TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 133. HOSPITAL LICENSING

SUBCHAPTER J. HOSPITAL LEVEL OF CARE DESIGNATIONS FOR NEONATAL [AND MATERNAL] CARE

25 TAC §§131.181 - 131.191

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes amendments to §133.181, concerning Purpose; §133.182, concerning Definitions; §133.183, concerning General Requirements; §133.184, concerning the Designation Process; §133.185, concerning Program Requirements; §133.186, concerning Neonatal Designation Level I; §133.187, concerning Neonatal Designation Level II; §133.188, concerning Neonatal Designation Level III; §133.189, concerning Neonatal Designation Level IV; §133.190, concerning the Survey Team; and new §133.191, concerning the Perinatal Care Regions (PCRs).

BACKGROUND AND PURPOSE

The purpose of this proposal is to update the content and processes with the advances and practices since these rules were adopted in 2016. Senate Bill (S.B.) 749, 86th Legislature, Regular Session, 2019, amended the Texas Health and Safety Code, Chapter 241.

In addition, the Perinatal Advisory Council (PAC) provided DSHS with rule language recommendations designed to clarify specific subsections of the rules. The recommendations include the use of prearranged consultative agreements using telemedicine technology, and consideration of a waiver agreement for facilities that cannot meet a specific designation requirement. The recommendations further define the process for the three-person appeal panel, pediatric echocardiography with pediatric cardiology interpretation and consultation to be completed in a time period consistent with standards of professional practice, and include national accredited organizations providing resuscitation courses.

DSHS integrated the subcommittee's recommended language in the proposed rules. DSHS presented the rule changes to the PAC during their February 7, 2022, meeting. The PAC formed a workgroup to collaborate with DSHS staff to review all feedback received during the informal comment period which ended on February 28, 2022. The PAC workgroup met with DSHS on March 2, 2022, to consider all comments and determine the most appropriate language to ensure the health and safety of neonatal patients and prevent unnecessary burden for the facilities providing neonatal care.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §133.181 adds the word "Texas" for clarity in the Texas Health and Safety Code.

The proposed amendment to §133.182, concerning Definitions, revises definitions for "attestation," "birth weight," "CAP," "department," "designation," "EMS," "gestational age," "high-risk infant," "immediately," "infant," "maternal," "neonate," "NRP," "PCR," "POC," "QAPI Program," "RAC," "TSA," and "urgent." New definitions include "available," "contingent designation," "contingent probationary designation," "focused survey," "inter-facility transport," "Neonatal Program Oversight," "on-site," "telehealth service," and "telemedicine medical service." The definitions "commission," "Executive Commissioner," "immediate supervision," "office," and "postpartum" were removed as these definitions are no longer necessary. The revised and new definitions provide clarity to the rule language and ensure consistency in interpretation of the rules.

The proposed amendment to §133.183, concerning General Requirements, clarifies language and the expectations for facilities seeking neonatal designation. Subsection (d) clarifies that DSHS determines requirements for the levels of neonatal designation. Subsection (e) removes PCRs from this subsection and is located in new §133.191. Subsection (f)(3)(E) clarifies outreach education language for the Level III Neonatal facilities. Subsection (f)(4)(E) clarifies outreach education language for the Level IV Neonatal facilities. Subsection (g)(5) defines the expectations for access to the QAPI (Quality Assessment and Performance Improvement) Plan documentation by DSHS and surveyors during a neonatal designation site review. Subsection (h)(1) - (2) outlines the surveyor conflict of interest and expectations. Subsection (i) defines that DSHS may appoint an observer to accompany the survey team. Subsection (j) defines that the surveyors' role is to validate the hospital's processes to meet the designation requirements.

The proposed amendment to §133.184, concerning the Designation Process, clarifies designation and process language and expectations for facilities seeking neonatal designation. Subsection (a)(2)(B) defines the process required to complete the attestation and self-survey report for hospitals seeking Level I designation. This section also defines that Level II, Level III, and Level IV facilities must submit the completed neonatal survey report documenting that the designation requirements are met and that medical record reviews are in their designation application. Subsection (a)(1)(C) outlines the expectations for developing the "Plan of Correction" if designation requirements are not met. Subsections (c) - (k) define the process for designating at a different level of care. Subsection (d) defines that the facility must submit the required documents described in subsection (a)(1) and (2) no later than 90 days before the facility's current neonatal designation expiration date. Subsection (e) states that a facility has the right to withdraw its application for neonatal designation any time before being approved for designation by DSHS. Subsection (f) outlines that the facility's neonatal designation will expire if the facility fails to provide a complete neonatal designation application renewal packet to DSHS. Subsection (k) defines the expectations of the site survey summary and that it is to be submitted to the facility by the survey organization no later than 30 days after completing the survey. Subsection (n)(1) and (2) defines the Corrective Action Plan expectations. Subsection (o) outlines the appeal process to include a three-person appeal panel. Subsection (p)(2) defines the requirements and process for a waiver agreement. Subsection (r) outlines steps for a neonatal facility that is relinquishing their designation status. Subsection (v) defines that DSHS may deny, suspend, or revoke the designation if a designated neonatal facility ceases to provide services to meet or maintain designation requirements defined in this section.

The proposed amendment to §133.185, concerning Program Requirements, addresses advances in care since the rules were adopted in 2016, integrates telemedicine, and integrates recommendations from the PAC. Subsection (b)(2) defines the requirements for the Neonatal Program Plan. Subsection (b)(2)(D) outlines the requirements for telemedicine and telehealth care for neonatal programs. Subsection (b)(3) defines the requirements for the QAPI Plan. Subsection (b)(3)(D) requires Level III and Level IV facilities to participate in quality benchmarking programs and to integrate the benchmarking reports into the QAPI Plan. Subsection (b)(3)(E) defines that the Neonatal Medical Director must have the authority to make referrals to peer review, receive feedback from the peer review process, and ensure a neonatal physician representation in the peer review process for neonatal cases. Subsection (d)(1) defines the requirements for the Neonatal Medical Director. Subsection (d)(2) defines the requirements for the Transport Medical Director. Subsection (e) clarifies the requirements and expectations for the Neonatal Program Manager.

The proposed amendment to §133.186, concerning Neonatal Designation Level I, reflects the advances and current practices since the adoption of the rules in 2016. Subsection (c)(4) defines the written guidelines for the availability of appropriate anesthesia, laboratory, radiology, respiratory, ultrasonography, and blood bank services on a 24-hour basis.

The proposed amendment to §133.187, concerning Neonatal Designation Level II, reflects the advances and current neonatal practices. Subsection (c)(1) defines the requirement for the neonatal program's collaboration with the maternal program, consulting physicians, and nursing leadership to ensure pregnant patients who are at high risk of delivering a neonate that requires a higher-level of care be transported to a higher-level facility before delivery, unless the transfer would be unsafe.

The proposed amendment to §133.188, concerning Neonatal Designation Level III, reflects the advances and current neonatal practices. Subsection (a)(5) clarifies the requirements for outreach education.

The proposed amendment to §133.189, concerning Neonatal Designation Level IV, reflects the advances and current neonatal practices. Subsection (d) clarifies the program requirements for the Level IV facilities.

The proposed amendment to §133.190, concerning the Survey Team, provides clarification regarding the survey team requirements. Subsection (c) provides clarification specific to survey team members' conflict of interest. Subsection (e) requires the survey team to evaluate the use of telehealth/telemedicine utilization for neonatal care.

New §133.191, concerning PCRs, includes rule language to reflect the expectations of the PCR. Subsection (f) clarifies the requirement that the PCR may define data needs for regional collaborations.

FISCAL NOTE

Donna Sheppard, DSHS Chief Financial Officer, has determined that for each year of the first five years that the rules will be in effect, enforcing and administering the rules do not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

DSHS has determined that during the first five years that the rules will be in effect:

(1) the proposed rules will not create or eliminate a government program;

(2) implementation of the proposed rules will not affect the number of DSHS employee positions;

(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;

(4) the proposed rules will not affect fees paid to DSHS;

(5) the proposed rules will create a new rule;

(6) the proposed rules will expand existing rules by providing the facility options for telemedicine and telehealth, and allowing the facility to request a waiver to assist in reaching designation;

(7) the proposed rules will not change the number of facilities subject to the rules; and

(8) the proposed rules will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Donna Sheppard has determined that there will not be an adverse impact on small business, micro businesses, rural communities, or persons if they operate a hospital since the neonatal designation process began in 2016 and there is no projected increase in the fees.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas and are necessary to implement legislation that does not specifically state that §2001.0045 applies to the rules.

PUBLIC BENEFIT AND COSTS

Timothy Stevenson, Associate Commissioner of Consumer Protection Division, has determined that for each year of the first five years the rules are in effect, the public will benefit from the adoption of the sections. The public benefit anticipated as a result of administering the sections is the designation of hospitals will enhance neonatal care capabilities and capacity necessary to improve neonatal outcomes in all regions of Texas.

Donna Sheppard has also determined that for the first five years the rules are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rules because the neonatal designation process began in 2016. The facilities are continuing their designation status. The designation fees will remain the same with no projected increase in fees.

REGULATORY ANALYSIS

DSHS has determined that this proposal is not a "major environmental rule" as defined by Texas Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule with specific intent of which is to protect the environment or reduce risk to the human health from the environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment, or public health and safety of a state or sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environment exposure.

TAKING IMPACT ASSESSMENT

DSHS has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code, §2007.043.

PUBLIC COMMENT

Written comments on the proposal may be submitted to Jorie Klein, MSN, MHA, BSN, RN, Director of EMS-Trauma Systems Section by P.O. Box 149347, Austin, Texas 78714-9347, or street address 1100 W. 49th Street, Austin, Texas 78754 or by email to DSHS.EMS-Trauma@dshs.texas.gov.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule 20R002 Neonatal Rules" in the subject line.

STATUTORY AUTHORITY

The amendments and new rule are authorized by Texas Health and Safety Code, Chapter 241, which provides DSHS with authority to recommend rules establishing the levels of care for neonatal care, establish a process of assignment or amendment of the levels of care to hospitals, divide the state into PCRs, and facilitate transfer agreements through regional coordination; and by Texas Government Code §531.0055, and Texas Health and Safety Code, §1001.075, which authorizes the Executive Commissioner of HHSC to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001.

The amendments and new rule are authorized by Texas Health and Safety Code, Chapters 241 and 1001; and Texas Government Code, Chapter 531.

§133.181.Purpose.

The purpose of this section is to implement Texas 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.

§133.182.Definitions.

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

(1) Attestation--A written statement, signed by the chief executive officer [Chief Executive Officer] of the facility, verifying the results of a self-survey represent a complete [true] and accurate assessment of the facility's capabilities required in this subchapter.

