NOTICES
DEPARTMENT OF HEALTH
Emergency Medical Services Patient Care Report Data Elements, Confidential and Nonconfidential Data Elements and Essential Patient Information for Transmission for Patient Care
[32 Pa.B. 4205] Under 28 Pa. Code § 1001.41 (relating to data and information requirements for ambulance services) the Department of Health (Department) is publishing the following: (a) a list of data elements and form specifications for the emergency medical services (EMS) patient care report (PCR); (b) a designation of data items for the PCR that are confidential; and (c) patient information in the PCR designated as essential for immediate transmission to the receiving facility for patient care.
(A) Data Elements and Form Specifications. The following standards must be met for an EMS data collection software program to satisfy the requirements for electronic PCR reporting:
1. A prospective vendor must contact the Department of Health, Emergency Medical Services Office, Room 1032, P. O. Box 90, Harrisburg, PA 17108, to request the output data specifications and the patient care information that a user of the software must be able to enter into the PCR.
2. The requirements that a PCR data collection software program must meet, after the vendor obtains the input and output specifications and the patient care information from the Emergency Medical Services Office (EMS Office), are the following:
i. It must have all the data elements identified in the column titled ''Required Data Elements'' on the EMS PCR Data and Information Chart included in this notice.
ii. It must have symbols for years that are consistent with ASCII codes assigned by the aggregating data program.
iii. It must be able to collect and print narrative.
iv. It must be able to generate an ASCII flat file (undelimited).
v. It must allow for the practitioner or ambulance service's designated data administrator to make corrections when data elements are omitted or an error occurred when the form was initially completed.
vi. It must annotate additions and corrections made to the PCR by identifying what data element was added or changed, the date of change and who made the change.
vii. It must assign a specific lithocode to each PCR and prevent duplication of lithocode assignments.
3. The prospective vendor must coordinate with a regional EMS council that is willing to conduct a beta test of the software program using 100 preprepared PCRs provided by the EMS Office. The regional EMS council will run the raw data files and generate reports from the Statewide PCR data system for validation.
The beta test will include:
i. Two ambulance services each entering the data from 50 of the 100 prepared PCRs provided by the EMS Office.
ii. Printing of the 100 PCRs.
iii. Printing a list of the data elements collected.
iv. Printing reports that identify unit utilization for:
a. Response outcome, hour/day of week.
b. Fractal time.
c. Municipal response for each of the two beta sites.
v. Printing the following reports:
a. Incident location/type report with number of calls and percentage of calls.
b. Trauma summary.
c. Revised trauma scores.
d. Glasgow coma scale.
e. Medical summary.
f. EKG.
g. Treatment summary.
h. Admission summary.
i. BLS and ALS skills report for each practitioner.
j. BLS and ALS skills report for each beta test site.
k. Demographics summary (age, gender, total).
l. Vital signs summary (ranges, systolic, diastolic, pulse, respiration).
m. Attendant activity.
vi. Printing output files of data elements to include:
a. Field number.
b. Field name.
c. Number of fields for each field name.
d. Type of field (that is, numeric, blanks stored as ''0,'' mm/dd/yyyy, character Boolean and acceptable field values).
To secure a determination of software compliance from the EMS Office the following must occur:
1. The vendor must request a determination of compliance from the EMS Office, upon which the EMS Office will notify the vendor of reports and information that the vendor must submit to the EMS Office to seek a determination of compliance.
2. The regional EMS council that coordinated the beta test shall submit a letter to the EMS Office recommending a determination of compliance or noncompliance. The regional EMS council will validate that all of the aforementioned criteria have been met before recommending a determination of compliance. The EMS Office will notify the vendor as to whether the data collection software program satisfies the requirements for electronic PCR reporting. If the EMS Office determines there are inadequacies, it will identify the corrections that need to be made.
Data software programs developed for handheld devices that transmit data to an approved software program must be evaluated by a regional EMS council prior to being used by an ambulance service in the field to ensure the transmitted data is accurate and complete and supports the ambulance service in meeting regulatory requirements for data submission. A minimum of 20 PCRs provided by the EMS Office will be used to evaluate the transfer and accuracy of the data collected and transmitted using the handheld device. The evaluation will consist of entering the PCR data on the handheld device and transmitting the data to the approved software program. The regional EMS council will compare data from the two sources. The regional EMS council will submit a letter to the EMS Office recommending a determination of compliance or noncompliance. The EMS Office will notify the vendor as to whether the data collection software program for the handheld device satisfies the requirements for electronic reporting. If the EMS Office finds inadequacies, it will identify the corrections that need to be made and provide notice to the vendor.
To secure endorsement of the software by the EMS Office, in addition to securing a determination of compliance from the EMS Office, the vendor must do the following:
1. The vendor must agree, in writing, to make changes to the software program at no cost to the customer if the change is a minor one requested by the EMS Office. A minor change is one that does not add or decrease a field. For example, a change of the year in the date field is a minor change.
2. The vendor must agree, in writing, to provide to the EMS Office and to all licensed users 30-days advance notice before selling the program source code and company or going out of business. The vendor must further agree, in writing, that if circumstances prevent the vendor from meeting the 30-day notice requirement, the vendor will provide input specifications and the source code for the software program to the EMS Office at no cost.
