Okla. Admin. Code § 310:550-23-1

Current through Vol. 42, No. 7, December 16, 2024

Section 310:550-23-1 - Procedures

(a) The Commissioner of Health shall establish procedures for newborn screening laboratories which shall include laboratory methodology, proficiency testing, quality assurance, sample collection, reporting, follow-up, handling, use, retention, storage and disposition of form kits.

(b) The Commissioner of Health shall establish procedures for the Department's newborn screening short-term follow-up program which shall include quality assurance, notification of providers and parents, follow-up guidelines, and parent and provider education.

(c) Hospitals, physicians, and laboratories shall comply with procedures for the Newborn Screening Program established by the Commissioner of Health.

(d) Any laboratory performing newborn screening tests shall be certified by the Department as a Newborn Screening Laboratory. In order to be certified as a Newborn Screening Laboratory, a laboratory shall maintain technical proficiency and ensure that test reagents and equipment are properly standardized.

(e) A Certified Laboratory refers to the Oklahoma State Public Health Laboratory or a laboratory approved by the Oklahoma State Department of Health to conduct newborn screening tests. A laboratory desiring certification as a Newborn Screening Laboratory shall make written application to the Public Health Laboratory Service of the Department. A certified laboratory shall meet the following minimum standards:

(1)Eligibility for approval. A laboratory in Oklahoma that meets the requirements of Section 353 of the Public Health Service Act ( 42 U.S.C. 263 a) as revised by the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), Public Law 100-578. The Laboratory must have a CLIA certificate for tests of High Complexity and meet the criteria for those tests as specified in CLIA '88 and amendments. The lab must have the capacity to provide testing for the mandated newborn screening panel on a single satisfactory filter paper specimen submitted by the birth hospital or provider.

(2)Minimum tests. A laboratory shall perform a sufficient number of tests each week, a minimum of 300 blood samples from different Oklahoma infants a week for each disorder, to maintain technical proficiency and ensure that test reagents and equipment are properly standardized.

(3)Record keeping.

(A) The laboratory shall log in each sample received with an identifier. All patient information and test results shall be linked to the identifier and maintained as a permanent record for a period of 21 years.

(B) The laboratory shall maintain quality control and proficiency test records and shall be available for inspection by the Department.

(4)Standard laboratory screening assay methods. All assay methods must be approved by the Commissioner of Health.

(5)Follow-up for certified laboratories.

(A) Within fifteen (15) days after specimen collection, the Certified Laboratory shall send a written report of the test results with repeat testing requirements, if indicated, to the submitter and physician listed on the filter paper requisition.

(B) The Certified Laboratory will reject any unsatisfactory samples for testing.

(C) The Certified Laboratory must maintain a database with the capacity to report abnormal results to the Department's Newborn Screening Program Coordinator or designee.

(D) The Certified Laboratory must report abnormal results that are possible disease conditions within eight to twenty-four hours to the Department's Newborn Screening Program Coordinator or designee.

(6)Reporting. Certified Laboratories shall compile quarterly and annual reports for the Newborn Screening Program of total screening tests, abnormal tests by disorder, unsatisfactory tests, and less than 24 hours of age at time of collection test.

(7)Certification of laboratories.

(A) Upon satisfying the requirements of these standards and demonstrating proficiency in the presence of an authorized representative from the Department the following is issued. A certificate of approval, which will specify:

(i) Name of laboratory

(ii) Test of certification must be approved for all mandated tests.

(iii) Date of issue and expiration: certificate issued for one (1) year and renewable annually.

(8)Revocation of certification.

(A) The laboratory shall be in compliance with all applicable Federal or State Laws, or regulations. The compliance with the requirements thereof shall be the responsibility of the laboratory, without reliance on or direction by the Oklahoma State Department of Health (OSDH). Following notice by OSDH of its intent to revoke the laboratory's certification and completion of an individual proceeding pursuant to Article II of the Oklahoma Administrative Procedures Act (APA), the certification of a laboratory may be revoked, based upon proof by a preponderance of the evidence for any of the following reasons:

(i) Failure to meet any requirements in these regulations.

(ii) Failure to use a standard laboratory assay approved by the Commissioner of Health.

(iii) Failure to participate in a recognized proficiency program and/or maintain proficiency.

(iv) Failure to keep adequate records of test results and quality control.

(v) Failure to give prompt notice of changes in personnel performing the tests.

(B) Upon notice of revocation the laboratory shall cease to perform newborn screening and return their certificate of approval.

(C) Reinstatement of laboratory certification shall be contingent upon the following:

(i) A laboratory shall not apply for reinstatement until a minimum of three months has elapsed from date of revocation.

(ii) All factors which can be identified must be corrected.

(iii) A laboratory applying for reinstatement must meet the same requirements as for initial application.

(D) Revocation of certified laboratory status by OSDH may be appealed pursuant to Article II of the Oklahoma APA.

Okla. Admin. Code § 310:550-23-1

Amended at 21 Ok Reg 1286, eff 5-27-04; Amended at 22 Ok Reg 794, eff 5-12-05