Original Notice.
Preproposal statement of inquiry was filed as WSR 17-21-018.
Hearing Location(s): On January 8, 2019, at 10:00 a.m., at the Department of Health, Town Center 2, Room 145, 111 Israel Road S.E., Tumwater, WA 98501.
Date of Intended Adoption: January 16, 2019.
Submit Written Comments to: Tim Orcutt, P.O. Box 47853, Olympia, WA 98504-7853, email https://fortress.wa.gov/doh/policyreview, fax 360-236-2830, by January 8, 2019.
Assistance for Persons with Disabilities: Contact Tim Orcutt, phone 360-236-2874, fax 360-236-2830, TTY 360-833-6388 or 711, email tim.orcutt@doh.wa.gov, by December 31, 2018.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The department is proposing updating rules to: (1) More closely align with the national trauma data standard (NTDS) data elements; (2) improve alignment with the new registry collection software (Collector V5); (3) allow for changes in the international classification of disease (ICD-10) coding system; (4) remove outdated or unnecessary data elements; and (5) add new data elements to improve data quality and overall trauma system evaluation. Rule amendments being proposed will potentially benefit the public's health by ensuring participating providers will collect and report trauma data based on current industry standards culminating in stronger trauma system evaluation for Washington state.
Reasons Supporting Proposal: WAC 246-976-420 and 246-976-430 were last updated in 2014. Since then, the American College of Surgeons Committee on Trauma (ACS-COT) has made changes to the data elements in NTDS. The department is proposing updating rules to more closely align with these national data standards.
In addition, the department updated the trauma registry data collection software (Collector) to version five (V5) in 2015. This software is provided to each designated trauma service to report mandatory data elements. To better align mandatory data elements with the new V5 software the department is proposing the rules be revised.
The proposed revisions will help ensure the Washington trauma registry is consistent with ongoing changes in the management and care of trauma patients. Removing unnecessary data elements and adding others will help improve data quality and overall system evaluation. The proposed rule amendments will benefit the public's health by ensuring participating trauma services will be collecting and reporting trauma data based on current industry standards that will culminate in stronger trauma system evaluation leading to improved trauma care outcomes for the citizens of Washington state.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Department of health, governmental.
Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Tim Orcutt, 111 Israel Road S.E., Olympia, WA 98504-7853, 360-236-2874.
The proposed rule does not impose more-than-minor costs on businesses. Following is a summary of the agency's analysis showing how costs were calculated. The NAICS code for general medical and surgical hospitals 622110 was used to calculate industry threshold which is one percent of annual payroll. The total $6,566,100,000.00 annual payroll from the NAICS table was divided by one hundred [(]number of establishment[s] in the industry[)] and one percent of the result was used as threshold for the industry as follows: (6,566,100*1000/100)*(0.01) = $656,610.00. The estimated costs of the proposed rule was determined to be between $0 - $28,169.00, which falls below the NAICS threshold of $656,610.00. It was determined that a small business economic impact statement was not required.
(1) Purpose: The department maintains a trauma registry, as required by RCW
70.168.060 and
70.168.090. The purpose of this registry is to:
(a) Provide data for trauma surveillance, analysis, and prevention programs;
(b) Monitor and evaluate the outcome of care of ((major)) trauma patients, in support of statewide and regional quality assurance and system evaluation activities;
(c) Assess compliance with state standards for trauma care;
(d) Provide information for resource planning, system design and management; and
(e) Provide a resource for research and education.
(2) Confidentiality: ((
It is essential for the department to protect information regarding specific patients and providers.))
RCW 70.168.090, 70.41.200, and chapter 42.56 RCW apply to trauma registry data and patient quality assurance proceedings, records, and reports developed pursuant to RCW 70.168.090. Data elements related to the identification of individual patient's, provider's, and facility's care outcomes ((
must))
shall be confidential, ((
must))
shall be exempt from ((
RCW 42.17.250 through 42.17.450, and must))
chapter 42.56 RCW, and shall not be subject to discovery by subpoena or admissible as evidence.
Patients pursuant to RCW 70.168.090 are confidential, exempt from chapter 42.56 RCW, and are not subject to discovery by subpoena or admissible as evidence.(a) The department may release confidential information from the trauma registry in compliance with applicable laws and regulations. No other person may release confidential information from the trauma registry without express written permission from the department.
(b) The department may approve requests for trauma registry data reports from qualified agencies or individuals, consistent with applicable statutes and rules. The department may charge reasonable costs associated with customized reports, prepared in response to such requests.
