Neonatal Rules Webinar

Neonatal Rules Webinar
Today is the Level III – Neonatal Intensive Care Unit (NICU) and Level IV – Advanced NICU Rules Webinar. Power Point Presentation and Webinar link – will be mailed out to participants, RACs and other stakeholders. Questions – will be answered at the end of the presentation. Welcome! Thank you everyone for taking the time out today to participate in this webinar. I have a presentation to begin the webinar and then we will move into answering questions. We will provide a link to this webinar and a copy of the power point presentation to the participants and to our stakeholder groups. The webinar will be posted on the Neonatal Designation website. It may take a day or two to send these out and get them posted, so please be patient. They will be sent to everyone on our contact list.

How do I send questions? You may type your questions in the chat box and hit “enter”; Or You may your questions to be answered at a later time to:

Hospital Level of Care Designations for Neonatal Care
Elizabeth Stevenson, Manager Neonatal & Maternal Designation Department of State Health Services Debbie Lightfoot, Designation Coordinator Neonatal & Maternal Designation Department of State Health Services June 16 and 20, 2016

Objectives Review of Subchapter J Sections that pertain to Level III and Level IV Neonatal Designation. Detailed review of Subchapter J Sections § , § and § Discuss deadlines for designation. Answer questions These are the objectives for today’s presentation. I want to let you know that some of these slides we will review rather quickly so we have ample time for questions.

Subchapter J This is a snapshot of the Texas Administrative Code or TAC. Subchapter J – the Hospital Level of Care Designations for Neonatal and Maternal Care became effective June 9, There was a question last week about how quickly a facility needed to be compliant with the rules. The final rules were released for review on June 3rd in the Texas Register. Facilities may not be compliant with the rule immediately because changes were made to the last revision published in November of last year. With this being a new program, it will take some time in order for facilities to meet some of the requirements set forth in the rule, especially if they were practicing in between two different levels. The rules may be effective, but there is a “grace” period for facilities to become compliant with the Level of Care designation in which they provide appropriate services to neonatal patients.

TAC § Purpose The purpose of this section is to implement Health and Safety Code, Chapter 241, Subchapter H, Hospital Level of Care Designations for Neonatal and Maternal Care, which requires a level of care designation of neonatal services to be eligible to receive reimbursement through the Medicaid program for neonatal services. Great reminder that designation is required to be eligible to receive reimbursement through the Medicaid program for neonatal services. August 31, 2018 is the deadline for being designated by the Executive Commissioner in order to receive Medicaid reimbursement. This is a firm date. There are no extensions or special circumstances for any facility.

TAC § Definitions The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

TAC § Definitions (3) CAP--Corrective Action(s) Plan. A plan for the facility developed by the Office of EMS/Trauma Systems Coordination that describes the actions required of the facility to correct identified deficiencies to ensure compliance with the applicable designation requirements. (11) Immediate supervision--The supervisor is actually observing the task or activity as it is performed. If our office determines that the facility has deficiencies, we may require a Corrective Action Plan to meet the requirements. The corrective action plan may require that the facility report specified information to our office quarterly, have a site visit performed by our office staff, attend an educational opportunity, and/or another action that assists the facility in achieving compliance with the rule. Our goal is for facilities to be compliant with the requirements and provide best care to our babies born in Texas. Immediate supervision – Included in the pharmacy requirements for compounding any medication to be administered to a neonate/infant. Immediate supervision and other types of supervision or also defined in the Hospital Licensing section.

TAC § 133.182 Definitions (12) Immediately--Without delay.
(22) PCR--Perinatal Care Region. (24) POC--Plan of Correction. A report submitted to the office by the facility detailing how the facility will correct any deficiencies cited in the survey report or documented in the self-attestation. Immediately – without delay. Immediately is not defined as 15 minutes or 30 minutes. The response will be without delay. There may a situation in which the physician may be in the middle of a procedure on another neonate or unable to be at the bedside within minutes, but the response will be without delay. Not to be assumed as 5 minutes, 20 minutes or 60 minutes. PCR – Perinatal Care Region. This is the organization (committee, workgroup, etc.) that will be developed in each region based on the Trauma Service Areas, with the support of the Regional Advisory Councils (RACs). Facilities are required to participate in these meetings for designation. Facilities need to make sure that they are represented at these meetings and when making decisions about disaster and emergency preparedness plans. The Plan of Correction will be submitted if your facility has potential deficiencies identified on the survey report. The plan of correction will include the following: Identify the deficiency; state the corrective action to be taken; title of the person responsible for the action; how the plan will be monitored; and the date for completion of the action. Make sure that the appropriate person is identified to implement or be responsible for the action. The Neonatal Program Manager cannot be held responsible for the entire plan of correction. The Neonatal Medical Director generally will be responsible for many of the deficiencies that the NPM is. Especially if it is the quality assessment/performance improvement program, or the policies and procedures concerning standards of care. If the deficiency is related to financial decisions, increasing FTE’s, physician related issues, or physician recruitment, it may be a person in administration or the “C” suite that is responsible for these issues.

