OAR 333-024-0400
Health Screen Testing: 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 333-024-0390 (Health Screen Testing: Personnel Qualifications and Responsibilities)(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 333-024-0026 (Equipment and Facilities)(12) & (13) and 333-024-0035 (Internal Quality Control for Moderate and High Complexity Laboratories)(1) and (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 (Health Screen Testing: Purpose) through 333-024-0400 (Health Screen Testing: Quality Assurance).

(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.

Source: Rule 333-024-0400 — Health Screen Testing: Quality Assurance, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-0400.

333‑024‑0005
Purpose 333‑024‑0010
Definitions 333‑024‑0012
Licensure 333‑024‑0016
Licensure Categories 333‑024‑0020
Licensure for Performance of Laboratory Specialties 333‑024‑0021
Qualifications and Responsibilities of Directors for High Complexity Laboratories 333‑024‑0022
Qualifications and Responsibilities for Director of Moderate Complexity Laboratories 333‑024‑0023
Qualifications and Responsibilities of Consultants, Supervisors and Testing Personnel for Moderate and High Complexity Laboratories 333‑024‑0026
Equipment and Facilities 333‑024‑0035
Internal Quality Control for Moderate and High Complexity Laboratories 333‑024‑0037
Specialty and Subspecialty Quality Control 333‑024‑0040
External Quality Control (Proficiency Testing Programs and On-Site Inspections) 333‑024‑0043
Quality Assurance 333‑024‑0045
Venereal Disease Testing 333‑024‑0050
Records and Reports 333‑024‑0053
Accreditation Organizations and Accredited Laboratories 333‑024‑0055
Incompetence 333‑024‑0260
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Purpose 333‑024‑0265
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Procedure 333‑024‑0305
Testing for Substances of Abuse: Purpose and Scope 333‑024‑0310
Testing for Substances of Abuse: Definitions 333‑024‑0315
Testing for Substances of Abuse: Licensure 333‑024‑0320
Testing for Substances of Abuse: Qualifications and Responsibilities of Directors 333‑024‑0325
Testing for Substances of Abuse: Incompetence 333‑024‑0330
Testing for Substances of Abuse: Specimen Collection, Chain of Custody, Records, and Reports 333‑024‑0335
Testing for Substances of Abuse: Internal Quality Assurance 333‑024‑0340
Testing for Substances of Abuse: External Quality Control (Proficiency Testing Program and On-Site Inspections) 333‑024‑0345
Testing for Substances of Abuse: Confirmatory Testing 333‑024‑0350
Testing for Substances of Abuse: Equipment and Facilities 333‑024‑0360
Testing for Substances of Abuse: Special Category Laboratories 333‑024‑0365
Testing for Substances of Abuse: Substance of Abuse Registration 333‑024‑0370
Health Screen Testing: Purpose 333‑024‑0375
Health Screen Testing: Definitions 333‑024‑0380
Health Screen Testing: Permits 333‑024‑0385
Health Screen Testing: Testing Site Schedule 333‑024‑0390
Health Screen Testing: Personnel Qualifications and Responsibilities 333‑024‑0395
Health Screen Testing: Tests Performed 333‑024‑0400
Health Screen Testing: Quality Assurance 333‑024‑1000
Newborn Screening: Purpose 333‑024‑1010
Newborn Screening: Definitions 333‑024‑1020
Newborn Screening: Persons Responsible for Ensuring that First Specimens are Collected and Submitted 333‑024‑1025
Newborn Screening: Persons Responsible for Ensuring that Second, Third and Repeat Specimens are Collected and Submitted 333‑024‑1030
Newborn Screening: Timing for Collecting Specimens 333‑024‑1040
Newborn Screening: Manner of Submitting Specimens 333‑024‑1050
Newborn Screening: Religious Exemption from Newborn Testing 333‑024‑1060
Newborn Screening: Improperly Collected Specimens 333‑024‑1070
Newborn Screening: The Newborn Screening Panel and Methods of Testing 333‑024‑1080
Newborn Screening: Result Reporting and Follow-up 333‑024‑1090
Newborn Screening: Use, Release and Retention of Residual Specimens 333‑024‑1100
Newborn Screening: Ordering Specimen Collection Kits and Fees 333‑024‑1110
Newborn Screening: Failure to Comply 333‑024‑2000
Fees for Communicable Disease Tests Performed in the State Laboratory
Last Updated

Jun. 8, 2021

Rule 333-024-0400’s source at or​.us