Existing law requires the State Department of Health Care Services to implement a newborn and infant hearing screening program and to develop and implement a reporting and tracking system for newborns and infants tested for hearing loss. Existing law requires certain medical providers to report specified information to the department or the departments designee to be included in the departments reporting and tracking system.

This bill would require those providers to report that information electronically. The bill would require the department to develop and implement an electronic reporting and tracking system for newborns and infants tested for hearing loss and would require general acute care hospitals to maintain a newborn and infant data management system, as defined. The bill would make additional conforming changes.

Existing law requires the State Department of Health Care Services to implement a newborn and infant hearing screening program and to develop and implement a reporting and tracking system for newborns and infants tested for hearing loss. Existing law requires certain medical providers to report specified information to the department or the departments designee to be included in the departments reporting and tracking system.

This bill would require those providers to report that information electronically.

SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: AB 612

SUBJECT: Newborns and infants: hearing screening

SUMMARY:

Amends the Newborn and Infant Hearing Screening, Tracking and Intervention Act to ensure the use of an Internet Web-based, external data enabled, automated newborn and infant data management system to effect early detection of hearing loss, including tracking of children identified with potential hearing loss.

Existing law:

1. Establishes the Newborn and Infant Hearing Screening, Tracking and Intervention Act (Act), which among other provisions indicates that the State of California supports the National Healthy People 2000 goals that promote early identification of children with hearing loss.
   
2. Establishes as the purpose of the Act, the following, to:
   1. Provide early detection of hearing loss in newborns, as soon after birth as possible, to enable children who fail a hearing screening and their families and other caregivers to obtain needed confirmatory tests or multidisciplinary evaluation, or both, and intervention services, at the earliest opportunity;
   2. Prevent or mitigate delays of language and communication development that could lead to academic failures associated with late identification of hearing loss; and,
   3. Provide the state with the information necessary to effectively plan, establish, and evaluate a comprehensive system of appropriate services for parents with newborns and infants who have hearing loss.
      
3. Requires every general acute care hospital with licensed perinatal services in this state to administer to every newborn, upon birth admission, a hearing screening test for the identification of hearing loss, using protocols approved by the Department of Health Care Services (DHCS) or its designee.
   
4. Requires a general acute care hospital to be responsible for developing a screening program that provides competent hearing screening, utilizes appropriate staff and equipment for administering the testing, completes the testing prior to the newborn’s discharge from a newborn nursery unit, refers infants with abnormal screening results, maintains and reports data as required by DHCS, and provides physician and family-parent education.
   
5. Requires DHCS to establish a system of early hearing detection and intervention centers that shall provide technical assistance and consultation to hospitals in the startup and ongoing implementation of a facility hearing screening program and follow-up system.
   
6. Requires DHCS to develop and implement a reporting and tracking system for newborns and infants tested for hearing loss that provides DHCS with information and data to effectively plan, establish, monitor, and evaluate the Newborn and Infant Hearing Screening, Tracking and Intervention Program (NHSP), including the screening and follow-up components, as well as the comprehensive system of services for newborns and infants who are deaf or hard-of-hearing and their families.

This bill:

1. Revises the Act to indicate that the State of California supports the National Healthy People 10-year national objective goals.
   
2. Adds that a purpose of the Act is to ensure the use of an Internet Web-based, external data enabled, automated newborn and infant data management system to effect early detection of hearing loss, including tracking of children identified with potential hearing loss.
   
3. Defines “Electronic database” as a scalable, multiple user, automated newborn and infant data management system supporting role-based security.
4. Defines “Electronically” as use of a scalable, growth capable, multiple user, automated newborn and infant data management system supporting role-based, user level security that enables the capture and reporting of all newborn hearing screens and collects data that is used to track and monitor newborn children identified or suspected of suffering from hearing loss.
5. Defines “External data enabled” as that the newborn and infant data management system is capable of sending and receiving protected health information data directly from authorized hospital information systems or of directly uploading data from newborn hearing screening equipment in state-approved formats.
6. Defines “Internet Web-based” as that the newborn and infant data management system resides on a secure environment that is compliant with the federal Health Insurance Portability and Accountability Act (HIPAA, Public Law 104-191). Requires all authorized users at state-certified provider locations to have access to data on their patients.
   
7. Defines “Newborn and infant data management system” as an automated system in which all data is stored in a secured database and that allows for entry through the Internet and electronic transfer of data from provider information systems into the secured database.

FISCAL EFFECT:

According to the Assembly Appropriations Committee, given the prevalence of electronic medical records, and the inefficiency and potential error associated with manual record-keeping, it is likely the state would pursue some avenue for electronic reporting in absence of this bill. However, in absence of a statutory requirement for an electronic system that must meet specific standards, DHCS is within its authority to pursue a lower-quality, manual reporting system, as is in place currently.