(2) Available--Relating to staff who can be contacted for consultation at all times without delay.

(3) [(2)] Birth weight--The weight of the neonate recorded at time of birth.

(A) Low birth weight--Birth weight less than 2500 grams (5 lbs., 8 oz.);

(B) Very low birth weight (VLBW)--Birth weight less than 1500 grams (3 lbs., 5 oz.); and

(C) Extremely low birth weight (ELBW)--Birth weight less than 1000 grams [1000grams] (2 lbs., 3 oz.).

(4) [(3)] CAP--Corrective Action [Action(s)] Plan. A plan for the facility developed by the department [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 are met.

[(4) Commission--The Health and Human Services Commission.]

(5) Contingent designation--A designation awarded to a facility with one to three requirements not met. The department develops a CAP for the facility and the facility must complete this plan and meet requirements to remain designated. Contingent designations may require a focused survey to validate requirements are met.

(6) Contingent probationary designation--A designation awarded to a facility with four or more requirements not met. The department develops a CAP for the facility and the facility must complete this plan and meet requirements to remain designated. The facility may be required to submit documentation reflecting the CAP to the department at defined intervals. Contingent probationary designation requires a full survey between twelve and eighteen months after the contingent probationary designation is awarded, and the facility must demonstrate requirements are met to maintain designation.

(7) [(5)] Department--The Texas Department of State Health Services.

(8) [(6)] Designation--A formal recognition by the department [executive commissioner] of a facility's neonatal [or maternal] care capabilities and commitment[,] for a period of three years.

(9) [(7)] EMS--Emergency medical services. Services used to respond to an individual's perceived need for immediate medical care.

[(8) Executive commissioner--The executive commissioner of the Health and Human Services Commission.]

(10) Focused survey--A department-defined, modified facility survey by a department-approved survey organization or the department. The specific goal of this survey is to review designation requirements identified as not met to resolve a contingent designation or requirement deficiencies.

(11) [(9)] Gestational age--The age of a fetus or embryo determined by the amount of time that has elapsed since the first day of the mother's last menstrual period or the corresponding age of the gestation as estimated by a physician through a more accurate method [at a specific point during a woman's pregnancy].

(12) [(10)] High-risk infant [Infant]--A newborn that has a greater chance of complications because of conditions that occur during fetal development, pregnancy conditions of the mother, or problems that may occur during labor or [and/or] birth.

[(11) Immediate supervision--The supervisor is actually observing the task or activity as it is performed.]

(13) [(12)] Immediately--Able to respond without [Without] delay, commonly referred to as STAT or near.

(14) [(13)] Infant--A child from birth to one [1] year of age.

(15) Inter-facility transport--Transfer of a patient from one health care facility to another health care facility.

(16) [(14)] Lactation consultant--A health care professional who specializes in the clinical management of breastfeeding.

(17) [(15)] Maternal--Pertaining to the mother.

(18) [(16)] NCPAP--Nasal continuous positive airway pressure.

(19) Neonatal Program Oversight--A multidisciplinary process responsible for the administrative oversight of the neonatal program and having the authority for approving the defined neonatal program's policies, procedures, and guidelines for all phases of neonatal care provided by the facility, to include defining the necessary staff competencies, monitoring to ensure neonatal designation requirements are met, and the aggregate review of the neonatal QAPI initiatives and outcomes. Neonatal Program Oversight may be performed through the neonatal program's performance improvement committee, multidisciplinary oversight committee, or other structured means.

(20) [(17)] Neonate--An infant from birth through 28 completed days [after].

(21) [(18)] NMD--Neonatal Medical Director.

(22) [(19)] NPM--Neonatal Program Manager.

(23) [(20)] NRP--Neonatal Resuscitation Program [NRP--]. A resuscitation course [that was] developed and [is] administered jointly by the American Heart Association/American Academy of Pediatrics.

[(21) Office--Office of Emergency Medical Services (EMS)/Trauma Systems Coordination.]

(24) On-site--At the facility and able to arrive at the patient bedside for urgent requests.

(25) [(22)] PCR--Perinatal Care Region. The PCRs are established for descriptive and regional planning purposes. The PCRs are geographically divided by counties and are integrated into the existing 22 Trauma Service Areas (TSAs) and the applicable Regional Advisory Council (RAC) of the TSA provided in §157.122 of this title (relating to Trauma Services Areas) and §157.123 of this title (relating to Regional Emergency Medical Services/Trauma Systems).

(26) [(23)] Perinatal--Of, relating to, or being the period around childbirth, especially the five months before and one month after birth.

(27) [(24)] POC--Plan of Correction. A report submitted to the department [office] by the facility detailing how the facility will correct any deficiencies cited in the neonatal designation site survey summary [report] or documented in the self-attestation.

(28) [(25)] Premature/prematurity--Birth at less than 37 weeks of gestation.

[(26) Postpartum--The six-week period following delivery.]

(29) [(27)] QAPI Plan [Program]--Quality Assessment and Performance Improvement Plan [Program]. QAPI is a data-driven and proactive approach to quality improvement. It combines two approaches - Quality Assessment (QA) and Performance Improvement (PI). QA is a process used to ensure services are meeting quality standards and assuring care reaches a defined level. PI is the continuous study and improvement process designed to improve system and patient outcomes.

(30) [(28)] RAC--Regional Advisory Council as described in §157.123 of this title [(relating to Regional Emergency Medical Services/Trauma Systems)].

(31) [(29)] Supervision--Authoritative procedural guidance by a qualified person for the accomplishment of a function or activity with initial direction and periodic inspection of the actual act of accomplishing the function or activity.

(32) Telehealth service--A health service, other than telemedicine medical service, delivered by a health professional licensed, certified, or otherwise entitled to practice in this state and acting within the scope of the health professional's license, certification, or entitlement to a patient at a different physical location than the health professional using telecommunications or information technology as defined in Texas Occupations Code §111.001.

(33) Telemedicine medical service--A health care service delivered by a physician licensed in this state, or health professional acting under the delegation and supervision of a physician licensed in this state, and acting within the scope of the physician's or health professional's license to a patient at a different physical location than the physician or health professional using telecommunications or technology as defined in Texas Occupations Code §111.001.

(34) [(30)] TSA--Trauma Service Area as described in §157.122 of this title [relating to (Trauma Service Areas)].

(35) [(31)] Urgent--Requiring [immediate] action or attention within 30 minutes of notification.

§133.183.General Requirements.

(a) The department reviews the applicant documents and approves the appropriate level of facility designation [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].

(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.

(c) Each location must [shall] be considered separately for designation and the department determines [office will determine] the designation level for each [that] location[,] based on the facility's ability to demonstrate that designation requirements are met.[, 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].

(d) The department determines requirements for the levels of neonatal designation. Facilities seeking Levels II, III, and IV neonatal designation must demonstrate compliance with department-approved requirements and have the compliance validated by a department-approved survey organization.

(e) Facilities seeking Level I neonatal designation must submit a self-survey attesting to compliance with department-approved requirements.

(f) The four levels of neonatal designation are:

(1) Level I (Well Care [Nursery]). The Level I neonatal designated facility must [will]:

(A) provide care for mothers and their infants generally of ≥35 [>=35] weeks gestational age who have routine, transient perinatal problems;

(B) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served; and

(C) [if an infant <35 weeks gestational age is retained, the facility shall] provide the same level of care that the neonate would receive at a higher-level [higher level] designated neonatal facility and [shall, through the QAPI Program,] complete an in-depth [in depth] critical review and assessment of the care provided to these infants through the QAPI Plan and process if an infant <35 weeks gestational age is retained.

(2) The Level II (Special Care [Nursery]). The Level II neonatal designated facility must [will]:

(A) provide care for mothers and their infants of generally ≥32 [>=32] weeks gestational age and birth weight ≥1500 [>=1500] grams who have physiologic immaturity or [who have] problems that are expected to resolve rapidly and are not anticipated to require subspecialty services on an urgent basis; [and]

(B) [either] provide care, either by including assisted endotracheal ventilation for less than 24 hours or nasal continuous positive airway pressure (NCPAP) until the infant's condition improves, or arrange for appropriate transfer to a higher-level [higher level] designated facility; and

(C) have [provide] skilled medical staff and personnel with [that have] documented training, competencies, and annual continuing education specific for the patient population served.

(3) Level III (Neonatal Intensive Care [Unit (ICU)]). The Level III neonatal designated facility must [will]:

(A) provide care for mothers and comprehensive care for [of] their infants of all gestational ages with mild to critical illnesses or requiring sustained life support;

(B) ensure access to [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 neonatal designated facility;

(C) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served;

(D) facilitate neonatal transports; and

(E) provide outreach education to lower-level neonatal [lower level] designated facilities, and as appropriate and applicable, to non-designated facilities, birthing centers, independent midwife practices, and prehospital providers based on findings in the QAPI Plan and process.

(4) Level IV (Advanced Neonatal Intensive Care [ICU]). The Level IV neonatal designated facility must [will]:

(A) provide care for mothers and comprehensive care for [of] their infants of all gestational ages with the most complex and critical medical and surgical conditions or [critically ill neonates/infants and/or] requiring sustained life support;

(B) ensure access to [have] a comprehensive range of pediatric medical subspecialists and pediatric surgical subspecialists available to arrive on-site, in person for [face to face] consultation and care, and the capability to perform major pediatric surgery, including the surgical repair of complex conditions on-site;

(C) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served;

(D) facilitate neonatal transports; and

(E) provide outreach education to lower-level neonatal [lower level] designated facilities, and as appropriate and applicable, to non-designated facilities, birthing centers, independent midwife practices, and prehospital providers based on findings in the QAPI Plan and process.

(g) [(d)] Facilities seeking neonatal [facility] designation must undergo an on-site or virtual survey as outlined in this section and: [shall be surveyed through an organization approved by the office to verify that the facility is meeting office-approved relevant neonatal facility requirements. The facility shall bear the cost of the survey.]

(1) schedule a neonatal designation survey through a department-approved survey organization;

(2) notify the department of the neonatal designation survey date;

(3) pay for expenses associated with the neonatal designation survey;

(4) not accept surveyors with any conflict of interest; and

(5) provide the survey team access to records and documentation regarding the QAPI Plan and process related to neonatal patients. The department may determine that failure by a facility to provide access to these records does not meet the requirements of this subchapter.

(h) If a conflict of interest is present, the facility seeking neonatal designation must decline the assigned surveyor through the surveying organization. A conflict of interest exists when a surveyor has a direct or indirect financial, personal, or other interest which would limit or could reasonably be perceived as limiting the surveyor's ability to serve in the best interest of the public. The conflict of interest may include a surveyor who, in the past four years, has personally trained a key member of the facility's leadership in residency or fellowship, collaborated with a key member of the facility's leadership team professionally, participated in a designation consultation with the facility, or conducted a designation survey for the facility.

