Subdivision (b) establishes certain general provisions relating to trauma care. More specifically, the regulation states that the Department has authority to determine whether a hospital meets the legal requirements for designation by the Department as a trauma center. Only trauma centers designated by the Department may admit and provide care to trauma patients, except in certain emergency situations. Any hospital not designated as a trauma center must transfer a trauma patient to the most appropriate trauma center pursuant to a transfer agreement. A hospital may not state that it has trauma center status unless it is designated by the Department.

Subdivision (c) establishes the process for obtaining trauma center designation. A hospital seeking designation as a trauma center must receive verification by the American College of Surgeons, Committee on Trauma (ACS-COT), or other entity determined by the Department. To receive verification, the hospital must undergo a consultation site visit and verification site visit. The regulation provides details on what must occur during consultation and verification site visits.

Subdivision (d) establishes certain requirements for operating a trauma center, including but not limited to complying with ACS-COT’s publication entitled Resources for Optimal Care of the Injured Patient (2014), maintaining appropriate equipment, maintaining transfer agreements, participating in a performance improvement process, submitting notices of noncompliance to the Department, and notifying the Department immediately of any inability to meet trauma care capabilities.

Subdivision (e) sets forth the conditions under which the Department may withdraw trauma center designation. Subdivision (f) requires trauma centers to submit information to the New York State Trauma Registry. Subdivision (g) requires trauma centers to participate with the coordinating Regional Trauma Center and other hospitals and healthcare facilities, EMS agencies and governmental disaster preparedness programs in regional trauma performance improvement activities. The regulation provides additional details concerning the trauma performance improvement program.

Two provisions in existing regulation relating to trauma centers are repealed as no longer needed, in light of the proposed regulations.

Changes made to the last published rule do not necessitate revision to the previously published Regulatory Impact Statement.

Effect of Rule:

This regulation will apply to the 228 general hospitals in New York State that either have or would seek trauma center designation. Currently, there are 40 designated trauma centers in New York State, four of which are operated by local government.

Compliance Requirements:

There are no additional programs, services, duties or responsibilities imposed by this rule upon any county, city, town, village, school district, fire district or any other special district. Hospitals would only need to comply with these regulations if they choose to become trauma centers.

Professional Services:

Most currently designated trauma centers already employ an adequate number of trauma surgeons, a trauma program manager and a registrar, and several hospitals already employ an injury prevention coordinator.

Compliance Costs:

Costs incurred by those hospitals voluntarily seeking trauma center designation would include the cost of a consultation site visit and verification site visit. The cost for a consultation site visit is approximately $15,000, while the cost for a verification site visit, including a nurse reviewer, is approximately $16,000. Verification must be completed every three years. Hospitals may also incur costs associated with the hiring of additional trauma surgeons, trauma registrars and an injury prevention coordinator.

The total costs per institution will vary depending on the resources already at hand. For current trauma hospitals, review and update of a hospital’s trauma policies and procedures could be accomplished with existing staff, imposing little or no additional cost. Those hospitals seeking trauma designation for the first time may need to create a full-time position for a trauma program manager. For those facilities seeking a new Level II designation, this new trauma program manager may also co-ordinate injury prevention activities. This position may be filled by someone currently employed by the hospital, or the hospital could choose to hire a new employee. Level I facilities must also have an injury prevention coordinator.

Designated trauma centers are already required to maintain a hospital-based trauma registry which captures information pertaining to the patient’s injury, pre-hospital care, Emergency Department care, hospital care and outcome information so that the hospital can submit information to the New York State Trauma Registry. ACS-COT standards require trauma data submission to the National Trauma Data Bank (NTDB) (a minimum of 80% of cases entered within 60 days of discharge) and the periodic monitoring of data validity. The New York State Trauma Registry “data dictionary” already incorporates the ACS-COT National Trauma Data Bank (NTDB) data elements along with 22 data elements specific to New York. At the state level, each record receives a unique identifier to protect patient confidentiality. Registry information is stored on a protected server with highly limited access.

