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Prenatal screening program

Healthcare provider using a laptop

​California Prenatal Screening Program Changes

Below is a checklist providers can use to prepare for program changes. This checklist is dynamic and information will be updated, so please plan return visits closer to program launch.

Steps What to do Where to do it
1 Read Prenatal Care Provider FAQ web page to understand program revision details. Watch recorded webinars for more details on cfDNA and program changes

PNS Program Provider FAQ web page;

PNS Program Webinars web page

2 Watch CalGenetic Portal Training videos PNS Program Portal Resources web page
3 Register on CalGenetic Portal. Ensure delegates are registered on CalGenetic Portal CalGenetic Portal
4 Read state-contracted cfDNA lab instructions to understand blood collection details. Order supplies directly from cfDNA laboratory, if needed

PNS Program Information for Providers web page – See Program Resources for cfDNA Lab Instructions

Instructions will be posted soon

5 Order Supplies. MSAFP blood draw kits, PNS Program label stationery and MSAFP mailing labels. Order printed PNS Program educational materials (Provider Handbook, Patient Booklet, screen-positive booklets, etc.) PNS Program Supplies web page



6 Download PNS Program Provider Handbook and view its appendices online. Bookmark "PNS Program Information for Providers web page," to access resources such as patient back-up consent and decline forms PNS Program Information for Providers web page

Forms will be posted closer to program launch
7 Download PNS Program patient educational materials (Patient booklet, etc.) from PNS Program website and locate QR code for patient video

PNS Program Education Resources - For Patients

Revised PNS Program educational materials will be posted closer to program launch

PNS Program Changes Details

NOTE: Kaiser providers should check with their internal systems to find out how ordering screening tests or result communications differs from what is summarized here for the revised California Prenatal Screening (PNS) Program planned to take effect on September 19, 2022.

The PNS Program is planning to make cfDNA screening available to all pregnant individuals in California. At program launch, cfDNA screening will be available starting at 10 weeks 0 days and can be done throughout pregnancy. However, the PNS Program recommends that cfDNA screening take place from 10 weeks 0 days through 21 weeks 0 days so that all follow-up services can be available to individuals determined to be high risk. In addition to cfDNA, MSAFP screening for neural tube defects will continue to be offered from 15 weeks 0 days through 21 weeks 0 days.

The PNS Program screening panel does not include sex chromosome abnormalities or microdeletions. Laboratories can use the same screening specimen if providers order these additional screenings independently of the PNS Program using a separate test request process. The laboratory conducting those tests will bill separately for these services.

The PNS Program will continue to cover follow-up genetic counseling and services for participants with screen-positive results for the three trisomies or MSAFP at state-approved Prenatal Diagnosis Centers.

New! Ordering supplies. You can now order supplies for the revised PNS Program using same mechanism you currently use to order PNS Program supplies. While your order will be placed, there may be some delay before you receive your supplies in advance of the revised program launch.

Ordering tests and forms for the revised PNS Program:  Starting September 19, 2022, providers should order both cfDNA and MSAFP screening using the online CalGenetic Portal. See the CalGenetic Portal Training Videos information below.

After a screening order is electronically submitted on the CalGenetic Portal, providers will need to print a Consent and Order Confirmation for each cfDNA and MSAFP order, respectively. The Consent and Order Confirmation will need to be printed on PNS Program label stationery provided at no cost. The PNS Program label stationery contains four peel-off barcodes to be affixed to the required specimen collection tube and to the required paperwork for each order.

Further logistical details about how to obtain the cfDNA blood draw kits and instructions for sending patients to an appropriate cfDNA blood draw station will be provided later this summer. The important message for you now is that you will need to order the PNS Program label stationery ahead of time, so you are ready for the revised PNS Program launch. 

For MSAFP screening, the state will continue to supply complete MSAFP blood collection kits, which include yellow-top collection tubes, bio-hazard wrappers, and plastic trays. 

  • What is different? If you do not ship your specimens to our laboratories via General Logistics Systems (GLS), you will need to preprint the USPS pre-paid MSAFP mailing label and affix it to the MSAFP blood collection kit so that it is sent to the appropriate state-contracted Newborn & Prenatal Screening (NAPS) Laboratory. In the past, the mailing label was included on the first trimester and second trimester TRFs. In the future, the PNS Program will be providing these blank MSAFP mailing labels for printing at no cost.
  • Further details about how to print your MSAFP mailing labels will be provided later this summer. The important message for you now is that you will need to order the MSAFP mailing labels ahead of time, so you are ready for the revised PNS Program launch.   

