Missouri Newborn Blood Spot Screening

Missouri Department of Health and Senior ServicesBureau of Genetics and Healthy Childhood

September 21, 2017

Newborn Screening Statute Senate Bill 50 By January 1, 2019, the Department of Health and Senior

Services shall, subject to appropriations, expand the newborn screening requirements in section 191.331 to include spinal muscular atrophy (SMA) and Hunter syndrome (MPS II).

To access newborn blood spot screening statutes and rules go to: www.health.mo.gov/newbornscreening

o Newborn Blood Spot Screening Laws, Regulations, and Policies

What does “Transit Time” mean???

Transit Time = the time from sample collection to the start of testing by the Missouri State Public Health Laboratory (MSPHL)

Transit time can be impacted by many factors. It is important for newborn nurseries, hospital

laboratories, the MSPHL, and the follow-up program to continuously communicate and collaborate.

Each and every screen should be treated as though it will make the difference between life and death for a newborn.

Missouri’s Principal Timeliness Issues No weekend or holiday courier pickup (the state contracted

courier had the same days off as the MSPHL). Smaller birthing hospitals were not provided courier (did not

have enough births) so they routinely utilized regular U.S. mail. MSPHL did not work weekends. MSPHL had several observed Monday holidays resulting in

three-day weekends. Some hospitals experienced logistical issues provoking delays

internally. Lack of traceability for hospitals to promptly verify their samples

were received by the MSPHL. Lack of funding to remedy the above issues.

Initial Improvements at MSPHL(with no additional funding)

Worked with hospitals who were not on the courier system to self-transport their newborn screening (NBS) samples to their nearest county health department (included midwives).

Worked one-on-one with any hospitals displaying timeliness issues.

Began providing customized monthly timeliness reports to Laboratory and OB managers in those institutions.

Increased timeliness education overall. During routine phone conversations with nurseries,

laboratories and PCP’s. Newborn Screening Regulations reminder on website…

“samples must be sent to the MSPHL (not received) within 24 hours of collection”.

“Top 10 Reminders” Notice.

Hospital formerly utilizingregular U.S. mail service

(most samples took 5 to 9 days)

Same hospital now utilizing a local county health department’s courier stop

(most samples took 1 to 4 days)

Reminder # 8

Education• Sent with all NBS Laboratory

reports for one full month• Sent with all NBS collection

card orders on a permanent basis

• Posted on NBS Laboratory website

• Posted on NBS Laboratory Report Access Portal

Improvements Requiring Funding

Implemented holiday courier pickup January 1, 2014 ($6,000 per year).

MSPHL received legislative funding to enhance the courier system and implement Saturday and holiday testing (supported by a Kansas City, MO legislator).

Implemented Sunday courier pickups starting July 5, 2015 ($36,000 per year).

Added 8 more birthing hospitals to the current 46 routine hospital sites for the courier starting July 5, 2015 ($44,000 per year).

Implemented Saturday and holiday testing beginning October 3, 2015 ($200,000 per year).

• NBS courier expansion announcement

• A reminder about getting the sample to the pickup site immediately after drying

• A reminder about the life-saving importance of timeliness

• State NBS Laboratory will be converting to a six-day work week

• A reminder to get connected to the NBS Laboratory report access portal to provide verification of sample receipt

A notice was sent out each day for one month with NBS Laboratory reports:

Missouri’s Saturday/Holiday Work Model 100% voluntary staffing process. A skeleton crew of seven scientists work each Saturday/holiday

(excludes Thanksgiving, Christmas, and New Year’s Day) and all screening tests are performed.

Hired one full-time employee, a manager to run the Saturday/holiday expansion and supervise the adjunct staff.

Two newborn screening laboratory employees were hired agreeing they would work Tuesday through Saturday until attrition allows them to move to Monday through Friday.

Four other adjunct employees work each Saturday/holiday making straight-time pay (classified as secondary assignment staff).

Holiday Courier Pickup Started January, 2014

Sunday Courier Pickup Started July, 2015

Saturday/Holiday Testing Began October, 2015

Chart1

0 - 30 - 30.7740.9010.9

440.1470.06250.0626

550.04880.01960.0193

6 - 86 - 80.02420.01230.0134

9 - 149 - 140.00290.00190.002

>14>140.00040.00040

Collection Date Not Provided - Transit Time UnknownCollection Date Not Provided - Transit Time Unknown0.00220.00210.0025

All of 2013

All of 2014

All of 2015

All of 2016

January - February 2017

Calendar Days from Sample Collection to Testing of Sample by MSPHL

Percentageof Samples

NBS Sample Transit Time Improvements

0.613

0.6823

0.216

0.2002

0.0976

0.0794

0.059

0.0312

0.0093

0.0036

0.004

0.0006

0.0043

0.0025

Sheet1

Transit Time (Days)All of 2013PercentAll of 2014PercentAll of 2015PercentAll of 2016PercentJanuary - February 2017Percent