TAC § Definitions (28) RAC--Regional Advisory Council as described in § of this title (relating to Regional Emergency Medical Services/Trauma Systems). The RAC for trauma and stroke is the equivalent of the Perinatal Care Regions for neonatal and maternal. The Regional Advisory Council is made up stakeholders in the specified trauma service area or region. These stakeholders are responsible for making decisions for their region concerning their program which may be trauma or stroke. The RAC or the stakeholders may have developed transport protocols, a plan for responding to a disaster, or a regional inventory of emergency preparedness equipment. Many of the RACs have different committees in their programs that discuss issues in the region and share best practices. The stakeholders drive their own process, how they will operate and make decisions. This is why it is important for all designated facilities to be at the table when decisions are made. Many urban hospitals do not understand or realize the challenges that rural hospitals face. They don’t know what they don’t know.

TAC § 133.183 General Requirements
(a) The Office of Emergency Medical Services (EMS)/Trauma Systems Coordination (office) shall recommend to the Executive Commissioner of the Health and Human Services Commission (executive commissioner) the designation of an applicant/healthcare facility as a neonatal facility at the level for each location of a facility, which the office deems appropriate. Our office recommends the appropriate designation for a facility to the Executive Commissioner of HHSC. The actual process from recommendation of approval of designation takes approximately days. Our office makes recommendations for designation to the commissioner once a month. The recommendations follow a specific process of lower approvals before being sent to the commissioner for final approval. The commissioner then returns the approved designations and signed letters back to our office. It is important to understand the basics of this program so you can appreciate the deadlines for designation application submittal. The entire process will need to be completed before the facility is considered to be successfully designated. This is why we have placed the July 1, 2018 deadline for all initial designations to be into our office, so that we may complete this process and all facilities will be designated before the September 1st, 2018 deadline.

(b) A healthcare facility is defined under this subchapter as a single location where inpatients receive hospital services or each location if there are multiple buildings where inpatients receive hospital services and are covered under a single hospital license. Hospitals are the only healthcare facilities that are required to become designated. There are no requirements for birthing centers or other healthcare facilities that may deliver babies. I would like to clarify that the designation is for the entire hospital and all neonatal services that are provided. The Level is directly related to the highest acuity of neonatal care that is provided. A hospital does not receive a designation for only the NICU. The description of the care provided states that care is provided for neonates/infants of all gestational ages, which includes the well born nursery, or any lower level care nurseries that are located in the facility. The neonatal designation program for Level III and Level IV is for all levels of neonatal care. The Level indicates to the public the highest level of care provided for neonates.

(c) Each location shall be considered separately for designation and the office will determine the designation level for that location, based on, but not limited to, the location's own resources and level of care capabilities; Perinatal Care Region (PCR) capabilities; compliance with Chapter 133 of this title, concerning Hospital Licensing. A stand-alone children's facility that does not provide obstetrical services is exempt from obstetrical requirements. The final determination of the level of designation may not be the level requested by the facility. Multiple locations under a single license requires that each location is separately designated. You may have four facilities that are under the same license number. One hospital may not provide OB services or care for babies, the largest hospital may be a Level IV nursery, and the other two facilities are both Level II nurseries. Each facility will need to apply for the appropriate designation for services provided.

(e) PCRs. Aligned with the Trauma Service Areas (TSAs) due to established infrastructure to support the functions of the PCRs. Established for regional planning purposes, including emergency and disaster preparedness. Not established for the purpose of restricting patient referral.

TAC § 133.184 Designation Process
(d) Non-refundable application fees for the three year designation period are as follows: Level III neonatal facility applicants, the fee is $2,000.00 Level IV neonatal facility applicants, the fee is $2,500.00 There were questions about the application fees last week so I wanted to include the fee for each level. This application fee is to fund the administration of the neonatal designation program by DSHS. The facility will also be responsible for any fees related to having a survey performed at the facility for compliance with the rule. These fees will be determined by approved agencies to provide a survey in the state of Texas. The two agencies that are preparing to perform the surveys are the American Academy of (AAP) and Texas EMS, Trauma and Acute Care Foundation (TETAF). Our office is going to have a meeting with both agencies soon to discuss questions that have been presented in the powerpoints and to receive an update on their progress with their neonatal surveying programs.

(A) All completed applications, received on or before July 1, 2018, including the application fee, evidence of participation in the PCR, an appropriate attestation if required, survey report, and that meet the requirements of the requested designation level, will be issued a designation for the full three-year term. If a facility has submitted the complete application packet, including a survey report, it will be issued a designation for the full three year term. Our office would like to minimize the financial impact to facilities for neonatal designation. Hence, the 3 year designation, for facilities that have paid for a survey.

(B) Any facility that has not completed an on-site survey to verify compliance with the requirements for a Level II, III or IV designation at the time of application must provide a self-survey and attestation and will receive a Level I designation. The office, at its sole discretion may recommend a designation for less than the full three-year term. A designation for less than the full three-year term will have a pro-rated application fee consistent with the one, two or three-year term length. This section serves as a safety net for facilities applying for Levels II, III and IV that may not undergo a survey prior to the required application deadline to successfully designate by September 1, The facility will apply for a Level I designation to ensure that they are eligible for the Medicaid reimbursement while waiting to have the survey performed to designate at the appropriate level for services provided to newborns. The Level I designation may be issued with less than a three year term and will have a pro-rated application fee. This will also assist our office in dispersing the designations evenly over the first three year cycle.