You can order both the label stationery and the mailing labels using the same mechanism you currently use to order PNS Program supplies. Please note that there is no special printer required to print the new labels. You can use any ink jet or laser jet.

NOTE: Kaiser providers should check with their internal systems to find out how ordering screening tests or result communications differs from what is summarized here.

Program Changes and Transition Period

On September 19, 2022, cfDNA will become the primary screening technology for trisomy 21, trisomy 18, and trisomy 13, starting at 10 weeks of gestation. cfDNA screening will also give patients the option to find out the sex of the fetus. In addition to cfDNA, maternal serum alpha-fetoprotein (MSAFP) screening for neural tube defects will continue to be offered in the second trimester of pregnancy.

A transition period between the current biochemical and the redesigned PNS Program using cfDNA screening for detection of chromosomal abnormalities will run from September 19 through November 28, 2022. The purpose of the transition period is to give patients that have had first trimester biochemical screening, a chance to complete second trimester biochemical screening, after the revised PNS Program starts. Providers should know the following information as it relates to closing out the current program during the transition to the revised PNS Program.



Ordering tests and forms during the PNS Program transition: The final day for ordering first trimester biochemical screening using the current PNS Program is September 18, 2022. These orders can be made using the existing first trimester Test Request Form (TRF). For these patients only, providers can submit a second trimester TRF through November 28, 2022, to order a serum integrated or sequential integrated screening test. The second specimen used in the integrated screening will allow those patients to obtain a revised chromosome risk assessment, as well as a risk assessment for neural tube defects.

Please refer to the "Dates to Know" chart below to see additional dates related to the program transition.

PNS Program Redesign: Dates to Know

​Event
​Date
​Last day to order first trimester Test Request Forms (TRFs)
​August 28, 2022
​Last day for first trimester biochemical blood draw
​September 18, 2022
​Redesigned PNS Program launch. There will not be any results available on first trimester biochemical drawn on or after this date
​September 19, 2022
​Last day to order second trimester Test Request Forms (TRFs)
​October 28, 2022
​Last day for patients to get second trimester biochemical blood draw for integrated screening results
​November 28, 2022
​Last day for NT information to be accepted
​November 28, 2022
​Last day for first trimester biochemical patients to receive PDC follow-up services based on 24 weeks 0 day mark
​December 26, 2022

Upcoming Webinars

Webinar 3: PNS Program Changes: Educational/Training Materials, August 24, 2022, 12 noon - 1 pm

For this webinar, PNS Program representatives will share more details on what training and educational resources prenatal care providers can expect when the revised PNS Program launches on September 19, 2022. 

New Educational Materials

Current patient educational materials should remain in use for patients who are completing the current program during the transition period. Revised PNS Program educational materials will be available later this summer. 

Patient materials will include an updated PNS Program Patient Booklet, four screen-positive booklets (for trisomy 21, trisomy 18, trisomy 13 and neural tube defects), and a patient video. Providers can order the printed patient materials or download them from the PNS Program website. 

Materials for providers include an updated PNS Program Provider Handbook and a provider video, both to be available on the PNS Program website.  

Summary of Prenatal Screening Program Changes (2 pages, PDF)

Prenatal Screening Portal Videos and Resources

Prenatal care providers and their staff have access to four videos that provide step-by-step instructions for using the CalGenetic Portal to create a profile and view results for the PNS Program. The videos explain how:

  • Providers can create, access, and manage their user profile
  • Providers create and manage their delegates’ access
  • All users search, view, and download prenatal screening results
  • Delegates create and access their user profile once an invitation from their managing provider is received

Visit the PNS Program Portal Resources web page or CalGenetic YouTube Playlist to view the videos.

Provider Access to the CalGenetic Portal

​Professions
All access with license verified by IDEAL*
All access with license verified by IDEAL*
Can access results as licensed users?
Can place orders as licensed users?
Can place orders as delegates?
Can add delegates?

