Current through Register Vol. 61, No. 4, April 1, 2022
laboratory performing physician performed microscopy, moderate or high
complexity testing must establish and follow written policies and procedures
for a comprehensive quality assurance program which is designed to monitor and
evaluate the ongoing and overall quality of the total testing process
(pre-analytic, analytic, post-analytic).
(2) The laboratory's quality assurance
program must evaluate the effectiveness of its policies and procedures;
identify and correct problems; assure the accurate, reliable and prompt
reporting of test results; and assure the adequacy and competency of the
(3) The laboratory must meet
the requirements of this rule as they apply to the services offered, complexity
of testing performed, test results reported, and the unique practices of each
must monitor, evaluate, and revise, if necessary, based on the results of its
evaluations, the following:
(a) The criteria
established for patient preparation, specimen collection, labeling,
preservation and transportation;
(b) The information solicited and obtained on
the laboratory's test requisition for its completeness, relevance, and
necessity for the testing of patient specimens;
(c) The use and appropriateness of the
criteria established for specimen rejection;
(d) The completeness, usefulness, and
accuracy of the test report information necessary for the interpretation or
utilization of test results;
The timely reporting of test results based on testing priorities (STAT,
routine, etc.); and
accuracy and reliability of test reporting systems, appropriate storage of
records and retrieval of test results.
(5) The laboratory must have an ongoing
mechanism to evaluate the corrective actions taken under remedial
and procedures must be revised based on the outcome of the evaluation. The
mechanism must evaluate and review the effectiveness of corrective actions
(a) Problems identified during the
evaluation of calibration and control data for each test method;
(b) Problems identified during the evaluation
of patient test values for the purpose of verifying the reference range of a
test method; and
detected in reported results.
(7) The corrective actions taken for any
unacceptable, unsatisfactory, or unsuccessful proficiency testing result(s)
must be evaluated for effectiveness.
(8) If a laboratory performs the same test
using different methodologies or instruments, or performs the same test at
multiple testing sites, the laboratory must have a system that twice a year
evaluates and defines the relationship between test results using the different
methodologies, instruments, or testing sites.
(9) If a laboratory performs tests that are
not included in an approved proficiency testing program, the laboratory must
have a system for verifying the accuracy of its test results at least twice a
The laboratory must
have a mechanism to identify and evaluate patient test results that appear
inconsistent with relevant criteria including:
(a) Patient age;
(c) Diagnosis or pertinent clinical data,
(d) Distribution of
patient test results, when available; and
(e) Relationship with other test parameters,
when available within the laboratory.
The laboratory must have an ongoing
mechanism to evaluate the effectiveness of its policies and procedures for
assuring employee competence and, if applicable, consultant competence:
(a) The assessment of employee competence
must be biannually the first year of employment; and
(b) Annually thereafter.
(12) The laboratory must have a system in
place to document problems that occur as a result of breakdowns in
communication between the laboratory and the authorized individual who orders
or receives the results of test procedures or examinations; Corrective actions
must be taken and documented, as necessary, to resolve the problems and
minimize communications breakdowns.
(13) The laboratory must have a system in
place to assure that all complaints and problems are documented. Investigations
of complaints must be made and appropriate corrective actions
(14) The laboratory
must have a mechanism for documenting and assessing problems identified during
quality assurance reviews and discussing them with the staff. The laboratory
must take corrective actions necessary to prevent recurrences.
(15) The laboratory must maintain
documentation of all quality assurance activities including problems identified
and corrective actions taken.
All quality assurance records must be available to the Division and maintained
for a period of 2 years.