(1) Surveyors cannot be from the same PCR or TSA region or a contiguous region of the facility's location.

(2) If a designation survey occurs with a surveyor who has an identified conflict of interest, the department, in its sole discretion, may refuse to accept the neonatal designation site survey summary and medical record review conducted by a surveyor with a conflict of interest.

(i) The department, at its sole discretion, may appoint an observer to accompany the survey team with the observer costs borne by the department.

(j) The survey team evaluates the facility's evidence that department-approved designation requirements are met and documents all requirements that are not met in the neonatal designation site survey summary and medical record reviews.

[(e) PCRs.]

[(1) The PCRs are established for descriptive and regional planning purposes and not for the purpose of restricting patient referral.]

[(2) The PCR will consider and facilitate transfer agreements through regional coordination.]

[(3) A written plan identifies all resources available in the PCRs for perinatal care including resources for emergency and disaster preparedness.]

[(4) The PCRs are geographically divided by counties and are integrated into the existing 22 TSAs and the applicable Regional Advisory Council (RAC) of the TSA provided in §157.122 and §157.123 of this title; will be administratively supported by the RAC; and will have fair and equitable representation on the board of the applicable RAC.]

[(5) Multiple PCRs can meet together for the purposes of mutual collaboration.]

§133.184.Designation Process.

(a) A facility seeking neonatal designation or renewal of designation must submit a completed [Designation] application packet. [The applicant shall submit the packet, inclusive of the following documents to the Office of EMS/Trauma Systems Coordination (office) within 120 days of the facility's survey date:]

(1) A complete application packet must contain the following:

(A) [(1)] neonatal [an accurate and complete] designation application [form] for the requested [appropriate] level of designation[, including full payment of the designation fee as listed in subsection (d) of this section];

[(2)] [any subsequent documents submitted by the date requested by the office;]

(B) [(3)] [a completed] neonatal attestation and self-survey report for Level I applicants or the documented neonatal designation site survey summary that includes the requirement compliance findings and the medical record reviews for Levels II, III, and IV applicants, submitted to the department no later than 90 days after the neonatal designation site survey date [a designation survey report, including patient care reviews if required by the office, for Level II, III and IV applicants];

(C) [(4)] Plan of Correction (POC), if required by the department, that addresses all designation requirements defined as "not met" in the neonatal designation site survey summary. The POC must include: [a plan of correction (POC), detailing how the facility will correct any deficiencies cited in the survey report, to include: the corrective action; the title of the person responsible for ensuring the correction(s) is implemented; how the corrective action will be monitored; and the date by which the POC will be completed; and]

(i) a statement of the cited designation requirement not met;

(ii) a statement describing the corrective action taken by the facility seeking neonatal designation to meet the requirement;

(iii) the title of the individuals responsible for ensuring the corrective actions are implemented;

(iv) the date the corrective actions were implemented;

(v) a statement on how the corrective action will be monitored; and

(vi) documented evidence that the POC was implemented within 90 days of the designation survey;

(D) [(5)] written evidence of annual participation in the applicable PCRs; and [ Perinatal Care Region (PCR).]

(E) any subsequent documents submitted by the date requested by the department.

(2) The application includes full payment of the non-refundable, non-transferrable designation fee listed:

(A) Level I neonatal facility applicants, the fees are as follows:

(i) ≤100 licensed beds, the fee is $250.00; or

(ii) >100 licensed beds, the fee is $750.00.

(B) Level II neonatal facility applicants, the fee is $1,500.00.

(C) Level III neonatal facility applicants, the fee is $2,000.00.

(D) Level IV neonatal facility applicants, the fee is $2,500.00.

(b) The application will not be processed if a facility seeking neonatal designation fails to submit the required application documents and designation fee. [Renewal of designation. The applicant shall submit the documents described in subsection (a)(1) - (5) of this section to the office not more than 180 days prior to the designation expiration date and at least 60 days prior to the designation expiration date.]

(c) A facility requesting to designate at a different level of care, experiencing a change in ownership, or a change in physical address must notify the department and submit a complete designation application packet outlined in subsection (a)(1) and (2) of this section [If a facility seeking designation fails to meet the requirements in subsection (a)(1) - (5) of this section, the application shall be denied].

(d) The facility must submit the required documents described in subsection (a)(1) and (2) of this section to the department no later than 90 days before the facility's current neonatal designation expiration date for all renewal designations. [Non-refundable application fees for the three year designation period are as follows:]

[(1) Level I neonatal facility applicants, the fees are as follows:]

[(A) ≤100 licensed beds, the fee is $250.00; or]

[(B) >100 licensed beds, the fee is $750.00.]

[(2) Level II neonatal facility applicants, the fee is $1,500.00.]

[(3) Level III neonatal facility applicants, the fee is $2,000.00.]

[(4) Level IV neonatal facility applicants, the fee is $2,500.00.]

[(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.]

[(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.]

[(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.]

(e) The facility has the right to withdraw its application for neonatal designation any time before being approved for designation by the department.

[(e) If a facility disagrees with the level(s) determined by the office to be appropriate for initial designation or re-designation, it may make an appeal in writing not later than 60 days to the director of the office. The written appeal must include a signed letter from the facility's governing board with an explanation of how the facility meets the requirements for the designation level.]

[(1) If the office upholds its original determination, the director of the office will give written notice of such to the facility not later than 30 days of its receipt of the applicant's complete written appeal.]

[(2) The facility may, not later than 30 days of the office's sending written notification of its denial, submit a written request for further review. Such written appeal shall then go to the Assistant Commissioner of the Division for Regulatory Services (assistant commissioner).]

(f) The facility's neonatal designation will expire if the facility fails to provide a timely and complete neonatal designation application packet to the department.

(g) The neonatal designation application packet in its entirety, including any recommendations or follow-up from the department and any opportunities for improvement, must be a written element of the facility's neonatal QAPI Plan and must be reviewed through this process, which is all subject to confidentiality as described in Texas Health and Safety Code, §241.184, Confidentiality; Privilege and all relevant laws related to the confidentiality of such records.

(h) The department reviews the application packet to determine and approve the facility's level of neonatal designation.

(i) The department defines the final neonatal designation level awarded to the facility, which may be different than the level requested based on the neonatal designation site survey summary.

(j) If the department determines the facility meets the requirements for neonatal designation, the department provides the facility with a designation award letter and a designation certificate.

(1) The facility must display its neonatal designation certificate in a public area of the licensed premises that is readily visible to patients, employees, and visitors.

(2) The facility must not alter the neonatal designation certificate. Any alteration voids neonatal designation for the remainder of that designation period.

(k) [(f)] The survey organization must [surveyor(s) shall] provide the facility with a written, signed neonatal designation site survey summary, including medical record reviews, [report] regarding their evaluation and validation of the facility's demonstration that [compliance with] neonatal designation [program] requirements are met. The neonatal designation site survey summary must [This survey report shall] be forwarded to the facility no later than 30 days after [of] the completion date of the survey. The facility is responsible for submitting [forwarding] a copy of the neonatal designation site survey summary, medical record reviews, and required documents [this report] to the department within 90 days of completion of the site survey to continue the designation process [office if it intends to continue the designation process].

[(g) The office shall review the findings of the survey report and any POC submitted by the facility, to determine compliance with the neonatal program requirements.]

(l) [(1)] The department reviews and approves designation of a facility that demonstrated the requirements are met [A recommendation for designation shall be made to the executive commissioner based on compliance with the requirements].

(m) [(2)] A neonatal level of care designation must [shall] not be denied to a facility that meets the minimum level of care designation requirements [for that level of care designation].

[(3) If a facility does not meet the requirements for the level of designation requested, the office shall recommend designation for the facility at the highest level for which it qualifies and notify the facility of the requirements it must meet to achieve the requested level of designation.]

(n) [(4)] If the department determines a facility does not meet the [a facility does not comply with] requirements for the level of designation requested, the department must [office shall] notify the facility of the requirements not met and may: [deficiencies and required corrective action(s) plan (CAP).]

(1) designate at the highest level for which requirements are met and notify the facility of the requirements it must meet to achieve the requested level of designation; or

(2) designate with a Corrective Action Plan (CAP) developed by the department to guide the facility in correcting the identified deficiencies, and the CAP may include requiring the facility to have a focused survey.

(A) The facility must [shall] submit to the department [office] reports as required and outlined in the CAP. The department [office] may require a second survey to ensure the facility meets [compliance with] the designation requirements. The cost of the second survey will be at the expense of the facility.

(B) If the department [office] substantiates actions taken by [action that brings] the facility demonstrating documented evidence that designation requirements in the CAP are met [into compliance with the requirements], the department will remove the designation contingencies [office shall recommend designation to the executive commissioner].

[(C) If a facility disagrees with the office's decision regarding its designation application or status, it may request a secondary review by a designation review committee. Membership on a designation review committee will:]

[(i) be voluntary;]

[(ii) be appointed by the office director;]

[(iii) be representative of neonatal care providers and appropriate levels of designated neonatal facilities; and]

[(iv) include representation from the office and the Perinatal Advisory Council.]

(o) If a facility disagrees with the designation level determined by the department, it may request an appeal in writing to the EMS/Trauma Systems Section Director not later than 30 days after the designation award. The written appeal must be from the facility's Chief Executive Officer, Chief Medical Officer, or Chief Nursing Officer with documented evidence of how the facility meets the requirements for the requested designation level.

(1) The EMS/Trauma Systems Section will establish a three-person appeal panel and follow approved appeal panel guidelines to assess the facility's designation appeal as referenced in Texas Health and Safety Code §241.1836.

(2) If the designation appeal panel upholds the original designation determination, the EMS/Trauma Systems Section Director will give written notice of the upheld designation determination to the facility not later than 30 days after the appeal panel's decision.

(3) [(D)] If the designation appeal panel [a designation review committee] disagrees with the department's original designation determination [office's recommendation for corrective action], the appropriate level of neonatal designation will be awarded [records shall be referred to the assistant commissioner for recommendation to the executive commissioner].

(4) [(E)] If a facility disagrees with the designation appeal panel's decision regarding its designation level, the facility may request a second appeal review with the department's Associate Commissioner of the Consumer Protection Division. If the Associate Commissioner upholds the designation appeal panel's decision, the designation status will remain the same. If the Associate Commissioner disagrees with the designation appeal panel's decision, the Associate Commissioner will define the appropriate level of designation. The department will send a notification letter of the second appeal decision within 30 days of receiving the second appeal request. [office's recommendation at the end of the secondary review, the facility has a right to a hearing, in accordance with a hearing request referenced in §133.121(9) of this title (relating to Enforcement Action), and Government Code, Chapter 2001.]

