Current through Register Vol. 24-18, September 15, 2024
(1)
The department may conduct an on-site review of a licensee or applicant at any
time to determine compliance with chapter 70.42 RCW and this chapter as
described in Table 020-1.
(2) The
department may at any time examine records of the medical test site to
determine compliance with chapter 70.42 RCW and this chapter.
(3) The department will:
(a) Provide written notice of deficiencies to
the medical test site;
(b) Allow
the owner a reasonable period of time, not to exceed sixty days after
department approval of the written plan of correction, to correct a deficiency
unless the deficiency is an immediate threat to public health, safety, or
welfare; and
(c) Impose a directed
plan of correction or a partial directed plan of correction as an alternative
sanction for any laboratory that has serious deficiencies per
42 C.F.R.
493.1832 and
RCW
43.05.100.
(4) The medical test site must:
(a) Present a written plan of correction to
the department within fourteen days following the date of postmark of the
notice of deficiencies;
(b) Comply
with the written plan of correction within a specified time, not to exceed
sixty days, after department approval of the written plan of correction which
must detail how and when the medical test site will correct the
deficiencies;
(c) Submit to
inspections by CMS or CMS agents as a condition of licensure for the purpose of
validation or in response to a complaint against the medical test
site;
(d) Authorize the department
to release all records and information requested by CMS to CMS or CMS
agents;
(e) Cooperate with any
on-site review conducted by the department; and
(f) Authorize the accreditation organization
to submit, upon request of the department:
(i) On-site inspection results;
(ii) Reports of deficiencies;
(iii) Plans of corrections for deficiencies
cited;
(iv) Any disciplinary or
enforcement action taken by the accreditation organization against the medical
test site and results of any disciplinary or enforcement action taken by the
accreditation organization against the medical test site; and
(v) Any records or other information about
the medical test site required for the department to determine whether or not
standards are consistent with chapter 70.42 RCW and this chapter.
Statutory Authority:
RCW
70.42.005 and 42 C.F.R. Part 493. 05-04-040,
§ 246-338-028, filed 1/27/05, effective 3/19/05. Statutory Authority:
RCW
70.42.005,
70.42.060. 01-02-069, §
246-338-028, filed 12/29/00, effective 1/29/01. Statutory Authority:
RCW
70.42.005,
70.42.060 and chapter 70.42 RCW.
00-06-079, § 246-338-028, filed 3/1/00, effective
4/1/00.