Therefore, relative to the status quo, this bill could result in significant additional costs based both on the requirement for an electronic system, and based on the prescriptiveness of the information technology features the system must have. An automated data system compliant with this bill was already used until late last year, until a higher-than-expected bid and related administrative issues resulted in the suspension of the contract with the vendor that was providing the service. The bid was for $1.88 million per year for over two years. It is unclear precisely how much more this contract would cost than an alternative system, but given DHCS is pursuing a lower-cost solution, implementing this bill could result in costs in the hundreds of thousands of dollars per year (General Fund).

PRIOR VOTES:

COMMENTS:

1. Author’s statement. I have introduced AB 612 to ensure proper follow up and outcomes for newborns with potential hearing loss. I am deeply concerned with the actions taken within NHSP administered under the Health and Human Services Agency.  As the chair of the Assembly Committee on Human Services, I am particularly concerned with the negative impact on newborns that may be lost to identification for hearing loss and intervention services as a result of the state, at times reverting to a manual tracking system.  Newborns lost to follow up who do not receive intervention services early in life (three to six months) will suffer in the short term and may not recover developmentally in the long term.  There are approximately 500,000 live births in California, all of which under Health and Safety Code §123975 and §124115 – 124120.5 are required to be tested and tracked for hearing loss. It is impossible that a manual, hand written and faxed tracking system is more efficient than an automated system. This is why I have introduced this bill to ensure that we protect newborns with potential hearing loss by requiring a more efficient system.
   
2. NHSP. NHSP is a comprehensive coordinated system of early identification, intervention and support services for infants with hearing loss and their families. The goal of the program is to identify infants with a hearing loss prior to three months of age and to link infants with early intervention services by six months of age. Studies show that hearing loss occurs in approximately two to four per 1,000 babies. Without newborn hearing screening, hearing loss is often not identified until 18 months to three years of age, when problems with speech are noted. Early identification is crucial to preventing delayed speech and language development. Tests can be performed while the baby is asleep or quiet and does not require the infant's participation. Infants who do not pass the initial hearing screening in the hospital are referred for a rescreening which should be performed before one month of age. Infants who do not pass the rescreening are referred to a California Children's Services (CCS)-approved Type C Communication Disorder Center (CDC) for a diagnostic hearing evaluation. A referral to the local CCS program for authorization of the evaluation is also made. Upon identification of a hearing loss, infants and their families are referred to the local Early Start Program for access to early intervention and related services. There are three Hearing Coordination Centers (HCCs) in the state that are responsible for serving the populations and facilities in specified geographic areas. The HCCs assure that the system operates efficiently; the screenings and services are of high quality; and, most importantly, babies failing the hearing screening test are not lost to follow-up. In states without coordinated tracking systems, up to 50% of the infants who fail the inpatient screen do not receive the necessary services to determine if a hearing loss is present. It is essential that infants who do not pass the screening tests receive prompt evaluation and intervention if appropriate. Otherwise, the benefit and purpose of early screening and identification is lost.
   
3. DHCS procurement. In 2008, DHCS issued a Request for Proposal (RFP) for a data management system for NHSP. Natus Medical Inc. was awarded the procurement to implement a statewide Infant Data Management Service (IDMS). By 2014, IDMS was fully operational statewide. The IDMS contract expired November 30, 2016. In July 2016, DHCS released an RFP for a data management system. Subsequent analysis of the procurement, however, identified risks to the state. Based on this and other reasons none of the proposals met the needs of California. In the interest of fairness to the bidders, the DHCS cancelled the procurement.
   

As an interim solution, DHCS reinstated the Infant Data Reporting Form (IRF) process that providers and the HCCs were using until 2014. This temporary reporting method was the least disruptive, quickest to implement, and did not require training for continued monitoring and tracking. Initially, the HCCs reported concerns related to receiving IRFs that were illegible or incomplete. DHCS responded by providing the HCCs a fillable form to use. According to DHCS, it has been actively pursuing all options for a database solution. DHCS is not assuming the IDMS is the only solution or that the state must contract with a sole vendor for providing these services. Considerations include: re-procurement with a vendor, contracting with a vendor to build an application that will be maintained by the state, and using the state’s web-portal for hosting an accessible form for providers. DHCS, in consideration of California’s budget, reinstated the IRF process as an interim solution while the state researches all viable options and the best solution long-term solution.

