WSR 14-12-079

PROPOSED RULES

DEPARTMENT OF HEALTH

[Filed June 3, 2014, 9:43 a.m.]

Original Notice.

Preproposal statement of inquiry was filed as WSR 13-24-106.

Title of Rule and Other Identifying Information: WAC 246-976-420 Trauma registry—Department responsibilities, and 246-976-430 Trauma registry—Provider responsibilities, the department of health (department) is proposing revising the trauma registry rules to amend and update the requirements.

Hearing Location(s): Washington State Department of Health, 111 Israel Road S.E., Town Center Building 2, Room 158, Tumwater, WA 98501, on July 9, 2014, at 9:00 a.m.

Date of Intended Adoption: July 16, 2014.

Submit Written Comments to: Susan Reynolds, Office of Community Health Systems, P.O. Box 47853, Olympia, WA 98504-7853, e-mail http://www3.doh.wa.gov/policyreview/, fax (360) 236-2830, by July 9, 2014.

Assistance for Persons with Disabilities: Contact Susan Reynolds by July 3, 2014, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The statewide trauma data registry was established to collect and analyze data on the incidence, severity and causes of trauma, including traumatic brain injury. The registry is used to improve the availability and delivery of prehospital and hospital trauma care services. The rules establish the data elements that must be reported by trauma agencies. The current registry rules were revised in December 2009. In order to collect the most relevant data and to improve the quality, quantity, efficiency and effectiveness of the trauma system, the trauma registry rules were reviewed and amendments are proposed as appropriate.

Reasons Supporting Proposal: The proposed rules will update the data requirements to reflect current and national best practices associated with trauma care data analysis in order to maintain the overall integrity and effectiveness of Washington state's trauma system. The requirements of the proposed rule will also allow the department and participating trauma care providers to improve their ability to accurately measure the number of lives saved through reporting of the new and revised data elements.

Statutory Authority for Adoption: RCW 70.168.060 and 70.168.090.

Statute Being Implemented: RCW 70.168.060 and 70.168.090.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Washington state department of health, governmental.

Name of Agency Personnel Responsible for Drafting and Implementation: Susan Reynolds, P.O. Box 47853, Olympia, WA 98504-7853, (360) 236-2872; and Enforcement: Kathy Schmitt, P.O. Box 47853, Olympia, WA 98504-7853, (360) 236-2869.

No small business economic impact statement has been prepared under chapter 19.85 RCW. The proposed rule would not impose more than minor costs on businesses in an industry.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Susan Reynolds, P.O. Box 47853, Olympia, WA 98504-7853, phone (360) 236-2872, fax (360) 236-2830, e-mail susan.reynolds@doh.wa.gov.

June 3, 2014

John Wiesman, DrPH, MPH

Secretary

AMENDATORY SECTION (Amending WSR 09-23-083, filed 11/16/09, effective 12/17/09)

WAC 246-976-420 Trauma registry—Department responsibilities.

(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 ((injury)) 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;

(d) Provide information for resource planning, system design and management;

(e) Provide a resource for research and education.

(2) Confidentiality: It is essential for the department to protect information regarding specific patients and providers. Data elements related to the identification of individual patient's, provider's, and facility's care outcomes ((shall)) must be confidential, ((shall)) must be exempt from RCW 42.17.250 through 42.17.450, and ((shall)) must not be 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 ((such requests)) customized reports, prepared in response to such requests.

(d) The department will establish criteria defining situations in which additional registry information is confidential, in order to protect confidentiality for patients, providers, and facilities.

(e) This paragraph does not limit access to confidential data by approved regional quality assurance programs established under chapter 70.168 RCW and described in WAC 246-976-910.

(3) Inclusion criteria:

(a) The department will establish inclusion criteria to identify those injured patients ((that)) whom designated trauma services must report to the trauma registry.

These criteria will include:

All patients who were discharged with International Classification of Diseases (ICD) diagnosis codes ((of 800.0 - 904.99, 910 - 959.9 (injuries), 994.1 (drowning), 994.7 (asphyxiation), or 994.8 (electrocution))) for injuries, drowning, burns, asphyxiation, or electrocution per the department's specifications; and:

(i) For whom the hospital trauma resuscitation team (full or modified) was activated; or

(ii) Who were dead on arrival at ((your)) the facility; or

(iii) Who were dead at discharge from ((your)) the facility; or

(iv) Who were transferred by ambulance into ((your)) the facility from another facility; or

(v) Who were transferred by ambulance out of ((your)) the facility to another acute care facility; or

(vi) Adult patients (age fifteen or greater) who were admitted ((as inpatients)) to ((your)) the facility ((and have a length of stay greater than two days or)) and have a length of stay of more than forty-eight hours; or

(vii) Pediatric patients (ages under fifteen years) who were admitted as inpatients to ((your)) the facility, regardless of length of stay; or

(viii) All injuries flown from the scene((;)).

