On Time / Every Time. A Partnership of Safety and Reliability for Newborn Screening
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1 On Time / Every Time A Partnership of Safety and Reliability for Newborn Screening
2 Welcome As a result of this program, the participant will be able to: Discuss the importance of obtaining a quality specimen on collection devices (cards). Identify key steps and responsibilities in the process of specimen collection, submission and reporting. Address the requirements for specimen handling, shipping, retention, and storage. Identify gaps in your facility s processes that impact accurate and timely collection and submission of the newborn screening tests. Identify key supporting resources
3 Presentations Rick Foster, MD Senior Vice President for Quality and Patient Safety, SCHA Fran Koch, MD Assistant Professor of Pediatrics and Medical Director or Neonatal Nursery, MUSC / Shelly-Ann Williams, MD Neonatal Fellow, MUSC Kathy Tomashitis, MNS, RD, LD Program Manager, Pediatric Screening Bureau of Maternal & Child Health DHEC Sandi Hall, MT(ASCP) Laboratory Supervisor, Newborn Screening and Clinical Lab - Bureau of Laboratories DHEC/ Roberta Bartholdi, MS, BSMT(ASCP), CLS(NCA) Program Director, Office of QA - Bureau of Laboratories DHEC Lorri Gibbons, RN Vice President for Quality Improvement and Patient Safety, SCHA
4 Purpose Historical Perspective South Carolina s Partnership Rapid Cycle Improvement Collaborative: On Time / Every Time
5 South Carolina Statewide Goal: All SC Birthing Hospitals will submit 100% of their newborn screening tests to the SC DHEC Bureau of Laboratories within 24 hours of collection. (within 120 days from February 10, 2014 Kickoff).
6 Understanding the Urgency SC DHEC Newborn Screening Program tests for 52 disorders (not just the PKU test!) Discretionary Advisory Committee on Heritable Disorders in Newborns and Children uses evidence based process to evaluate candidate conditions for addition to the US Recommended Screening Panel (RUSP) Most US newborn screening programs follow the RUSP in determining the conditions for which infants are screened in their states
7 SC Newborn Screening Test Panel 1. Metabolic disorders Disorders of Amino Acid Metabolism Disorders of Carbohydrate Metabolism Disorders of Organic Acid Metabolism Disorders of Fatty Acid Metabolism
8 2. Hormone and Endocrine Disorders Congenital Adrenal Hyperplasia Congenital Hypothyroidism Biotinidase Deficiency 3. Other Genetic Disorders Cystic Fibrosis Sickle Cell Disease Hemoglobin C Disease Sickle B Thalassemia Variant Hemoglobin Disorders and Traits
9 Disorder PKU 3 Galactosemia 1 MCAD 3 Other Metabolic Disorders Cong. Hypothyroidism 10 Cong. Adrenal Hyperplasia Biotinidase Deficiency 1 Hemoglobinopathy Disorders Projected Number of Infants Born with Disorder in SC Hemoglobinopathy traits 2000 Cystic Fibrosis 11 Taken from: SC DHEC Newborn Screening Manual s/manual/nbs_intro.pdf
10 The purpose of Newborn Screening is to identify infants at risk and in need of more definitive testing. The healthcare provider of record is the physician responsible for providing follow up based on results of screening tests Sending repeat specimen Further diagnostic testing and medical management (initiation of treatment or referral to specialist)
11 It is also physician s responsibility to notify DHEC of final diagnosis and date of initiation of treatment or if test was determined to be false negative based on diagnostic work up. If the physician of record will not be providing follow up care, he or she must notify DHEC s Division of Children s Health of the name of the physician who will be providing follow up care as soon as possible If name of physician is not known DHEC will attempt to locate the infant and obtain repeat specimens.