1. Effectiveness of manual vs. electronic tracking. Information provided by the author indicates that manual entry has a longer turnaround time (7-14 days vs <24 hours) when compared to automated data transmission, more errors, is less secure, more costly and infant transfers are delayed instead of in real time. According to DHCS, California has consistently, whether using the IRF and associated monitoring and tracking database systems or IDMS, remained under the national average for loss to follow-up (LTF) despite being the largest birthing state in the country (see data below). DHCS indicates that while there is no dispute that a data management system is more efficient, there is no independent statistical data to show that IDMS is more effective. Additionally, DHCS says it cannot be derived from the information provided by CDC if there has been a reduction of LTF since the implementation of IDMS. Information provided by the author shows an increase of unscheduled outpatient appointments and unscheduled diagnostic appointments in one particular HCC region beginning in late 2016.

1. No cost contract. DHCS and Natus have entered into a contract free of charge to make IDMS available to DHCS, the HCCs, and every acute care hospital with a licensed perinatal service in order to receive infant screening data and to facilitate infant tracking and monitoring. This contract expires January 1, 2018.
   
2. Assembly budget proposal. According to the conference committee agenda, the Assembly approved placeholder trailer bill language to require NHSP to operate utilizing an online, web-based reporting system. The Governor and the Senate had no similar proposal. The conference committee voted not to include the Assembly’s proposal on a vote of Senators: 5-0 Assemblymembers: 5-0.
   
3. Prior legislation. AB 2651 (Jones, Chapter 335, Statutes of 2006) requires every general acute care hospital that has not been approved by CCS and with licensed perinatal services, on or after January 1, 2008, to administer a hearing screening test to every newborn, as specified.

AB 2870 (Gallegos, Chapter 310, Statutes of 1998) was the health budget trailer bill which also established NHSP.

1. Support. The California Academy of Audiology writes that the newborn screening program typically identifies 900-1,200 infants per year with hearing disabilities in need of treatment and this bill modernizes the program and enables audiologists to more easily report and access the information needed to manage and maintain secure newborn and infant hearing screening data. The California Children’s Hospital Association (CCHA) indicates prior to January of this year, children’s hospitals were able to automatically transmit the results of newborn hearing screenings to DHCS. However, the state’s contract with the relevant information technology vendor has since expired, and DHCS is now requiring hospitals to manually document and report the results of newborn hearing screenings. Manual documentation and reporting of this screening data is quite labor-intensive and takes up considerable staff time, deflecting valuable resources away from other important activities that improve patient care. This bill will help ensure a new system is developed that allows hospitals to resume electronic reporting of this information. CCHA also encourages the author and committee to consider amending this bill to add a deadline by which DHCS must establish a new electronic reporting system for NHSP.
   
2. Opposition. DHCS opposes this bill because the specifications narrow the potential vendors that may be able to compete for this procurement. DHCS wants to ensure that all interested parties are not intentionally prohibited from applying. DHCS works in alignment with the California Health and Human Services Agency Shared Services Policy regarding information technology acquisition and development and is committed to reducing reliance on single vendors and inflexibility in negotiating and executing service contracts.
   
3. Policy Comment. DHCS admits that a data management tracking system is more efficient but is concerned about narrowly crafting the requirements of this bill in favor of one particular vendor. The Chair requests amendments that would require a more efficient automated system without being specific to a particular proprietary approach.
   

SUPPORT AND OPPOSITION:

Support: California Academy of Audiology

California Children’s Hospital Association

Hearing Healthcare Providers of California

Oppose: Department of Health Care Services

-- END --

SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: AB 612

SUBJECT: Newborns and infants: hearing screening

SUMMARY:

Amends the Newborn and Infant Hearing Screening, Tracking and Intervention Act to ensure the use of an Internet Web-based, external data enabled, automated newborn and infant data management system to effect early detection of hearing loss, including tracking of children identified with potential hearing loss.

Existing law:

1. Establishes the Newborn and Infant Hearing Screening, Tracking and Intervention Act (Act), which among other provisions indicates that the State of California supports the National Healthy People 2000 goals that promote early identification of children with hearing loss.
   
2. Establishes as the purpose of the Act, the following, to:
   1. Provide early detection of hearing loss in newborns, as soon after birth as possible, to enable children who fail a hearing screening and their families and other caregivers to obtain needed confirmatory tests or multidisciplinary evaluation, or both, and intervention services, at the earliest opportunity;
   2. Prevent or mitigate delays of language and communication development that could lead to academic failures associated with late identification of hearing loss; and,
   3. Provide the state with the information necessary to effectively plan, establish, and evaluate a comprehensive system of appropriate services for parents with newborns and infants who have hearing loss.
      
3. Requires every general acute care hospital with licensed perinatal services in this state to administer to every newborn, upon birth admission, a hearing screening test for the identification of hearing loss, using protocols approved by the Department of Health Care Services (DHCS) or its designee.
   
