Nebraska Administrative Code
Topic - HEALTH AND HUMAN SERVICES SYSTEM
Title 181 - SPECIAL HEALTH PROGRAMS
Chapter 2 - SCREENING OF INFANTS FOR INHERITED AND CONGENITAL INFANT OR CHILDHOOD-ON SET DISEASES
Section 181-2-007 - TESTING LABORATORY DUTIES

Universal Citation: 181 NE Admin Rules and Regs ch 2 ยง 007

Current through September 17, 2024

007.01 GENERAL RULES.

007.01(A) ELECTRONIC TRANSMISSION. The testing laboratory must report all of the information on the collection and reporting form electronically, at its own expense, to the Nebraska Newborn Screening Program (NNSP) in electronic format that provides complete demographic and test results records for each infant and that provides the reporting functions as specified by the Department in this chapter and in contract. The testing laboratory must provide, at its own expense, the necessary software and hardware.

007.01(B) TEST PERFORMANCE. The testing laboratory must perform all tests required in the contract between the Department and the laboratory at least six days a week.

007.01(C) CONTACT PERSON. The testing laboratory must keep the Nebraska Newborn Screening Program (NNSP) informed of the contact person responsible for newborn screening.

007.01(D) SCREENING TESTS. Except as provided in the disaster preparedness plan as required in the contract, the screening tests must be completed only by the laboratory designated by contract with the Department beginning with the effective date of the contract.

007.01(E) CONFIRMATORY TESTS. Confirmatory tests may be done by any laboratory including the laboratory designated by the Department as long as it is certified under the Clinical Laboratory Improvement Amendments (CLIA) and meets standards as set forth in this chapter. The contracted newborn screening laboratory will append to the laboratory report for all presumptive positive screening results, disorder specific recommendations for immediate testing and clinical follow-up, as approved by the Department.
(i) Confirmatory testing laboratories must be Clinical Laboratory Improvement Amendments (CLIA) certified and maintain data to support validation of the assays and normal reference ranges for neonates and infants for whom confirmatory testing is provided.

(ii) Confirmatory testing laboratories must provide, at a minimum, written or electronic laboratory reports back to the specimen submitter that includes:
(1) Name of the test;

(2) Validated age-appropriate normal reference ranges for the analytes tested when confirming for endocrinopathies (Congenital Adrenal Hyperplasia and Congenital Primary Hypothyroidism) and hemoglobinopathies;

(3) Test method and relative amounts of hemoglobin's when confirming for hemoglobinopathies;

(4) Identification of ratios when hemoglobin's A and S are present;

(5) Test results in quantitative values (except hemoglobin's above) and units of measure consistent with units of measure in the normal reference ranges or values;

(6) Interpretation of results appropriate to the age of the newborn or infant;

(7) Name and address where testing was completed;

(8) Name and phone number of person providing the interpretation; and

(9) Written acknowledgement of conditions that may interfere with the appropriate interpretation of results.

007.02 REPORTING AND RECORD KEEPING.Testinq laboratories must maintain records and make reports in the following manner:

007.02(A) ELECTRONIC REPORT. The laboratory must provide an electronic report to the Department which includes the following information:
(i) All information contained on the Department approved form;

(ii) The serial number located on the Department approved form;

(iii) If applicable, identification of any unsatisfactory specimen and the reason for its unsatisfactory nature;

(iv) Screening, repeat, and confirmatory test results, including numerical data where applicable; and

(v) Any notifications to the physician, the Nebraska Newborn Screening Program (NNSP), or the submitter.

007.02(B) BLOOD SPOT STORAGE, USE, AND DISPOSAL RECORDS. The testing laboratory must maintain for 25 years an index or catalog of the residual dried blood spots processed in the laboratory that includes the following information:
(i) The serial number or unique identifier of each specimen processed;

(ii) The test results of each specimen processed;

(iii) Verification of disposal of specimens not released for research, public health, quality assurance, or diagnostic purposes. This information may be batched by test completion date so long as each serial number or unique identifier can be linked with its test completion date;

(iv) Date of disposal;

(v) Location of disposal if other than the laboratory;

(vi) For specimens released for public health research, documentation as required in this chapter; and

(vii) Signature of the person who released, disposed of, or witnessed the disposal of the specimen; or for specimens disposed of by a contractor, written evidence that the contract for disposal of residual dried blood spots requires disposal be done in accordance with this chapter.