12 Congenital Hypothyroidism One of most common treatable causes of intellectual disability Delayed treatment results in lower IQ and impairment in growth Essential that treatment begun by 21 days of age. Tests performed: T4/TSH May have false negative if specimen collected < 24 hrs of age Premature infants may have transient abnormalities that resolve with maturity
13 Congenital Hypothyroidism If TSH >=40mIU/mL, Physician of record will be called about results(result will also be mailed) Any other abnormal result is only mailed to Physician of Record Abnormal result-physician should send Free T4 and TSH ASAP and Contact Local Endocrinologist ASAP Resend Specimen to DHEC Do Not wait for results of second DHEC specimen to confirm diagnosis Treatment is with L-Thyroxine tablets and should begin by 21 days of age.
14 Congenital Adrenal Hyperplasia Potential Medical Emergency Most commonly due to 21 hydroxylase deficiency Newborn screening tests only for presence of 21 hydroxylase deficiency Test: 17- OH progesterone Treatment prevents adrenal crisis which can result in death prevents effects of excessive androgens
15 Congenital Adrenal Hyperplasia 17-OHP >=48ng/mL for infants >=2500 g 17-OH P>=130ng/mL for infants <2500g Physician of record will be called with results (in addition to mailing) Other abnormal results mailed Abnormal result obtained Infant should be evaluated immediately Endocrinologist should be contacted immediately 17-OHP,electrolytes and glucose should be obtained
16 Potential Emergent Metabolic Disorders Amino Acid Metabolism Disorders Maple Syrup Urine Disease (MSUD)- (Elevated VAL and/or Elevated LEU+ILE) Urea Cycle Disorders ( Elevated CIT) Citrullinemia Argininosuccinic Aciduria Galactosemia (Abn GALT and Galactose levels) Organic Acid Metabolism Disorders Fatty Acid Metabolism Disorders
17 Metabolic Disorders All require prompt evaluation Any result that suggests likelihood of disease will be called to the physician of record (in addition to mailed result) Contact Metabolic Specialists with these results ASAP Do not just refer the patient, speak to Metabolic Specialist directly. Utilize 24 hr metabolic emergency line as necessary. If unable to reach Metabolic Specialist, particularly over a weekend/holiday, refer patient to a Pediatric ER. Coordinate care with Pediatric ER physician to ensure he/she knows which disorder the infant may have.
18 Metabolic Disorders (con t) Work with Metabolic Specialist in obtaining further diagnostic investigations Work with DHEC in sending repeat filter paper tests Metabolic Specialists in SC: Greenwood Genetic Center Richard Schroer, MD Neena Champaigne, MD 24 hr metabolic emergency line MUSC: Shashidhar Pai, MD,
19 Other Genetic Disorders Hemoglobinopathies Prematurity and Transfusions can affect Results Results are mailed only Work with DHEC in obtaining repeat specimens Consult Pediatric Hematologist Cystic Fibrosis Elevated IRT (immunoreactive trypsinogen) Prematurity and Illness can lead to false positives Meconium Ileus can cause false negative results in an affected infant Abnormal Result mailed only Work with DHEC in obtaining repeat testing Consult local Pulmonologist for recommendations regarding further diagnostic testing and management
20 Resources for Providers Pediatric genetic/metabolic, endocrine, hematology and pulmonology specialists SC DHEC Newborn screening manual and algorithms also includes parent information sheets manual.htm ACMG ACT sheets and confirmatory Algorithms (
21 Physicians should ensure that NB screen results are followed up Physician of record assumes this responsibility All abnormal results should be further evaluated Physicians should work with DHEC and local specialists to ensure that abnormal results are handled appropriately
22 References Kaye CI, Committee on G, Accurso F, La Franchi S, Lane PA, Hope N, Sonya P, S GB, Michele AL. Newborn screening fact sheets. Pediatrics. 2006;118(3):e doi: /peds PubMed PMID: American Academy of P, Rose SR, Section on E, Committee on Genetics ATA, Brown RS, Public Health Committee LWPES, Foley T, Kaplowitz PB, Kaye CI, Sundararajan S, Varma SK. Update of newborn screening and therapy for congenital hypothyroidism. Pediatrics. 2006;117(6): doi: /peds PubMed PMID: MUSC Children s Hospital Facts Fax, Volume Issue 12 SC DHEC Newborn Screening Manual
23 Steps in the Process Prior to Specimen Collection: Specific consent/authorization not requiredcovered under general authorization to treat Usually part of MD standing orders Only allowable refusal is religious objection Provide mother with brochure explaining NBS Confirm mother s address and phone number Confirm name of baby s MD post D/C
24 Steps in the Process: Reports All reports (normal, unacceptable and abnormal) sent to MD and hospital or other sender Hospitals required to check records by 10 days after birth to ensure specimen sent to DHEC Health Regulation will check during audits to ensure copy of NBS report is in medical record
25 The Form: It s All in the Details Information blocks on DHEC 1327 form: Check the expiration date of the form The sender keeps the second copy for records MUST have baby s last name, DOB, sex MUST have physician name & address MUST have hospital sender number Use military time ONLY: 1400 for 2 PM
