Post on 11-Jul-2020
1 |
Colorado Newborn Screening Stakeholders’ Meeting 4/27/2017, 4:00 pm Laboratory Services building, 8100 Lowry Blvd, Denver, CO 80230
Attendees: Darren Michael, Margaret Ruttenber, Michelle Miller, Mark Dymerski, Marilyn Heil, Bill Vertrees, Kyle Senger, Dana Erpelding, Cory Porter, Olga Ivanova, Kay Kelly, Mary Kohn, Suzanne Rogers, Lyn Elliott, Tista Ghosh, Steven Cass, Stacy Claycomb, Kathryn Hassell, Donna Holstein, Marci Sontag Attendees via conference call: Jennifer Barker, Lori Weiss, Stephanie Barry The meeting opened with introductions. Dr. Tista Ghosh opened the meeting, explained the stakeholder meeting process and introduced the Newborn Screening Program Manager, Dr. Darren Michael. Dr. Darren Michael shared his credentials, his personal connection to newborn screening and discussed more specific information about his vision for the newborn screening program. Dr. Michael serves as the lab’s CLIA Laboratory Director and Clinical Consultant. He presented “A Day in the Life of the NBS Lab”, including summary data. Please see Attachment A. Dr. Michael shared his vision for the future of the Newborn Screening program at CDPHE. Please see Attachment B. Questions and Answers:
1. Question was posed about the work flow relative to notification of PCPs re: borderline results. A: Lab scientists reach out to PCPs regarding these results.
2. How are PCPs identified?
A: The process of identification can be time consuming for referral sources. Dr. Michael discussed his efforts to improve the quality of demographic information submitted.
3. Kathryn Hassel asked about the role of the IDS in the newborn screening process. A: Dr. Michael and Bill Vertrees noted that the IDS is separate from the NBS system. Dr. Michael wants to standardize the operations and the IDS is not universally used by subspecialists.
4. Question was posed about follow-up.
A: Dr. Michael noted that the follow-up responsibility lies with the lab. The follow-up model was described as “connect-to-care”: specialists receive critical results from the laboatory and the specialists reach out to the PCP regarding follow-up. Borderline results are called by
2 |
the lab scientists to the PCP directly. Mark Dymerski noted that there are about twenty (20) critical results on average called out to the specialists per month.
5. Kathryn Hassell noted that the specialists are contracted to do the follow-up and, as such, are
agents of the state and are, therefore, responsible.
6. Does the state monitor the subspecialty contracts to assure that follow-up is completed? A: Olga Ivanova explained the contract monitoring process and the quarterly contractor reporting process. Olga reiterated that CDPHE attempts to align funding and administrative burden with quality.
Dr. Tista Ghosh asked if the group would be interested in a comprehensive review of NBS summary data annually and the group agreed. Mary Kohn noted that there is a need to reach out to general pediatricians relative to the borderlines and follow-up. Borderline reports are communicated to the PCP directly. Lori Weiss raised continued concern about the follow-up so that no infants fall through the cracks. The group discussed potential limits of short-term follow-up. Suzanne Rogers asked that information on the NBS process be provided to PCPs and that there is a central contact source, available at all times. Suzanne suggested contacting the “One-Call” service at Children’s Hospital Colorado. Some discussion occurred around newborn hearing screening. Suzanne Rogers reiterated that it is the pediatrician’s responsibility to follow up on newborn screening results and refer appropriately for diagnosis and treatment. Kay Kelly asked if the program is still tracking timelines. The lab established timeline metrics and participates in the NewSteps national data project. The next meeting of the Colorado Newborn Screening Stakeholder meetings will be held on 6/27/2017 from 4:00 to 6:00 pm. Margaret Ruttenber reminded the group that the Colorado Critical Congenital Heart Defects Advisory Committee will reconvene this summer. Margaret will be adding a pediatric cardiologist to the committee. Kay recommended identifying a family with experience with CCHD to serve.
