera shall be tested and inspected each day of use for reactivity and
deterioration.
(a) If the laboratory performs
tests in the subspecialties of bacteriology and mycology, staining materials
shall be tested for intended reactivity by application to smears of
microorganisms with predictable staining characteristics; and each batch of
medium shall be tested before, or concurrently with, use with selected
organisms to confirm required growth, characteristics, selectivity, enrichment,
and biochemical response.
(b) If
the laboratory performs tests in the subspecialty of parasitology, a reference
collection of slides, photographs, or gross specimens of identified parasites
shall be available and used in the laboratory for appropriate comparison with
diagnostic specimens; and a calibrated ocular micrometer shall be used for
determining the size of ova and parasites, if size is a critical
factor.
(c) If the laboratory
performs tests in the subspecialty of virology, systems for the isolation of
viruses and reagents for the identification of viruses shall be available to
cover the entire range of viruses which are etiologically related to clinical
diseases for which services are offered; records shall be maintained which
reflect the systems used and the reactions observed; in tests for the
identification of viruses, controls shall be employed which identify erroneous
results; and if sero-diagnostic tests for virus diseases are performed,
requirements for quality control as specified for serology shall
apply.
(2) If the
laboratory performs tests in the specialty of serology, the following controls
shall be established:
(a) Serologic tests on
unknown specimens shall be run concurrently with a positive control serum of
known titer or controls of graded reactivity plus a negative control in order
to detect variations in reactivity levels.
(b) Controls for all test components
(antigens, complement, erythrocyte indicator systems, etc.) shall be employed
to ensure reactivity and uniform dosage.
(c) Test results shall not be reported unless
the predetermined reactivity pattern of the controls is obtained.
(d) Equipment, glassware, reagents, controls,
and techniques for tests for syphilis shall conform to those recommended in the
"Manual of Tests for Syphilis", American Public Health Association, 1990,
incorporated by reference, or to any subsequent revisions. A copy of the
"Manual of Tests for Syphilis" may be inspected or obtained at the Office of
the Commissioner for Health Services, 275 East Main Street, Frankfort, Kentucky
40621, Monday through Friday, 8 a.m. until 4:30 p.m.
(3) If the laboratory performs tests in the
specialty of clinical chemistry:
(a) Each
instrument or other device shall be recalibrated or rechecked at least once on
each day of use. Records which document the routine precision of each method,
automated or manual, and its recalibration schedule shall be maintained and
available to laboratory personnel and the cabinet; at least one (1) standard
and one (1) reference sample (control) shall be included each day of testing
unknown specimens; and control limits for standards and reference samples shall
be recorded and displayed and shall include the course of action to be
instituted if the results are outside the acceptable limits.
(b) Screening or qualitative chemical
urinalysis shall be checked daily by use of suitable reference
samples.
(4) If the
laboratory performs tests in the specialty of immunohematology:
(a) ABO grouping shall be performed by
testing unknown red cells with anti-A and anti-B grouping serums licensed under
Part 73, Title 42, Code of Federal Regulations, or possessing equivalent
potency, using the technique for which the serum is specifically designed to be
effective; for confirmation of ABO grouping the unknown serum shall be tested
with known A1 and B red cells.
(b)
The Rho(D) type shall be determined by testing unknown red cells with anti-Rho
(anti-D) typing serum licensed under 42 CFR Part 73 , or possessing equivalent
potency using the technique for which the serum is specifically designed to be
effective; anti-Rho' (CD), anti-Rho" (DE) and anti-Rhorh'rh" (CDE) serums
licensed pursuant to 42 CFR Part 73 , or possessing an equivalent potency, may
be used for typing donor blood; all Rho negative donor and patient cells shall
be tested for the Rho variant (Du); a control system of patient's cells
suspended in his own serum or in albumin shall be employed if the test is
performed in a protein medium.
(c)
The potency and reliability of reagents (antisera, known test cells, and
antiglobulin - Coombs serum) used for ABO grouping, Rh typing, antibody
detection, and compatibility determinations shall be tested for reactivity on
each day of use and if a new lot of reagents is used.
(5) If the laboratory performs tests in the
specialty of hematology, instruments and other devices used in hematological
examination of specimens shall be recalibrated, retested, or reinspected, as
may be appropriate, each day of use; each procedure shall be rechecked each day
of use with two (2) levels of controls; tests such as the one (1) stage
prothrombin time test shall be run in duplicate unless the laboratory can
demonstrate that low frequency of random error or high precision makes the
testing unnecessary; standard deviation, coefficient of variation, or other
statistical estimates of precision shall be determined by random replicate
testing of specimens; and the accuracy and precision of blood cell counts,
hematocrit, and hemoglobin measurements shall be tested each day of
use.
(6) If the laboratory performs
tests in the specialties of exfoliative cytology, histopathology, or oral
pathology, the following controls shall be established:
(a) If the laboratory performs tests in the
specialty of exfoliative cytology, the laboratory director or supervisor
qualified in cytology shall rescreen for proper staining and correct
interpretation at least a ten (10) percent random sample of gynecological
smears which have been interpreted to be in one (1) of the benign categories by
personnel not possessing director or supervisor qualifications; all
gynecological smears interpreted to be in the "suspicious" or positive
categories by screeners shall be confirmed by the laboratory director or
qualified supervisor and the report shall be signed by a physician qualified in
pathology or cytology; all nongynecological cytological preparations, positive
or negative, shall be reviewed by a director or supervisor qualified in
cytology; nonmanual methods shall provide quality control similar to that in
other nonmanual laboratory procedures; and all smears shall be retained for not
less than five (5) years from date of examination.
(b) If the laboratory performs tests in the
specialties of histopathology and oral pathology, all special stains shall be
controlled for intended reactivity by use of positive slides; stained slides
shall be retained for not less than two (2) years from date of examination, and
blocks shall be retained for not less than one (1) year from the date of
examination; and remnants of tissue specimens shall be retained in a fixative
solution until those portions submitted for microscopy have been examined and a
diagnosis made by a pathologist.
(7) If the laboratory performs tests in the
specialty of radiobioassay, the counting equipment shall be checked for
stability at least once each day of use, with radioactive standards or
reference sources; reference samples with known activity and within expected
levels of normal samples shall be processed in replicate quarterly; for each
method, records which document the routine precision and the recalibration
schedule shall be maintained and be available to the staff and the
cabinet.
STATUTORY AUTHORITY: KRS 194.050
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