​California Prenatal Screening Program Changes

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

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.  

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:

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

Provider Access to the CalGenetic Portal

* 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. 

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

• Webinar 2: Prenatal Screening Program Changes: What to Expect, July 26, 2022, 5 pm (pre-registration required)
• Webinar 3: Prenatal Screening Program Changes: Educational/Training Materials, August 24, 2022, 12 noon (pre-registration required) 

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)