4. Requires a general acute care hospital to be responsible for developing a screening program that provides competent hearing screening, utilizes appropriate staff and equipment for administering the testing, completes the testing prior to the newborn’s discharge from a newborn nursery unit, refers infants with abnormal screening results, maintains and reports data as required by DHCS, and provides physician and family-parent education.
   
5. Requires DHCS to establish a system of early hearing detection and intervention centers that shall provide technical assistance and consultation to hospitals in the startup and ongoing implementation of a facility hearing screening program and follow-up system.
   
6. Requires DHCS to develop and implement a reporting and tracking system for newborns and infants tested for hearing loss that provides DHCS with information and data to effectively plan, establish, monitor, and evaluate the Newborn and Infant Hearing Screening, Tracking and Intervention Program (NHSP), including the screening and follow-up components, as well as the comprehensive system of services for newborns and infants who are deaf or hard-of-hearing and their families.

This bill:

1. Revises the Act to indicate that the State of California supports the National Healthy People 10-year national objective goals.
   
2. Adds that a purpose of the Act is to ensure the use of an Internet Web-based, external data enabled, automated newborn and infant data management system to effect early detection of hearing loss, including tracking of children identified with potential hearing loss.
   
3. Defines “Electronic database” as a scalable, multiple user, automated newborn and infant data management system supporting role-based security.
4. Defines “Electronically” as use of a scalable, growth capable, multiple user, automated newborn and infant data management system supporting role-based, user level security that enables the capture and reporting of all newborn hearing screens and collects data that is used to track and monitor newborn children identified or suspected of suffering from hearing loss.
5. Defines “External data enabled” as that the newborn and infant data management system is capable of sending and receiving protected health information data directly from authorized hospital information systems or of directly uploading data from newborn hearing screening equipment in state-approved formats.
6. Defines “Internet Web-based” as that the newborn and infant data management system resides on a secure environment that is compliant with the federal Health Insurance Portability and Accountability Act (HIPAA, Public Law 104-191). Requires all authorized users at state-certified provider locations to have access to data on their patients.
   
7. Defines “Newborn and infant data management system” as an automated system in which all data is stored in a secured database and that allows for entry through the Internet and electronic transfer of data from provider information systems into the secured database.

FISCAL EFFECT:

According to the Assembly Appropriations Committee, given the prevalence of electronic medical records, and the inefficiency and potential error associated with manual record-keeping, it is likely the state would pursue some avenue for electronic reporting in absence of this bill. However, in absence of a statutory requirement for an electronic system that must meet specific standards, DHCS is within its authority to pursue a lower-quality, manual reporting system, as is in place currently.

Therefore, relative to the status quo, this bill could result in significant additional costs based both on the requirement for an electronic system, and based on the prescriptiveness of the information technology features the system must have. An automated data system compliant with this bill was already used until late last year, until a higher-than-expected bid and related administrative issues resulted in the suspension of the contract with the vendor that was providing the service. The bid was for $1.88 million per year for over two years. It is unclear precisely how much more this contract would cost than an alternative system, but given DHCS is pursuing a lower-cost solution, implementing this bill could result in costs in the hundreds of thousands of dollars per year (General Fund).

PRIOR VOTES:

COMMENTS:

1. Author’s statement. I have introduced AB 612 to ensure proper follow up and outcomes for newborns with potential hearing loss. I am deeply concerned with the actions taken within NHSP administered under the Health and Human Services Agency.  As the chair of the Assembly Committee on Human Services, I am particularly concerned with the negative impact on newborns that may be lost to identification for hearing loss and intervention services as a result of the state, at times reverting to a manual tracking system.  Newborns lost to follow up who do not receive intervention services early in life (three to six months) will suffer in the short term and may not recover developmentally in the long term.  There are approximately 500,000 live births in California, all of which under Health and Safety Code §123975 and §124115 – 124120.5 are required to be tested and tracked for hearing loss. It is impossible that a manual, hand written and faxed tracking system is more efficient than an automated system. This is why I have introduced this bill to ensure that we protect newborns with potential hearing loss by requiring a more efficient system.
   