26 How to Complete Form The following slides will illustrate how to properly fill out the DHEC 1327 Form.
27 1. Check expiration date of form. 2. Do NOT cover the Biohazard symbol. This visible symbol is required by OSHA to be on the secondary container for this specimen. The fold-over flap serves as the secondary container.
28 3. Legibly write in newborn and mother demographic information: newborn s name mother s name address Parent/guardian phone number hospital medical record number newborn s sex & race 28
29 4. Legibly write in remaining information: Physician Medical license no., name, address, phone number Hospital Sender no., name, address Newborn s DATE OF BIRTH & TIME OF BIRTH *** Specimen DATE OF COLLECTION & TIME OF COLLECTION *** Newborn s BIRTH WEIGHT & PRESENT WEIGHT *** MULTIPLE BIRTHS (Y/N) TRANSFUSED (Y/ DATE OF LAST TRANSFUSION) *** FEEDING TYPE ***Information is used to interpret test results VERY IMPORTANT THAT THIS INFORMATION IS ACCURATE.
30 It is imperative that all fields on the collection form be completed accurately. All of the fields are important and must be completed. There are a subset of fields that, when not completed accurately, can delay and/or disrupt testing or followup care for newborns who have an abnormal test result or an unsatisfactory specimen. Missing information that can delay testing and/or result reporting. Missing information that can delay follow-up care of patient.
31 Common Errors on DHEC 1327 Form Missing demographic information Physician field: do NOT enter unknown or leave blank Do NOT place computer label over biohazard symbol Writing in area block at top Lab Use Only
32 Before Collection Do NOT store unused forms flat; forms need to be standing on side Keep the plastic wrap on the forms that come wrapped around the forms until you open Do NOT store forms on chart Do NOT use addressograph or photocopy Do NOT use felt-tip pens; use ballpoint pen
33 Puncture Sites ONLY ONE ACCEPTABLE Site: most medial or lateral of the plantar surface of the heel Unacceptable Sites: Central area of the infant s foot (arch) Fingers of newborns Earlobes of newborns Swollen or previously punctured site
34 Specimen Collection: Overview Fill circles at least ¾ full; if less than ¾ full the circle may not be used Collect continuous blood flow to fill ALL circles Do NOT layer the blood drops: ONE DROP PER CIRCLE Do NOT fill the circles from the back Do NOT mash the blood specimen into the circle
35 Specimen Collection Gather appropriate supplies Follow standard precautions and wear PPE Keep infant warm and position foot lower than heart Wipe site with 70% alcohol; puncture with lancet Wipe away first drop of blood Allow second blood drop to form
36 Specimen Collection, cont. Gently apply and release pressure on heel Allow ONE DROP of blood per circle DO NOT excessively squeeze or milk the site Allow drop of blood to drop onto the circle Let blood completely soak through filter paper Repeat steps 1-11 until all 5 circles ¾ filled Elevate infant s foot and apply pressure to site with sterile gauze pad until bleeding stops
37 After Specimen Collection Do NOT hang form vertically to allow blood to dry Form MUST be flat and away from heat while blood spots/circles are drying Allow blood to dry for at least 4 hours Do NOT put form in a plastic bag
38 Examples of Satisfactory/Unsatisfactory Collection The following slide shows examples of blood spots submitted that are Satisfactory The following slide shows examples of blood spots submitted that are Unsatisfactory
39 SATISFACTORY Specimen UNSATISFACTORY Specimen Quantity Not Sufficient (QNS) Front of Card Layered Specimen Quantity Not Sufficient (QNS) Back of Card Some layering and one spot is clotted Clotted/Layered and Abraded Abraded 39
40 Preparing DHEC 1327 for Shipping Once the blood spots have dried, prepare for mailing or transporting Mail ALL dried specimens within 24 hours after collection Do NOT staple and fold the form Do NOT use ANY kind of tape to secure the fold Fold flap over the blood specimens Place form in envelope. Do NOT overstuff envelope. Forms should lay flat within the envelope.
