Virginia State Law for newborn blood spot collection protocol
DCLS operational speed
Acceptance of proposal by LewisGale Hospital
Criteria
Lower interruption in breast feeding to below 3 weeks
Decrease cost for patient and family, Lewis Gale Hospital, and Virginia State
Standards/Specifications
Health Insurance Portability and Accountability Act (HIPAA)
This standard requires the protection and confidential handling of protected health information (PHI) and mandates industry-wide standards for health care information on electronic billing and other processes (DHCS,2019). HIPAA gives patients' rights over their health information and sets limits on the uses and disclosures that may be made of PHI without patient authorization. This protection was extended in 2003 to ensure the confidentiality of electronic health information as well (Office for Civil Rights, 2017)
Good Laboratory Practices (GLP)
Good Laboratory Practice regulations need to be accounted for when doing the newborn screening. These regulations were published in 2012 by the CDC (Shahangian & Chen, 2012). These regulations ensure the quality of the newborn screening test and integrity of the data being collected. All labs that are performing any biochemical genetic testing, metabolic screening, or newborn screening must also uphold the Clinical Laboratory Improvement Amendments of 1988. Both of these standards compliment each other to ensure that patients are receiving accurate and honest health outcomes that were executed correctly. These standards are going to be investigated at Lewis Gale Hospital to see how they comply with regulations and to identify areas of improvement to create faster and potentially more accurate testing results.
A standard that must be accounted for is Metabolic Screening for Newborns OB Tech Competency Validation. This is a training process given to the OB techs prior to beginning work to assure they are fully competent in all of the necessary areas needed to properly perform the screening tests. They are rated in three areas: psychomotor skills, critical thinking skills, and interpersonal skills. The skills of the new hires are rated and validated my multiple RNs (Gilman, RN & Pyne, 2019).
Metabolic Screening for Newborns Obstetrician Technician Competency Validation
This standard is a monthly report given to hospitals in the state of Virginia. This report includes specifics and statistics on the samples received and tested by DCLS. Some of the specifics given are the numbers of samples from the hospital, the average amount of time it took the laboratory to receive the samples, the number of samples received that did not meet protocol, and the number of unsatisfactory samples. The report also includes statistics and rankings of how effective the hospitals are at retrieving and sending samples. The purpose of this report is to update hospitals on the efficiency of their NBS collection process so that improvements can be made if needed. This report card will be used to improve the efficiency of the screening process (Gilman, RN & Pyne, 2019).
Code of Virginia, Title 32.1, Chapter 2, Article 7, § 32.1-65
This code states that every infant born in the Commonwealth of Virginia shall be subjected to screening tests for various disorders consistent, but not identical to, the condition panel recommended by U.S. Secretary of Health and Human Services and the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children. Any infant whose parent or guardian objects to the test on the grounds that the test conflicts with religious practices or tenets shall not be required to receive these tests.
References:DHCS. (2019, June 13). Retrieved from CA.gov:https://www.dhcs.ca.gov/formsandpubs/laws/hipaa/Pages/1.00WhatisHIPAA.aspx Gillman, RN, J., & Pyne, M. (2019, November 8). Lewis Gale Montgomery Hospital NewbornScreening Protocol. (C. McClenny, J. Hemmen, M. Herrera, A. Petrosky, & S. Bond,Interviewers) Office for Civil Rights. (2017, May 12). Health Information Privacy. Retrieved from HHS.gov:https://www.hhs.gov/hipaa/for-professionals/security/index.html Shahangian, S., & Chen, B. (2012). CDC Recommendations: Good Laboratory Practices forBiochemical Genetic Testing and Newborn Screening for Inherited MetabolicDisorders. Clinical Chemistry, 58(12), 1728-1728. doi: 10.1373/clinchem.2012.195362