Current through Vol. 42, No. 1, September 16, 2024
(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.
Amended at 21 Ok Reg
1286, eff 5-27-04; Amended at 22 Ok Reg 794, eff
5-12-05