(C) A facility applying for Level I designation requiring an attestation may receive a shorter term designation at the discretion of the office. A designation for less than the full three-year term will have a pro-rated application fee. (D) The office, at its discretion, may designate a facility for a shorter term designation for any application received prior to September 1, 2018. (E) An application for a higher or lower level designation may be submitted at any time. These were included so that our office may disperse the workload involved with designation of facilities. We do not want every facility to expire in the same year. Therefore, your facility may receive a shorter term for designation. If you are a facility that may want to upgrade to a higher level, you may do this at any time. Upgrading or downgrading to a different levels require a new application and survey performed by an approved agency.

Guiding Principles If the rule does not specify the exact requirement (ex. Successful NRP completion), it is up to the facility to define the expectation appropriate for the population served. Medical Practice decisions are not regulated by the Department of State Health Services. Please keep these basic principles in mind when reviewing the rules and evaluating your program. Rules are not developed to be prescriptive or give specific directions on how your facility functions. Texas is a diverse state and so are the hospitals that provide care to our residents and visitors. Therefore, each facility will make decisions on how to function dependent on their location and their resources. We all know that Level I facilities will function much differently than a Level III. The rules provide the basic requirements and the facility decides how to meet compliance. My reference for this is cooking. We may all start out with chicken to make an entree, but we will all probably fix it differently. I used cooking as an example because it sounds better than 100 different ways to skin a cat! The DSHS not regulate medical practice. Therefore, the rules are not going to dictate how a physician practices at your facility. When your facility has a survey, the patient care will be reviewed by peers. These will be physicians that are in active practice in a facility that has a program with a higher designation. The peer review process is optimal when medical practice decisions are being reviewed for appropriateness and compliance with current standards of care.

TAC § 133.185 Program Requirements
(a) Designated facilities shall have a family centered philosophy. Parents shall have reasonable access to their infants at all times and be encouraged to participate in the care of their infants. The facility environment for perinatal care shall meet the physiologic and psychosocial needs of the mothers, infants, and families. Overall expectation of the neonatal program. Most facilities are probably already compliant with this requirement.

(b) Program Plan. The facility shall develop a written plan of the neonatal program that includes a detailed description of the scope of services available to all maternal and neonatal patients, defines the neonatal patient population evaluated and/or treated, transferred, or transported by the facility, that is consistent with accepted professional standards of practice for neonatal and maternal care, and ensures the health and safety of patients. Generally, facilities have these program plans in place. They may be “department” specific plans and not titled as program plans. Many agencies that perform accreditation require these plans, as well as CMS. The plan is going to describe the patient population that is served, the services that are provided for this population and if the service is not provided, how the facility will ensure the patient receives the appropriate care. Usually, this is transferring patients to an appropriate facility that offers the necessary services and care.

(1) The written plan and the program policies and procedures shall be reviewed and approved by the facility's governing body. The governing body shall ensure that the requirements of this section are implemented and enforced. (2) The written neonatal program plan shall include, at a minimum: (A) standards of neonatal practice that the program policies and procedures are based upon that are adopted, implemented and enforced for the neonatal services it provides; (B) a periodic review and revision schedule for all neonatal care policies and procedures; The written plan, and the program policies and procedures, being reviewed and approved by the governing body have been included in a process that is usually followed by accrediting bodies for hospitals. Policies and procedures will be based up current standards of care and they will be reviewed and revised periodically in order to keep patient care with best practices. Healthcare is changing frequently and facilities need to be up to date with the care provided to patients.

(C) written triage, stabilization and transfer guidelines for neonates and/or pregnant/postpartum women that include consultation and transport services; (D) ensure appropriate follow up for all neonates/infants; (E) provisions for disaster response to include evacuation of mothers and infants to appropriate levels of care; Triage, stabilization and transfer guidelines for neonates will be in your policies and procedures. Pregnant women are included so that the decision about care is best for the mother and the fetus. Ensure appropriate follow up for all neonates/infants – making physician or specialist appointments, referrals for social programs, therapies, home care, nutrition, etc. Disaster response is not only possibly transferring patients out to other facilities, but if there is a fire how will you move the babies out of the unit quickly.

(F) a QAPI Program as described in §133.41(r) of this title (relating to Hospital Functions and Services). The facility shall demonstrate that the neonatal program evaluates the provision of neonatal care on an ongoing basis, identify opportunities for improvement, develop and implement improvement plans, and evaluate the implementation until a resolution is achieved. The neonatal program shall measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and is outcome based. Evidence shall support that aggregate patient data is continuously reviewed for trends and data is submitted to the department as requested; The facility or program will determine the model used for QA/PI. It may be PDCA, Six Sigma, Lean or RCA (Root Cause Analysis). Monitoring core measures for neonates is already a requirement. Other areas of monitoring will be determined by the facility. In the rule there are no required indicators for all facilities to monitor. Examples I have seen are for pain and sedation, patient education in newborn care, teaching of medication, newborn screening for metabolic or congenital disorders, hearing tests, readmission, Transfers, and nosocomial infections. Your facilities that offer a higher level of service will have additional indicators that will be tracked for neonatal care. It is important to understand that the QA/PI process is the backbone of the program. This is where the facility identifies area for improvement in care and processes. In the Neonatal QA/PI committee, staff participating in the care of the neonate, will review cases that may have poor outcomes, or deviate from the standard of care. The committee will complete a critical in-depth review of the care provided and decide upon the corrective action so the likelihood of this deviation occurring again with any other newborns in the future will not occur. This is also a time to discuss if there may have been a better way to manage a patient. The care may have been appropriate without a bad outcome, but is there a different or better way to manage the patient? A robust and effective QA/PI program will be evaluated through case reviews, QA/PI minutes and peer review documentation. These documents will be reviewed and evaluated by the surveyors during the survey visit at your facility. This supports the importance of having peers review the programs and processes when evaluation compliance.