41 Shipping Issues for DHEC 1327 If sending more than one form in an envelope, rotate the forms 180 degrees from each other. Do NOT collect forms over a period of time before mailing or shipping. Do NOT batch forms. Do NOT place forms or envelopes containing forms in plastic bags.
42 New Saturday Hours! The Newborn Screening laboratory is going to be implementing Saturday hours in a 2-stage process: Phase 1 March 1, 2014, start to review Friday test results Also will receive specimens that come in late Friday or early Saturday morning Phase 2 Everything in Phase 1 Begin testing specimens received late Friday and early Saturday (Start date TBD)
43 Continued Success: Effective QA Plan Train the Trainer is Available Overall quality of services provided is the ultimate goal!
44 Steps in the Process: Follow-up Repeat tests are required when: one of the screening tests was abnormal, the initial sample was unacceptable, the initial sample was collected before 24 hours of age MD assumes responsibility to ensure repeat specimens collected If MD not providing care after D/C, he/she must notify DHEC as soon as possible If infant has been D/C from NICU before needed repeat testing, NICU must contact follow-up MD and provide DHEC with name of follow-up MD If infant expires before repeat testing, DHEC must be informed so that the parent is not contacted inappropriately
45 Steps in the Process: Follow-up Follow-up program calls MD when results are highly suggestive of immediate morbidity/mortality. Information also faxed. Follow-up program sends letter to MD when results are outside of normal limits, but not highly suggestive of a disorder Follow-up program sends mother letter when specimen rejected as unsatisfactory
46 Steps in the Process: Follow-up Follow-up continues until case determination is made: confirmed disorder, false positive, expired before repeat/confirmatory testing, lost to follow-up Can take 6 months or more Follow-up also investigates any false negative reports
47 On Time/ Every Time A Rapid Cycle Improvement Collaborative Kickoff February 10, Webinars March 5 and May 1 Office Hours March 9 AM Monthly data reports through Feb 2015 Quarterly data reports through 2015
48 Key Resources CDC newborn screening website DHEC website DHEC address Newborn Screening Law Newborn Screening Regulations archtext=dhec&category=codeofregs&conid= &result_pos=&keyval=107&numrows=10
49 Next Steps Create improvement team Identify Newborn Screening Point of Contact and to: Review and examine all steps to identify your specific gaps in the screening process Attend Webinar II May 1, am & 4 pm Celebrate your success June 9, 2014!
50 Special thanks to the following for their commitment and dedication to improving the process of newborn screening across South Carolina. Beth DeSantis, RN, MSN, WHNP Director, Maternal and Child Health Bureau, DHEC Lucy Gibson, MSW, LMSW Director, Division of Children s Health, DHEC Carla Griffin Assistant to the Director, Public Health, DHEC Lisa Hobbs, RN Perinatal Consultant - Bureau of Maternal/Child Health, DHEC
51 QUESTIONS?
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