(b) For all licensed rehabilitation services, these criteria will include all patients who were included in the trauma registry for acute care.

(4) Other data: The department and regional quality assurance programs may request data from medical examiners and coroners in support of the registry.

(5) ((Data linking: To link data from different sources, the department will establish procedures to assign a unique identifying number to each trauma patient. All providers reporting to the trauma registry must include this trauma number.

(6))) Data submission: The department will establish procedures and format for providers 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.

(((7))) (6) Data quality: The department will establish 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.

(((8))) (7) Trauma registry reports:

(a) Annually, the department will report:

(i) Summary statistics and trends for demographic and related information about trauma care, for the state and for each EMS/TC region;

(ii) Outcome measures, for system-wide evaluation, and regional quality improvement programs;

(iii) Trends, patient care outcomes, and other data, for each EMS/TC region and for the state, for the purpose of regional evaluation;

(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 upon request, according to the confidentiality provisions in subsection (2) of this section.

AMENDATORY SECTION (Amending WSR 09-23-083, filed 11/16/09, effective 12/17/09)

WAC 246-976-430 Trauma registry—Provider responsibilities.

(1) All trauma care providers must protect the confidentiality of data in their possession and as it is transferred to the department.

(2) All designated trauma care ((providers must)) facilities shall correct and resubmit records ((which)) that fail the department's validity tests described in WAC 246-976-420(7). ((You must)) The trauma care facilities shall send corrected records to the department within three months of notification of errors.

(3) ((Licensed)) Verified prehospital ((services)) agencies that transport trauma patients ((must)) shall:

(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 ((ten days)) 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.

(4) Designated trauma services ((must)) shall:

(a) Have a person identified as responsible for ((coordination of)) trauma registry activities, and who has completed a department-approved trauma registry training.

(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 calendar quarter in a department-approved format by the end of the following quarter.

(5) Designated trauma rehabilitation services ((must:)) shall provide data to the trauma registry upon request.

(((a))) Data elements shown in Table G((; or

(b) If the service submits data to the Centers for Medicare and Medicaid Services (CMS) for medical rehabilitation, provide a copy of the data to the department)) 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
		Pre-Hosp Transport	Inter-Facility
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
((Mode)) Method of transport		X	X
Incident county		X
Incident zip code		X
Incident location type		X
((Incident response area 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
((Extrication ˃ 20 minutes))
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 ((licensed hospitals)) designated trauma services must submit the following data for trauma patients ((identified in)); all other licensed hospitals must submit data upon request per WAC 246-976-420(3):

Record Identification

Identification (ID) of reporting facility;

Date and time of arrival at reporting facility;

Unique patient identification number assigned to the patient by the reporting facility;

Patient Identification

Name;

Date of birth;

Sex;

Race;

Ethnicity;

((Was the patient pregnant;))

Last four digits of Social Security number;

Home zip code;

Prehospital Incident Information

Date and time of incident;

Incident zip code;

Mechanism/type of injury;

First EMS agency on-scene identification (ID) number;

Transporting agency ID and unit number;

Transporting agency patient care report number;

Cause of injury;

Incident county code;

Incident location type;

((Incident response area type;))

Work related((?));

Use of safety equipment (occupant);

Procedures performed;

Earliest Available Prehospital Vital Signs

Time;

Systolic blood pressure (first);

Respiratory rate (first);

Pulse rate (first);

Glascow coma score (GCS) eye, ((GCS)) verbal, ((GCS)) motor, ((GCS)) qualifier, ((GCS)) total;

Intubated at time of scene GCS;

Pharmacologically paralyzed at time of scene GCS;

Vitals from first EMS agency on-scene;

Extrication;

((Extrication time over twenty minutes;))

Transportation Information

Date and time unit dispatched;

Time unit arrived at scene;

Time unit left scene;

Transportation mode;

Crew member level;

Transferred in from another facility;

Transported from (hospital patient transferred from);

Who initiated the transfer((?));

Emergency Department (ED) or Admitting Information

((Was patient intubated prior to arrival at hospital?;))

Readmission;

