Or. Admin. R. 333-024-0400

Current through Register Vol. 63, No. 8, August 1, 2024

Section 333-024-0400 - Quality Assurance

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;

(2) Test reports and records shall include:

(a) Name and address of health screen testing service;

(b) Patient name and results of tests performed;

(c) Date test performed;

(d) Expected ranges;

(e) Initials of individual performing tests;

(f) If indicated, fasting or non-fasting;

(g) Documentation of referral to a licensed physician or clinician for counseling per section (6) of this rule if results are outside expected normal ranges;

(h) Health Screen Testing services must maintain records of patient name, address and test values for at least 2 years;

(i) Health Screen Testing laboratories performing moderate complexity testing must comply with the rules in OAR 333-024-026(12) & (13) and 333-024-035(1) & (2).

(3) Quality assurance activities:

(a) If the laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites.

(b) If a laboratory performs tests that are not included in an approved proficiency testing program, the laboratory must have a system for verifying the accuracy of its test results at least twice a year.

(c) The health screen testing service shall establish a quality assurance plan and monitors; and document quality assurance activities for test reporting and referral, quality control assessment and annual personnel competency.

(d) Any health screen testing service which tests for triglycerides must clearly display at the testing site a notice that triglyceride testing can only be performed after an individual has fasted for 12 to 16 hours.

(4) Safety: Permitted health screen testing services shall assure that:

(a) Eating, drinking, smoking, or applying cosmetics are prohibited at the bench where specimen collection and sample testing is performed;

(b) Laboratory coats or other protective clothing are worn by health screen testing personnel;

(c) Skin puncture sites are cleansed with an appropriate disinfectant;

(d) Gloves designed for medical use for bloodborne pathogen protection are worn during the skin puncture and changed between clients;

(e) Gloves designed for medical use for bloodborne pathogen protection are worn during specimen handling and testing;

(f) Used lancets, needles and blood tubes are disposed of in impervious biohazard labeled containers;

(g) Other potentially infectious materials are disposed of in a biohazard labeled container; refer to the infectious waste rules under 333-018-0040 through 333-018-0070;

(h) Electrical equipment is maintained in a safe condition with regards to shock and fire hazards;

(i) Work surfaces are disinfected with a virucidal reagent after each blood spill, and prior to and after each day of testing.

(5) External Quality Control:

(a) Permitted health screen testing services shall:

(A) Assure proficiency testing is performed on each moderate or high complexity regulated analyte listed in the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Subpart I, available on request from the Authority.

(B) Meet the proficiency testing requirements as described in CLIA 88, 42 CFR, Part 493, Subpart H, available on request from the Authority.

(C) Analyze test samples submitted by the Authority prior to, during, or subsequent to inspection if requested by the Authority and achieve a score of at least 80 percent.

(D) Notify the Authority within six months if the analysis of a test has been discontinued or added to patient testing.

(E) Notify the Authority of change of director, owner, name, and address of the permanent location within 30 days of the change.

(b) Surveys for compliance will be performed either onsite or as paper surveys and the entity will be required to submit documentation to the Authority that quality control and quality assurance activities and test records meet this rule. Onsite inspections may be conducted by representatives of the Authority at reasonable times during the health screen testing service's normal business hours without advance notice. The representative shall review the personnel policies, procedures, staff qualifications/training, equipment records, quality control, reports, specimen handling and waste disposal, as related to health screen testing activities.

(c) Additional inspections may be performed by the Authority or HCFA without notice to verify correction of deficiencies, investigate complaints, review unsatisfactory proficiency testing, perform validation surveys, verify personnel qualifications or other monitoring of compliance with OAR 333-024-0370 through 333-024-0400.

(6) Counseling and Referral: The health screen testing service shall provide or contract for counseling and medical referral policies for each person tested and shall include:

(a) The ranges of results expected for that test;

(b) The value or test range that is recommended nationally for each test performed;

(c) A list of possible health risks associated with abnormal results;

(d) The recommended action which a person should follow if the test results are outside the expected value or range; and

(e) Procedures and follow-up for critical values.

Or. Admin. R. 333-024-0400

HD 16-1990, f. & cert. ef. 6-15-90; HD 20-1994, f. & cert. ef. 7-20-94; HD 6-1995, f & cert. ef. 9-13-95; OHD 9-2000, f. & cert. ef. 11-3-00; OHD 20-2001, f. & cert. ef. 9-14-01

Stat. Auth.: ORS 438.010(10), 438.060, 438.130(2), 438.150(5), 438.150(6) & 438.150(7)

Stats. Implemented: ORS 438.150