OAR 333-024-0026
Equipment and Facilities

(1)

All equipment shall be maintained in good working order, checked routinely, and precisely calibrated according to manufacturer’s requirements or a minimum of every six months.

(2)

Work bench space shall be ample, clean, well-organized, well-lighted, and convenient to sink, water and electrical outlets.

(3)

The laboratory shall be ventilated to protect the health of the personnel and patients against accidental release of hazardous vapors or aerosols.

(4)

Laboratory procedure manuals and policies shall be available for the use of the personnel in the laboratory and shall be reviewed by the Director initially and when there is a change in methods or policy.

(5)

The premises shall be free from unnecessary physical, chemical, and biological hazards. All materials containing pathogenic organisms shall be:

(a)

Autoclaved at 121°C for 30 minutes to ensure nonviability prior to being discarded; or

(b)

Incinerated in a State-approved incinerator; or

(c)

Disposed using another Division approved method.

(6)

Safety precautions must be posted and observed.

(7)

Glassware shall be free from excessive scratches and cloudiness and graduations must be legible. “To contain” and “to deliver” pipettes are to be kept separated. Cleanliness of glassware must be adequate for the purpose for which it is used.

(8)

Blood-letting lancets, needles, and syringes, if not sterile and disposable, shall be sterilized prior to each use by standard and accepted methods. Each sterilizing cycle shall contain a satisfactory indicating device to assure proper sterilization.

(9)

Electrical equipment shall be maintained in a safe condition with regards to shock and fire hazards. All electrical equipment, except battery operated, shall be grounded. Protective fuses shall not be bypassed.

(10)

Caustic, explosive, and flammable materials shall carry labels to indicate their nature and shall be placed in containers and stored in locations which are suitable to ensure stability, purity, and safety as is necessary regarding the material involved.

(11)

The laboratory shall define, establish and document a function check and maintenance protocol that ensures equipment, instrument, and test system performance necessary for accurate and reliable test results and result reporting.

(12)

Requirements for calibration and calibration verification for unmodified moderate complexity test procedures that are performed using instruments, kits, or test systems that have been cleared by the Food and Drug Administration (FDA) through the 510(k) or Premarket Approval (PMA) process:

(a)

Until September 1, 1996, the laboratory must meet the requirements in OAR 333-024-0035 (Internal Quality Control for Moderate and High Complexity Laboratories)(1)(e) and (f);

(b)

After September 1, 1996, the laboratory must meet the requirements in OAR 333-024-0026 (Equipment and Facilities)(13).

(13)

Requirements for calibration and calibration verification for laboratories performing high complexity testing procedures, tests not cleared by the FDA through the 510(k) or PMA process, modified moderate complexity testing:

(a)

The laboratory must:

(A)

Establish the number, type, and concentration of calibration materials required to assure accurate and reliable test results;

(B)

Establish the frequency and acceptable limits for calibration and calibration verification, if not provided by the manufacturer;

(C)

Use calibration materials appropriate for the methodology, and if possible, traceable to a reference method or reference material of known value; and

(b)

The laboratory must perform and document calibration:

(A)

At the frequency required by the manufacturer;

(B)

In accordance with criteria established by the laboratory, if more frequent than manufacturer’s requirements; and

(C)

When calibration verification fails to meet the laboratory’s acceptable limits for calibration verification.

(c)

The laboratory must perform calibration verification to verify the laboratory’s established reportable range for patient test values using calibration or control materials, including at least a minimal value (zero), a mid-point value, and a maximum value at the upper limit of that range:

(A)

When a complete change of reagents is introduced;

(B)

When there is a major preventative maintenance or replacement of critical parts that may influence test performance;

(C)

When controls reflect an unusual trend or shift or are outside the laboratory’s acceptable limits and other means of assessing and correcting unacceptable control values have failed to identify and correct the problem;

(D)

At least once every six months, unless the laboratory’s established schedule for verifying the reportable range for patient test results requires more frequent calibration verification.

(d)

Calibration and calibration verification must meet the laboratory’s acceptable ranges prior to patient test reporting;

(e)

Calibration and calibration verification documentation must be maintained for a minimum of two years.

Source: Rule 333-024-0026 — Equipment and Facilities, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-0026.

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 333-024-0026’s source at or​.us