(c) ((The data elements indicated in Tables E, F and G below are considered confidential.
(d))) The department ((will establish))has established criteria defining situations in which additional trauma registry information is confidential, in order to protect confidentiality for patients, providers, and facilities.
((
(e) This paragraph))
(d) Subsection (2)(a) through (d) of this section does not limit access to confidential data by approved regional quality assurance
and improvement programs established under chapter
70.168 and described in WAC 246-976-910.
(3) Inclusion criteria: (((a))) The department ((will establish))establishes inclusion criteria to identify those injured patients whom ((designated)) trauma services must report to the trauma registry.
((These))(a) The criteria ((will)) includes((:))all patients who were discharged with International Classification of Diseases (ICD) diagnosis codes for injuries, drowning, burns, asphyxiation, or electrocution per the department's specifications((;)) and one of the following additional criteria:
(i) ((For whom the hospital))The trauma service trauma resuscitation team (full or modified) was activated for the patient; ((or))
(ii) ((Who were))The patient was dead on arrival at the ((facility; or))trauma service;
(iii) ((Who were))The patient was dead at discharge from the ((facility; or))trauma service;
(iv) ((Who were))The patient was transferred by ambulance into the ((facility))trauma service from another facility; ((or))
(v) ((Who were))The patient was transferred by ambulance out of the ((facility))trauma service to another acute care facility; ((or))
(vi) The patient was an adult patient((s)) (age fifteen or greater) ((who were))and was admitted to the ((facility))trauma service and ((have))had a length of stay of more than ((forty-eight))twenty-four hours; ((or))
(vii) The patient was a pediatric patient((s)) (ages under fifteen years) ((who were))and was admitted ((as inpatients)) to the ((facility))trauma service, regardless of length of stay; or
(viii) ((All injuries))The patient was an injured patient flown from the scene.
(b) For all licensed rehabilitation services, ((these))the criteria ((will)) includes all patients who ((were included in the trauma registry for acute care))received rehabilitative care for acute injury or illness.
(4) Other data: The department and regional quality assurance programs may request data from medical examiners and coroners to be used in support of the trauma registry.
(5) Data submission: The department ((will establish))establishes procedures and format for ((providers))trauma services to submit data electronically. These will include a mechanism for the reporting agency to check data for validity and completeness before data is sent to the trauma registry.
(6) Data quality: The department ((will establish))establishes mechanisms to evaluate the quality of trauma registry data. These mechanisms will include ((at least)):
(a) Detailed protocols for quality control, consistent with the department's most current data quality guidelines.
(b) Validity studies to assess the timeliness, completeness and accuracy of case identification and data collection.
(7) Trauma registry reports:
(a) Annually, the department ((will)) reports:
(i) Summary statistics and trends for demographic and related trauma care information ((about trauma care,)) for the state and for each emergency medical service/trauma care (EMS/TC) region;
(ii) Risk adjusted benchmarking and outcome measures, for system-wide evaluation((,)) and regional quality improvement programs;
(iii) Trends, patient care outcomes, and other data, for the state and each EMS/TC region ((and for the state)), for the purpose of regional evaluation; and
(iv) Aggregate regional data ((to the regional EMS/TC council)) upon request, excluding any confidential or identifying data.
(b) The department will provide reports to ((facilities))trauma services and qualified agencies upon request, according to the confidentiality provisions in subsection (2) of this section.
(1) ((All))A trauma care provider((s must))shall protect the confidentiality of data in their possession and as it is transferred to the department.
(2) A verified prehospital ((agencies))agency that transports trauma patients ((shall))must:
(a) Provide an initial report of patient care to the receiving facility at the time the trauma patient is delivered as described in WAC 246-976-330.
(b) Within twenty-four hours after the trauma patient is delivered, send a complete patient care report to the receiving facility to include the data shown in Table ((E))A.
Table A:
Prehospital Patient Care Report Elements for the Washington Trauma Registry
Data Element | Prehospital-Transport: | Inter-Facility: |
Incident Information | | |
Transporting emergency medical services (EMS) agency number | X | X |
Unit en route date/time | X | |
Patient care report number | X | X |
First EMS agency on scene identification number | X | |
Crew member level | X | X |
Method of transport | X | X |
Incident county | X | |
Incident zip code | X | |
Incident location type | X | |
Patient Information | | |
Name | X | X |
Date of birth, or age | X | X |
Sex | X | X |
Cause of injury | X | |
Use of safety equipment | X | |
Extrication required | X | |
Transportation | | |
Facility transported from (code) | | X |
Times | | |
Unit notified by dispatch date/time | X | X |
Unit arrived on scene date/time | X | X |
Unit left scene date/time | X | X |
Vital Signs | | |
Date/time of first vital signs taken | X | |
First systolic blood pressure | X | |
First respiratory rate | X | |
First pulse | X | |
First oxygen saturation | X | |
First Glasgow coma score (GCS) with individual component values (eye, verbal, motor, total, and qualifier) | X | |
Treatment | | |
Procedure performed | X | |
(3) A designated trauma service((s shall))must:
(a) Have a person identified as responsible for trauma registry activities, and who has completed ((a department-approved))the department trauma registry training((.