(5) If the facility continues to disagree with the second level of appeal decision, the facility has a right to a hearing in the manner referenced in §133.121 of this title (relating to Enforcement Action).

(p) Exceptions and Notifications.

(1) A designated neonatal facility must provide written or electronic notification of any significant change to the neonatal program impacting patient care. The notification must be provided to the following:

(A) all emergency medical services (EMS) providers that transfer neonatal patients to or from the designated neonatal facility;

(B) the hospitals to which it customarily transfers out or transfers in neonatal patients;

(C) applicable PCRs and RACs; and

(D) the department.

(2) If the designated neonatal facility is unable to meet the requirements to maintain its current designation, it must submit to the department a POC as described in subsection (a)(1)(C) of this section, and a request for a temporary exception to the designation requirements. Any request for an exception must be submitted in writing from the facility's Chief Executive Officer and define the facility's timeline to meet the designation requirements. The department reviews the request and the POC, and either grants the exception with a specific timeline based on the public interest, geographic maternal care capabilities, and access to care, or denies the exception. If the facility is not granted an exception or it does not meet the designation requirements at the end of the exception period, the department will elect one of the following:

(A) re-designate the facility at the level appropriate to its revised capabilities;

(B) outline an agreement with the facility to satisfy all designation requirements for the level of care designation within a time specified under the agreement, which may not exceed the first anniversary of the effective date of the agreement; or

(C) may waive one specific designation requirement for a level of care designation if the department determines the waiver is justified considering:

(i) the expected impact on accessibility of neonatal care in the geographic area served by the facility if the waiver is not granted;

(ii) the expected impact on the quality of care and patient safety;

(iii) whether these services can be met by other facilities in the area or with telehealth/telemedicine services; and

(iv) whether the facility met all other designation requirements for the level of care designation that are not waived in the agreement.

(3) Waivers expire with the expiration of the current designation but may be renewed. The department may specify any conditions for ongoing reporting during this time.

(4) The department maintains a current list on its internet website of facilities that have contingency agreements or an approved waiver with the department and an aggregated list of the designation requirements conditionally met or waived.

(5) Facilities that have contingency agreements or an approved waiver with the department must post on the facility's internet website the nature and general terms of the agreement.

(q) An application for a higher or lower level of neonatal designation may be submitted to the department at any time.

(1) A designated neonatal facility that is increasing its neonatal capabilities may choose to apply for a higher-level of designation at any time. The facility must follow the designation process as described in subsection (a)(1) and (2) of this section to apply for the higher-level.

(2) A designated neonatal facility that is unable to maintain the facility's current level of neonatal designation may choose to apply for a lower level of designation at any time.

(r) If the facility is relinquishing its neonatal designation, the facility must provide 30 days written, advance notice of the relinquishment to the department, the applicable PCRs/RACs, EMS providers, and facilities it customarily transfers out or are transfers in neonatal patients. The facility is responsible for continuing to provide neonatal care services or ensuring a plan for neonatal care continuity for the 30 days following the written notice of relinquishing its neonatal designation.

(s) A hospital providing neonatal services must not use the terms "designated neonatal facility" or similar terminology in its signs, advertisements, facility internet website, social media, or in the printed materials and information it provides to the public unless the facility is currently designated at that level of neonatal care.

(t) During a virtual, on-site, or focused designation review conducted by the department or a survey organization, the department or surveyor has the right to review and evaluate neonatal patient records, neonatal multidisciplinary QAPI Plan documents, peer review documentation demonstrating why the case was referred, the date reviewed, pertinent discussion, and any action specific to improving neonatal care and outcomes, as well as any other documents relevant to neonatal care in a designated neonatal facility or facility seeking neonatal facility designation to validate evidence that designation requirements are met.

(u) The department complies with all relevant laws related to the confidentiality of such records.

(v) The department may deny, suspend, or revoke designation if a designated neonatal facility ceases to provide services to meet or maintain the designation requirements of this section.

§133.185.Program Requirements.

(a) Neonatal Program Philosophy. Designated facilities must [shall] have a family-centered [family centered] philosophy. Parents must [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 must [shall] meet the physiologic and psychosocial needs of the mothers, infants, and families.

(b) Neonatal Program Plan. The facility must [shall] develop a written neonatal operational plan for [of] the neonatal program that includes a detailed description of the scope of services and clinical resources available for [to] all [maternal and] neonatal patients, mothers, and families. The plan must define [defines] the neonatal patient population evaluated, [and/or] treated, transferred, or transported by the facility[, that is] consistent with clinical guidelines based on current [accepted professional] standards of neonatal practice ensuring [for neonatal and maternal care, and ensures] the health and safety of patients.

(1) The written Neonatal Program Plan must [plan and the program policies and procedures shall] be reviewed and approved by the Neonatal Program Oversight and then submitted to the facility's governing body for review. The governing body must [shall] ensure [that] the requirements of this section are implemented and enforced.

(2) The written Neonatal Program Plan must [neonatal program plan shall] include[, at a minimum]:

(A) clinical guidelines based on current standards of neonatal practice, and [that the program] policies and procedures [are based upon] that are adopted, implemented, and enforced by the neonatal program [for the neonatal services it provides];

(B) a process to ensure and validate that these clinical guidelines based on current standards of neonatal practice, policies, and procedures are reviewed and revised a minimum of every three years [periodic review and revision schedule for all neonatal care policies and procedures];

(C) written triage, stabilization, and transfer guidelines for neonatal patients [neonates and/or pregnant/postpartum women] that include consultation and transport services;

(D) the role and scope of telehealth/telemedicine practices, if utilized, including:

(i) documented and approved written policies and procedures that outline the use of telehealth/telemedicine for inpatient hospital care or for consultation, including appropriate situations, scope of care, and documentation that is monitored through the QAPI Plan and process; and

(ii) written and approved procedures to gain informed consent from the patient or designee for the use of telehealth/telemedicine that are monitored for compliance;

(E) [(D)] written guidelines for discharge planning instructions and [ensure] appropriate follow-up appointments [follow up] for all neonates/infants;

(F) [(E)] written guidelines for the hospital's [provisions for] disaster response, including a defined neonatal [to include] evacuation plan and process to relocate [of] mothers and infants to appropriate levels of care with identified resources, which must be evaluated annually to ensure neonatal care can be sustained and adequate resources are available;

[(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;]

(G) written [requirements for] minimal education and credentialing requirements [credentials ] for all staff participating in the care of neonatal patients, which are documented and monitored by the managers who have oversight of staff;

(H) written requirements [provisions] for providing continuing staff education,[;] including annual competency and skills assessment that is appropriate for the patient population served, which are documented and monitored by the managers who have oversight of staff;

(I) documentation of compliance with the requirement for a perinatal staff registered nurse to serve as a representative on the nurse staffing committee under §133.41 [§133.41(o)(2)(F)] of this title (relating to Hospital Functions and Services);

(J) measures to monitor the availability of all necessary equipment and services required to provide the appropriate level of care and support for [of] the patient population served; and

(K) documented guidelines for consulting [the availability of] personnel with knowledge and skills in breastfeeding, which includes expected response times, defined roles, responsibilities, and expectations.

(3) The facility must have a documented and approved QAPI Plan.

(A) The Chief Executive Officer, Chief Medical Officer, and Chief Nursing Officer must implement a culture of safety for the facility and ensure adequate resources are available to support a concurrent, data-driven QAPI Plan.

(B) The facility must demonstrate that the neonatal QAPI Plan consistently assesses the provision of neonatal care provided. The assessment must identify variances in care, the impact to the patient, and the appropriate levels of review. The process must identify opportunities for improvement and develop a plan of correction to address the variances in care or the system response and monitor until the needed change is sustained.

(C) The neonatal program must measure, analyze, and track performance through defined quality indicators, core performance measures, and other aspects of performance that the facility adopts or develops to evaluate processes of care and patient outcomes. Summary reports of these findings are reported through the Neonatal Program Oversight.

(D) Level III and IV neonatal facilities must participate in benchmarking programs to assess their outcomes as an element of the QAPI Plan.

(E) The Neonatal Medical Director (NMD) must have the authority to make referrals for peer review, receive feedback from the peer review process, and ensure neonatal physician representation in the peer review process for neonatal cases.

(F) The NMD and Neonatal Program Manager (NPM) must participate in PCR meetings, QAPI regional initiatives, and regional collaboratives and submit requested data to assist with data analysis to evaluate regional outcomes as an element of the facility's neonatal QAPI Plan.

(G) The facility must have documented evidence of neonatal QAPI summary reports that monitor compliance to the telehealth and telemedicine standards of care and are reported through the Neonatal Program Oversight.

(H) The facility must have documented evidence of neonatal QAPI summary reports to support that aggregate neonatal data are consistently reviewed to identify developing trends, opportunities for improvement, and necessary corrective actions. Summary reports must be provided to the Neonatal Program Oversight, available for site surveyors, and submitted to the department as requested.

(c) Medical Staff. The facility must [shall ] have an organized, effective neonatal program that is recognized by the medical staff bylaws [and] approved by the facility's governing body.

(1) The credentialing of the neonatal medical staff must [shall] include a process for the delineation of privileges for neonatal care.

(2) The neonatal medical staff must participate in ongoing staff and team-based education and training in the care of the neonatal patient.

(d) Medical Director. There must be an identified NMD and an identified Transport Medical Director (TMD), if the facility has its own transport program. The NMD and TMD must be credentialed by the facility for treatment of neonatal patients and have their responsibilities and authority defined in a job description. The NMD and TMD must maintain a current status of successful completion of the Neonatal Resuscitation Program (NRP) or a department-approved equivalent course. [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.]

(1) [(2)] The NMD is responsible for the provision of neonatal care services and must [The responsibilities and authority of the NMD and/or TMD shall include but are not limited to]:

(A) examine [examining] qualifications of medical staff and advanced practice providers requesting [neonatal] privileges to participate in neonatal/infant care, and make [makes] recommendations to the appropriate committee for such privileges;

(B) ensure neonatal medical [assuring] staff and advanced practice provider competency in managing neonatal emergencies, complications, and resuscitation techniques;

(C) monitor neonatal patient care from transport if applicable, to admission, through to discharge, and review variations in care through the QAPI Plan;

(D) [(C)] participate [participating] in ongoing neonatal staff and team-based education and training in the care of the neonatal patient;

(E) [(D)] oversee [oversight of] the inter-facility neonatal transport as appropriate;

[(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) collaborate with the NPM, maternal teams, consulting physicians, and nursing leaders and units providing neonatal care to include developing, implementing, or revising:

(i) written policies, procedures, and guidelines for neonatal care that are implemented and monitored for compliance;

(ii) the neonatal QAPI Plan, specific reviews, and data initiatives;

(iii) criteria for transfer, consultation, or higher-level of care; and

(iv) staff competencies, education, and training;

(G) [(F)] participate as a clinically active and practicing physician [regular and active participation] in neonatal care at the facility where medical director services are provided;

(H) [(G)] ensure [ensuring ] that the QAPI Plan [Program] is specific to neonatal/infant care, is ongoing, data driven, and outcome based; [and regularly participates in the neonatal QAPI meeting; and]

(I) co-chair the Neonatal Program Oversight with the NPM and other neonatal QAPI meetings as appropriate;

(J) [(H)] maintain [maintaining] active staff privileges as defined in the facility's medical staff bylaws; and[.]