(B) Confidential PCR Data Elements. Section 1001.42 of 28 Pa. Code (relating to dissemination of information) prohibits the release of the PCR, disclosure of confidential information in the PCR or a report or record thereof, except as authorized under 28 Pa. Code § 1001.42(a)(1)--(7). The Department has the authority under 28 Pa. Code § 1001.41(b) to designate some of the information in the PCR as nonconfidential but has chosen not to do so at this time. Consequently, the PCR is confidential in its entirety, and all information in the PCR is subject to the disclosure restrictions in 28 Pa. Code § 1001.41(b). The EMS Office and the regional EMS councils will, however, release aggregate data extracted from PCRs.
To protect against the indirect disclosure of patient information, patient data will be aggregated into groups large enough to prevent an individual from being identified.
Regional EMS councils will release aggregate information from the PCR at a geographic level no smaller than minor civil division (MCD). The report contents will be limited to the following PCR data items:
* Number of calls by an MCD.
* Demographic characteristics of patients, age and sex.
* Number of calls made by month.
* Level of certification of prehospital personnel.
* Average response time.
* Response outcomes.
* Incident location.
* Incident type.
* Suspected illness.
* Medical command facility.
If requests are made for information from a geographic area smaller than an MCD or for PCR data not previously listed, the following is applicable:
1. No PCR or information contained therein shall be released unless the patient (or an authorized representative of the patient) gives a written request or consent to release the PCR or another regulatory exception is met. A request for a specific ambulance service's response record will be referred directly to the service.
2. When a request is made for PCR data elements identified for other purposes, for example, research or statistical analysis, the elements will be released only after the person requesting the data secures written approval from the EMS Office. The request must be submitted in writing to the appropriate regional EMS council. The regional EMS council will forward the request to the EMS Office for consideration. After the EMS Office gives written approval of a request, prior to the EMS Office releasing data, the requesting party must submit a signed data user agreement provided by the EMS Office.
The PCR data elements applicable to the foregoing paragraphs are:
* Patient identifiers.
* Ambulance service identifiers.
* Prehospital care personnel identifiers.
* Medical command facility identifiers.
* MCD identifiers.
(C) Patient Information Required to be Transmitted to Hospital at Time of Patient Delivery. Section 1001.41(d) of 28 Pa. Code requires an ambulance service to provide to the individual at the hospital assuming responsibility for the patient the patient information designated in the PCR as essential for immediate transmission to personnel for patient care. The EMS Office encourages ambulance services to transmit immediately to the facility all information solicited by the PCR, including the narrative section. If the ambulance service does not provide all of the information solicited by the PCR at the time the hospital or facility assumes care, essential information that must be transmitted are the items listed on the following EMS PCR Data and Information Chart. The information may be transmitted verbally, electronically or in a format developed by the hospital or other entity that the hospital finds acceptable to ensure the confidentiality of information designated as confidential in the PCR form.
Persons with a disability who require an alternate format of this notice (for example, large print, audiotape or Braille) should contact Fay Geegee, Department of Health, Emergency Medical Services Office, Room 1032, Health and Welfare Building, Harrisburg, PA 17120, (717) 787-8740, V/TT: (717) 783-6154 for speech or hearing impaired persons or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT).
Required Data Elements
Essential Information for Immediate Transmission to
Receiving Facility at Time of Patient Delivery
28 Pa. Code § 1001.41(d)
Lithocode Affiliate Number/Unit Number Incident Location MCD Code Date--Month/Day/Year Required Attendant #1 Type Attendant #1 Required Attendant #2 Type Attendant #2 Attendant #3 Type Attendant #3 Attendant #4 Type Attendant #4 Driver Response Mode Transport Mode Dispatch Time Enroute Time Arrive Scene Time Depart Scene Time Arrive Destination Time Available Time In Quarters Time Response Outcome Service Incident Number Incident Location Type Work Related Incident Type Suspected Illness Required Sex Required Age Required Age Type (month/day) Initial Vital Sign--Systolic Required Initial Vital Sign--Diastolic Required Initial Vital Sign--Palp Required Initial Vital Sign--Pulse Required Initial Vital Sign--Respira tion Required Eyes/Verbal/Motor Safety Devices Required Contributing Factors Situation of Injury Required Injury Site/Type Required Revised Trauma Score BLS Treatment Required ALS Treatment Required EKG Initial Required EKG Last IV Fluid Required IV Rate Required Medication Required CPR Information Patient Condition On Scene/At Facility Medical Command (Type) Receiving Facility Patient Received By Research Code Command Facility ID # Service Name Required Service Number Incident Number Today's Date Incident Location (descrip tion) Patient Name Required Phone Age Date of Birth Sex Patient Address Social Security Number Membership Private Physician Insurance Code Number Bill To (Company or Name) Bill To Address & Phone Mileage Chief Complaint Required Current Medication Required Allergies (Meds) Required Past Medical History Narrative Vital Signs Name Patient Received by Crew Signatures (No. 1 through No. 4) Person Receiving Patient Signature and Date Command Physician Name and ID# ROBERT S. ZIMMERMAN, Jr.,
Secretary
[Pa.B. Doc. No. 02-1485. Filed for public inspection August 23, 2002, 9:00 a.m.]
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