Direct admit;

Time ED physician called;

Time ED physician available for patient care;

Trauma team activated;

Level of trauma team activation;

Time of trauma team activation;

Time trauma surgeon called;

Time trauma surgeon available for patient care;

Vital Signs in ED;

First systolic blood pressure;

First temperature;

First pulse rate;

First spontaneous respiration rate;

Controlled rate of respiration;

Lowest systolic blood pressure (SBP);

Lowest SBP confirmed Y/N?;

First hematocrit level;

((Controlled rate of respiration;

Glasgow coma scores)) GCS (eye, verbal, motor);

Intubated at time of ED GCS;

Pharmacologically paralyzed at time of ED GCS;

MCI disaster plan implemented;

Injury ((severity)) scores

Injury severity score (ISS);

Revised trauma score (RTS) on admission;

For pediatric patients:

Pediatric trauma score (PTS) on admission;

TRISS;

ED procedures performed;

ED care issues;

Date and time of ED discharge;

ED discharge disposition, including

If transferred out, ID of receiving hospital;

Was patient admitted to hospital?;

If admitted, the admitting service;

Reason for referral (receiving facility);

Reason for transfer (sending facility);

Diagnostic and Consultative Information

Did the patient receive aspirin in the four days prior to the injury?

Did the patient receive clopidogrel (Plavix) in the four days prior to the injury?

Did the patient receive any oral anticoagulation medication in the four days prior to the injury, such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto) or others?

What was the name of the anticoagulation medication?

Date and time of head CT scan;

((For patients with diagnosis of brain or facial injury:

Was the patient diagnosed with brain or facial injury before transfer?;

Was the diagnosis of brain or facial injury based on either physician documentation or head CT report?;

Did the patient receive Coumadin or warfarin medication in the four days prior to injury?;))

Date/time of first international normalized ratio (INR) performed at your hospital;

Results of first INR done at your hospital;

Date/time of first partial thrombin time (PTT) performed at the hospital;

Results of first PTT done at the hospital;

Source of date and time of CT scan of head;

((Was fresh frozen plasma (FFP) or Factor VIIa administered for reversal of)) Was an attempt made to reverse anticoagulation?;

What medication (other than Vitamin K) was first used to reverse anticoagulation?;

Date and time of first dose of anticoagulation reversal medication;

Elapsed time from ED arrival;

Date of physical therapy consult;

Date of rehabilitation consult;

Blood alcohol content;

Toxicology screen results;

Drugs found;

Was a brief substance use intervention done?;

Comorbid factors/preexisting conditions;

((Surgical)) Procedural Information

For the first operation:

Date and time patient arrived in operating room;

Date and time operation started;

OR procedure codes;

OR disposition;

For later operations:

Date and time of operation;

OR procedure codes;

OR disposition;

Critical Care Unit Information

Patient admitted to ICU;

Patient readmitted to ICU;

Date and time of admission for primary stay in critical care unit;

Date and time of discharge from primary stay in critical care unit;

Length of readmission stay(s) in critical care unit;

Other in-house procedures performed (not in OR)

Discharge Status

Date and time of facility discharge;

Most recent ICD diagnosis codes/discharge codes, including nontrauma codes;

E-codes, primary and secondary;

Glasgow Score at discharge;

Disability at discharge (feeding/locomotion/expression);

Total ventilator days;

Discharge disposition

Hospital discharge disposition;

If transferred out, ID of facility the patient was transferred to;

Rehabilitation facility ID;

If patient died in ((your)) the facility;

Date and time of death;

Location of death;

Was an autopsy done?;

Was patient declared brain dead ((prior to expiring?;

Was life support withdrawn))?;

Was organ donation requested?;

Organs donated((?));

Did the patient have an end-of-life care document before injury?;

Was there any new end-of-life care decision documented during the inpatient stay in the facility?;

Did the patient receive a consult for comfort care, hospice care, or palliative care during the inpatient stay?;

Did the patient receive any comfort care, in-house hospice care, or palliative care during the inpatient stay (i.e., was acute care withdrawn?);

Financial Information (All Confidential)

For each patient

Total billed charges;

Payer sources (by category);

Reimbursement received (by payer category);

TABLE G: Data Elements for Designated Rehabilitation Services

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

((Facility code))

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 (((ICD-9))) Codes

Etiologic diagnosis

((Other significant diagnoses)) Comorbidities

Complications((/comorbidities))

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

((Prehospital vocational category))

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 ((by category))

Rehabilitation, Level III