Current through Register Vol. 24-18, September 15, 2024
(1) All licensed
medical test sites, excluding those granted a certificate of waiver, must:
(a) Comply with federal proficiency testing
requirements listed in 42 C.F.R. Part 493 - Laboratory Requirements, Subparts H
and I;
(b) Submit to the department
a copy of proficiency testing enrollment confirmation form(s) for the tests the
medical test site will perform during the following calendar year, by December
31st of each year; and
(c)
Authorize the proficiency testing program to release to the department all data
required to determine the medical test site's compliance with this
section.
(2) The
department will:
(a) Recognize only those
proficiency testing programs approved by HHS; and
(b) Furnish, upon request:
(i) A copy of 42 C.F.R. Part 493 Subparts H
and I;
(ii) A list of the
proficiency testing programs approved by HHS; and
(iii) A list of tests that must be covered by
proficiency testing.
(3) The department will evaluate proficiency
testing results by using the following criteria:
(a) An evaluation of scores for the last
three testing events of proficiency testing samples including:
(i) Tests;
(ii) Subspecialties; and
(iii) Specialties;
(b) Maintenance of a minimum acceptable score
of eighty percent for all tests, subspecialties, and specialties except one
hundred percent for:
(i) ABO grouping and Rh
typing;
(ii) Compatibility testing;
and
(iii) Antihuman
immunodeficiency virus;
(c) Unsatisfactory performance occurs when:
(i) Unsatisfactory scores are obtained in any
specialty or subspecialty in a testing event; or
(ii) An unsatisfactory score is obtained on a
single test in a testing event.
(4) Unsatisfactory performance on two of any
three successive testing events is considered unsuccessful participation, and
will result in the following actions:
(a) The
department will mail a letter to the director stating that the medical test
site may choose to:
(i) Discontinue patient
testing for the identified test, specialty or subspecialty; or
(ii) Follow a directed plan of correction;
and
(b) The medical test
site must notify the department, within fifteen days of receipt of the notice
of the decision to:
(i) Discontinue testing
patient specimens for the identified test, subspecialty or specialty;
or
(ii) Agree to a directed plan of
correction.
(5) Continued unsatisfactory performance for
a test, specialty or subspecialty in either of the next two consecutive sets of
proficiency testing samples, after completing a directed plan of correction,
will result in the following action:
(a) The
department will send, by certified mail, a notice to the owner and director of
the medical test site to cease performing the identified test, subspecialty, or
specialty; and
(b) The owner must
notify the department in writing within fifteen days of the receipt of the
notice of the decision to voluntarily stop performing tests on patient
specimens for the identified test, subspecialty, or specialty.
(6) The owner may petition the
department for reinstatement of approval to perform tests on patient specimens
after demonstrating satisfactory performance on two successive testing events
of proficiency testing samples for the identified test, subspecialty, or
specialty.
(7) The department will
notify the owner in writing, within fifteen days of receipt of petition, of the
decision related to the request for reinstatement.
Statutory Authority: RCW 70.42.005 and 42 C.F.R. Part 493.
05-04-040, § 246-338-050, 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, § 246-338-050, filed 3/1/00, effective 4/1/00. Statutory
Authority: Chapter 70.42 RCW. 94-17-099, § 246-338-050, filed 8/17/94,
effective 9/17/94; 93-18-091 (Order 390), § 246-338-050, filed 9/1/93,
effective 10/2/93; 91-21-062 (Order 205), § 246-338-050, filed 10/16/91,
effective 10/16/91. Statutory Authority:
RCW
43.70.040. 91-02-049 (Order 121), recodified
as § 246-338-050, filed 12/27/90, effective 1/31/91. Statutory Authority:
Chapter 70.42 RCW. 90-20-017 (Order 090), § 248-38-050, filed 9/21/90,
effective 10/22/90.