0 - 35582561.30%6229868.23%7088577.40%8318590.10%1280390.00%

41967921.60%1828020.02%1346414.70%57676.25%8916.26%

588929.76%72507.94%44634.88%18081.96%2751.93%

6 - 854065.90%28503.12%22192.42%11311.23%1901.34%

9 - 148460.93%3310.36%2680.29%1740.19%290.20%

>14370.40%590.06%400.04%370.04%10.00%

Collection Date Not Provided - Transit Time Unknown3890.43%2340.25%2020.22%1920.21%350.25%

Note: Holiday courier pickup was added in January of 2014. The Sunday courier addition, along with 8 additional hospital pickup sites, was implemented July 5th, 2015. Saturday and Holiday

testing began October 3rd, 2015.

When the sample collection date is not provided, the sample is tested for everything, however we cannot provide normal results for all testing categories. A repeat screen is required.

Sheet1

All of 2013

All of 2014

All of 2015

All of 2016

January - February 2017

Days from Sample Collection to Testing of Sample by MSPHL

Percentageof Samples

NBS Sample Transit Time Improvements

Sheet2

Sheet3

What Can Hospitals Do? Aim to collect NBS specimens at 24 hours of age for all babies. Fill out the collection card completely, accurately, and legibly. Check the specimen. If there is any doubt about quality,

recollect immediately. Dry specimen horizontally for three to four hours making sure it

does not touch anything. Package specimens for transport daily and know your courier’s

pickup time. Routinely check the laboratory report access portal to ensure

specimens were received and determine if any action is necessary.

The Missouri Newborn Screening Laboratory Report Access Portal

• The Laboratory Report Access Portal provides a secure website where submitters can track their NBS samples along with printing and/or saving their laboratory reports in real time.

• NBS announcements are displayed on this page.

Three ways to search for results.

What are the benefits of the portal? A secure website for hospitals to verify daily that the MSPHL has

received their samples. Sample receipt verification is a College of American

Pathologists (CAP) Laboratory Accreditation requirement for laboratories for all send-out samples.

Hospitals can notify the MSPHL if they determine that samples may not have been received and investigations on both sides can commence quickly.

Hospitals can print and/or save their own NBS reports from this site and not have to wait for them to come through the mail.

Reduces the number of calls into the MSPHL requesting NBS lab reports.

Both submitting hospital and MSPHL can become paperless.

Saturday and Holiday Work Team

Jami Kiesling, RN, BSNBureau of Genetics and Healthy Childhood

573-751-6266Jami.Kiesling@health.mo.gov

Newborn Screening Website:www.health.mo.gov/newbornscreening

Contact Information

Objectives

Identify newborn vaccines Identify vaccines for healthcare

workers Identify vaccines for pregnant

women

Who makes vaccine recommendations?

Advisory Committee on Immunization Practices (ACIP) Medical personnel○ Vaccinology○ Immunology○ Pediatrics○ Internal and Family medicine○ Nursing○ Infectious disease ○ Public health

Why is the ACIP schedule recommended?

Best immune response Protects at the earliest possible age Provides appropriate spacing for best

outcomes Research has shown this schedule to be

the safest and most effective

Why are vaccinations recommended for newborns?

Protect as soon as possible Passive immunity wanes Vaccine-preventable diseases still exist The body responds best to some

vaccinations early in life

At what age should vaccines be started?

Within 24 hours of birth Hepatitis B

6 weeks – 8 weeks of age Diphtheria, Tetanus and acellular Pertussis (DtaP) Haemophilus Influenza B (Hib) Polio (IPV) Hepatitis B (HepB) Pneumococcal Conjugate Vaccine 13 (PCV13) Rotavirus (Rota)

Hepatitis B Vaccine

Protects against the virus Hepatitis B Hepatitis B is contracted through blood and bodily

fluids

Why do we vaccinate against Hepatitis B at birth? Children who contract the disease at a young age have

a 90% chance of developing chronic infection Children who have chronic infection tend to have a

shortened life expectancy

Hepatitis B Vaccine (cont.)

