Original Notice.

     Preproposal statement of inquiry was filed as WSR 06-02-086.

     Title of Rule and Other Identifying Information: WAC 246-976-420 Trauma registry -- Department responsibilities and 246-976-430 Trauma registry -- Provider responsibilities. These sections establish the statewide trauma data registry in order for the department to collect and analyze data on the incidence, severity and causes of trauma. The sections establish the department's and providers' responsibilities as it relates to the trauma registry.

     Hearing Location(s): Department of Health, Point Plaza East, 1st Floor, Conference Room 152/153, 310 Israel Road S.E., Tumwater, WA 98501, on September 14, 2009, at 10:00 a.m.

     Date of Intended Adoption: September 28, 2009.

     Submit Written Comments to: Susan Reynolds, Department of Health, P.O. Box 47853, Olympia, WA 98504-7853, e-mail susan.reynolds@doh.wa.gov, web site http://www3.doh.wa.gov/policyreview/, fax (360) 236-4626, by September 14, 2009.

     Assistance for Persons with Disabilities: Contact Susan Reynolds by September 7, 2009, TTY (800) 833-6388 or 711.

     Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The purpose of the proposed rule revisions is to update the trauma registry requirements in order for the department to collect the most critical and relevant data on trauma injuries. The anticipated effects of the proposal include: (1) Better quality and quantity trauma data submitted to the department; (2) the department's enhanced ability to do quality assurance of the state's trauma system; (3) assess, identify, and report preventable trauma incidents; and (4) provide trauma review teams with critical analysis of each trauma designated site.

     Reasons Supporting Proposal: 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 data elements submitted to the department are analyzed to improve the availability and delivery of prehospital and hospital trauma care services. The current registry rules were last revised in 2002. More relevant data is needed to assess the current trauma delivery system and thereby improve the quality, effectiveness, efficiency, and accessibility of the state's trauma system.

     Statutory Authority for Adoption: RCW 70.168.060 and 70.168.090.

     Statute Being Implemented: RCW 70.168.090 and 70.168.060.

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

     Name of Proponent: Department of health, office of community health systems, governmental.

     Name of Agency Personnel Responsible for Drafting and Implementation: Susan Reynolds, 243 Israel Road S.E., Tumwater, WA 98501, (360) 236-2872; and Enforcement: Kathy Schmitt, 243 Israel Road S.E., Tumwater, WA 98501, (360) 236-2869.

     No small business economic impact statement has been prepared under chapter 19.85 RCW. A small business economic impact statement was not prepared. 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, Trauma Registry Administrator, 243 Israel Road S.E., P.O. Box 47853, Olympia, WA 98504-7853, phone (360) 236-2872, fax (360) 236-2830, e-mail susan.reynolds@doh.wa.gov.

August 5, 2009

Mary C. Selecky

Secretary

OTS-2548.3

AMENDATORY SECTION(Amending WSR 02-02-077, filed 12/31/01, effective 1/31/02)

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 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;

     (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 be confidential, shall be exempt from RCW 42.17.250 through 42.17.450, and shall 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 from qualified agencies or individuals, consistent with applicable statutes and rules. The department may charge reasonable costs associated with such requests.

     (c) The data elements indicated ((as confidential)) in Tables E, F and G below are considered confidential.

     (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 designated trauma services must report to the trauma registry.

     These criteria will include:

     (((i))) All patients who were discharged with ICD diagnosis codes of 800.0 - 904.99, 910 - 959.9 (injuries), 994.1 (drowning), 994.7 (asphyxiation), or 994.8 (electrocution) and:

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

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

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

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

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

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

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

     (((ii) All patients who meet the requirements of the state of Washington prehospital trauma triage procedures described in WAC 246-976-930(3);)) (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 (((trauma band 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 registry.

     (7) 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. ((The department will report quarterly on the timeliness, accuracy and completeness of data.))

     (8) 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 ((evaluation of clinical care and)) system-wide ((quality assurance and)) evaluation, and regional quality improvement programs((.

     (b) Semiannually, the department will report:

     (i)));

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

     (((ii) On all patient data entered into the trauma registry during the reporting period;

     (iii))) (iv) Aggregate regional data to the regional EMS/TC council, excluding any confidential or identifying data.

     (((c) The department will provide:

     (i) Provider-specific raw data to the provider that originally submitted it;

     (ii) Periodic reports on financial data;

     (iii) Registry reports to all providers that have submitted data;

     (iv) For the generation of quarterly reports to all providers submitting data to the registry, for the purpose of planning, management, and quality assurance.)) (b) The department will provide reports to facilities upon request, according to the confidentiality provisions in subsection (2) of this section.

[Statutory Authority: RCW 70.168.060 and 70.168.090. 02-02-077, § 246-976-420, filed 12/31/01, effective 1/31/02. Statutory Authority: Chapters 18.71, 18.73, and 70.168 RCW. 00-08-102, § 246-976-420, filed 4/5/00, effective 5/6/00. Statutory Authority: RCW 43.70.040 and chapters 18.71, 18.73 and 70.168 RCW. 93-01-148 (Order 323), § 246-976-420, filed 12/23/92, effective 1/23/93.]