2. NHSP. NHSP is a comprehensive coordinated system of early identification, intervention and support services for infants with hearing loss and their families. The goal of the program is to identify infants with a hearing loss prior to three months of age and to link infants with early intervention services by six months of age. Studies show that hearing loss occurs in approximately two to four per 1,000 babies. Without newborn hearing screening, hearing loss is often not identified until 18 months to three years of age, when problems with speech are noted. Early identification is crucial to preventing delayed speech and language development. Tests can be performed while the baby is asleep or quiet and does not require the infant's participation. Infants who do not pass the initial hearing screening in the hospital are referred for a rescreening which should be performed before one month of age. Infants who do not pass the rescreening are referred to a California Children's Services (CCS)-approved Type C Communication Disorder Center (CDC) for a diagnostic hearing evaluation. A referral to the local CCS program for authorization of the evaluation is also made. Upon identification of a hearing loss, infants and their families are referred to the local Early Start Program for access to early intervention and related services. There are three Hearing Coordination Centers (HCCs) in the state that are responsible for serving the populations and facilities in specified geographic areas. The HCCs assure that the system operates efficiently; the screenings and services are of high quality; and, most importantly, babies failing the hearing screening test are not lost to follow-up. In states without coordinated tracking systems, up to 50% of the infants who fail the inpatient screen do not receive the necessary services to determine if a hearing loss is present. It is essential that infants who do not pass the screening tests receive prompt evaluation and intervention if appropriate. Otherwise, the benefit and purpose of early screening and identification is lost.
   
3. DHCS procurement. In 2008, DHCS issued a Request for Proposal (RFP) for a data management system for NHSP. Natus Medical Inc. was awarded the procurement to implement a statewide Infant Data Management Service (IDMS). By 2014, IDMS was fully operational statewide. The IDMS contract expired November 30, 2016. In July 2016, DHCS released an RFP for a data management system. Subsequent analysis of the procurement, however, identified risks to the state. Based on this and other reasons none of the proposals met the needs of California. In the interest of fairness to the bidders, the DHCS cancelled the procurement.
   

As an interim solution, DHCS reinstated the Infant Data Reporting Form (IRF) process that providers and the HCCs were using until 2014. This temporary reporting method was the least disruptive, quickest to implement, and did not require training for continued monitoring and tracking. Initially, the HCCs reported concerns related to receiving IRFs that were illegible or incomplete. DHCS responded by providing the HCCs a fillable form to use. According to DHCS, it has been actively pursuing all options for a database solution. DHCS is not assuming the IDMS is the only solution or that the state must contract with a sole vendor for providing these services. Considerations include: re-procurement with a vendor, contracting with a vendor to build an application that will be maintained by the state, and using the state’s web-portal for hosting an accessible form for providers. DHCS, in consideration of California’s budget, reinstated the IRF process as an interim solution while the state researches all viable options and the best solution long-term solution.

1. Effectiveness of manual vs. electronic tracking. Information provided by the author indicates that manual entry has a longer turnaround time (7-14 days vs <24 hours) when compared to automated data transmission, more errors, is less secure, more costly and infant transfers are delayed instead of in real time. According to DHCS, California has consistently, whether using the IRF and associated monitoring and tracking database systems or IDMS, remained under the national average for loss to follow-up (LTF) despite being the largest birthing state in the country (see data below). DHCS indicates that while there is no dispute that a data management system is more efficient, there is no independent statistical data to show that IDMS is more effective. Additionally, DHCS says it cannot be derived from the information provided by CDC if there has been a reduction of LTF since the implementation of IDMS. Information provided by the author shows an increase of unscheduled outpatient appointments and unscheduled diagnostic appointments in one particular HCC region beginning in late 2016.

1. No cost contract. DHCS and Natus have entered into a contract free of charge to make IDMS available to DHCS, the HCCs, and every acute care hospital with a licensed perinatal service in order to receive infant screening data and to facilitate infant tracking and monitoring. This contract expires January 1, 2018.
   
2. Assembly budget proposal. According to the conference committee agenda, the Assembly approved placeholder trailer bill language to require NHSP to operate utilizing an online, web-based reporting system. The Governor and the Senate had no similar proposal. The conference committee voted not to include the Assembly’s proposal on a vote of Senators: 5-0 Assemblymembers: 5-0.
   
3. Prior legislation. AB 2651 (Jones, Chapter 335, Statutes of 2006) requires every general acute care hospital that has not been approved by CCS and with licensed perinatal services, on or after January 1, 2008, to administer a hearing screening test to every newborn, as specified.

AB 2870 (Gallegos, Chapter 310, Statutes of 1998) was the health budget trailer bill which also established NHSP.

1. Support. The California Academy of Audiology writes that the newborn screening program typically identifies 900-1,200 infants per year with hearing disabilities in need of treatment and this bill modernizes the program and enables audiologists to more easily report and access the information needed to manage and maintain secure newborn and infant hearing screening data. The California Children’s Hospital Association (CCHA) indicates prior to January of this year, children’s hospitals were able to automatically transmit the results of newborn hearing screenings to DHCS. However, the state’s contract with the relevant information technology vendor has since expired, and DHCS is now requiring hospitals to manually document and report the results of newborn hearing screenings. Manual documentation and reporting of this screening data is quite labor-intensive and takes up considerable staff time, deflecting valuable resources away from other important activities that improve patient care. This bill will help ensure a new system is developed that allows hospitals to resume electronic reporting of this information. CCHA also encourages the author and committee to consider amending this bill to add a deadline by which DHCS must establish a new electronic reporting system for NHSP.
   
