Washington Administrative Code › Title 246 - Health, Department of › FACILITY STANDARDS AND LICENSING › Chapter 246-338 - Medical test site rules › Section 246-338-010 - Definitions

Current through Register Vol. 24-14, July 15, 2024
For the purposes of this chapter, the following words and
				  phrases have these meanings unless the context clearly indicates
				  otherwise.
(1) "Accreditation
				organization" means a public or private organization or agency approved by CMS
				as having standards which are consistent with federal law and regulation, and
				judged by the department to be equivalent to this chapter.
(2) "Authorized person" means any individual
				allowed by Washington state law or rule to order tests or receive test
				results.
(3) "Biannual
				verification" means a system for verifying the accuracy of test results, at
				least twice a calendar year, for those tests for which proficiency testing is
				not required by the department.
(4)
				"Calibration" means a process of testing and adjusting an instrument, kit, or
				test system to provide a known relationship between the measurement response
				and the value of the substance that is being measured by the test
				procedure.
(5) "Calibration
				verification" means the assaying of materials of known concentration in the
				same manner as patient samples to confirm that the calibration of the
				instrument, kit, or test system has remained stable throughout the laboratory's
				reportable range for patient test results.
(6) "Calibrator" means a material, solution,
				or lyophilized preparation designed to be used in calibration. The values or
				concentrations of the analytes of interest in the calibration material are
				known within limits ascertained during its preparation or before use.
(7) "Case" means any slide or group of
				slides, from one patient specimen source, submitted to a medical test site, at
				one time, for the purpose of cytological or histological examination.
(8) "CDC" means the federal Centers for
				Disease Control and Prevention.
(9)
				"CMS" means the federal Centers for Medicare and Medicaid Services.
(10) "CLIA" means Section 353 of the Public
				Health Service Act, Clinical Laboratory Improvement Amendments of 1988, and
				regulations implementing the federal amendments, 42 C.F.R. Part 493-Laboratory
				Requirements in effect on September 22, 2003.
(11) "Control" means a material, solution,
				lyophilized preparation, or pool of collected serum designed to be used in the
				process of quality control. The concentrations of the analytes of interest in
				the control material are known within limits ascertained during its preparation
				or before routine use.
(12)
				"Control slide" means a preparation of a material known to produce a specific
				reaction which is fixed on a glass slide and is used in the process of quality
				control.
(13) "Days" means calendar
				days.
(14) "Deemed status" means
				recognition that the requirements of an accreditation organization have been
				judged to be equal to, or more stringent than, the requirements of this chapter
				and the CLIA requirements, and the accreditation organization has agreed to
				comply with all requirements of this chapter and CLIA.
(15) "Deficiency" means a finding from an
				inspection or complaint investigation that is not in compliance with this
				chapter and requires corrective action.
(16) "Department" means the department of
				health.
(17) "Direct staff time"
				means all state employees' work time; travel time; telephone contacts and staff
				or management conferences; and expenses involved with a complaint investigation
				or an on-site follow-up visit.
(18)
				"Director," defined as the designated test site supervisor in
				RCW
				70.42.010, means the individual responsible
				for the technical functions of the medical test site. This person must meet the
				qualifications for Laboratory Director, listed in 42 C.F.R. Part 493 Subpart M
				- Personnel for Nonwaived Testing.
(19) "Disciplinary action" means license or
				certificate of waiver denial, suspension, condition, revocation, civil fine, or
				any combination of the preceding actions, taken by the department against a
				medical test site.
(20) "Facility"
				means one or more locations within one campus or complex where tests are
				performed under one owner.
(21)
				"Forensic" means investigative testing in which the results are never used for
				clinical diagnosis, or referral to a health care provider for treatment of an
				individual.
(22) "HHS" means the
				federal Department of Health and Human Services.
(23) "High complexity" means a test system,
				assay, or examination that is categorized under CLIA as a high complexity
				test.
(24) "May" means permissive
				or discretionary.
(25) "Medical
				test site" or "test site" means any facility or site, public or private, which
				analyzes materials derived from the human body for the purposes of health care,
				treatment, or screening. A medical test site does not mean:
(a) A facility or site, including a
				residence, where a test approved for home use by the Federal Food and Drug
				Administration is used by an individual to test himself or herself without
				direct supervision or guidance by another and where this test is not part of a
				commercial transaction; or
(b) A
				facility or site performing tests solely for forensic purposes.