Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.06 - Medical Laboratories-Quality Assurance
Section 10.10.06.06 - Quality Control - Single-Use Test Devices
Universal Citation: MD Code Reg 10.10.06.06
Current through Register Vol. 51, No. 19, September 20, 2024
A. Primary Standard. This regulation applies to test systems that use single-use test devices as defined in COMAR 10.10.01.03B.
B. Standards.
(1) General. A licensee shall ensure that the
test system is validated on a continuing basis and that the ongoing validation
includes:
(a) Calibration
verification;
(b) Parallel testing
before or, when appropriate, instead of proficiency testing; and
(c) Proficiency testing.
(2) Requirements of the Test System's
Manufacturer. In addition to the standards set forth in this regulation, a
licensee shall ensure that the laboratory meets the quality control and quality
assurance requirements of the test system's manufacturer.
(3) Test System Validation.
(a) Initial. Before implementing patient
testing, a licensee shall ensure that the test system is validated to assure
consistency with the test system manufacturer's performance attributes for
acceptable accuracy, precision, and functions that affect test reliability and
the competency of the testing personnel by:
(i) Performing and documenting at least 20
quality control tests for a period of at least 5 days of test system use in the
environment and under the conditions that the test system will be used;
and
(ii) Having all testing
personnel participate in the validation process.
(b) Prior Testing. A test system placed in
service for patient testing before the effective date of this chapter does not
require an initial validation if a licensee ensures that the laboratory has:
(i) Maintained documented evidence of an
established, comprehensive, and active quality assurance program; and
(ii) Participated satisfactorily in and
continues to participate satisfactorily in an approved proficiency testing
program or, when appropriate, periodically has conducted documented, parallel
testing with split samples and periodically continues to conduct documented
parallel testing with split samples.
(4) Validity Check. A licensee shall ensure
that each time a test is performed the result of the validity check and any
corrective action are documented when the result:
(a) Shows a single-use test device or test
system failure;
(b) Indicates any
substandard performance; or
(c)
Requires operator intervention.
(5) System Check.
(a) Quantitative Test System. A licensee
shall ensure that a system check for a quantitative test system is performed
and documented:
(i) As specified by the
manufacturer or at least once each 8 hours of test system use; and
(ii) After a single-use test device is
exposed to an environment or condition that could affect the accuracy or
reliability of test results.
(b) Qualitative Test System. A licensee shall
ensure that a system check for a qualitative test system, if available, is
performed and documented:
(i) As required by
the manufacturer; or
(ii) Each day
the test system is used.
(6) Quality Control Tests.
(a) Quantitative Test Systems. A licensee
shall ensure that quality control testing for a quantitative test system is
performed and documented using at least two levels of control material before
patient testing:
(i) On each lot of a
single-use test device received in a shipment;
(ii) At least weekly for each lot of a
single-use test device used for patient testing;
(iii) After the test system undergoes
maintenance, repair, adjustment, or an environmental exposure that could affect
the accuracy and reliability of test results; and
(iv) Each day of use during the test system's
validation.
(b)
Qualitative Test System. A licensee shall ensure that quality control testing
for a qualitative test system is performed and documented using known positive
and negative control materials before patient testing:
(i) On each lot of a single-use test device
received in a shipment;
(ii) At
least weekly for each lot of a single-use test device used for patient
testing;
(iii) After a single-use
test device is exposed to an environment or condition that could affect the
accuracy or reliability of test results; and
(iv) Each day of use during test system
validation.
(7) Calibration and Verifying Calibration.
(a) Calibration. A licensee shall ensure that
the test system is calibrated as directed by the manufacturer.
(b) Verifying Calibration. A licensee shall
ensure that calibration of the test system is verified as directed by the
manufacturer or at least every 6 months.
(8) Quality Assurance.
(a) Activities and Documentation. In addition
to following other appropriate quality assurance standards in this chapter, a
licensee shall ensure that quality assurance activities and documentation
include reviewing, monitoring, and evaluating:
(i) Single-use test device lot number,
expiration, and disposal; and
(ii)
Testing discrepancies, including failed or repeat quality control or patient
tests, validity checks, and system checks.
(b) Comparison of Test Results. When a
facility performs a test using more than one method or test system, has
multiple testing sites, or has multiple licensees performing the same test
within a facility, the facility's primary or central testing site shall
establish and maintain a quality assurance system that twice a year evaluates
and defines the relationship of test results using the different methods, test
systems, or testing sites.
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