The ACS-COT currently recommends one registrar for every 750-1,000 patients entered into the registry. Currently designated trauma centers, which already maintain a hospital-based trauma registry, may need to hire an additional registrar to meet these registry standards. According to one of the vendors currently supporting the New York State Trauma Registry, for those facilities pursuing designation as a trauma center for the first time, the average cost of purchasing the software necessary to begin a hospital-based trauma registry is approximately $5,000 - 10,000, and the annual cost for maintaining such registry is approximately $2,000 - 3,000.

The goal of the New York State Trauma Registry is to capture all data for trauma patients cared for in the state. For those non-designated hospitals that occasionally receive trauma patients, there will be a mechanism for capturing an abbreviated set of data elements. The mechanism for submitting an abbreviated subset of trauma data is expected to be offered free of charge. For the small numbers of trauma patients expected at these facilities, entry of trauma data can be accomplished by existing staff and should not require additional hiring.

Those hospitals that will be caring for pediatric trauma patients must also ensure that their equipment is age and size appropriate.

Economic and Technological Feasibility:

This proposal is economically and technically feasible.

Minimizing Adverse Impact:

Trauma center designation is voluntary. Those hospitals that do not wish to care for trauma patients will not need to comply with this regulation.

In May 2012, the Department advised currently designated trauma centers that it intended to make compliance with ACS-COT standards a requirement of designation and advised those hospitals to contact the ACS-COT to schedule a consultation site visit by May 2013. Following receipt of their final consultation site visit report, those centers have two years in which to schedule a verification site visit. In March 2013, the Department advised those hospitals seeking trauma center designation for the first time that they should contact the ACS-COT by May 2015 to schedule a consultation site visit and within two years following receipt of their final consultation site visit report to request a verification site visit. The Department has also advised these hospitals that, prior to having a consultation site visit, they should have in place: a trauma service, a trauma medical director, a trauma program manager, a hospital-based trauma registry, 9-12 months of trauma data and a performance improvement process of some kind. In this way, the Department has sought to facilitate compliance with these regulations in advance of their proposal.

Small Business and Local Government Participation:

The Department has conducted outreach to the affected parties. The State Trauma Advisory Committee (STAC) has discussed and reviewed this proposal during open, webcast meetings, and the Department has shared this proposal with the Greater New York Hospital Association (GNYHA) and the Healthcare Association of New York State (HANYS). Organizations that represent the affected parties are also given notice of this proposal by its inclusion on the agenda of the Codes and Regulations Committee of the Public Health and Health Planning Council (PHHPC). This agenda and the proposal will be posted on the Department’s website. The public, including any affected party, is invited to comment during the Codes and Regulations Committee meeting.

Cure Period:

Chapter 524 of the Laws of 2011 requires agencies to include a “cure period” or other opportunity for ameliorative action to prevent the imposition of penalties on the party or parties subject to enforcement when developing a regulation or explain in the Regulatory Flexibility Analysis why one was not included. This regulation creates no new penalty or sanction. Hence, a cure period is not necessary.

Changes made to the last published rule do not necessitate revision to the previously published Rural Area Flexibility Analysis and Job Impact Statement.

As a rule that requires a RFA, RAFA or JIS, this rule will be initially reviewed in the calendar year 2021, which is no later than the 3rd year after the year in which this rule is being adopted.

Public comments were submitted to the NYS Department of Health (Department) in response the proposed addition to Title 10 NYCRR Part 405.45. These comments and the Department’s responses are summarized below:

Multiple commenters submitted the following comments:

COMMENT: Multiple comments indicated concern that the proposed regulations refer to the 2014 edition of the American College of Surgeon's Committee on Trauma (ACS-COT) Resources for the Optimal Care of the Injured Patient. The comments recommend that the proposed regulations refer to “the most current ACS-COT standard” without citing the specific version of the Resources for the Optimal Care of the Injured Patient.

RESPONSE: The Department will review the latest edition of the Resources for the Optimal Care of the Injured Patient once it has been produced and will determine at that time if a regulation change is necessary. Procedural rules do not allow for “most current version” language as it is required that the Department of State have a copy of any document being incorporated by reference into regulation.