(b)))course within eighteen months of hire. For level I-III trauma services the person identified must also complete the abbreviated injury scale (AIS) course within eighteen months of hire;
(b) Report data elements ((shown in Table F)) for all patients defined in WAC 246-976-420((.));
(c) Report patients with a discharge date ((in a))for each calendar quarter in a department-approved format by the end of the following quarter((.
(4) All designated trauma care facilities shall));
(d) Have procedures in place for internal monitoring of data validity, which may include methods to reabstract data for accuracy; and
(e) Correct and resubmit records that fail the department's validity tests as described in WAC 246-976-420(7)((. The trauma care facilities shall send corrected records to the department)) within three months of notification of errors.
(((5)))(4) A designated trauma rehabilitation service((s shall))must provide data, as identified in subsection (7) of this section, to the trauma registry in a format determined by the department upon request.
((Data elements shown in Table G are to be provided to the trauma registry in a format determined by the department.
TABLE E: Prehospital Data Elements for the Washington Trauma Registry |
Data Element | Type of patient | Pre-Hosp Transport | Inter-Facility |
Incident Information | | |
Transporting EMS agency number | X | X |
Unit en route date/time | X | |
Patient care report number | X | X |
First EMS agency on scene identification number | X | |
Crew member level | X | X |
Method of transport | X | X |
Incident county | X | |
Incident zip code | X | |
Incident location type | X | |
Mass casualty incident declared | | |
Patient Information | | |
Name | X | X |
Date of birth,or Age | X | X |
Sex | X | X |
Cause of injury | X | |
Use of safety equipment (occupant) | X | |
Extrication required | X | |
Transportation | | |
Facility transported from (code) | | X |
Times | | |
Unit notified by dispatch date/time | X | X |
Unit arrived on scene date/time | X | X |
Unit left scene date/time | X | X |
Vital Signs | | |
Date/time vital signs taken | X | |
Systolic blood pressure (first) | X | |
Respiratory rate (first) | X | |
Pulse (first) | X | |
GCS eye, GCS verbal, GCS motor, GCS total, GCS qualifier | X | |
Treatment: Procedure performed | X | |
Procedure performed prior to this unit's care | X | |
TABLE F: Hospital-Designated Trauma Services Data Elements for the Washington Trauma Registry
All))(5) A designated trauma service((s)) must submit the following data elements for trauma patients((;)). All other licensed hospitals must submit data upon request per WAC 246-976-420(3):
(a) Record identification data elements must include:
(i) Identification (ID) of reporting facility;
(ii) Date and time of arrival at reporting facility;
(iii) Unique patient identification number assigned to the patient by the reporting facility((;)).
(b) Patient identification data elements must include:
(i) Name;
(ii) Date of birth;
(iii) Sex;
(iv) Race;
(v) Ethnicity;
(vi) Last four digits of the patient's Social Security number;
(vii) Home zip code((;)).
(c) Prehospital ((Incident Information))data elements must include:
(i) Date and time of incident;
(ii) Incident zip code;
(iii) Mechanism/type of injury;
(iv) External cause codes;
(v) Injury location codes;
(vi) First EMS agency on-scene identification (ID) number;
(vii) Transporting agency ID and unit number;
(viii) Transporting agency patient care report number;
(ix) Cause of injury;
(x) Incident county code;
((Incident location type;))
(xi) Work related;
(xii) Use of safety equipment (((occupant)));
(xiii) Procedures performed((;
Earliest Available)).
(d) Prehospital vital signs data elements (from first EMS agency on scene) must include:
(i) Time;
(ii) First systolic blood pressure (((first)));
(iii) First respiratory rate (((first)));
(iv) First pulse rate (((first);
Glascow coma score (GCS)));
(v) First oxygen saturation;
(vi) First GCS with individual component values (eye, verbal, motor, total, and qualifiers)((, total));
(vii) Intubated at time of ((scene GCS))first vital sign assessment;
(viii) Pharmacologically paralyzed at time of ((scene GCS;
Vitals from first EMS agency on-scene))first vital sign assessment;
(ix) Extrication((;)).
