Current through Register Vol. 24-18, September 15, 2024
Each medical test site performing moderate complexity
(including PPMP) or high complexity testing, or any combination of these tests,
must establish and follow written policies and procedures for a comprehensive
quality assurance program. The quality assurance program must be designed to
monitor and evaluate the ongoing and overall quality of the total testing
process (preanalytic, analytic, postanalytic). The medical test site'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
staff. As necessary, the medical test site must revise policies and procedures
based upon the results of those evaluations. The medical test site must meet
the standards as they apply to the services offered, complexity of testing
performed and test results reported, and the unique practices of each testing
entity. All quality assurance activities must be documented.
(1) The medical test site must establish and
implement a written quality assurance plan, including policies and procedures,
designed to:
(a) Monitor, evaluate, and
review quality control data, proficiency testing results, and test results,
including biannual verification of:
(i)
Accuracy of test results for:
(A) Tests that
are not covered by proficiency testing;
(B) Tests that are covered by proficiency
testing but have unsatisfactory scores, are not scored by the proficiency
testing program, or where scoring does not reflect actual test performance
(e.g., the proficiency testing program does not obtain the agreement required
for scoring); and
(ii)
Relationship between test results when the medical test site performs the same
test on different instruments or at different locations within the medical test
site;
(b) Identify and
correct problems;
(c) Establish and
maintain accurate, reliable, and prompt reporting of test results;
(d) Verify all tests performed and reported
by the medical test site conform to specified performance criteria in quality
control under WAC
246-338-090;
(e) Establish and maintain the adequacy and
competency of the technical personnel; and
(f) Establish and follow written policies and
procedures that ensure positive identification and optimum integrity of a
patient's specimen from the time of collection or receipt of the specimen
through completion of testing and reporting of results.
(2) The quality assurance plan must include
mechanisms or systems to:
(a) Establish and
apply criteria for specimen acceptance and rejection;
(b) Notify the appropriate individuals as
soon as possible when test results indicate potential life-threatening
conditions;
(c) Assess problems
identified during quality assurance reviews and discuss them with the
appropriate staff;
(d) Evaluate all
test reporting systems to verify accurate and reliable reporting, transmittal,
storage, and retrieval of data;
(e)
Document all action taken to identify and correct problems or potential
problems;
(f) Issue corrected
reports when indicated;
(g) Provide
appropriate instructions for specimen collection, handling, preservation, and
transportation;
(h) Ensure that
specimens are properly labeled, including patient name or unique patient
identifier and, when appropriate, specimen source;
(i) Ensure confidentiality of patient
information throughout all phases of the testing process; and
(j) Provide clients updates of testing
changes that would affect test results or the interpretation of test
results.
(3) The medical
test site must establish criteria for and maintain appropriate documentation of
any remedial action taken in response to quality control, quality assurance,
personnel, proficiency testing, and transfusion reaction
investigations.
(4) When results of
control or calibration materials fail to meet the established criteria for
acceptability, the medical test site must have a system in place to determine
if patient test results have been adversely affected. The system must include:
(a) A review of all patient test results
obtained in the unacceptable test run; and
(b) A review of all patient test results
since the last acceptable test run.
(5) The medical test site must have a system
in place to assure:
(a) All complaints and
problems reported to the medical test site are documented and investigated when
appropriate; and
(b) Corrective
actions are instituted as necessary.
(6) The owner must:
(a) Maintain adequate space, facilities, and
essential utilities for the performance and reporting of tests;
(b) Ensure that molecular amplification
procedures that are not contained in closed systems have a unidirectional
workflow. This must include separate areas for specimen preparation,
amplification and production detection, and as applicable, reagent
preparation;
(c) Establish, make
accessible, and observe safety precautions to ensure protection from physical,
chemical, biochemical, and electrical hazards and biohazards; and
(d) Establish and implement policies and
procedures for infectious and hazardous medical wastes consistent with local,
state, and federal authorities.
(7) Information that must be available to
authorized persons ordering or utilizing the test results includes:
(a) A list of test methods, including
performance specifications;
(b)
Reference ranges; and
(c) Test
method limitations.
(8)
If the medical test site refers specimens to another site for testing, the site
to which specimens are referred must have a valid medical test site license or
meet equivalent requirements as determined by CMS.
Statutory Authority: RCW 70.42.005 and 42 C.F.R. Part 493.
05-04-040, § 246-338-080, filed 1/27/05, effective 3/19/05. Statutory
Authority:
RCW
70.42.005,
70.42.060 and chapter 70.42 RCW.
00-06-079, § 246-338-080, filed 3/1/00, effective 4/1/00. Statutory
Authority: Chapter 70.42 RCW. 93-18-091 (Order 390), § 246-338-080, filed
9/1/93, effective 10/2/93; 91-21-062 (Order 205), § 246-338-080, filed
10/16/91, effective 10/16/91. Statutory Authority:
RCW
43.70.040. 91-02-049 (Order 121), recodified
as § 246-338-080, filed 12/27/90, effective 1/31/91. Statutory Authority:
Chapter 70.42 RCW. 90-20-017 (Order 090), § 248-38-080, filed 9/21/90,
effective 10/22/90.