(K) maintain collaborative relationships with other NMDs of designated neonatal facilities within the applicable Perinatal Care Region.

(2) The TMD is responsible for the facility neonatal transport program and must:

(A) collaborate with transport team to develop, revise, and implement written policies, procedures, and guidelines for neonatal care that are implemented and monitored for compliance;

(B) participate in ongoing transport staff competencies, education, and training;

(C) review and evaluate transports from initial activation of the transport team through delivery of patient, resources, quality of patient care provided, and patient outcomes; and

(D) integrate review findings into the overall neonatal QAPI Plan and process.

(3) The NMD may also serve as the TMD.

(e) NPM [Neonatal Program Manager (NPM)]. The facility must identify an NPM who has the authority and oversight responsibilities, written in his or her job description, [responsible] for the provision of neonatal [care] services through all phases of care, including discharge, and identifying variances in care for inclusion in the QAPI Plan. [shall be identified by the facility and:]

(1) The NPM must be a registered nurse with defined education and credentials for neonatal care applicable to the level of care being provided.[:]

(2) The NPM must maintain a current status of successful completion of [have successfully completed and is current in] the Neonatal Resuscitation Program (NRP) or a department-approved [an office-approved] equivalent course.[:]

(3) The NPM must: [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.]

(A) ensure staff competency in resuscitation techniques;

(B) participate in ongoing staff and team-based education and training in the care of the neonatal patient;

(C) track utilization of telehealth/telemedicine, if used;

(D) [(4)] collaborate with the NMD, maternal program, consulting physicians, and nursing leaders and units providing neonatal care [in areas] to include developing, implementing, or revising:[, 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]

(i) written policies, procedures, and guidelines for neonatal care that are implemented and monitored for compliance;

(ii) the neonatal QAPI Plan, specific reviews, and data initiatives;

(iii) criteria for transfer, consultation, or higher-level of care; and

(iv) staff competencies, education, and training;

(E) regularly and actively participate in neonatal care at the facility where program manager services are provided;

(F) consistently review the neonatal care provided and ensure the QAPI Plan is specific to neonatal/infant care, data driven, and outcome-based;

(G) co-chair the Neonatal Program Oversight with the NMD and other neonatal QAPI meetings as appropriate; and

(H) [(5)] maintain [develop] collaborative relationships with other NPMs [NPM(s)] of designated neonatal facilities within the applicable PCR [Perinatal Care Region].

§133.186.Neonatal Designation Level I.

(a) Level I (Well Care [Nursery]). The Level I neonatal designated facility must [will]:

(1) provide care for mothers and their infants generally of ≥35 [>=35] weeks gestational age who have routine, transient perinatal problems;

(2) have skilled medical staff and personnel with documented training, competencies, and continuing education specific for the patient population served; and

(3) [if an infant<35 weeks gestational age is retained, the facility shall] provide the same level of care that the neonate would receive at a higher-level [higher level] designated neonatal facility and [shall, through the QAPI Plan Program] complete an in-depth [in depth] critical review and assessment of the care provided to these infants through the QAPI Plan and process, if an infant <35 weeks gestational age is retained.

(b) Neonatal Medical Director (NMD). The NMD must [shall] be a physician who:

(1) is a currently practicing pediatrician, family medicine physician, or physician specializing in obstetrics and gynecology with experience in the care of neonates/infants;

(2) maintains [demonstrates] a current status of [on] successful completion of the Neonatal Resuscitation Program (NRP) or a department-approved equivalent course;

(3) maintains [demonstrates] effective administrative skills and oversight of the QAPI Plan [Program]; and

(4) completes [has completed] continuing medical education [annually] specific to the care of neonates annually.

(c) Program Functions and Services.

(1) The neonatal program must collaborate with the maternal program, consulting physicians, and nursing leadership to ensure [Triage and assessment of all patients admitted to the perinatal service with identification of] pregnant mothers [patients] who are at high risk of delivering a neonate that requires a higher-level [higher level] of care are [who will be] transferred to a higher-level [higher level] facility before [prior to] delivery unless the transfer would be unsafe.

(2) The facility provides appropriate, supportive, [Supportive] and emergency care delivered by [appropriately] trained personnel[,] for unanticipated maternal-fetal or neonatal problems that occur during labor and delivery through the disposition of the patient.

[(3) The ability to perform an emergency cesarean delivery.]

(3) [(4)] The on-call [primary] physician, advanced practice nurse, or [and/or ] physician assistant must have documented [with] special competence in the care of neonates, privileges and [whose] credentials to participate in neonatal/infant care [have been] reviewed and approved by the NMD [and is on-call], and:

(A) maintain [shall demonstrate] a current status of [on] successful completion of the [American Heart Association/American Academy of Pediatrics for the resuscitation of all infants] NRP or a department-approved equivalent course;

(B) complete [has completed] continuing education [annually,] specific to the care of neonates annually;

(C) [shall] arrive at the patient bedside within 30 minutes of an urgent request;

(D) if not immediately available to respond or is covering more than one facility, ensure [be provided] appropriate back-up [backup] coverage is [who shall be] available, back-up call providers are documented in the neonatal on-call [an on call] schedule and must be readily available to respond to the facility staff; and

(E) [if] the back-up call physician, advanced practice nurse, or [and/or] physician assistant must [is providing backup coverage, shall] arrive at the patient bedside within 30 minutes of an urgent request.

(4) [(5)] Written guidelines defining the availability [Availability] of appropriate anesthesia, laboratory, radiology, respiratory, ultrasonography, and blood bank services on a 24-hour [24 hour] basis as described in §133.41 [§133.41(a), (h), and (s)] of this title (relating to Hospital Functions and Services)[, respectively].

(A) If preliminary reading of imaging studies pending formal interpretation is performed, the preliminary findings must be documented in the medical record.

(B) The facility must ensure [There must be] regular monitoring and comparison of the preliminary and [versus] final readings through [reading in] the radiology QAPI Plan [Program]. Summary reports of activities must be presented at the Neonatal Program Oversight.

(5) Pharmacy services must be in compliance with the requirements in §133.41 of this title and must have a pharmacist available at all times.

[(6)] A pharmacist shall be available for consultation on a 24 hour basis.]

(A) If medication compounding is done by a pharmacy technician for neonates/infants, a pharmacist must [will] provide immediate supervision of the compounding process.

(B) When medication compounding is done for neonates/infants, the pharmacist must implement guidelines to ensure the accuracy of the compounded final product and ensure:

(i) the process is monitored through the QAPI Plan; and

(ii) summary reports of activities are presented to the Neonatal Program Oversight.

[(B) If medication compounding is done for neonates/infants, the pharmacist will develop and implement checks and balances to ensure the accuracy of the final product.]

(6) [(7)] [Resuscitation.] The facility must [shall] have personnel with appropriate training for managing neonates/infants, written [appropriately trained staff,] policies, [and] procedures, and guidelines specific to the facility for the stabilization and resuscitation of neonates based on current standards of professional practice. The facility must[; shall] ensure the availability of personnel who can stabilize distressed neonates, including those <35 weeks gestation until they are [can be] transferred to a higher-level [higher level] facility. Variances from these standards are monitored through the QAPI Plan and process.

(A) Each birth must [shall] be attended by at least one person who maintains [demonstrates ] a current status of successful completion of the NRP or a department-equivalent course, whose primary focus [responsibility] is [for the] management of the neonate and initiating resuscitation.

(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.

(C) Additional personnel [providers] with current status of successful completion of the NRP, or a department-equivalent course, must [shall] be on-site and immediately available upon request for the following:[;]

(i) multiple birth deliveries, to care for each neonate;

(ii) deliveries with unanticipated maternal-fetal problems that occur during labor and delivery; and

(iii) deliveries determined or suspected to be high-risk for the pregnant patient or neonate.

(D) Compliance to this staffing requirement is monitored through the QAPI Plan and reported at the Neonatal Program Oversight.

(E) [(D)] Neonatal resuscitative [Basic NRP] equipment, [and] supplies, and medications must [shall] be immediately available for trained personnel [staff] to perform resuscitation and stabilization on any neonate/infant.

(7) [(8)] [Perinatal Education. ] A registered nurse with experience in neonatal or [and/or] perinatal care must [shall] provide supervision and coordination of staff education.

(8) [(9)] The neonatal program ensures [Ensures] the availability of support personnel with knowledge and skills in breastfeeding to assist and counsel [meet the needs of new] mothers.

(9) [(10)] Social services, supportive spiritual [and pastoral] care, and counseling must [shall] be provided as appropriate to meet the needs of the patient population served.

§133.187.Neonatal Designation Level II.

(a) Level II (Special Care [Nursery]).

[(1)] The Level II neonatal designated facility must [will]:

(1) [(A)] provide care for mothers and their infants of generally ≥32 [>=32] weeks gestational age and birth weight ≥1500 [>=1500] grams who have physiologic immaturity or [who have] problems that are expected to resolve rapidly and are not anticipated to require subspecialty services on an urgent basis; and

(A) if a facility is located more than 75 miles from the nearest Level III or IV designated neonatal facility and retains a neonate <32 weeks of gestation or having a birth weight of <1500 grams, the facility must provide the same level of care that the neonate would receive at a higher-level designated neonatal facility; and

(B) any facility that retains a neonate <32 weeks of gestation or a birth weight <1500 grams, must through the QAPI Plan, complete an in-depth critical review and assessment of the care provided;

(2) [(B)] [either] provide care, either by including assisted endotracheal ventilation for less than 24 hours or nasal continuous positive airway pressure (NCPAP) until the infant's condition improves or arrange for appropriate transfer to a higher-level [higher level] designated facility[. If the facility performs neonatal surgery, the facility shall provide the same level of care that the neonate would receive at a higher level designated facility. The facility must, through the QAPI Program, complete an in depth critical review of the care provided]; and

(A) if the facility performs neonatal surgery, it must provide the same level of care that the neonate would receive at a higher-level designated facility; and

(B) the neonatal surgical procedure and follow-up must be reviewed through the QAPI Plan; and

(3) [(C)] have [provide ] skilled medical staff and personnel with [that have] documented training, competencies, and annual continuing education specific for the patient population served.