(e) Transportation ((Information))data elements must include:
(i) Date and time unit dispatched;
(ii) Time unit arrived at scene;
(iii) Time unit left scene;
(iv) Transportation mode;
((Crew member level;))
(v) Transferred in from another facility;
((Transported from (hospital patient transferred from);
Who initiated the transfer;))
(vi) Transferring facility ID number.
(f) Emergency department (ED) ((or Admitting Information))data elements must include:
(i) Readmission;
(ii) Direct admit;
(iii) Time ED physician was called;
(iv) Time ED physician was available for patient care;
(v) Trauma team activated;
(vi) Level of trauma team activation;
(vii) Time of trauma team activation;
(viii) Time trauma surgeon was called;
(ix) Time trauma surgeon was available for patient care;
(x) Vital signs in ED((;)), which must also include:
(A) First systolic blood pressure;
(B) First temperature;
(C) First pulse rate;
(D) First spontaneous respiration rate;
(E) Controlled rate of respiration;
(F) First oxygen saturation measurement;
(G) Lowest systolic blood pressure (SBP);
((Lowest SBP confirmed Y/N?;
First hematocrit level;
GCS))(H) GCS score with individual component values (eye, verbal, motor, total, and qualifiers);
(I) Whether intubated at time of ED GCS;
(J) Whether pharmacologically paralyzed at time of ED GCS;
((MCI))(K) Height;
(L) Weight;
(M) Whether mass casualty incident disaster plan implemented((;)).
(xi) Injury scores must include:
(A) Injury severity score (((ISS)));
(B) Revised trauma score (((RTS))) on admission;
((For pediatric patients:))
(C) Pediatric trauma score (((PTS))) on admission;
((TRISS;))(D) Trauma and injury severity score.
(xii) ED procedures performed;
((ED care issues;))
(xiii) Blood and blood components administered;
(xiv) Date and time of ED discharge;
(xv) ED discharge disposition, including:
(A) If transferred ((out)), ID number of receiving hospital;
(B) Was patient admitted to hospital?((;))
(C) If admitted, the admitting service;
((Reason for referral (receiving facility);))
(D) Reason for transfer (sending facility)((;)).
(g) Diagnostic and consultative ((Information
Did))data elements must include:
(i) Whether the patient ((receive))received aspirin in the four days prior to the injury((?
Did));
(ii) Whether the patient ((receive clopidogrel (Plavix)))received any oral antiplatelet medication in the four days prior to the injury((?
Did)), such as clopidogrel (Plavix), or other antiplatelet medication, and, if so, include:
(A) Whether the patient ((receive))received any oral anticoagulation medication in the four days prior to the injury, such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), or other((s?
What was))anticoagulation medication, and, if so, include:
(B) The name of the anticoagulation medication((?)).
(iii) Date and time of head ((CT))computed tomography scan;
((Date/time))(iv) Date and time of first international normalized ratio (INR) performed at ((your hospital))the reporting trauma service;
(v) Results of first INR ((done at your hospital))preformed at the reporting trauma service;
((Date/time))(vi) Date and time of first partial ((thrombin))thromboplastin time (PTT) performed at the ((hospital))reporting trauma service;
(vii) Results of first PTT ((done))performed at the ((hospital;
Source of date and time of CT scan of head))reporting trauma service;
((Was an))(viii) Whether any attempt was made to reverse anticoagulation((?))at the reporting trauma service;
((What))(ix) Whether any medication (other than Vitamin K) was first used to reverse anticoagulation((?))at the reporting trauma service;
(x) Date and time of the first dose of anticoagulation reversal medication at the reporting trauma service;
(xi) Elapsed time from ED arrival;
((Date of physical therapy consult;))
(xii) Date of rehabilitation consult;
(xiii) Blood alcohol content;
(xiv) Toxicology ((screen)) results;
((Drugs found;
Was))(xv) Whether a brief substance ((use intervention done?))abuse assessment, intervention, and referral for treatment done at the reporting trauma service;
(xvi) Comorbid factors/preexisting conditions;
(xvii) Hospital events.
(h) Procedural ((Information
For the))data elements:
(i) First operation information must include:
((Date and time patient arrived in operating room;))
(A) Date and time operation started;
(B) Operating room (OR) procedure codes;
(C) OR disposition((;)).