2. Opposition. DHCS opposes this bill because the specifications narrow the potential vendors that may be able to compete for this procurement. DHCS wants to ensure that all interested parties are not intentionally prohibited from applying. DHCS works in alignment with the California Health and Human Services Agency Shared Services Policy regarding information technology acquisition and development and is committed to reducing reliance on single vendors and inflexibility in negotiating and executing service contracts.
   
3. Policy Comment. DHCS admits that a data management tracking system is more efficient but is concerned about narrowly crafting the requirements of this bill in favor of one particular vendor. The Chair requests amendments that would require a more efficient automated system without being specific to a particular proprietary approach.
   

SUPPORT AND OPPOSITION:

Support: California Academy of Audiology

California Children’s Hospital Association

Hearing Healthcare Providers of California

Oppose: Department of Health Care Services

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 612

Author:(Rubio)

As Amended Ver:March 15, 2017

Majority vote

SUMMARY: Establishes electronic reporting requirements for providers participating in the California Department of Health Care Services (DHCS) newborn and infant hearing screening program (NHSP); requires DHCS to develop and implement an electronic reporting and tracking system for newborns and infants tested for hearing loss; and, requires general acute care hospitals (GACHs) to maintain a newborn and infant data management system, as defined. Specifically, this bill:

1. Requires providers participating in the NHSP to report information to DHCS electronically and maintain a newborn and infant data management system.
2. Requires DHCS to ensure the NHSP uses an Internet Web-based, external data enabled, automated data management system to effect early detection of hearing loss, including tracking of children identified with potential hearing loss.

EXISTING LAW:

1. Requires every GACH with licensed perinatal services to administer to every newborn, upon birth, a hearing screening test for the identification of hearing loss, using protocols approved by DHCS or its designee.
2. Requires GACHs to develop a screening program that provides competent hearing screening, utilizes appropriate staff and equipment for administering the testing, completes the testing prior to the newborn's discharge, refers infants with abnormal screening results, and reports data as required by DHCS.
3. Requires DHCS to develop and implement a reporting and tracking system for newborns and infants tested for hearing loss.

FISCAL EFFECT: According to the Assembly Appropriations Committee, given the prevalence of electronic medical records, and the inefficiency and potential error associated with manual record-keeping, it is likely the state would pursue some avenue for electronic reporting in absence of this bill. However, in absence of a statutory requirement for an electronic system that must meet specific standards, DHCS is within its authority to pursue a lower-quality, manual reporting system, as is in place currently.

Therefore, relative to the status quo, this bill could result in significant additional costs based both on the requirement for an electronic system, and based on the prescriptiveness of the IT features the system must have. As explained in Comments, below, an automated data system compliant with this bill was already used until late last year, until a higher-than-expected bid and related administrative issues resulted in the suspension of the contract with the vendor that was providing the service. The bid was for $1.88 million per year for over two years. It is unclear precisely how much more this contract would cost than an alternative system, but given the department is pursuing a lower-cost solution, implementing this bill could result in costs in the hundreds of thousands of dollars per year (General Fund).

COMMENTS: According to the author, this bill will ensure proper follow up and outcomes for newborns and children with potential hearing loss. The author states that there are concerns with the effectiveness of the NHSP administered by DHCS. The author contends that recent actions by DHCS have resulted in the elimination of the automated newborn hearing tracking system referred to as the Infant Data Management System (IDMS), which is a proprietary automated software system available through an external consultant contract which DHCS permitted to terminate and be replaced with the former inferior manual system. The author states that DHCS recently cancelled a competitive bid contracting process that would have permitted the automated tracking system to continue without disruption. The author concludes that children lost to follow up and who do not receive intervention services early in life (three to six months) will not only suffer in the short term but will not recover developmentally in the long term.

The NHSP provides a hearing screen to all newborns in California and guides families to the appropriate services needed to develop communication skills. Any newborn that does not pass the initial screening test is referred to California Hearing Coordination Centers (HCCs) for follow-up and case management. Data related to the results are managed by an automated system that was formerly contracted to a California-based vendor (Natus). Natus has provided the automated system since August 2009, and the HCC services since July 2015. The state partnered with Natus to create the IDMS. The IDMS supports the reporting, tracking, monitoring, and quality assurance activities of the NHSP. The IDMS provides information and data to effectively plan, establish, monitor, and evaluate the NHSP.