[(2) If a facility is located more than 75 miles from the nearest Level III or IV designated neonatal facility and retains a neonate < between 30 and 32 weeks of gestation having a birth weight of < between 1250 1500 grams, the facility shall provide the same level of care that the neonate would receive at a higher-level designated neonatal facility. The facility must through the QAPI Program, complete an in depth critical review of the care provided.]

(b) Neonatal Medical Director (NMD). The NMD must [shall] be a physician who is:

(1) a board eligible/certified neonatologist, with experience in the care of neonates/infants and maintains [demonstrates] a current status of [on] successful completion of the Neonatal Resuscitation Program (NRP) or a department-approved equivalent course; or

(2) [by the effective date of this rule, a] pediatrician or neonatologist by the effective date of this section who:

(A) [has] continuously provided neonatal care for the last consecutive two years and[;] has experience and training in the care of neonates/infants, including assisted endotracheal ventilation and NCPAP management;

(B) maintains a consultative relationship with a board eligible/certified neonatologist;

(C) maintains [demonstrates] effective administrative skills and oversight of the QAPI Plan [Program];

(D) maintains [demonstrates] a current status of [on] successful completion of the NRP or a department-approved equivalent course; and

(E) completes [has completed] continuing medical education [annually] specific to the care of neonates annually.

(c) Program Functions and Services.

(1) The neonatal program must collaborate with the maternal program, consulting physicians, and nursing leadership to ensure pregnant patients who are at high risk of delivering a neonate that requires a higher-level of care are transferred to a higher-level facility before delivery unless the transfer would be unsafe. [Triage and assessment of all patients admitted to the perinatal service with the identification of pregnant women with a high likelihood of delivering a neonate requiring a higher level of care be transferred prior to delivery unless the transfer is unsafe.]

(2) The facility provides appropriate, supportive, [Supportive] and emergency care delivered by [appropriately] trained personnel, for unanticipated maternal-fetal or neonatal problems that occur during labor and delivery through the disposition of the patient.

[(3) The ability to perform an emergency cesarean delivery.]

(3) [(4)] The on-call physician, advanced practice nurse, or [and/or] physician assistant must have documented [with] special competence in the care of neonates, privileges and [whose ] credentials to participate in neonatal/infant care [have been] reviewed and approved by the NMD [and is on-call], and must:

(A) maintain [shall demonstrate] a current status of [on] successful completion of the NRP or a department-approved equivalent course;

(B) complete [shall have completed] continuing education [annually] specific to the care of neonates annually;

(C) [shall] arrive at the patient bedside within 30 minutes of an urgent request;

(D) if not immediately available to respond or is covering more than one facility, ensure appropriate back-up coverage is [shall be] available, back-up call providers are documented in the neonatal on-call [an on call] schedule and must be readily available to respond to the facility staff;

(i) [(E)] the back-up call physician, advanced practice nurse, or [and/or] physician assistant must [providing backup coverage shall] arrive at the patient bedside within 30 minutes of an urgent request; and

(ii) [(F)] the on-call staff must [shall] be on-site to provide ongoing care and to respond to emergencies when a neonate/infant is maintained on endotracheal ventilation.

(4) The neonatal program ensures if surgeries are performed for neonates/infants, a surgeon privileged and credentialed to perform surgery on a neonate/infant is on-call and must arrive at the patient bedside within 30 minutes of an urgent request.

(5) Anesthesia providers [services] with pediatric experience and competence must provide services [will be provided] in compliance with the requirements [found] in §133.41 [§133.41(a)] of this title (relating to Hospital Functions and Services).

(6) A dietitian [Dietitian] or nutritionist with sufficient training and experience in neonatal and maternal nutrition, appropriate to meet the needs of the population served, must [shall] be available and in compliance with the requirements [found] in §133.41 [§133.41(d)] of this title.

(7) Laboratory services must [shall] be in compliance with the requirements [found] in §133.41 [§133.41(h)] of this title and must [shall] have:

(A) personnel on-site at all times as defined by written management guidelines, which may include when a neonate/infant is maintained on endotracheal ventilation; and

(B) a blood bank capable of providing blood and blood component therapy within the timelines defined in approved blood transfusion guidelines.[; and]

(8) [(C)] The facility must provide neonatal/infant blood gas monitoring capabilities.

(9) [(8)] Pharmacy services must [shall] be in compliance with the requirements [found ] in §133.41 [§133.41q)] of this title and must [shall] have a pharmacist with experience in neonatal/pediatric [neonatal/perinatal ] pharmacology available at all times.

(A) If medication compounding is done by a pharmacy technician for neonates/infants, a pharmacist must [will] provide immediate supervision of the compounding process.

(B) When medication compounding is done for neonates/infants, the pharmacist must implement guidelines to ensure the accuracy of the compounded final product and ensure:

(i) the process is monitored through the QAPI Plan; and

(ii) summary reports of activities are presented to the Neonatal Program Oversight.

[(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 must [shall] be available, if requested.

(10) [(9)] A speech, [An] occupational, or physical therapist with sufficient neonatal expertise must [shall] be available to meet the needs of the population served.

(11) [(10)] [Medical Imaging.] Radiology services must [shall] be in compliance with the requirements [found] in §133.41 [§133.41(s)] of this title, [and will] incorporate the "As Low as Reasonably Achievable" principle when obtaining imaging in neonatal [and maternal] patients,[; ] and must [shall] have:

(A) personnel appropriately trained[,] in the use of x-ray and ultrasound equipment;

(B) personnel at the bedside within 30 minutes of an urgent request;

(C) personnel, appropriately trained [personnel shall be] available on-site to provide ongoing care and to respond to emergencies when an infant is maintained on endotracheal ventilation; [and]

(D) interpretation capability of neonatal and perinatal x-rays and ultrasound studies are available at all times;[.]

(E) preliminary findings documented in the medical record, if preliminary reading of imaging studies pending formal interpretation is performed; and

(F) regular monitoring and comparison of preliminary and final readings through the radiology QAPI Plan and provide summary reports of activities to the Neonatal Program Oversight.

(12) [(11)] A respiratory therapist, with experience and specialized training in the respiratory support of neonates/infants, whose credentials have been reviewed and approved by the NMD, must [shall] be immediately available on-site when:

(A) a neonate/infant is on a respiratory ventilator to provide ongoing care and to respond to emergencies; or

(B) a neonate/infant is on a Continuous Positive Airway Pressure (CPAP) apparatus.

(13) [(12)] [Resuscitation.] The facility must [shall] have staff with appropriate training for managing neonates/infants, written policies, [and] procedures, and guidelines specific to the facility for the stabilization and resuscitation of neonates based on current standards of professional practice. Variances from these standards are monitored through the QAPI Plan.

(A) Each birth must [shall] be attended by at least one person [provider] who maintains a [demonstrates] current status of successful completion of the NRP or a department-approved equivalent course, whose primary focus [responsibility] is [the] management of the neonate and initiating resuscitation.

(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.

(C) Additional personnel who maintain a [providers with] current status of successful completion of the NRP or a department-approved equivalent course must [shall] be on-site and immediately available upon request for the following: [.]

(i) multiple birth deliveries, to care for each neonate;

(ii) deliveries with unanticipated maternal-fetal problems that occur during labor and delivery; and

(iii) deliveries determined or suspected to be high-risk for the pregnant patient or neonate.

(D) Compliance to this staffing requirement is monitored through the QAPI Plan and reported at the Neonatal Program Oversight [Additional providers who demonstrate current status of successful completion of the NRP shall attend each neonate in the event of multiple births].

(E) Neonatal resuscitative [A full range of NRP] equipment, [and] supplies, and medications must [shall] be immediately available for trained staff to perform resuscitation and stabilization on any neonate/infant.

(14) [(13)] [Perinatal Education. ] A registered nurse with experience in neonatal care, including special care, or [nursery, and/or] perinatal care must [shall] provide supervision and coordination of staff education.

(15) [(14)] Social services, supportive spiritual [and pastoral] care, and counseling must [shall] be provided as appropriate to meet the needs of the patient populationserved.

(16) [(15)] Written and implemented policies and procedures to ensure [Ensure] the timely evaluation of retinopathy of prematurity, documented [monitoring,] referral for treatment, and follow-up [follow up, in the case] of an at-risk infant, which must be monitored through the QAPI Plan.

(17) [(16)] The neonatal program ensures [Ensure] the availability of support personnel with knowledge and expertise in breastfeeding [lactation] to assist and counsel [meet the needs of new] mothers [while breastfeeding].

(18) [(17)] The neonatal program ensures [Ensure] provisions for follow-up [follow up] care at discharge for infants at high risk for neurodevelopmental, medical, or psychosocial complications.

§133.188.Neonatal Designation Level III.

(a) Level III (Neonatal Intensive Care [Unit (ICU))]. The Level III neonatal designated facility must [will]:

(1) provide care for mothers and comprehensive care for [of] their infants of all gestational ages with mild to critical illnesses or requiring sustained life support;

(2) ensure access to [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 neonatal designated facility;

(3) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served;

(4) facilitate neonatal transports; and

(5) provide outreach education to lower-level neonatal [lower level] designated facilities, and as appropriate and applicable, to non-designated facilities, birthing centers, independent midwife practices, and prehospital providers based on findings in the QAPI Plan and process.

(b) Neonatal Medical Director (NMD). The NMD must [shall] be a physician who is a board eligible/certified neonatologist with experience in the care of neonates/infants and maintains [demonstrates] a current status of [on] successful completion of the Neonatal Resuscitation Program (NRP) or a department-approved equivalent course.

(c) If the facility has its own transport program, there must [shall] be an identified Transport Medical Director (TMD). The TMD or Transport Medical Co-Director must [shall] be a physician who is a board eligible/certified neonatologist or pediatrician with expertise and experience in neonatal/infant transport.

(d) Program Functions and Services.

(1) The neonatal program must collaborate with the maternal program, consulting physicians, and nursing leadership to ensure pregnant patients who are at high risk of delivering a neonate that requires a higher-level of care are transferred to a higher-level facility before delivery unless the transfer would be unsafe [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].

(2) The facility provides appropriate, supportive, [Supportive] and emergency care [shall be] delivered by [appropriately] trained personnel[,] for unanticipated maternal-fetal or neonatal problems that occur during labor and delivery through the disposition of the patient.

[(3) The ability to perform an emergency cesarean delivery within 30 minutes.]