007.02(C) QUALITY ASSURANCE REPORTS. The testing laboratory must provide to the Nebraska Newborn Screening Program (NNSP), copies of written reports of participation in and results of appropriate quality assurance proficiency testing programs offered by the Centers for Disease Control and Prevention (CDC) of the United States Department of Health and Human Services and any other professional laboratory organization.

007.03 UNSATISFACTORY SPECIMEN. If a specimen is unsatisfactory for any reason for any test(s), including but not limited to, being of insufficient volume or quality, the testing laboratory must reject it. Within 24 hours of receiving any unsatisfactory specimen, the testing laboratory must:

(A) Notify the submitter and physician or designee by telephone and in writing that the specimen was unsatisfactory and that a repeat specimen must be collected within 48 hours of notification to the parent, guardian, or custodian;

(B) Schedule any tests possible on the specimen received in accordance with the testing laboratory's standard operating procedure and testing times; and

(C) Enter the applicable information identified in this chapter into the or database accessible to the Department.

007.04 NEGATIVE SCREENING, NEGATIVE REPEAT SCREENING, AND NEGATIVE CONFIRMATORY TEST RESULTS. Within 24 hours of obtaining a negative screening, negative repeat screening, or negative confirmatory test result, the testing laboratory must:

(A) Send a copy of the test results to the submitter; and

(B) Enter the applicable information identified in this chapter into the Department's electronic database or database accessible to the Department.

007.05 PRESUMPTIVE POSITIVE SCREENING, POSTIVE REPEAT SCREENING, OR POSITIVE CONFIRMATORY TEST RESULTS. Immediately after obtaining any presumptive positive screening, positive repeat screening, or positive confirmatory test result, the testing laboratory must:

(A) Provide test result information to the submitter and physician or designee by telephone and in writing;

(B) Utilize the Nebraska Newborn Screening Program (NNSP) telephone number provided by the Department and relay the information on the form approved by the Department and the presumptive positive or positive results; and

(C) Enter the applicable information identified in this chapter into the or database accessible to the Department.

007.06 STANDARDIZED LABORATORY TEST METHODS. The testing laboratory must use only the standardized test methods provided for in the contract with the Department and the methods used must produce results for which the specified cutoff value, or cutoff value and-algorithms for assigning presumptive positive results are appropriate. The screening test approved analytical method, cutoff value, and algorithms for assigning presumptive positive results (identification protocol) will be specified in the contract between the Department and the laboratory conducting newborn screening testing for the diseases specified in these regulations. Identification protocols used by the performing laboratory must be agreed upon in contract by the Department with the advice of the Newborn Screening Advisory Committee.

007.07 NEWBORN SCREENING ADVISORY COMMITTEE TECHNICAL OVERSITE. The Newborn Screening Advisory Committee is responsible for reviewing technical aspects of the identification protocol for the initial screening test relevant to repeat and confirmatory testing. The Committee must make recommendations for approval, disapproval, or revision to identification protocols. The Department has final decision authority for contractually agreed upon tests, analytic methods, and identification protocols for normal and abnormal results and reporting specifications.

007.08 STORAGE OF RESIDUAL DRIED BLOOD SPOTS. The testing laboratory must store the residual dried blood spots for 90 days. Specimens must be refrigerated in sealed bags of low gas permeability.

007.09 USE OF RESIDUAL DRIED BLOOD SPOTS. Residual dried blood spots may be used for public health research, further patient diagnostic testing, and public health purposes, for example, quality assurance and improvement of newborn screening practices.

007.09(A) REQUIREMENTS FOR USE OF RESIDUAL DRIED BLOOD SPOTS. Residual dried blood spots may be used for public health research only when:
(i) The Division of Public Health Chief Medical Officer and the Newborn Screening Advisory Committee have reviewed and approved the application for research containing, but not limited to, the following information:
(1) The full report of the review and approval of the research by a Human Subjects Review or Institutional Review Board (IRB);

(2) The qualifications of the applicant and of the principal investigator, if other than the applicant, including education, experience, prior publications, and recommendations of professional colleagues who have knowledge and experience of scientific or medical research;

(3) The purpose of the research project, a summary of the project, and the anticipated time of completion of the project;

(4) The location where the research project will be conducted and the equipment, personnel, and other resources available to the applicant to carry out the project;

(5) The identity of the individual or entity funding the research project, a description of the availability of funds for the research project, and any conditions on the receipt or continuation of the funding;