(G) requirements for minimal credentials for all staff participating in the care of neonatal patients; (H) provisions for providing continuing staff education; including annual competency and skills assessment that is appropriate for the patient population served; (I) a perinatal staff registered nurse as a representative on the nurse staffing committee under §133.41(o)(2)(F) of this title; Facility will determine the minimal credentials outside of the specified requirements in the rule (NRP). It is important to make sure that the staff caring for newborns are provided with education, and that their knowledge and skills are appropriate for the population served. The nurse staffing committee is a compromise for staffing ratios. We do not want to prescribe what the facility staffing ratios are because the facilities are varied and so are their resources. Therefore, requiring that a perinatal staff RN be member or representative on the committee allows a voice in the process of determining staffing neonatal and maternal areas in the hospital.

(J) the availability of all necessary equipment and services to provide the appropriate level of care and support of the patient population served; and (K) the availability of personnel with knowledge and skills in breastfeeding. The facility will also determine the equipment necessary to provide the services described in the neonatal program plan. If your program plan includes providing care for infants that may require assisted ventilation for less than 24 hours, then the equipment and qualified personnel must be available to provide these services. The availability of personnel with knowledge and skills in breastfeeding. These may be your OB nurses that support the breast-feeding moms or it may be a community member that is a lay person with expertise in breastfeeding. Personnel need to be available.

(c) Medical Staff. The facility shall have an organized, effective neonatal program that is recognized by the medical staff and approved by the facility's governing body. The credentialing of the medical staff shall include a process for the delineation of privileges for neonatal care. Your program may follow the normal credentialing process in your facility. You will need to make sure there is a process for delineation of privileges specifically for neonatal care. I have seen that some physician services have a general description of privileges for credentialing in the facility, so be sure that neonatal privileges are addressed.

(d) Medical Director. There shall be an identified Neonatal Medical Director (NMD) and/or Transport Medical Director (TMD) as appropriate, responsible for the provision of neonatal care services and credentialed by the facility for the treatment of neonatal patients.

(1) The NMD and/or TMD shall have the authority and responsibility to monitor neonatal patient care from admission, stabilization, operative intervention(s) if applicable, through discharge, inclusive of the QAPI Program. (2) The responsibilities and authority of the NMD and/or TMD shall include but are not limited to:

(A) examining qualifications of medical staff requesting neonatal privileges and makes recommendations to the appropriate committee for such privileges; (B) assuring staff competency in resuscitation techniques; (C) participating in ongoing staff education and training in the care of the neonatal patient; The Medical Director will review the qualifications of the neonatal medical staff requesting privileges in the program and makes recommendations to the appropriate committee for these privileges. The recommendation may be made to the section leader, the credentialing committee, or directly to the medical staff committee. This is all dependent on how your facility completes credentialing and the different levels involved. When the Medical Director is reviewing qualifications, they will consider competency in resuscitation, participating in staff education and training in neonatal care. The ongoing education may be viewing online programs such as Health Stream or it may be the Medical Director sending out journal articles and requiring the neonatal providers to review the articles. Meetings with the neonatal Medical Staff may include specific education topics or case reviews that will also provide ongoing education to the providers. There are many ways to meet compliance with educations requirements.

(D) oversight of the inter-facility neonatal transport; (E) participating in the development, review and assurance of the implementation of the policies, procedures and guidelines of neonatal care in the facility including written criteria for transfer, consultation or higher level of care; (F) regular and active participation in neonatal care at the facility where medical director services are provided; The Medical Director will be actively involved in developing policies, procedures and guidelines in neonatal care and participating in the care of newborns at the facility in which they serve as the Medical Director. In other programs we have had physicians that have been contracted to serve as the Medical Director of a program. This physician would come to the facility quarterly, review cases and attend the PI meeting. Consider how effective this Medical Director is in the program if they are not working side by side with all of the other providers and staff. They do not know how the processes work in the facility or how decision making is done. An effective Medical Director needs to be familiar with the staff, the physical facility and the processes involved for providing neonatal care.

(G) ensuring that the QAPI Program is specific to neonatal/infant care, is ongoing, data driven and outcome based; and regularly participates in the neonatal QAPI meeting; and (H) maintaining active staff privileges as defined in the facility's medical staff bylaws. Medical Director will be responsible for an effective QA/PI program and will participate in the neonatal meetings. Maintain active staff privileges speaks for itself.