Multiple commenters submitted the following comments:

COMMENT: Multiple comments were submitted regarding the proposed amendment to Part 405.45(g)(2)(iii), regarding Performance Improvement, as follows:

a) The comments expressed concern that the requirement to submit quarterly reports to the Department is a new “deliverable” for the regional trauma centers and requested that the Department develop specific instructions on how to submit reports.

RESPONSE: The Department will provide specific guidance regarding the quarterly reporting requirements.

b) The comments requested that the Department provide a specific deadline for the quarterly report be submitted.

RESPONSE: The Department will publish all deadlines through guidance, in a manner that ensures that all trauma centers receive the information.

c) The comments ask how the Regional Trauma Center will obtain data regarding all pediatric trauma deaths and delayed patients transported or admitted to non-trauma centers.

RESPONSE: 405.45(f) of the proposed regulation grants the authority for a representative or representatives of the Regional Trauma Center to participate in and receive information from the affiliate hospital’s quality assurance committee, participate in other reviews of the quality of trauma care provided by the affiliate, and provide recommendations for quality improvement of trauma care. These sections enable the trauma centers to obtain the data necessary to comply with the reporting requirements.

d) The comments request that the age range for a pediatric patient be provided to ensure uniform data.

RESPONSE: Chapter 10 of the Resources for the Optimal Care of the Injured Patient (2014) divides the pediatric population into several groups, and provides detailed age ranges for each. Specifically, the Resources for Optimal Care of the Injured Patient indicates that infants means birth to 12 months old; toddlers means children 1 to 2 years old; preschoolers means children 3 to 5 years old; school-aged children means children 6-12 years old, and adolescents means children and adults 13-19 years old.

e) The comments assert that the requirement to report a delay of three hours or more in transferring trauma patients to a higher level of trauma care seems arbitrary, given the diversity of geography and resources throughout the state.

RESPONSE: The “delay” referred to is delay in the referring hospital transferring the patient to the trauma center – the time from patient arrival at the referring hospital to the time the patient left the referring hospital en-route to the trauma center – regardless of any inter-hospital transportation issues. Three hours is a performance improvement benchmark based on data from the New York State Trauma Registry showing that for 2010-2013 the statewide median (50th percentile) of Time at Referring Hospital across all Injury Severity Scores ranged from 2 hours 14 minutes to 3 hours 41 minutes; and for 2014-2015, ranged from 2 hours 5 minutes to 4 hours 39 minutes.

f) Commenters requested a definition of “delay” in transport.

RESPONSE: The term “delay” is used throughout the Resources for the Optimal Care of the Injured Patient (2014). Regulated parties should refer to that resource as guidance for interpreting the term, which includes several examples of different situations.

g) Commenters suggested that rather than establishing criteria in regulation, a list of standardized quality improvement recommendations should be generated at the regional level.

RESPONSE: Regions and Centers are not prohibited from and will be encouraged to establish quality improvement indexes and benchmarks specific to the Region and Center.

COMMENT: The Department received multiple comments regarding the requirement that the American College of Surgeons, Committee on Trauma’s (ACS-COT) verification review team include a nurse reviewer on the team. Each of the comments state that this is not a requirement of the ACS-COT and that it adds additional cost to the trauma center verification process.

RESPONSE: The proposed regulation states that a hospital seeking Level I, Level II, or Level III trauma center designation shall require that any verification review team, as provided by ACS-COT, or other entity determined by the Department, include a nurse reviewer. However, the proposed regulation does not require that a nurse be a third member of the review team, but rather that one of the reviewers on the team be a nurse with expertise in trauma care.

COMMENT: A representative of a trauma center expressed concern that the definition of a “trauma patient” was not clear.

RESPONSE: The definition used in the proposed regulations is taken directly from the definition of a trauma patient published in New York State Public Health Law, Article 30-B, § 3062(8). The Department believes that "trauma patient" defined as a patient at high risk of death or disability from multiple and severe injuries is sufficiently clear.