According to DHCS testimony at the March 27, 2017, Assembly Budget Sub-Committee No. 1 hearing, the Natus contract for IDMS was set to expire in December 2016 and DHCS implemented a request for proposal (RFP) process in order to enter into a new contract, either with Natus or another vendor, to continue an automated process for managing the hearing screening test results. DHCS explained that DHCS lawyers found errors in the RFP process, thereby nullifying the process and requesting DHCS to re-start the process. DHCS legal also indicated that the contract needed to be changed from a service contract to an information technology contract. As a result, DHCS has not had an automated system to use for this program since the contract ended on November 30, 2016. In the absence of an automated system, DHCS reports that hospitals have been submitting the test results to Natus, under the HCC contract, via paper and fax, and more recently via email. This is not an automated, real-time system like IDMS, and stakeholders have expressed concerns about delays in the transmission of screening results and in services being provided to infants who need them.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0000672

Date of Hearing: April 26, 2017

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez Fletcher, Chair

ABPCA Bill Id:AB 612

Author:(Rubio) – As Amended Ver:March 15, 2017

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill specifies that existing requirements related to newborn hearing screening, including data collection, reporting, and management, must be conducted through an electronic system. Specifically, this bill:

1. Requires the system used by the state to track and manage newborn hearing screening data to be electronic, and prescribes related information technology (IT) requirements for the system, such as electronic data linkage with providers and hospitals.
2. Conforms current-law data reporting and management requirements that apply to providers, hospitals, and hearing coordination centers with the electronic system established in (1), above.

FISCAL EFFECT:

Given the prevalence of electronic medical records, and the inefficiency and potential error associated with manual record-keeping, it is likely the state would pursue some avenue for electronic reporting in absence of this bill. However, in absence of a statutory requirement for an electronic system that must meet specific standards, DHCS is within its authority to pursue a lower-quality, manual reporting system, as is in place currently.

Therefore, relative to the status quo, this bill could result in significant additional costs based both on the requirement for an electronic system, and based on the prescriptiveness of the IT features the system must have. As explained in Comments, below, an automated data system compliant with this bill was already used until late last year, until a higher-than-expected bid and related administrative issues resulted in the suspension of the contract with the vendor that was providing the service. The bid was for $1.88 million per year for over two years. It is unclear precisely how much more this contract would cost than an alternative system, but given the department is pursuing a lower-cost solution, implementing this bill could result in costs in the hundreds of thousands of dollars per year (GF).

COMMENTS:

1. Purpose. This bill establishes a statutory requirement for electronic data management system for the state's newborn hearing screening program. The author explains DHCS eliminated the contract for the state's electronic data system late last year, and is currently using an inefficient, manual system that risks allowing children with hearing loss to fall through the cracks. A statutory requirement is thus necessary to ensure the state implements a modern and efficient system.
2. Background. According to the Centers for Disease Control and Prevention, most babies in the United States are screened for hearing loss, which can impede speech, language and cognitive development if not detected and treated early. California law requires birthing hospitals to administer a hearing screening test, and providers to report data to the state Newborn Hearing Screening Program (NHSP), a coordinated system of early identification and service delivery for infants with hearing loss. The state contracts with hearing coordination centers, which track infants who screen positive for hearing loss and provide technical assistance to facilities and providers to ensure follow-up services are provided to such children.

Prior to 2008, the NHSP used a paper-based system. In 2008, DHCS issued an RFP for a data management system, and contracted with a vendor to deploy the Infant Data Management Service (IDMS). IDMS was fully operational statewide by 2014, and was used until the most recent contract expired on November 30, 2016.

1. Recent Developments. According to DHCS, in July 2016, it released a new RFP for a data management system. The existing vendor submitted a bid that was three times the cost of their current contract with the state. Given this, and a subsequent analysis of the RFP that revealed major faults, the department cancelled the procurement. The problems identified in the RFP included no maximum budget, no provision for a transition phase between vendors, and a two-year time period that would be insufficient to configure and test a new system if a new vendor was chosen. Due to the failed RFP, DHCS has not had an electronic system in place since the contract ended on November 30, 2016. Instead, the department has implemented a manual reporting system, similar to what was in place prior to the IDMS. This manual system requires providers to report data using handwritten or fillable PDF forms, and may not capture data on all newborns screened.
2. Related Budget Hearing. This issue was discussed in the Assembly Subcommittee #1 on Health and Human Services on Monday, March 27^th, 2017.
3. Staff Comments. When weighing the costs and benefits of alternative options, it should be considered whether universal data collection (record of a positive or negative screen for each child) is a worthwhile goal. This bill provides that the system must allow for universal data collection. The system prior to IDMS only required positive screens to be submitted, and the department has proposed reverting to this process to decrease provider workload. If only positive screens are submitted, there is a default assumption that any child for which a screen is not received has screened negative. However, this is an assumption and it is not easy to verify a negative screen without universal data collection. If seamlessly integrated with provider data systems, an electronic system can provide universal data collection without significantly increased workload. A manual system or any system that does not provide for universal data collection has greater inherent risks of missing cases of hearing loss.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 4, 2017

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 612

Author:(Rubio) – As Amended Ver:March 15, 2017

SUBJECT: Newborns and infants: hearing screening.