(e) Neonatal Program Manager (NPM). The NPM responsible for the provision of neonatal care services shall be identified by the facility and: (1) be a registered nurse: (2) have successfully completed and is current in the Neonatal Resuscitation Program (NRP) or an office-approved equivalent: The Neonatal Program Manager is responsible for neonatal care services. This person may be the Director or Manager of the Nursery because they are probably already performing these responsibilities. The facility does have to identify a person that is responsible for the neonatal program. The requirements of an RN and NRP are self-explanatory.

(3) have the authority and responsibility to monitor the provision of neonatal patient care services from admission, stabilization, operative intervention(s) if applicable, through discharge, inclusive of the QAPI Program as defined in subsection (b)(2)(E) of this section. (4) collaborate with the NMD in areas to include, but not limited to: developing and/or revising policies, procedures and guidelines; assuring staff competency, education, and training; the QAPI Program; and regularly participates in the neonatal QAPI meeting; and (5) develop collaborative relationships with other NPM(s) of designated facilities within the applicable Perinatal Care Region.

TAC §133.187 Level III TAC §133.188 Level IV
III - NICU. (1) provide care for mothers and comprehensive care of their infants of all gestational ages with mild to critical illnesses or requiring sustained life support; IV - Advanced NICU (1) provide care for the mothers and comprehensive care of their infants of all gestational ages with the most complex and critically ill neonates/infants with any medical problems, and/or requiring sustained life support; A Level III facility has a Neonatal Intensive Care Unit (NICU) and a Level IV has an Advanced NICU. These facilities provide comprehensive care to infants of all gestational ages. The distinction is that the Level III newborns will have mild to critical illnesses or require sustained life support. The Level IV facilities are expected to care for all newborns with the most complex and critically ill medical problems, and/or requiring sustained life support. Please note that not all Level IV facilities will have the exact same services. There are some services that are more specialized and only a few Level IV facilities may provide this service. An example of this service is ECMO(Extracorporeal membrane Oxygenation). The Guidelines for Perinatal Care, 7th Edition, does not list specific diagnoses for Mild, Critical or Most Complex. The facility will identify the population of patients with mild and/or critical illnesses that will be treated in their facility and provide the appropriate services to meet their needs for the best outcomes.

III - NICU. (2) provide for consultation to a full range of pediatric medical subspecialists and pediatric surgical specialists, and the capability to perform major pediatric surgery on-site or at another appropriate designated facility; IV - Advanced NICU (2) ensure that a comprehensive range of pediatric medical subspecialists and pediatric surgical subspecialists are available to arrive on-site for face to face consultation and care, and the capability to perform major pediatric surgery including the surgical repair of complex conditions; Consultation to a full range of pediatric medical and surgical subspecialists will be determined by the facility for the neonate population served. If your Level III facility does not frequently have neonates that require a pediatric endocrinology, this subspecialist may not be included in the full range of subspecialists and this patient may be transferred to a higher level of care for the appropriate services for the patient. A Level IV facility will provide all of the specialists required to care for the most critical newborns. The exception may be for a very specialized service such as ECMO. Both levels are required to have the subspecialist available to evaluate the patient on-site. For the Level III, they may transfer the patient for subspecialists that are not utilized often or have a very low volume of patient population. CHANGE THE NOTES ON THIS SLIDE. LEVEL III IS SURGICAL SPECIALISTS.

III - NICU (3) have skilled medical staff and personnel with documented training, competencies and continuing education specific for the patient population served; (4) facilitate transports; and (5) provide outreach education to lower level designated facilities. IV - Advanced NICU (3) have skilled personnel with documented training, competencies and continuing education specific for the patient population served; (4) facilitate transports; and (5) provide outreach education to lower level designated facilities. Both Levels will have skilled medical staff and personnel with appropriate training and documented evidence of the training and continuing education. Facilitating transports and outreach are required for both. This does not mean that a facility has to have a transport program, the facility has to have a process for facilitating transports of the neonatal population served.

III - NICU (b) Neonatal Medical Director (NMD). The NMD shall be a physician who is a board eligible/certified neonatologist and demonstrates a current status on successful completion of the Neonatal Resuscitation Program (NRP). IV - Advanced NICU (b) Neonatal Medical Director (NMD). The NMD shall be a physician who is a board eligible/certified neonatologist and demonstrates a current status on successful completion of the Neonatal Resuscitation Program (NRP). The Neonatal Medical Director for both a Level III and IV program will be a board eligible/certified neonatologist current in NRP.

III - NICU (c) If the facility has its own transport program, there shall be an identified Transport Medical Director (TMD). The TMD or Co-Director shall be a physician who is a board eligible/certified neonatologist or pediatrician with expertise and experience in neonatal/infant transport. IV - Advanced NICU (c) If the facility has its own transport program, there shall be an identified Transport Medical Director (TMD). The TMD and/or Co-Director shall be a physician who is a board eligible/certified neonatologist. If is the first key word here, If the facility has its own transport program, there shall be an identified Transport Medical Director and/or Co-Director. Co-Director was included because some facilities with a transport program utilizes an Emergency Medicine physician as the Medical Director. To provide the best care for our newborns, the Transport Medical Director or Co-Director will be a BC/BE neonatologist. The Level III is allowed to have a pediatrician with expertise and experience in Neonatal Transport.

