OAR 333-024-0265
Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Procedure

(1)

Prior to performing patient screening, the laboratory shall have available documentation of its expertise with the assays of MSAFP, AFAFP, Serum Human Chorionic Gonadotropin, Unconjugated Estriol, Amniotic Fluid Acetylcholinesterase or other related markers for the purposes of congenital/genetic screening.

(2)

Each laboratory shall establish reference data based on the laboratory’s own test results for normal MSAFP, AFAFP, Serum Human Chorionic Gonadotropin, Unconjugated Estriol, Amniotic Fluid Acetylcholinesterase or other related markers for medically applicable times throughout the pregnancy.

(3)

When required for calculation or interpretation of results, protocols shall be developed and implemented for adjusting test values for variables such as: gestational age, maternal weight, diabetic status, race or other factors.

(4)

At least annually, the laboratory shall:

(a)

Review the most recent patient test results;

(b)

Compare current patient test data to previous results to ascertain changes in the median and dispersion of values;

(c)

Investigate the causes of variation;

(d)

Make corrections as needed; and

(e)

Calculate and review percentages of abnormal results.

(5)

Laboratories shall obtain and use in the calculation and interpretation, where applicable, at least the following information on each patient:

(a)

Date of birth;

(b)

An accurate estimation of gestational age, and method used for this determination;

(c)

Patient’s weight at the time the sample was obtained;

(d)

Whether the patient is an insulin-dependent diabetic (IDDM);

(e)

Patient’s racial extraction;

(f)

Date sample was collected;

(g)

Patient history of multiple gestations; and

(h)

Other pertinent medical information.

(6)

The multiples of the median (MOM) shall be calculated using the laboratory’s own reference data for each medically applicable time during gestation.

(7)

Patient reports shall include information as indicated in section (5) of this rule. Additional information shall include:

(a)

Defects screened for;

(b)

Risk or cutoff used for determination of abnormal results;

(c)

Interpretation of results; and

(d)

Any other medically relevant information necessary for the interpretation of results.

(8)

Policies shall be established for timely reporting of all results to the individual authorized to receive the patient’s results.

Source: Rule 333-024-0265 — Alpha-Fetoprotein Testing and Other Serum and Amniotic Fluid Based Markers for Congenital/Genetic Defects: Procedure, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-024-0265.

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 333-024-0265’s source at or​.us