SUMMARY: Establishes electronic reporting requirements for providers participating in the California Department of Health Care Services (DHCS) newborn and infant hearing screening program (NHSP); requires DHCS to develop and implement an electronic reporting and tracking system for newborns and infants tested for hearing loss; and, requires general acute care hospitals (GACHs) to maintain a newborn and infant data management system, as defined. Specifically, this bill:

1. Requires providers participating in the NHSP to report information to DHCS electronically and maintain a newborn and infant data management system.
   
2. Requires DHCS to ensure the NHSP uses an Internet Web-based, external data enabled, automated data management system to effect early detection of hearing loss, including tracking of children identified with potential hearing loss.
   

EXISTING LAW:

1. Requires every GACH with licensed perinatal services to administer to every newborn, upon birth, a hearing screening test for the identification of hearing loss, using protocols approved by DHCS or its designee.
2. Requires GACHs to develop a screening program that provides competent hearing screening, utilizes appropriate staff and equipment for administering the testing, completes the testing prior to the newborn's discharge, refers infants with abnormal screening results, and reports data as required by DHCS.
3. Requires DHCS to develop and implement a reporting and tracking system for newborns and infants tested for hearing loss.

FISCAL EFFECT: This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, this bill will ensure proper follow up and outcomes for newborns and children with potential hearing loss. The author states that there are concerns with the effectiveness of the NHSP administered by DHCS. The author contends that recent actions by DHCS have resulted in the elimination of the automated newborn hearing tracking system referred to as the Infant Data Management System (IDMS), which is a proprietary automated software system available through an external consultant contract which DHCS permitted to terminate and be replaced with the former inferior manual system. The author states that DHCS recently cancelled a competitive bid contracting process that would have permitted the automated tracking system to continue without disruption. The author concludes that children lost to follow up and who do not receive intervention services early in life (three to six months) will not only suffer in the short term but will not recover developmentally in the long term.
2. BACKGROUND. The NHSP provides a hearing screen to all newborns in California and guides families to the appropriate services needed to develop communication skills. Any newborn that does not pass the initial screening test is referred to California Hearing Coordination Centers (HCCs) for follow-up and case management. Data related to the results are managed by an automated system that was formerly contracted to a California-based vendor (Natus). Natus has provided the automated system since August 2009, and the HCC services since July 2015. The state partnered with Natus to create the IDMS. The IDMS supports the reporting, tracking, monitoring, and quality assurance activities of the NHSP. The IDMS provides information and data to effectively plan, establish, monitor, and evaluate the NHSP.
   
   According to DHCS testimony at the March 27, 2017, Assembly Budget Sub-Committee No. 1 hearing, the Natus contract for IDMS was set to expire in December 2016 and DHCS implemented a request for proposal (RFP) process in order to enter into a new contract, either with Natus or another vendor, to continue an automated process for managing the hearing screening test results. DHCS explained that DHCS lawyers found errors in the RFP process, thereby nullifying the process and requesting DHCS to re-start the process. DHCS legal also indicated that the contract needed to be changed from a service contract to an information technology contract. As a result, DHCS has not had an automated system to use for this program since the contract ended on November 30, 2016.
   
   In the absence of an automated system, DHCS reports that hospitals have been submitting the test results to Natus, under the HCC contract, via paper and fax, and more recently via email. This is not an automated, real-time system like IDMS, and stakeholders have expressed concerns about delays in the transmission of screening results and in services being provided to infants who need them.
3. SUPPORT. The Center for Early Intervention on Deafness (CEID) supports this bill stating that it ensures the state does not regress on behalf of deaf and hard of hearing newborns by requiring the continued utilization of an electronic data management system. CEID points to past data that show there are substantially more children lost to follow-up as a result of a manual system, tragically leaving babies and their families behind. The California Academy of Audiology supports this bill because it modernizes the NHSP and enables audiologists to more easily report and access the information needed to manage and maintain secure newborn and infant hearing screening data.

REGISTERED SUPPORT / OPPOSITION:

Support
California Academy of Audiology
Center for Early Intervention on Deafness

Opposition
None on file.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097