III - NICU (d) Program Functions and Services. (1) Triage and assessment of all patients admitted to the perinatal service with identification of pregnant patients who are at high risk of delivering a neonate that requires a higher level of care who will be transferred to a higher level facility prior to delivery unless the transfer is unsafe. IV - Advanced NICU (d) Program Functions and Services. (1) Triage and assessment of all patients admitted to the perinatal service with identification of pregnant patients who are at high risk of delivering a neonate that requires a higher level of care who will be transferred to another facility prior to delivery unless the transfer is unsafe. All patients will be triaged and assessed. If the patient is identified as at high risk of delivering a neonate that requires a higher level of care, the Level III facility will transfer to patient to a higher level facility unless the transfer is determined as unsafe. For the Level IV facility, they may need to transfer to another facility that offers a specialized service beyond their capabilities.

III – NICU (2) Supportive and emergency care shall be delivered by appropriately trained personnel, for unanticipated maternal-fetal problems that occur during labor and delivery through the disposition of the patient. IV - Advanced NICU (2) Supportive and emergency care shall be delivered by appropriately trained personnel, for unanticipated maternal-fetal problems that occur during labor and delivery, through the disposition of the patient. Self-explanatory and no difference between the levels.

III – NICU (3) The ability to perform an emergency cesarean delivery within 30 minutes. IV - Advanced NICU (3) The ability to perform an emergency cesarean delivery within 30 minutes. Self Explanatory and the same.

III – NICU (4) At least one of the following neonatal providers shall be on-site and available at all times and includes pediatric hospitalists, neonatologists, and/or neonatal nurse practitioners or neonatal physician assistants, as appropriate, who have demonstrated competence in management of severely ill neonates/infants, whose credentials have been reviewed by the NMD and is on call, and: IV - Advanced NICU (4) Board certified/board eligible neonatologists whose credentials have been reviewed by the NMD and is on call, and who: Level III will have one of the following providers on-site and available at all times. Level IV will have a BC/BE neonatologist on-site and available at all times. You will see this on the next slide.

III – NICU (C) if the on-site provider is not a neonatologist, a neonatologist shall be available for consultation at all times and shall arrive on-site within 30 minutes of an urgent request; IV – Advanced NICU (C) shall be on-site and immediately available at the neonate/infant bedside as requested. Level III – because there are options for providers that may be on-site, if this provider is not a neonatologist, a neonatologist will be available for consultation at all times and will arrive on-site within 30 minutes of an urgent request. An urgent request will be determined or defined by the facility.

III – NICU (D) if the neonatologist is covering more than one facility, the facility must ensure that a back-up neonatologist be available, documented in an on call schedule and readily available to facility staff; and (E) ensure that the neonatologist providing back-up coverage shall arrive on-site within 30 minutes. IV – Advanced NICU For Level III – to ensure that a neonatologist is available for our newborns, if the neonatologist is covering more than one facility, there must be a back up neonatologist and they must arrive on-site with 30 minutes of an urgent request.

III – NICU (5) Anesthesiologists with pediatric expertise, shall directly provide the anesthesia care to the neonate, in compliance with the requirements found in §133.41(a) of this title (relating to Hospital Functions and Services). IV – Advanced NICU (5) Pediatric anesthesiologists shall directly provide anesthesia care to the neonate, in compliance with the requirements in §133.41(a) of this title. Level III – Anesthesiologists with pediatric expertise. Pediatric expertise will be determined by the program/facility. Level IV requires pediatric anesthesiologists.

Here is a snapshot of the anesthesia section in Hospital Licensing which I referenced in the previous slide. This is very small print, but you will need to know how to find these rules for reference.

III – NICU (6) A dietitian or nutritionist who has special training in perinatal and neonatal nutrition and can plan diets that meet the special needs of neonates/infants is available at all times, in compliance with the requirements found in §133.41(d) of this title. IV – Advanced NICU (6) A dietitian or nutritionist who has special training in perinatal and neonatal nutrition and can plan diets that meet the special needs of neonates in compliance with the requirements in §133.41(d) of this title. Available at all times – may be in person, by phone, etc. This requirement is the same for both levels.

III – NICU IV – Advanced NICU (7) A comprehensive range of pediatric medical subspecialists and pediatric surgical subspecialists will be immediately available to arrive on-site for face to face consultation and care for an urgent request. Level IV will have the pediatric medical and surgical subspecialists that will be immediately available to arrive on-site for face-to-face consultation and care for an urgent request.

III – NICU (7) Laboratory services shall be in compliance with the requirements found at §133.41(h) of this title and shall have: (A) laboratory personnel on-site at all times; (B) perinatal pathology services available; (C) a blood bank capable of providing blood and blood component therapy; and (D) neonatal blood gas monitoring capabilities. IV – Advanced NICU (8) Laboratory services shall be in compliance with the requirements in §133.41(h) of this title and shall have: (A) appropriately trained and qualified laboratory personnel on-site at all times; (B) perinatal pathology services; (C) a blood bank capable of providing blood and blood component therapy; and (D) neonatal/infant blood gas monitoring capabilities. Basically the requirements are the same for both levels.