OTS-2549.2

AMENDATORY SECTION(Amending WSR 02-02-077, filed 12/31/01, effective 1/31/02)

WAC 246-976-430   Trauma registry -- Provider responsibilities.   (1) ((Trauma care providers, prehospital and hospital, must place a trauma ID band on trauma patients, if not already in place from another agency.

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

     (((3))) (2) All trauma care providers must correct and resubmit records which fail the department's validity tests described in WAC 246-976-420(((6))) (7). You must send corrected records to the department within three months of notification.

     (((4))) (3) Licensed prehospital services that transport trauma patients must:

     (a) ((Assure personnel use the trauma ID band.)) 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) ((Report data as shown in Table E for trauma patients defined in WAC 246-976-420. Data is to be reported to the receiving facility in an approved format within ten days.

     (5))) Within ten days 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:

     (a) ((Assure personnel use the trauma ID band.)) Have a person identified as responsible for coordination of trauma registry activities.

     (b) Report data elements shown in Table F for all patients defined in WAC 246-976-420.

     (c) Report patients ((discharged)) in a calendar quarter in ((an)) a department-approved format by the end of the following quarter. ((The department encourages more frequent data reporting.

     (6))) (5) Designated trauma rehabilitation services must:

     (((a) Report data on all patients who were included in the trauma registry for acute care.

     (b) Report either:

     (i))) Provide data to the trauma registry upon request.

     (a) Data elements shown in Table G; or

     (((ii))) (b) If the service submits data to the uniform data set for medical rehabilitation, provide a copy of the data to the department.

TABLE E: Prehospital Data Elements for the Washington Trauma Registry
		Pre-Hosp Transport	Inter-Facility
Data Element	Type of patient
((Note: (C) identifies elements that are confidential. See WAC 246-976-420 (2)(c).))
Incident Information
((Agency identification number (C))) Transporting EMS agency number		X	X
((Date of response (C - day only))) Unit en route date/time		X	((X))
((Run sheet number (C))) Patient care report number		X	X
First EMS agency on scene identification number (((C)))		X
((Level of personnel)) Crew member level		X	X
Mode of transport		X	X
Incident county ((code))		X
Incident zip code		X
Incident location ((())type(()))		X
Incident response area type		X
Mass casualty incident declared
Patient Information
((Patient's trauma identification band number (C)		X	X))
Name (((C)))		X	X
Date of birth (((C))), or Age		X	X
Sex		X	X
((Mechanism of injury)) Cause of injury		X
((Safety restraint or device used)) Use of safety equipment (occupant)		X
Extrication required
Extrication > 20 minutes
Transportation
Facility transported from (code) (((C - if hospital ID)))		((X))	X
((Reason for destination decision		X	X))
Times
((Transporting agency dispatched)) Unit notified by dispatch date/time		X	X
((Transporting agency arrived at scene)) Unit arrived on scene date/time		X	X
((Transporting agency departed from scene)) Unit left scene date/time		X	X
Vital Signs
((Time)) Date/time vital signs taken		X	((X))
Systolic blood pressure (first)		X	((X))
Respiratory rate (first)		X	((X))
Pulse (first)		X	((X))
((Glasgow coma score (three components))) GCS eye, GCS verbal, GCS motor, GCS total, GCS qualifier		X	((X))
((Pupils		X	X
Vitals from 1st agency on scene?		X
Trauma Triage Criteria
Vital signs, consciousness level		X
Anatomy of injury		X
Biomechanics of injury		X
Other risk factors		X
Gut feeling of medic		X
Prehospital trauma system activation?		X
Other Severity Measures
Respiratory quality		X
Consciousness		X
Time (interval) for extrication		X))
Treatment: ((EMS interventions)) Procedure performed		X	((X))
Procedure performed prior to this unit's care

     Identification of reporting facility (((C)));

     Date and time of arrival at reporting facility (((C - day only)));

     Unique patient identification number assigned to the patient by the reporting facility (((C)));

     ((Patient's trauma identification band number (C);))

Patient Identification

     Name (((C)));

     Date of birth (((C - day only)));

     Sex;

     Race;

     Ethnicity;

     Was the patient pregnant;

     Last four digits of Social Security number (((C)));

     Home zip code;

Prehospital Incident Information

     Date and time of incident (((C - day only)));

     ((Prehospital trauma system activated?;))

     Incident zip code;

     Mechanism/type of injury;

     First EMS agency on-scene ID number;

     ((Arrival via EMS system?;))

     Transporting (((reporting))) agency ID and unit number;

     Transporting agency ((run)) patient care report number (((C)));

     ((Mechanism of injury;

     Respiratory quality;

     Consciousness;)) Cause of injury;

     Incident county code;

     Incident location type;

     Incident response area type;

     ((Occupational injury?;

     Safety restraint/device used;)) Work related?;

     Use of safety equipment (occupant);

Earliest Available Prehospital Vital Signs

     Time;

     Systolic blood pressure (first);

     Respiratory rate (first);

     Pulse rate (first);

     ((Glasgow coma score (three components);

