Oregon Administrative Rules › Chapter 333 - OREGON HEALTH AUTHORITY, PUBLIC HEALTH DIVISION › Division 24 - CLINICAL LABORATORIES › Section 333-024-0400 - Quality Assurance

Current through Register Vol. 63, No. 7, July 1, 2024
Quality Assurance shall be comprised of Internal Quality
				Control, Tests Reports and Records, Quality Assurance Activities, Safety,
				External Quality Control, Counseling and Referral:
(1) Internal Quality Control:
(a) Documentation of training of testing
			 personnel as specified in OAR 333-024-390(2)(e) shall be kept on file at the
			 permanent location and made available to the Authority at the health screen
			 testing site;
(b) Laboratory
			 procedure manuals and relevant reference materials for current screening
			 methods shall be available for the use of the personnel at the health screen
			 testing site and permanent location and include:
(A) Specimen collection
			 requirements;
(B) Specimen labeling
			 requirements;
(C) Specimen
			 preservation requirements;
(D)
			 Principle and instructions for test performance;
(E) Quality control requirements, including
			 criteria for reporting tests;
(F)
			 Equipment calibration and maintenance procedures;
(G) Normal ranges and test
			 limitations.
(c)
			 Procedure manuals shall be reviewed by the Director;
(d) Performance of each instrument shall be
			 validated according to the manufacturer's specification at each new
			 site;
(e) At each site, standards
			 or controls shall be run which cover the range of expected results and be
			 included at least once per day of use per instrument, per each reagent lot in
			 use, unless the instrument is not moved, in which case it may qualify for
			 external controls with each lot shipment of reagent cartridges per
			 manufacturer's instructions;
(f)
			 When control values are outside the established acceptable range, patient test
			 results shall not be reported;
(g)
			 The following shall be clearly stated and recorded: limits for controls;
			 correction action taken when analyses are outside control limits, and the
			 values for the standards;
(h) For
			 each screening test, data shall be recorded and available to document
			 confirmation of accuracy and precision at least once every six months for each
			 instrument;
(i) Instrument
			 maintenance, reagent storage, and test performance shall be performed according
			 to manufacturer's instructions and recommendations;
(j) Records shall be recorded and retained at
			 each site, with each instrument, for six site days, then transferred to the
			 permanent location for a period of at least two years for:
(A) Client results;
(B) Instrument performance and calibration if
			 applicable;
(C) Quality control;
			 and
(D) Preventive
			 maintenance.
(k) If an
			 instrument is borrowed, the testing permittee shall have the following
			 information (for the past six site days) on each instrument:
(A) Instrument performance to include, but
			 not be limited to, wavelength verification, linearity, and calibration, if
			 applicable;
(B) Quality control;
			 and
(C) Preventive
			 maintenance.
(l) All
			 reagents and solutions shall be labeled to indicate identity, preparation date,
			 lot number, expiration date, and storage conditions as appropriate. No reagents
			 or solutions may be used beyond their expiration date;
(m) All quality control and equipment
			 maintenance records shall be reviewed by the Director each month of
			 operation;