1. (a) The Commissioner of Health shall establish procedures for newborn screening laboratories that include laboratory methodology, proficiency testing, quality assurance, sample collection, reporting, follow-up, handling, use, retention, storage and disposition of form kits.
2. (b) The Commissioner of Health shall establish procedures for the Department's newborn screening short-term follow-up program that include quality assurance, notification of providers and parent(s) or guardian(s), follow-up guidelines, and parent or guardian and provider education.
3. (c) Birthing facilities, physicians, and laboratories shall comply with procedures for the Newborn Screening Program established by the Commissioner of Health.
4. (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.

5. (e) A laboratory desiring certification as a Newborn Screening Laboratory shall make written application to the Public Health Laboratory of the Department. A certified laboratory shall meet the following minimum standards:

   1. (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. 263a) 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 laboratory must have the capacity to provide testing for the mandated newborn screening panel on a single satisfactory Newborn Screening Form Kit submitted by the birthing facility or provider.
   2. (2) Minimum tests. A laboratory shall test, a minimum of 300 blood specimens from different Oklahoma infants for each disorder each week, to maintain technical proficiency and ensure that test reagents and equipment are properly standardized.

   3. (3) Record keeping.

      1. (A) The laboratory shall log each specimen received using at least two unique identifiers. All patient information and test results are linked to the identifier and maintained as a permanent record for a period of at least twenty-one (21) years.
      2. (B) The laboratory shall maintain quality control,proficiency test records, and which will be available for inspection by the Department.
      3. (C) If the laboratory should close, records must be maintained for the same time period. Records may be given to the Department for maintenance.
   4. (4) Standard laboratory screening assay methods. All assay methods must be approved by the Commissioner of Health.

   5. (5) Follow-up for certified laboratories.

      1. (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 Newborn Screening Form Kit.
      2. (B) The Certified Laboratory will reject any unsatisfactory specimens for testing.
      3. (C) The Certified Laboratory must maintain a secure database with the capacity to report abnormal test results to the Department's Newborn Screening Program Coordinator or designee.
      4. (D) The Certified Laboratory must report abnormal test results that are possible disease conditions within eight (8) to twenty-four (24) hours to the Department's Newborn Screening Program Coordinator or designee.
   6. (6) Activity reports. Certified Laboratories shall compile quarterly and annual reports of total screening tests, abnormal tests by disorder, unsatisfactory tests, and for specimens collected from newborns at or less than twenty-four (24) hours of age for submission to the Newborn Screening Program.

   7. (7) Certification of laboratories.

      1. (A) A Certificate of Approval will be issued upon satisfying the requirements of these standards and demonstrating proficiency in the presence of an authorized representative from the Department. This Certificate of Approval will specify:

         1. (i) Name of laboratory
         2. (ii) Test of certification must be approved for all mandated tests.
         3. (iii) Date of issue and expiration: certificate issued for one (1) year and renewable annually.

   8. (8) Revocation of certification.

      1. (A) The laboratory shall be in compliance with all applicable Federal and State Laws, and regulations. The compliance with the requirements is the responsibility of the laboratory, without reliance on or direction by the Oklahoma State Department of Health. Following notice by the Department 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:

         1. (i) Failure to meet any requirements in these regulations; or
         2. (ii) Failure to use a standard laboratory assay approved by the Commissioner of Health; or
         3. (iii) Failure to participate in a recognized proficiency program and/or maintain proficiency; or
         4. (iv) Failure to keep adequate records of test results and quality control; or
         5. (v) Failure to give prompt notice of changes in personnel performing the tests or supervising testing.
      2. (B) Upon notice of revocation the laboratory shall cease to perform newborn screening and return their certificate of approval.

      3. (C) Reinstatement of laboratory certification is contingent upon the following:

         1. (i) A laboratory cannot apply for reinstatement until a minimum of three months has elapsed from date of revocation; and
         2. (ii) All factors that lead to revocation of certification are corrected; and
         3. (iii) A laboratory applying for reinstatement must meet the same requirements as for initial application.
      4. (D) Revocation of certified laboratory status by the Department may be appealed pursuant to Article II of the Oklahoma APA.

Amended at 21 Ok Reg 1286, eff 5-27-04

Amended at 22 Ok Reg 794, eff 5-12-05

Amended at 36 Ok Reg 1688, eff 9-13-19

Amended at 38 Ok Reg 2040, eff 9-11-21