     Pupils;)) 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 ((1st on-scene)) first EMS agency((?)) on-scene;

Extrication;

Extrication time over twenty minutes((?));

((Prehospital procedures performed;

Prehospital Triage

     Vital signs/consciousness;

     Anatomy of injury;

     Biomechanics of injury;

     Other risk factors;

     Gut feeling of medic;))

Transportation Information

     Date and time ((transporting agency)) unit dispatched;

     Time ((transporting agency)) unit arrived at scene;

     Time ((transporting agency)) unit left scene;

     Transportation mode;

     ((Personnel)) Crew member level;

     Transferred in from another facility;

     Transported from (hospital patient transferred from);

     ((Reason for destination;)) Who initiated the transfer?;

ED or Admitting Information

     Was patient intubated prior to arrival at hospital?;

     Readmission;

     Direct admit;

     Time ED physician called;

     ((ED physician called "code"?;))

     Time ED physician available for patient care;

     ((Time)) 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

          ((Patient dead on arrival at your facility?;))

          First ((and last)) systolic blood pressure;

          First ((and last)) temperature;

          First ((and last)) pulse rate;

          First ((and last)) spontaneous respiration rate;

          Lowest systolic blood pressure;

          First hematocrit level;

          Controlled rate of respiration;

          Glasgow coma scores (eye, verbal, motor);

          Intubated at time of ED GCS;

          Pharmacologically paralyzed at time of ED GCS;

          Disaster plan implemented;

     Injury severity scores

          ((Prehospital Index (PHI) score;))

          Revised trauma score (RTS) on admission;

          For pediatric patients:

               Pediatric trauma score (PTS) on admission;

               ((Pediatric Risk of Mortality (PRISM) score on      admission;

               Pediatric Risk of Mortality - Probability of      Survival (PRISM P(s));

               Pediatric Overall Performance Category (POPC);

               Pediatric Cerebral Performance Category (PCPC):)) TRISS;

     ED procedures performed;

     ED ((complications)) care issues;

     Date and time of ED discharge;

     ED discharge disposition, including

          ((If admitted, the admitting service;))

          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

     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;

     Source of date and time of CT scan of head;

     Was fresh frozen plasma (FFP) or Factor Vlla administered for reversal of anticoagulation?;

     What medication was first used to reverse anticoagulation?;

     Date and time of first dose of anticoagulation reversal medication;

     Date of physical therapy consult;

     Date of rehabilitation consult;

     Blood alcohol content;

     Toxicology screen results;

     Drugs found;

     Was a brief substance use intervention done?;

     ((Co-morbid)) Comorbid factors/preexisting conditions;

Surgical 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 (((C - day only)));

     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 patient was transferred to (((C)))

     Rehabilitation facility ID;

     If patient died in your facility

          Date and time of death (((C - day only)));

          Was an autopsy done?;

          ((Was case referred to coroner or medical examiner?

          Did coroner or medical examiner accept jurisdiction?))

          Was patient declared brain dead prior to expiring?;

          Was life support withdrawn?;

          Was ((patient evaluated for)) organ donation requested?;

          Organs donated?;

Financial Information (All Confidential)

     For each patient

          Total billed charges;

          Payer sources (by category);

          Reimbursement received (by payer category);

     ((Annually, submit ratio-of-costs-to-charges, by department.))

     Facility ID (((C)))

     Facility code

     Patient code

     Trauma tag/identification number (((C)))

     Date of birth (((C - day only)))

     Social Security number (((C)))

     Patient name (((C)))

     Patient sex

Care Information

     Date of admission (((C - day only)))

     Admission class

     Date of discharge (((C - day only)))

     Impairment group code

     ASIA impairment scale

Diagnosis (ICD-9) Codes

     Etiologic diagnosis

     Other significant diagnoses

     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

Functional Independence Measure (FIM) - 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

     Remitted reimbursement by category

     Facility ID (((C)))

     Patient number (((C)))

     Trauma tag/identification number (((C)))

     Social Security number (((C)))

     Patient name (((C)))

Care Information

     Date of admission (((C - day only)))

Impairment Group Code

Diagnosis (ICD-9) Codes

     Etiologic diagnosis

     Other significant diagnoses

     Complications/comorbidities

Other Information

     Admit from (type of facility)

     Admit from (ID of facility) (((C)))

     Acute trauma care given by (ID of facility) (((C)))

     Inpatient trauma rehabilitation given by (ID of facility) (((C)))

     Discharge-to-living setting

Payment Information (all confidential)

     Payer source - primary and secondary

     Total charges

     Remitted reimbursement by category

[Statutory Authority: RCW 70.168.060 and 70.168.090. 02-02-077, § 246-976-430, filed 12/31/01, effective 1/31/02. Statutory Authority: Chapters 18.71, 18.73, and 70.168 RCW. 00-08-102, § 246-976-430, filed 4/5/00, effective 5/6/00. Statutory Authority: RCW 43.70.040 and chapters 18.71, 18.73 and 70.168 RCW. 93-01-148 (Order 323), § 246-976-430, filed 12/23/92, effective 1/23/93.]

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