A Day in the Life of the CO NBS Lab(How to find needles in a haystack)
April 27, 2017
Darren J. Michael, PhD, CC (NRCC), SC (ASCP)
Big Picture~150,000 samples per year>800,000 tests per year
80-100 true positives per year200+ submitters
9 major contracts—courier,instruments/reagents, software, clinicians, confirmatory testing
~$7.0M annual budget10 FTE’s
The Haystack
Sample Collection (Nurses, Midwives,
Physician Assistants)
Submitters(Hospitals/Quest,
Midwives, Pediatricians)
Transportation (Courier, USPS,
PO Box, Wyoming)
CDPHE NBS LaboratoryReceiving(CDPHE)
5:00-7:00AM
Sorting/Processing(CDPHE)[‘Mail’]
5:30AM-8:00AM
Punching(CDPHE)
8:00AM-9:00AM
Testing(CDPHE)
10:00AM-11:59PM
Reviewing of Results(CDPHE)
8:00AM-6:00PM
Reporting of Results(CDPHE)8:00AM-6:00PM
‘Normal’(USPS)
Linking—Match 1st & 2nd Screen(CDPHE)
4:00PM-5:00PM
Borderline(Alert PCP)
Critical(Connect to Care)
Contract Monitoring/Case Reporting
Accessioning(CDPHE)
8:00AM-12:00PM
WorkflowFax, Email, Phone
Medical Consultants
Submitters & PCP’s
‘Mail’ Processing
‘Mail’ Processing
Sample Volume by Day of Week and Sample Type
Firsts vs Day of Week (2016) Seconds vs Day of Week (2016) Total vs Day of Week (2016)
Accessioning
Stack of accessioning slips(one person’s morning work)
Accessioning
Accessioning slip
Barcode scanner
Stack of accessioning slips
Accessioning ‘Playbook’
LIMS Interface
The Accessioning Playbook
• Facility-specific examples• Arranged alphabetically• Training new accessioning staff—difficult and time consuming
The Challenge of Accessioning
Linking Second Screens to First Screens
• 90% Automated through LIMS• 10% Manual• Mother’s name• Mother’s phone number• Birth date & time
Stack of accessioning slips
LIMS Interface
Punching
Guided punching (sample quality)
Single-punch mode (inefficient; sample volume
and/or sample quality)
Multiple-punch mode (efficient)
Punching Station
Testing—rely on automation
MS/MS AnalysisGenetic Screening Processor
(phenotypic tests)
Separate Punching and Clean Room for DNA Work
Dedicated Punching Station for DNA-based Tests
Clean Room Entrance
Interior of Clean Room
Thermocyclers for PCR
Automated Liquid Handling—Biotinidase
Automated Liquid Handling—Isoelectric Focusing for Hemoglobin Testing
Short- and Long-term Storage of Samples
Long-term Storage(6 months at room temp.)
Short-term Storage(two weeks at 4°C)
Six Months of Accessioning Slips Stored Locally
~12,000 accessioning slips per month
Several Years of Accessioning Slips Stored in our Warehouse
~12,000 accessioning slips per month
Hundreds of Manifests per Month
Hundreds of Fax Requests per Month
Hundreds of Courier Envelopes per Month
Vision for the CO Newborn Screening Laboratory
April 27, 2017
Darren J. Michael, PhD, CC (NRCC), SC (ASCP)
Comprehensive Review
• What do we do?• Why do we do it?• Is there a better way to do it?• Where are the systemic risks?• Meeting one-on-one and in small
groups with clients and stakeholders—stress that CDPHE is willing to listen & consider change
Vision for the Future• Improve the flow of information throughout the CO
NBS program• Identify best practices and spread them—put peers in
front of peers• Data-driven decisions—expand analytics capabilities
within CDPHE’s NBS laboratory• Activate other state resources—local public health
authorities, Office of Information Technology• Establish boundaries for the state’s obligation in NBS
testing and follow-up• Bring new technologies to CDPHE’s NBS laboratory,
e.g. NextGen sequencing, HPLC, LC-MS/MS• Expand our expertise—focus on molecular biology
(one new hire)