WSR 09-23-083

PERMANENT RULES

DEPARTMENT OF HEALTH


[ Filed November 16, 2009, 4:53 p.m. , effective December 17, 2009 ]


Effective Date of Rule: Thirty-one days after filing.

Purpose: WAC 246-976-420 and 246-976-430, amending sections to update the trauma registry requirements. The purpose of the 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. More relevant data is needed to assess the current trauma delivery system and improve the quality, effectiveness, efficiency and accessibility of the state's trauma system.

Citation of Existing Rules Affected by this Order: Amending WAC 246-976-420 and 246-976-430.

Statutory Authority for Adoption: RCW 70.168.060 and 70.168.090.

Adopted under notice filed as WSR 09-16-140 on August 5, 2009.

Changes Other than Editing from Proposed to Adopted Version: In response to stakeholders' requests, minor clarifying edits were made in the rules submitted in the CR-103 documents. The department of health (department) amended proposed trauma registry standards rules following the CR-102 public hearing in response to requests for clarification from stakeholders. Clarifying language changes were made as follows:

WAC 246-976-430:

▪ Subsection (5)(b), clarifying language on where data is to be submitted.

▪ Subsection (5) Table F, revising the abbreviation for fresh frozen plasma - Factor VIIa - to be upper case rather than lower case.

▪ Subsection (5) Table G, under patient information, eliminating reference to "trauma tag/identification number (C)."

▪ Subsection (5) Table G, under other information, eliminating reference to functional independence measure (FIM) and adding clarifying term, "Inpatient rehabilitation facility -- Patient assessment instrument (IRF - PAI)" as the more current terminology.

▪ Subsection (5) Table G, under patient information, eliminating term, "trauma tag/identification number (C)."

A final cost-benefit analysis is available by contacting Kathy Schmitt, P.O. Box 47853, Olympia, WA 98504-7853, phone (360) 236-2869, fax (360) 236-2830, e-mail kathy.schmitt@doh.wa.gov.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 2, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 2, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 2, Repealed 0.

Date Adopted: November 16, 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-2549.3


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)) Centers for Medicare and Medicaid Services (CMS) 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


TABLE F: Hospital Data Elements for the

Washington Trauma Registry

All licensed hospitals must submit the following data for patients identified in WAC 246-976-420(3):

((Note: (C) identifies elements that are confidential. See WAC 246-976-420(2).))



Record Identification

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 VIIa 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.))


TABLE G: Data Elements for Designated Rehabilitation Services

Designated trauma rehabilitation services must ((submit)) provide the following data upon request by the department for patients identified in WAC 246-976-420(3).

((Note: (C) identifies elements that are confidential. WAC 246-976-420(2)))


Rehabilitation services, Levels I and II



Patient Information

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))) 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

Remitted reimbursement by category


Rehabilitation, Level III


Patient Information

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.]

Washington State Code Reviser's Office