III – NICU (8) Pharmacy services shall be in compliance with the requirements found in §133.41(q) of this title and will have a pharmacist, with experience in neonatal/pediatric and perinatal pharmacology, available at all times. IV – Advanced NICU (9) Pharmacy services shall be in compliance with the requirements in §133.41(q) of this title and shall have a pharmacist, with experience in neonatal/pediatric and perinatal pharmacology available on-site at all times. Pharmacy services for Level III pharmacist with experience in Neonatal/pediatric and perinatal pharmacology is available at all times. This may be on-site, by phone, etc. Level IV requires a pharmacist with the same experience on-site at all times. Once again, there is no specific definition of the experience required, so this will be defined by the program/facility per the population served.

III – NICU (A) If medication compounding is done by a pharmacy technician for neonates/infants, a pharmacist will provide immediate supervision of the compounding process; IV – Advanced NICU (A) If medication compounding is done by a pharmacy technician for neonates/infants, a pharmacist will provide immediate supervision of the compounding process. If any medication is compounded for administration to a neonate/infant, the pharmacist will actually observe the process. Immediate supervision is also defined in the Hospital Licensing section along with others.

III – NICU (B) If medication compounding is done for neonates/infants, the pharmacist will develop checks and balances to ensure the accuracy of the final product. (C) Total parenteral nutrition appropriate for neonates/infants shall be available. IV – Advanced NICU (B) If medication compounding is done for neonates/infants, the pharmacist shall develop and implement checks and balances to ensure the accuracy of the final product. (C) Total parenteral nutrition appropriate for neonates/infants shall be available. Essentially, these requirements are the same. The pharmacist will develop a process to ensure accuracy of the final product. TPN appropriate for the neonate/infant population served will be available.

III – NICU (9) An occupational or physical therapist with sufficient neonatal expertise shall be available to meet the needs of the population served. IV – Advanced NICU (10) An occupational or physical therapist with neonatal expertise shall be available to meet the needs of the population served. Level III allows sufficient expertise for the therapists which will be defined by the program/facility. Level IV requires neonatal expertise for the therapists which will also be defined by the program/facility.

III – NICU (10) Medical Imaging. Radiology services shall be in compliance with the requirements found in §133.41(s) of this title; will incorporate the "As Low as Reasonably Achievable" principle when obtaining imaging in neonatal and maternal patients; and shall have: IV – Advanced NICU (11) Medical Imaging. Radiology services shall be in compliance with the requirements in §133.41(s) of this title will incorporate the "As Low as Reasonably Achievable" principle when obtaining imaging in neonatal and maternal patients; and shall have: Self Explanatory and the same for both levels.

III – NICU (A) personnel appropriately trained in the use of x-ray equipment shall be on-site and available at all times; personnel appropriately trained in ultrasound, computed tomography, magnetic resonance imaging, echocardiography, and/or cranial ultrasound equipment shall be on-site within one hour of an urgent request; fluoroscopy shall be available; IV – Advanced NICU (A) personnel appropriately trained in the use of x-ray equipment shall be on-site and available at all times; personnel appropriately trained in ultrasound, computed tomography, magnetic resonance imaging, echocardiography and/or cranial ultrasound equipment shall be on-site within one hour of an urgent request; and fluoroscopy shall be available at all times; Both are the same and self-explanatory with the exception of Fluoroscopy available at all times for the Level IV program.

III – NICU (B) interpretation of neonatal and perinatal diagnostic imaging studies by radiologists with pediatric expertise at all times; and (C) pediatric echocardiography with pediatric cardiology interpretation and consultation within one hour of an urgent request. IV – Advanced NICU (B) neonatal and perinatal diagnostic imaging studies available at all times with interpretation by radiologists with pediatric expertise, available within one hour of an urgent request; and (C) pediatric echocardiography with pediatric cardiology interpretation and consultation within one hour of an urgent request. Interpretation of diagnostic imaging studies by radiologists with pediatric expertise will be available at all times. Expertise is defined by the program/facility. In a Level IV program, if an urgent request is made the interpretation of imaging studies will be available within one hour. Urgent request will be defined by the program/facility. (C) Is the same for both Levels and self explanatory.

III – NICU (11) Speech language pathologist, an occupational therapist, or a physical therapist with neonatal/infant experience shall be available to evaluate and manage feeding and/or swallowing disorders. IV – Advanced NICU (12) Speech language pathologist with neonatal expertise shall be available to evaluate and manage feeding and/or swallowing disorders. Level III requires an occupational or physical therapist, or a speech language pathologist with neonatal experience, to be available. Experience will be defined by the program/facility. Available – on-site, by phone, etc. Level IV requires a speech language pathologist with neonatal expertise to be available. Expertise will be defined by the program/facility. Same for available.

III – NICU (12) A respiratory therapist, with experience and specialized training in the respiratory support of neonates/infants, whose credentials have been reviewed by the NMD, shall be immediately available on-site. IV – Advanced NICU (13) A respiratory therapist, with experience and specialized training in the respiratory support of neonates/infants, whose credentials have been reviewed by the Neonatal Medical Director, shall be on-site and immediately available. Respiratory Therapists for both Level III and IV have the same requirements for experience and training with neonatal care. Their credentials will be reviewed by the Neonatal Medical Director. On-site and immediately available. The requirement is written differently, but has the same meaning.