Recommendations: Dose one at birth (within 24 hours of birth) Dose two at two or four months of age Dose three at six months of age

Spacing guidelines for vaccination At least four weeks between dose one and two At least eight weeks between dose two and three At least 16 weeks between dose one and three Infant must be at least 24 weeks of age for 3rd

dose

Other infant immunizations DTaP, IPV, Hib,PCV13

Start between 6-8 weeks of age Are repeated at four, six and between 12-18 months

of age Infants are not fully protected until completing each

vaccine series Rotavirus is started between 6-16 weeks of age and

finished by eight months of age Hep B

Dose 2 administered at 2 months or 4 months Dose 3 administered at 6 months or 24 weeks of age

Tetanus, Diphtheria and acellular Pertussis (Tdap)

Why does this affect adults? Protects against tetanus, diphtheria and

pertussis Half of infants under twelve months of age who

contract pertussis will require hospitalization 1 in 100 of those will die due to pertussis Infants are not protected until all four doses of

DTaP have been administered

Tetanus, Diphtheria and acellular Pertussis (Tdap)

Recommendations One dose for all adults One dose for all healthcare workers One dose recommended during each pregnancy for

women beginning at 27 weeks gestation

Efficacy 73% effective at reducing disease for up to two years

after vaccination 91% protection rate following pregnancy for infants

through the first two months

Tetanus, Diphtheria acellular Pertussis (Tdap)

Efficacy Infants who contracted pertussis after mother

was vaccinated during pregnancy were shown to have:○ Decreased need for hospitalization○ Decreased need for intubation○ Quicker recovery○ Pertussis was not life-threatening

Safety Research has shown that the vaccine is safe

and has shown no adverse effects for mom or baby

Influenza

Flu season is October-May each year Peaks January-March Influenza A occurs early with Influenza B later Missouri had 71,000+ individuals test positive for the

2016 flu season 2,093 Missourians died due to

influenza/pneumococcal complications in 2016 alone 1 pediatric death

Influenza Spread

Individuals are contagious one day before start of symptoms

Recommendations Flu vaccination for everyone six months of age and

older Flu vaccination for every pregnant woman any time

during pregnancy Flu vaccination for all healthcare providers/staff

InfluenzaWhy should pregnant women and healthcare workers receive the flu vaccine? Pregnant women who contract the flu tend to have more

serious complications from influenza Infants tend to have lower birth weights

Healthcare workers Spread influenza to vulnerable patients Unimmunized healthcare workers are often the source of

influenza outbreaks in hospitals and long-term care facilities Immunized healthcare workers are associated with fewer

patient deaths in nursing homes and long-term care facilities.

Talking points for providers Why are vaccines important?

Vaccines stimulate your baby’s immune system to create antibodies so they can fight off these serious diseases

I don’t know anyone with these diseases, so why do I need to vaccinate my baby? Even though we do not see some of these diseases here in

the United States, they do still occur overseas and we do see outbreaks of whooping cough, measles and mumps

Isn’t it better for my baby to get these diseases naturally? While natural infection is best for some of these

diseases, unfortunately, the price paid could be paralysis, brain damage, cancer, blindness or even death

Talking Points to staff

Inactivated Influenza Vaccine does not give you the flu

Influenza is not treated with antibiotics Influenza season is October-May Hospital patients, both the very young and

the very old, are vulnerable to complications from influenza

Vaccine safety Are there side effects?

Pain/redness at injection site

Are there risks to vaccinations? Limited risk - greater benefit Screening questions limit the risk

Vaccine Adverse Events Reporting System (VAERS) Does not show causality System is routinely checked

Vaccine safety never stops

They are continuously monitored for safety

Lana Hudanick, Public Health Consultant NurseBureau of Immunizations314-982-8260lana.hudanick@health.mo.gov

Jeanine Pagan, Public Health Senior NurseBureau of Immunizations573-441-6248jeanine.pagan@health.mo.gov

Thank You

mailto:lana.hudanick@health.mo.govmailto:jeanine.pagan@health.mo.gov

Slide Number 1Slide Number 2Newborn Screening StatuteSlide Number 4Missouri’s Principal Timeliness IssuesInitial Improvements at MSPHL�(with no additional funding)Slide Number 7Slide Number 8Improvements Requiring FundingSlide Number 10Missouri’s Saturday/Holiday Work ModelSlide Number 12�������What Can Hospitals Do?Slide Number 14Slide Number 15Slide Number 16Slide Number 17What are the benefits of the portal?Slide Number 19Contact InformationImmunizations�uPDATE ObjectivesWho makes vaccine recommendations? Why is the ACIP schedule recommended?Why are vaccinations recommended for newborns?At what age should vaccines be started?Hepatitis B Vaccine Slide Number 28Hepatitis B Vaccine (cont.) Other infant immunizations ADULT VACCINATIONSTetanus, Diphtheria and acellular Pertussis (Tdap)Tetanus, Diphtheria and acellular Pertussis (Tdap)Tetanus, Diphtheria acellular Pertussis (Tdap)InfluenzaInfluenzaInfluenzaTalking points for providersTalking Points to staffVaccine safetySlide Number 41Slide Number 42