(6) The specific data or biological sample information requested and a description of the use to be made of it and, if subject-identifying data is requested, a substantiation of the need for access to the subject-identifying data;

(7) A description of the measures to be taken to secure the data and biological sample information and to maintain the confidentiality of such during the research project, for disposal of the data and biological sample upon completion of the study, and to assure that the results of the study will not divulge or make public, information that will disclose the identity of any individual subject;

(8) A written assurance agreement that the research will be published in the public domain and communication of research results will not be restricted on the basis of the proprietary interests of commercial, private, or other partners;

(9) A description of the process that will be used for obtaining written consent from the legally responsible parent or guardian of the individuals whose specimens will be requested;

(10) If contact with a subject or subject's parent or legal guardian is planned or expected beyond obtaining consent as required in this chapter, substantiation of the need for the contact and a description of the method to be used to obtain permission from the subject or subject's parent or legal guardian for the contact;

(11) Such additional information as the Department determines to be necessary to assure that release of data to the applicant is appropriate and consistent with this chapter; and

(12) A Material Transfer Agreement (MTA) between the newborn screening laboratory responsible for the storage and release of specimens and the specimen recipients. The Material Transfer Agreement (MTA) must address prohibitions on secondary transfer and secondary research of dried blood spot specimens (DBS) without state authorization; data sharing back to the state program; intellectual property rights, publication requirements, and acknowledgement of state resource use in publications.

(ii) Specimens released that meet the requirements of this chapter, with or without patient identifying information, the laboratory must keep records documenting the following:
(1) Who had access to the specimen;

(2) To whom the specimen was released;

(3) The amount of specimen released; and

(4) Evidence from the research entity that written consents were obtained from the legally responsible parent or guardian of the individuals whose specimens were released.

(iii) The blood spot is not released for public health research until after the 90-day storage time. During the 90-day storage time, it must be available for clinical purposes for the patient.

007.09(B) LABORATORY RECORD KEEPING REQUIREMENTS FOR USE OF RESIDUAL DRIED BLOOD SPOTS. Per this chapter must be retained for 25 years.

007.09(C) USE OF RESIDUAL DRIED BLOOD SPOTS FOR PATIENT DIAGNOSTIC TESTING. Residual dried blood spots may be used for patient diagnostic testing when the ordering physician files with the laboratory a written request for specimen retrieval and a written authorization for release of the specimen signed by the parent or legal guardian.

007.09(D) USE OF RESIDUAL BLOOD SPOTS FOR PUBLIC HEALTH PURPOSES. Residual dried blood spots may be used for public health purposes as follows:
(i) They may be used for quality assurance and improvement of newborn screening practices subject to the following:
(1) Only dried blood spots deemed unsatisfactory for testing may be released to the submitting hospital to use as examples of poor specimen quality;

(2) The filter paper portion of the Collection and Report (CARe) Form containing the dried blood spots must be detached from the written patient identification part of the form prior to release;

(3) The bar code and filter paper serial number linking the dried blood spot to the patient identification information must be removed from the residual dried blood spot prior to release; and

(4) Requests for return of unsatisfactory specimens must be made by the submitting facility through the Nebraska Newborn Screening Program (NNSP).

(ii) They may be used for other public health purposes when:
(1) The Division of Public Health Chief Medical Officer has determined there is a valid public health purpose;

(2) The Division of Public Health Chief Medical Officer has informed the Newborn Screening Advisory Committee about the public health use of the residual dried blood spots;

(3) Patient information linking the specimen to the patient will be protected;

(4) There are assurances that all applicable provisions of federal law will be complied with; and

(5) The blood spot is not released or used for the public health purpose until after the 90-day storage time. During the 90-day storage time it must be available for clinical or identification purposes for the patient unless a public health emergency is declared.

007.10 DATA REPORTS. Reported data may be made available by the Department for purposes of research in aggregate statistical form or de-identified anonymous form. Written requests for release of this data for the purposes of research must be made to the Nebraska Newborn Screening Program (NNSP).

007.11 DISPOSAL OF RESIDUAL DRIED BLOOD SPOTS. Residual dried blood spots not released under this chapter must be disposed of within 30 days of the end of the 90-day storage time. Destruction of the specimens, by incineration, by autoclaving and shredding, or by some other reasonable and prudent means, must ensure that identifying information cannot be linked to the residual dried blood spots.

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