Oklahoma Administrative Code › Title 310 - Oklahoma State Department of Health › Chapter 550 - Newborn Screening and resources for trisomy 13, 18, and 21 › Subchapter 23 - Newborn Screening Standards, Procedures, and Follow-Up for Certified Laboratories › Section 310:550-23-1 - Procedures

Current through Vol. 41, No. 20, July 1, 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.