(3) [(4)] At least one of the following neonatal providers must [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 must have documented [demonstrated ] competence in the management of severely ill neonates/infants, and privileges and [whose] credentials to participate in neonatal/infant care [have been] reviewed and approved by the NMD and must [is on call, and]:

(A) maintain [has] a current status of successful completion of the NRP or a department-approved equivalent course;

(B) complete [has completed] continuing education [annually,] specific to the care of neonates annually;

(C) have [if the on-site provider is not a neonatologist, a] a neonatologist [shall be] available for consultation at all times that arrives [and shall arrive] on-site within 30 minutes of an urgent request, if the on-site provider is not a neonatologist; and

(D) ensure [if the neonatologist is covering more than one facility,] the facility has [must ensure that] a back-up neonatologist [be] available, the back-up neonatologist is documented in the neonatal on-call [an on call] schedule, and readily available to respond to the facility staff and arrive at the patient bedside within 30 minutes of an urgent request.[; and]

[(E) ensure that the neonatologist providing back-up coverage shall arrive on-site within 30 minutes.]

(4) The neonatal program that performs surgeries for neonates/infants must have a surgeon privileged and credentialed to perform surgery on a neonate/infant on-call. The surgeon on-call must be available to arrive at the patient bedside within 30 minutes of an urgent request.

(5) Anesthesiologists with pediatric expertise and competence must direct and evaluate[, shall directly provide the] anesthesia care provided to neonates [the neonate,] in compliance with the requirements [found] in §133.41 [§133.41(a)] of this title [(relating to Hospital Functions and Services)].

(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 [§133.41(d)] of this title.

(7) Laboratory services must [shall] be in compliance with the requirements in §133.41 [found at §133.41(h)] of this title and must [shall] have:

(A) laboratory personnel on-site at all times;

(B) neonatal and pediatric [perinatal] pathology services available for the population served;

(C) neonatal and pediatric surgical pathology available in the operative suite at the request of the operating surgeon; and

(D) [(C)] a blood bank capable of providing blood and blood component therapy within the timelines defined in approved blood transfusion guidelines.[; and]

(8) [(D)] The facility must provide neonatal/infant [neonatal] blood gas monitoring capabilities.

(9) [(8)] Pharmacy services must [shall] be in compliance with the requirements [found ] in §133.41 [§133.41(q)] of this title and must [will] have a pharmacist[, ] with experience in neonatal/pediatric [and perinatal] pharmacology[,] available at all times.

(A) If medication compounding is done by a pharmacy technician for neonates/infants, a pharmacist must [will] provide immediate supervision of the compounding process;

(B) When medication compounding is done for neonates/infants, the pharmacist must implement guidelines to ensure the accuracy of the compounded final product and ensure:

(i) the process is monitored through the QAPI Plan; and

(ii) summary reports of activities are presented to the Neonatal Program Oversight.

[(B) If medication compounding is done for neonates/infants, the pharmacist shall develop checks and balances to ensure the accuracy of the final product.]

(C) Total parenteral nutrition appropriate for neonates/infants must [shall] be available.

[(9) An occupational or physical therapist with sufficient neonatal expertise shall be available to meet the needs of the population served.]

(10) [Medical Imaging.] Radiology services must [shall] be in compliance with the requirements [found] in §133.41 [§133.41(s)] of this title,[; will] incorporate the "As Low as Reasonably Achievable" principle when obtaining imaging in neonatal [and maternal] patients,[;] and must [shall] have:

(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;]

(B) personnel appropriately trained in ultrasound, computed tomography, magnetic resonance imaging, and cranial ultrasound equipment available on-site within 30 minutes of an urgent request;

(C) fluoroscopy available at all times;

(D) [(B)] neonatal diagnostic imaging studies and [interpretation of neonatal and perinatal diagnostic imaging studies by] radiologists with pediatric expertise to interpret the neonatal diagnostic imaging studies, available at all times; [and]

(E) a radiologist with pediatric expertise to interpret within 30 minutes from receipt of images for an urgent request; and

(F) regular monitoring and comparison of the preliminary and final readings through the radiology QAPI Plan and provide summary reports of activities at the Neonatal Program Oversight.

(11) [(C)] Pediatric [pediatric] echocardiography with pediatric cardiology interpretation and consultation completed within a time period consistent with current standards of professional practice [within one hour of an urgent request].

(12) [(11)] Speech [language pathologist], [an] occupational [therapist], or a physical therapist with neonatal/infant expertise and experience must [shall] be available to: [evaluate and manage feeding and/or swallowing disorders.]

(A) evaluate and manage feeding or swallowing disorders; and

(B) provide therapy services to meet the needs of the population served.

(13) [(12)] A respiratory therapist, with experience and specialized training in the respiratory support of neonates/infants, whose credentials have been reviewed and approved by the NMD, must [shall] be on-site and immediately available [on-site].

(14) [(13)] The facility must have staff with appropriate training for managing neonates/infants and written [Resuscitation. Written] policies, [and] procedures, and guidelines [shall be] specific to the facility for the stabilization and resuscitation of neonates based on current standards of professional practice. Variances from these standards are monitored through the QAPI Plan.

(A) Each birth must [shall] be attended by at least one person [provider] who maintains a [demonstrates] current status of successful completion of the NRP or a department-approved equivalent course, and whose primary focus [responsibility] is [the] management of the neonate and initiating resuscitation.

(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.

(C) Additional personnel [providers] who maintain a [demonstrate] current status of successful completion of the NRP or a department-approved equivalent course must be on-site and immediately available upon request for the following: [shall attend each neonate in the event of multiple births.]

(i) multiple birth deliveries, to care for each neonate;

(ii) deliveries with unanticipated maternal-fetal problems that occur during labor and delivery; and

(iii) deliveries determined or suspected to be high-risk for the pregnant patient or neonate.

(D) Compliance to this staffing requirement is monitored through the QAPI Plan and reported at the Neonatal Program Oversight.

[(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.]

(E) Neonatal resuscitative [A full range of resuscitative] equipment, supplies, and medications must [shall] be immediately available for trained staff to perform complete resuscitation and stabilization for [on] each neonate/infant.

(15) [(14)] [Perinatal education. ] A registered nurse with experience in neonatal care, including neonatal intensive care, must [shall] provide supervision and coordination of staff education.

(16) [(15)] Social services, supportive spiritual care, and [Pastoral care and/or] counseling must [shall] be provided as appropriate to meet the needs of the patient population served.

[(16) Social services shall be provided as appropriate to the patient population served.]

(17) Written and implemented policies and procedures to ensure [Ensure the] timely evaluation of retinopathy of prematurity, documented [monitoring,] referral for treatment and follow-up [follow up, in the case] of an at-risk infant, which must be monitored through the QAPI Plan.

(18) The neonatal program ensures a [A] certified lactation consultant must [shall] be available at all times to assist and counsel mothers.

(19) The neonatal program ensures [Ensure] provisions for follow-up [follow up] care at discharge for infants at high risk for neurodevelopmental, medical, or psychosocial complications.

§133.189.Neonatal Designation Level IV.

(a) Level IV (Advanced Neonatal Intensive Care [Unit]). The Level IV neonatal designated facility must [will]:

(1) provide care for the mothers and comprehensive care for [of] their infants of all gestational ages with the most complex and critical medical and surgical conditions or [critically ill neonates/infants with any medical problems, and/or] requiring sustained life support;

(2) ensure access to [that] a comprehensive range of pediatric medical subspecialists and pediatric surgical subspecialists are available to arrive on-site in person for [face to face] consultation and care, and the capability to perform major pediatric surgery including the surgical repair of complex conditions on-site;

(3) have skilled medical staff and personnel with documented training, competencies, and annual continuing education specific for the patient population served;

(4) facilitate neonatal transports; and

(5) provide outreach education to lower-level neonatal [lower level] designated facilities, and as appropriate and applicable, to non-designated facilities, birthing centers, independent midwife practices, and prehospital providers based on findings in the QAPI Plan and process.

(b) Neonatal Medical Director (NMD). The NMD must [shall] be a physician who is a board eligible/certified neonatologist and maintains [demonstrates] a current status of [on] successful completion of the Neonatal Resuscitation Program (NRP) or a department-approved equivalent course.

(c) If the facility has its own transport program, there must [shall] be an identified Transport Medical Director (TMD). The TMD or Transport Medical [and/or ] Co-Director must [shall] be a physician who is a board eligible/certified neonatologist with expertise and experience in neonatal/infant transport.

(d) Program Functions and Services.

(1) The neonatal program must collaborate with the maternal program, consulting physicians, and nursing leadership to ensure pregnant patients who are at high risk of delivering a neonate that requires specialized care are transferred to a facility with specialized care capabilities before delivery unless the transfer would be unsafe. [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.]

(2) The facility provides appropriate, supportive, [Supportive] and emergency care [shall be] delivered by [appropriately] trained personnel[,] for unanticipated maternal-fetal or neonatal problems that occur during labor and delivery, through the disposition of the patient.

[(3) The ability to perform an emergency cesarean delivery within 30 minutes.]

(3) [(4)] A board eligible/certified neonatologist, with documented competence in the management of the most complex and critically ill neonates/infants, with neonatal privileges and [Board certified/board eligible neonatologists whose] credentials [have been] reviewed and approved by the NMD, must be on-site and immediately available at the neonate/infant bedside as requested. The neonatologist must [and is on call, and who]:

(A) maintain [shall demonstrate] a current status of [on] successful completion of the NRP or a department-approved equivalent course; and

(B) complete [have completed] continuing education [annually,] specific to the care of neonates annually.[; and]

[(C) shall be on-site and immediately available at the neonate/infant bedside as requested.]

(4) [(5)] Pediatric anesthesiologists must direct and evaluate [shall directly provide] anesthesia care provided to neonates [the neonate,] in compliance with the requirements in §133.41 [§133.41(a)] of this title (relating to Hospital Functions and Services).

(5) A comprehensive range of pediatric medical subspecialists and pediatric surgical subspecialists privileged and credentialed to participate in neonatal/infant care must be available to arrive on-site for in-person consultation and care within 30 minutes of an urgent request.

(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, [neonates] in compliance with the requirements in §133.41 [§133.41(d)] of this title.

[(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.]

(7) [(8)] Laboratory services must [shall] be in compliance with the requirements in §133.41 [§133.41(h)] of this title and must [shall] have:

(A) appropriately trained and qualified laboratory personnel on-site at all times;

(B) neonatal and pediatric [perinatal] pathology services available for the population served;

(C) neonatal and pediatric surgical pathology available in the operative suite at the request of the operating surgeon; and

(D) [(C)] a blood bank capable of providing blood and blood component therapy within the timelines defined in approved blood transfusion guidelines.[; and]

(8) [(D)] The facility must provide neonatal/infant blood gas monitoring capabilities.