​Start Date

June 2021

May 16, 2022

​May 16, 2022

​September 19, 2022

September 19, 2022

​June 2021

​Physicians and Surgeons
​Yes
​-
​Yes
​Yes
​-
​Yes
​Osteopathic Physicians and Surgeons
​Yes
​-
​Yes
​Yes
​-
​Yes
​Licensed Midwife
​-
​Yes
​Yes
​Yes
​-
​No
​Physician Assistant

-
​Yes
​Yes
​Yes
​-
​No
​Nurse Midwife
​-
​Yes
​Yes
​Yes
​-
​No
​Nurse Practitioner
​-
Yes
​Yes
​Yes
​-
​No
​Registered Nurse
​-
​Yes
​Yes
​-
​Yes
​No
Temporary Registered Nurse License

-
​Yes
​Yes
​-
​Yes
No
​Clinician Nurse Specialist

​-
​Yes
​Yes
​-
​Yes
​No
Public Health Nurse
​-
​Yes
​Yes
​-
​Yes
​No
​Genetic Counselors
​-
​-
​Yes
​-
​Yes
No

Interoperability Development Effort to Authenticate Licensees (IDEAL) is used by Medical Board of California to authenticate and support access to the CalGenetic Portal

Program Changes Summary

The California Prenatal Screening (PNS) Program will make cell-free DNA (cfDNA) screening available to all pregnant Californians, beginning on September 19, 2022. In addition to cfDNA, biochemical screening for maternal serum alpha-fetoprotein (MSAFP) for neural tube defects should continue to be offered in the second trimester (15 weeks 0 days to 21 weeks 0 days). The PNS Program will continue to fund follow-up genetic counseling and diagnostic services for participants with screen-positive results through 24 weeks 0 days at state-approved Prenatal Diagnosis Centers. 

cfDNA as a primary screen through the PNS Program provides these benefits compared to biochemical screening: 

(1) cfDNA provides higher sensitivity and lower false-positive rates, resulting in fewer screen-positive cases referred for follow-up diagnostic services;

(2) the gestational age window will allow screening as early as 10 weeks of gestation; and 

(3) cfDNA can provide results for one additional aneuploidy (trisomy 13).

Moving to cfDNA screening will make high-quality prenatal screening accessible for all pregnant individuals in California for the three most common autosomal trisomies at an affordable price covered by third-party payors and Medi-Cal.

Prenatal providers will have the choice of several state-contracted cfDNA laboratories/brands to conduct testing for patients.

The PNS Program, at this time, will not include screening for sex chromosome abnormalities or microdeletions. Providers can order these screens, if they choose, as an additional lab which can be drawn at the same lab visit.  The additional screens will require separate billing to the patient or their third-party payor and will not include follow-up services by the PNS Program as they are not part of the approved PNS Program.

The new program regulations will be promulgated through a Regulations Hearing.  Providers will receive an announcement as soon as the final date and time are set.

For downloading and sharing: Prenatal Information and Update Newsletter, Winter, 2022 (PDF)

Coming Soon: Electronic Prenatal Screening Orders Through CalGenetic Portal

A new electronic order requisition application on the CalGenetic Portal will be launched when cfDNA screening goes live. cfDNA and MSAFP screening will require providers to complete a separate electronic test order form through the online portal. Providers will be required to obtain a signed patient consent document for each both screens, which must accompany the sample sent to the testing laboratory. Training on how to order screening through the portal, obtain the patient consent, and collect samples will be available soon.  

The CalGenetic Portal is already live and authenticated users can obtain secure online access to:

1) View patient prenatal screening results. The PNS Program will continue to mail results but accessing them on the portal is quicker and easier for providers.

2) Submit Outcome of Pregnancy forms. These data are used to evaluate screening performance, and all data requests should be now entered on the portal.

The CalGenetic Portal is already a proven success! In the first six months more than 137,000 searches took place on the portal and over 53,000 PNS results were viewed. All physicians and their delegates are encouraged to log into the portal and set up an account now

Certified Nurse Midwives and Nurse Practitioners Will Have Independent Portal Access

Certified nurse midwives, nurse practitioners, and others will be able to independently access patient screening results in the CalGenetic Portal later this year and will no longer be required to be enrolled and managed in the portal as delegates of a physician (see chart above). When cfDNA screening is launched in September 2022, these providers will also be able to order cfDNA and MSAFP screening through the portal.

Stay Tuned for Trainings and New Educational Materials!

The PNS Program is offering a series of educational webinars to provide information and details about the new cfDNA screening, how to order screening through the online portal, how to obtain the required patient consent document, and other PNS Program updates. The webinars are recorded and posted on the PNS Webinars web page. Short "how-to" videos will also be available on the website, as well as other provider training opportunities to learn more about the benefits and limitations of cfDNA screening. Stay tuned for further announcements.

Save the Dates

In Case You Missed It

Webinar 1: cfDNA Screening: A Clinical Overview was held April 18, 2022. The webinar recording and evaluation survey is posted on the PNS Program Webinars web page.



In case you missed earlier Prenatal Information and Update Newsletters  ... Winter 2022 (PDF) ... Fall 2021 (PDF)

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