COMMENT: The Department received several comments indicating a belief that the proposed regulations require trauma centers to have a specific ratio of trauma registrars to trauma patients admitted to the trauma center.

RESPONSE: The proposed regulations do not set such ratios. To eliminate any confusion, the Department has revised the Regulatory Flexibility Analysis for Small Business and Local Governments documents to make clear that the proposed regulations do not set ratios.

COMMENT: A representative of a trauma center submitted a comment regarding section 405.45(c)(1)(i) of the proposed regulations, which requires a hospital to undergo a consultative visit prior to a final verification visit for their initial application to the ACS. The commenter asserted that current ACS-COT guidelines from which the proposed regulations are derived recommend, but do not require, a consultative visit prior to the verification site survey and they would prefer that the decision to invite a consultative visit should be the decision of the applicant trauma center.

RESPONSE: Based on the Resources for Optimal Care of The Injured Patient (2014), the ACS-COT will provide a hospital consultation visit at the request of a hospital, community, or regulatory authority to assess trauma care and prepare for a subsequent verification review. The focus is on providing recommendations and assistance to the facility in preparation for future verification. The Department believes that the consultative visit is essential prior to a verification visit to provide both positive and deficient aspects of a trauma program. The benefits of the consultative visit afford the applicant the opportunity to make the corrections and changes necessary to insure their successful verification.

COMMENT: A representative of a trauma center submitted a comment regarding the requirement in the proposed regulations that trauma centers be re-verified every three years. The comment asserts that the ACS-COT has been discussing changing the review process and cycle, potentially using facilities’ Trauma Quality Improvement Process (TQIP) data to identify those needing site visit reviews, with only paper or electronic reviews of centers.

RESPONSE: The Department believes that a three-year verification cycle is appropriate. The verifying entity may independently establish its own verification cycle.

A representative from a trauma center submitted written comments as follows:

COMMENT: A comment stated that the salary figures quoted in the Regulatory Impact Statement are understated for the New York State healthcare market and, in particular, the NYC healthcare market.

RESPONSE: The Department believes that the salary figures provided are a fair representation, as they were provided by trauma centers throughout New York State.

COMMENT: A comment states that there needs to be a population-based registry that includes all significant trauma cases within the region from both trauma and non-trauma hospitals. The data from non-trauma centers should needs to include enough data points to allow for comparable risk adjusted mortality analysis for all hospitals. In addition to the hospital data, EMS reports for all trauma cases are needed to evaluate trauma triage criteria.

RESPONSE: The Department maintains an extensive trauma patient registry called the New York State Trauma Registry (NYSTR). The NYSTR is a well-established system and is populated by all NYS trauma centers submitting trauma data based on the Department’s data dictionary, which may be found at: https://www.health.ny.gov/professionals/ems/state_trauma/docs/trauma_data_dictionary_v9_01-2016.pdf

This NYSTR is population-based and compliant with national standards. The NYSTR data set is currently used for research, and the Department publishes reports at regular intervals that include risk adjusted mortality. These reports, dating back to 2000, may be found at: https://www.health.ny.gov/professionals/ems/state_trauma/trauma_system_reports.htm

COMMENT: A trauma center emergency department submitted a comment stating that, with respect to the proposed 405.45(b)(2), which governs transfer of severely injured patients from non-trauma centers, it should be recognized that on occasion the transferring hospital may have the capability to address time sensitive life-saving procedures. The commenter requested that the regulation be changed so that hospitals that are not trauma centers can also provide trauma care.

RESPONSE: The Department recognizes that trauma patients will arrive at or be brought to non-trauma centers for stabilization and treatment from time to time. However, the purpose of these proposed regulations is to ensure that critically injured patients are taken to hospitals that have the resources and capabilities to treat their injuries. Studies indicate that the overall risk of death is significantly lower when care is provided in a trauma center than when it is provided in a non-trauma center.

COMMENT: The Department received two (2) letters in support of the proposed regulations from State Trauma Advisory Committee members.

RESPONSE: The Department acknowledges the letters of support.