(9) Pharmacy services must [shall] be in compliance with the requirements in §133.41 [§133.41(q) ] of this title and must [shall] have a pharmacist[,] with experience in neonatal/pediatric [and perinatal] pharmacology available on-site at all times.

(A) If medication compounding is done by a pharmacy technician for neonates/infants, a pharmacist must [will] provide immediate supervision of the compounding process.

(B) When medication compounding is done for neonates/infants, the pharmacist must implement guidelines to ensure the accuracy of the compounded final product and must ensure:

(i) the process is monitored through the QAPI plan; and

(ii) summary reports of activities are presented to the Neonatal Program Oversight.

[(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 must [shall] be available.

[(10) An occupational or physical therapist with neonatal expertise shall be available to meet the needs of the population served.]

(10) [(11)] [Medical Imaging.] Radiology services must [shall] be in compliance with the requirements in §133.41 [§133.41(s)] of this title, [will] incorporate the "As Low as Reasonably Achievable" principle when obtaining imaging in neonatal [and maternal] patients,[;] and must [shall] have:

(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 at all times];

(B) personnel appropriately trained in ultrasound, computed tomography, magnetic resonance imaging, and cranial ultrasound equipment be on-site within 30 minutes of an urgent request;

(C) fluoroscopy be available at all times;

(D) [(B)] neonatal [and perinatal] diagnostic imaging studies and radiologists with pediatric expertise to interpret neonatal diagnostic imaging studies, available at all times; [with interpretation by radiologists with pediatric expertise, available within one hour of an urgent request; and]

(E) a radiologist with pediatric expertise to interpret within 30 minutes from receipt of images for an urgent request; and

(F) regular monitoring and comparison of the preliminary and final readings through the radiology QAPI Plan and provide a summary report of activities at the Neonatal Program Oversight.

(11) [(C)] Pediatric [pediatric ] echocardiography with pediatric cardiology interpretation and consultation completed within a time period consistent with current standards of professional practice [within one hour of an urgent request].

(12) Speech, occupational, or physical therapists with neonatal expertise and experience must be available to:

(A) evaluate and manage feeding and swallowing disorders; and

(B) provide therapy services to meet the needs of the population served.

[(12) Speech language pathologist with neonatal expertise shall be available to evaluate and manage feeding and/or swallowing disorders.]

(13) A respiratory therapist, with experience and specialized training in the respiratory support of neonates/infants, whose credentials have been reviewed and approved by the Neonatal Medical Director, must [shall] be on-site and immediately available.

(14) [Resuscitation.] The facility must [shall] have staff with appropriate training for managing neonates/infants, written policies, [and] procedures, and guidelines specific to the facility for the stabilization and resuscitation of neonates/infants based on current standards of professional practice. Variances from these standards are monitored through the QAPI Plan.

(A) Each birth must [shall] be attended by at least one person [provider] who maintains a [demonstrates] current status of successful completion of the NRP or a department-approved equivalent course and whose primary focus [responsibility] is [the] management of the neonate and initiating resuscitation.

(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.

(C) Additional personnel [providers] who maintain a [demonstrate] current status of successful completion of the NRP or a department-approved equivalent course must be on-site and immediately available upon request for the following: [shall attend each neonate in the event of multiple births.]

(i) multiple birth deliveries, to care for each neonate;

(ii) deliveries with unanticipated maternal-fetal problems that occur during labor and delivery; and

(iii) deliveries determined or suspected to be high-risk for the pregnant patient or neonate.

(D) Compliance to this staffing requirement is monitored through the QAPI Plan and reported at the Neonatal Program Oversight.

[(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.]

(E) Neonatal resuscitative [A full range of resuscitative] equipment, supplies, and medications must [shall] be immediately available for trained staff to perform complete resuscitation and stabilization for [on] each neonate/infant.

(15) [Perinatal Education.] A registered nurse with experience in neonatal care, including advanced neonatal intensive care, must [shall] provide supervision and coordination of staff education.

(16) Social services, supportive spiritual care, and [Pastoral care and/or] counseling must [shall] be provided as appropriate to meet the needs of the patient population served.

[(17) Social services shall be provided as appropriate to the patient population served.]

(17) [(18)] Written and implemented policies and procedures to [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 of [in the event that] an at-risk infant. [at risk is present, and a documented policy for the monitoring, treatment and] Patient follow-up of retinopathy of prematurity must be documented and monitored through the QAPI Plan.

(18) [(19)] The neonatal program ensures a [A] certified lactation consultant must [shall] be available at all times to assist and counsel mothers.

(19) [(20)] The neonatal program ensures [Ensure] provisions for follow-up care at discharge for infants at high risk for neurodevelopmental, medical, or psychosocial complications.

§133.190.Survey Team.

(a) The survey team composition must [shall ] be as follows:

(1) Level I facilities neonatal program staff must [shall] conduct a self-survey, documenting the findings on the approved department [office] survey form. The department [office] may periodically require validation of the survey findings[,] by an on-site review conducted by department staff.

(2) Level II facilities must be surveyed by a multidisciplinary team that includes, at a minimum, one neonatologist and one neonatal nurse who:

(A) has completed a department survey training course;

(B) has observed a minimum of one neonatal survey;

(C) is currently active in the management of neonatal patients and active in the neonatal QAPI Plan and process at a facility providing the same or a higher-level of neonatal care; and

(D) meets the criteria outlined in the department survey guidelines.

(3) Level III facilities must be surveyed by a multidisciplinary team that includes, at a minimum, one neonatologist, one neonatal nurse, and a pediatric surgeon when neonatal surgery is performed who:

(A) has completed a survey training course;

(B) has observed a minimum of one neonatal survey;

(C) is currently active in the management of neonatal patients and active in the neonatal QAPI Plan and process at a facility providing the same or a higher-level of neonatal care; and

(D) meets the criteria outlined in the department survey guidelines.

(4) Level IV facilities must be surveyed by a multidisciplinary team that includes, at a minimum, one neonatologist, one neonatal nurse, and one pediatric surgeon, who:

(A) has completed a survey training course;

(B) has observed a minimum of one neonatal survey;

(C) is currently active in the management of neonatal patients and active in the neonatal QAPI Plan and process at a facility providing the same level of neonatal care; and

(D) meets the criteria outlined in the department survey guidelines.

[(2) Level II facilities shall be surveyed by a team that is multi-disciplinary and includes at a minimum of one neonatologist and one neonatal nurse, all approved in advance by the office and currently active in the management of neonatal patients at a facility providing the same or a higher level of neonatal care.]

[(3) Level III facilities shall be surveyed by a team that is multi-disciplinary and includes at a minimum of one neonatologist and one neonatal nurse, all approved in advance by the office and currently active in the management of neonatal patients at a facility providing the same or a higher level of neonatal care. An additional surveyor may be requested by the facility or at the discretion of the office.]

[(4) Level IV facilities shall be surveyed by a team that is multi-disciplinary and includes at a minimum of one neonatologist, a surgeon with pediatric expertise and one neonatal nurse, all approved in advance by the office and currently active in the management of neonatal patients at a facility providing the same level of neonatal care. If the facility holds a current pediatric surgery verification by the American College of Surgeons, the facility may be exempted from having a pediatric surgeon as a member of the survey team.]

(b) All members of the survey team, except department staff, must come from a Perinatal Care Region outside the facility's region or a contiguous region.

(c) Survey team members cannot have a conflict of interest:

(1) A conflict of interest exists when a surveyor has a direct or indirect financial, personal, or other interest which would limit or could reasonably be perceived as limiting the surveyor's ability to serve in the best interest of the public. The conflict of interest may include a surveyor who, within the past four years, has personally trained a key member of the facility's leadership in residency or fellowship, collaborated with a key member of the facility's leadership professionally, participated in a designation consultation with the facility, or conducted a designation survey for the facility.

(2) If a designation survey occurs with a surveyor who has a conflict of interest, the department, in its sole discretion, may refuse to accept the neonatal designation site survey summary conducted by a surveyor with a conflict of interest.

[(b) Office-credentialed surveyors must meet the following criteria:]

[(1) have at least three years of experience in the care of neonatal patients;]

[(2) be currently employed/practicing in the coordination of care for neonatal patients;]

[(3) have direct experience in the preparation for and successful completion of neonatal facility verification/designation;]

[(4) have successfully completed an office-approved neonatal facility site surveyor course and be successfully re-credentialed every four years; and]

[(5) have current credentials as follows:]

[(A) a registered nurse who is current in the NRP and has successfully completed an office approved site survey internship; or]

[(B) a physician who is board certified in the respective specialty, current in the NRP, and has successfully completed an office approved site survey internship; or]

[(C) a surgeon who is board certified, has demonstrated expertise in pediatric surgery, and has successfully completed an office approved site survey internship.]

[(c) All members of the survey team, except department staff, shall come from a Perinatal Care Region outside the facility's location and at least 100 miles from the facility. There shall be no business or patient care relationship or any potential conflict of interest between the surveyor or the surveyor's place of employment and the facility being surveyed.]

(d) The survey team must follow the department survey guidelines to [shall] evaluate and validate that the facility demonstrates the [facility's compliance with the] designation requirements are met. [criteria by:]

[(1) reviewing medical records; staff rosters and schedules; documentation of QAPI Program activities including peer review; the program plan; policies and procedures; and other documents relevant to neonatal care;]

[(2) reviewing equipment and the physical plant;]

[(3) conducting interviews with facility personnel; and]

[(4) evaluating appropriate use of telemedicine capabilities where applicable.]

(e) The survey team must evaluate appropriate use of telehealth/telemedicine utilization for neonatal care.

(f) [(e)] All information and materials submitted by a facility to the department [office ] under Texas Health and Safety Code, §241.183 [§241.183(d)], are subject to confidentiality as articulated in Texas Health and Safety Code, §241.184, Confidentiality [Confidentially]; Privilege, and are not subject to disclosure under Texas Government Code, Chapter 552, or discovery, subpoena, or other means of legal compulsion for release to any person.

§133.191.Perinatal Care Regions (PCRs).

(a) The PCR must consider and facilitate transfer agreements through regional coordination.

(b) The PCR must coordinate regional perinatal system QAPI reviews.

(c) The PCRs must not restrict patient referrals.

(d) The PCR integrates with the Regional Advisory Council (RAC) system plans to ensure there is a written perinatal system plan specific to the regional area utilizing the RAC criteria and self-assessment tools.

(e) The PCRs must be administratively supported by the RAC and must have fair and equitable representation on the board of the applicable RAC.

(f) Each PCR may define data needs for regional collaboratives.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on December 29, 2022.

TRD-202205262

Cynthia Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: February 12, 2023

For further information, please call: (512) 535-8538