(ii) For later operations information must include:
(A) Date and time of operation;
(B) OR procedure codes;
(C) OR disposition((;
Critical Care Unit Information
Patient admitted to ICU;
Patient readmitted to ICU;)).
(i) Admission data elements must include:
(i) Date and time of admission order;
(ii) Date and time of admission or readmission;
(iii) Date and time of admission for primary stay in critical care unit;
(iv) Date and time of discharge from primary stay in critical care unit;
(v) Length of readmission stay(s) in critical care unit;
(vi) Other in-house procedures performed (not in OR).
((Discharge Status))
(j) Disposition data elements must include:
(i) Date and time of facility discharge;
(ii) Most recent ICD diagnosis codes/discharge codes, including nontrauma diagnosis codes;
((E-codes, primary and secondary;
Glasgow Score at discharge;))
(iii) Disability at discharge (feeding/locomotion/expression);
(iv) Total ventilator days;
((Discharge Disposition
Hospital))(v) Discharge disposition location;
(vi) If transferred out, ID of facility the patient was transferred to;
(vii) If transferred to rehabilitation, facility ID;
((If patient died in the))(viii) Death in facility((;)).
(A) Date and time of death;
(B) Location of death;
((Was an autopsy done?;
Was patient declared brain dead?;
Was))(C) Autopsy performed;
(D) Organ donation requested((?));
(E) Organs donated((;
Did)).
(ix) End-of-life care and documentation;
(A) Whether the patient ((have))had an end-of-life care document before injury((?));
((Was))(B) Whether there was any new end-of-life care decision documented during the inpatient stay ((in the facility?))at the reporting trauma service;
((Did))(C) Whether the patient receive a consult for comfort care, hospice care, or palliative care during the inpatient stay((?))at the reporting trauma service;
((Did))(D) Whether the patient ((receive))received any comfort care, in-house hospice care, or palliative care during the inpatient stay (i.e., was acute care withdrawn((?))) at the reporting trauma service;
(k) Financial information (((All Confidential)
For each patient))must include:
(i) Total billed charges;
(ii) Payer sources (by category);
(iii) Reimbursement received (by payer category)((;
TABLE G: Data Elements for Designated Rehabilitation Services)).
(6) Designated trauma rehabilitation services must provide the following data upon request by the department for patients identified in WAC 246-976-420(3).
((Rehabilitation services, Levels I and II
Patient Information
Facility ID
Patient code
Date of birth
Social Security number
Patient name
Patient sex
Care Information
Date of admission
Admission class
Date of discharge
Impairment group code
ASIA impairment scale
Diagnosis Codes
Etiologic diagnosis
Comorbidities
Complications
Diagnosis for transfer or death
Other Information
Date of onset
Admit from (type of facility)
Admit from (ID of facility)
Acute trauma care by (ID of facility)
Prehospital living setting
Discharge-to-living setting
Inpatient Rehabilitation Facility - Patient Assessment Instrument (IRF-PAI) - One set on admission and one on discharge
Self care
Eating
Grooming
Bathing
Dressing - Upper
Dressing - Lower
Toileting
Sphincter control
Bladder
Bowel
Transfers
Bed/chair/wheelchair
Toilet
Tub/shower
Locomotion
Walk/wheelchair
Stairs
Communication
Comprehension
Expression
Social cognition
Social interaction
Problem solving
Memory
Payment Information (all confidential)
Payer source - Primary and secondary
Total charges
Total remitted reimbursement
Rehabilitation, Level III
Patient Information
Facility ID
Patient number
Social Security number
Patient name
Care Information
Date of admission
Impairment Group Code
Diagnosis Codes
Etiologic diagnosis
Comorbidities
Complications
Other Information
Admit from (type of facility)
Admit from (ID of facility)
Acute trauma care given by (ID of facility)
Inpatient trauma rehabilitation given by (ID of facility)
Discharge-to-living setting
Payment Information (all confidential)
Payer source - Primary and secondary
Total charges
Total remitted reimbursement))(a) Data submission elements will be based on the current inpatient rehabilitation facility patient assessment instrument (IRF-PAI). All individual data elements included in the IRF-PAI categories below and defined in the data dictionary must be submitted upon request:
(i) Identification information;
(ii) Payer information;
(iii) Medical information;
(iv) Function modifiers (admission and discharge);
(v) Functional measures (admission and discharge);
(vi) Discharge information;
(vii) Therapy information.
(b) In addition to IRF-PAI data elements each rehabilitation service must submit the following information to the department:
(i) Admit from (facility ID);
(ii) Payer source (primary and secondary);
(iii) Total charges;
(iv) Total remitted reimbursement.