III – NICU (13) Resuscitation. Written policies and procedures shall be specific to the facility for the stabilization and resuscitation of neonates based on current standards of professional practice. IV – Advanced NICU (14) Resuscitation. The facility shall have written policies and procedures specific to the facility for the stabilization and resuscitation of neonates/infants based on current standards of professional practice. Written policies and procedure for resuscitation based on current standards of practice are required for both Level III and Level IV based on facility capability and population served.

III – NICU (A) Each birth shall be attended by at least one provider who demonstrates current status of successful completion of the NRP whose primary responsibility is the management of the neonate and initiating resuscitation. IV – Advanced NICU (A) Each birth shall be attended by at least one provider who demonstrates current status of successful completion of the NRP whose primary responsibility is the management of the neonate and initiating resuscitation. Both Levels must have at least one provider – RN, Physician, PA, NP – with current NRP who will manage the care of the neonate.

III – NICU (B) At least one person must be immediately available on-site with the skills to perform a complete neonatal resuscitation including endotracheal intubation, establishment of vascular access and administration of medications. IV – Advanced NICU (B) At least one person must be immediately available on-site with the skills to perform a complete neonatal resuscitation including endotracheal intubation, establishment of vascular access and administration of medications. On person must be immediately available on-site with the skills and training to perform a complete resuscitation.

III – NICU (C) Additional providers who demonstrate current status of successful completion of the NRP shall attend each neonate in the event of multiple births. IV – Advanced NICU (C) Additional providers who demonstrate current status of successful completion of the NRP shall attend each neonate in the event of multiple births. For multiple births there needs to be a provider for each neonate.

III – NICU (D) Each high-risk delivery shall have in attendance at least two providers who demonstrate current status of successful completion of the NRP whose only responsibility is the management of the neonate. IV – Advanced NICU (D) Each high-risk delivery shall have in attendance at least two providers who demonstrate current status of successful completion of the NRP whose only responsibility is the management of the neonate. High-risk deliveries will have at least 2 providers with NRP who are responsible for managing only the neonate. This high-risk deliveries will be defined or determined by the program/facility.

III – NICU (E) A full range of resuscitative equipment, supplies, and medications shall be immediately available for trained staff to perform complete resuscitation and stabilization on each neonate/infant. IV – Advanced NICU (E) A full range of resuscitative equipment, supplies and medications shall be immediately available for trained staff to perform resuscitation and stabilization on each neonate/infant. Provide the appropriate equipment, supplies, medications and staff immediately available to perform resuscitation.

III – NICU (14) Perinatal Education. A registered nurse with experience in neonatal care, including neonatal intensive care, shall provide supervision and coordination of staff education. IV – Advanced NICU (15) Perinatal Education. A registered nurse with experience in neonatal care, including neonatal intensive care, shall provide supervision and coordination of staff education. Perinatal Education. Specifies that a Registered Nurse with Neonatal intensive care experience will provide supervision and coordination of staff education. Same for both levels.

III – NICU (15) Pastoral care and/or counseling shall be provided as appropriate to the patient population served. (16) Social services shall be provided as appropriate to the patient population served. IV – Advanced NICU (16) Pastoral care and/or counseling shall be provided as appropriate to the patient population served. (17) Social services shall be provided as appropriate to the patient population served. Appropriate Pastoral Care and Social Services will be available. Same for both levels.

III – NICU (17) Ensure the timely evaluation of retinopathy of prematurity, monitoring, referral for treatment and follow-up, in the case of an at-risk infant. IV – Advanced NICU (18) The facility must ensure the timely evaluation and treatment of retinopathy of prematurity on-site by a pediatric ophthalmologist or retinal specialist with expertise in retinopathy of prematurity in the event that an infant at risk is present, and a documented policy for the monitoring, treatment and follow-up of retinopathy of prematurity. Level III must ensure evaluation of ROP, monitoring, referral for treatment and follow up for an at-risk infant. Level IV will do the same with an on-site pediatric ophthalmologist or retinal specialist with expertise in ROP. Both Levels will need a documented policy.

III – NICU (18) A certified lactation consultant shall be available at all times. (19) Ensure provisions for follow up care at discharge for infants at high risk for neurodevelopmental, medical, or psychosocial complications. IV – Advanced NICU (19) A certified lactation consultant shall be available at all times. (20) Ensure provisions for follow up care at discharge for infants at high risk for neurodevelopmental, medical, or psychosocial complications. Certified Lactation Consultant will be available at all times. This does not specify that the consultant has to be IBCLC. If the facility has nurses available that are IBCLC, then the requirement has been met. The program/facility may define certified.

Designation Deadline Dates
Each hospital that provides neonatal care will need to be designated by September 1, to receive Medicaid funds. Applications must be received in our office before July 1, 2018 to be approved for designation by the Executive Commissioner before September 1, 2018.

DSHS Website The DSHS website is now available. Yay!
The website will be updated with this webinar, the rule, educational opportunity dates and a Frequently Asked Questions (FAQ) section.

DSHS Website

Neonatal Designation Coordinator
Debbie Lightfoot, RN (512) ext. 2032

Contact Information Please send your name, title, facility name, address and phone number to: or

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