OBX|6|NM|8625-6^P-R INTERVAL ^LN||.22|msec
|.18-.22||||F|...<cr>
Order record for CXR
OBR|2|P8754^OE|XR1501^XR|71020^Chest X-ray AP \T\ Lateral|||198703290800|||
401-0^INTERN^JOE^^^^MD^L|...<cr>
Two CXR diagnostic impressions
OBX|1|CE|71020&IMP^Radiologist's
Impression|1|.61^RUL^ACR~.212^Bronchopneumonia^ACR|||A|||F|...<cr>
OBX|2|CE|71020&IMP|2|51.71^Congestive heart
failure^ACR|||A|||F|...<cr>
CXR Description with continuation records
OBX|3|TX|71020&GDT||Infiltrate probably representing bronchopneumonia in
the right
lower lobe. Also pulmonary venous congestion cardiomegaly and cephalization,
indicating early congestive heart failure.|...<cr>
Recommendations about CXR report to follow up one month with a repeat CXR
OBX|4|CE|71020&REC||71020^Followup CXR 1 month^AS4||||||F|...<cr>
Order record for pathology report
OBR|3|P8755^OE|SP89-739^SP|88304^Surgical Path
Report|||198703290800|||401-0^INTERN^JOE^^^^MD^L|...<cr>
OBX|1|CE|88304&ANT^Surgical Path Report|1|Y0480-912001^orbital
region^SNM||||||F|...<cr>
Gross description record (with overflow) for pathology
OBX|2|TX|88304&GDT^GrossSpecimenDescription|1|The specimen is received in
four containers. The first is labeled with the patient's name and consists of
three fragments of reddish-brown tissue each of which measures 2 mm in greatest
dimension. They are wrapped in tissue paper and submitted in toto in a single
cassette|...<cr>
Microscopic description record for pathology
OBX|3|TX|88304&MDT^MicroscopicDescription|1|Sections of the first specimen
received for frozen section diagnosis reveal thick walled, ramifying vessels
lined by a single layer of flattened endothelial cells. The thick smooth
muscle walls exhibit no malignant cytologic features nor do the endothelial
lining cells. Within the same specimen are also found fragments of fibrous
connective tissue, bone, and nerve which are histologically
unremarkable||||||F|...<cr>
Vital signs using LOINC® codes as observation identifiers
OBR|4|P8756^OE|N2345^NR|3000.02^VITAL SIGNS|
||198703290800|||401-0^INTERN^JOE^^^^MD^L|...<cr>
OBX|1|NM|8462-4^INTRAVASCULAR
DIASTOLIC:PRES:^LN||90|mm(hg)|60-90||||F|...<cr>
OBX|2|NM|8479-8^INTRAVASCULAR SYSTOLIC:PRES:^LN||120|mm(hg)
|100-160||||F|...<cr>
OBX|3|NM|8478-0^INTRAVASCULAR
MEAN:PRES:^LN||100|mm(hg)|80-120|N|||F|...<cr>
OBX|4|NM|8867-4^HEART BEAT RATE^LN||74|/min|60-100|N|||F|...<cr>
OBX|5|ST|8357-6^BLOOD PRESSURE METHOD^LN||MANUAL BY
CUFF||||||F|...<cr>
OBX|6|ST|8886-4^HEART RATE METHOD^LN||MANUAL BY PALP||||||F|...<cr>
Part of the patient's history
OBR|5|P8568^OE|HX2230^CLN||2000^HISTORY| ||198703290800||401
0^INTERN^JOE^^^^MD^L||...<cr>
OBX|1|CE|8661-1^CHIEF COMPLAINT^LN||...<cr>
OBX|2|ST|8674-4^HISTORY SOURCE^LN||PATIENT||||||F|...<cr>
OBX|3|TX|8684-3^PRESENT ILLNESS^LN||SUDDEN ONSET OF CHEST PAIN. 2 DAYS,
PTA ASSOCIATED WITH NAUSEA, VOMITING \T\ SOB. NO RELIEF WITH ANTACIDS
OR NTG. NO OTHER SX. NOT PREVIOUSLY ILL.||||||F|...<cr>
.
.
and so on.
Organisms
and other observations/tests are reported using multiple OBX segments. The
granularity expected for HL7culture reports is one observation per organism.
All OBX segments which have the same observation ID and sub-ID are part of a
single observation.
Each organism in a culture battery is assigned a unique OBX-4-observation
sub-ID (and is therefore a separate observation). The organism name is
given in OBX-5-observation value (results). It is recommended, but not
required, that the organism name may change over time, but the corresponding
observation sub-ID never changes. (The observation ID will be identical for
all organisms reported.)
Recommended:
OBX|1|CE|organism^413^L|1|^E. Coli||||||F|...<cr>
OBX|2|CE|organism^413^L|2|^S. Aureus||||||F|...<cr>
Not recommended:
OBX|1|CE|organism1^413^L|1|^E. Coli||||||F|...<cr>
OBX|2|CE|organism2^413^L|1|^S. Aureus||||||F|...<cr>
Each
antimicrobial should be reported as a separate (OBX) observation where the
Observation ID is a code for the antimicrobial. (OBXs for non-antimicrobials
observations and related information may be present in the same battery.)
MIC and disk diffusion (Kirby Bauer) susceptibility results can be combined in
the same OBX segment. An OBX can contain a MIC value (in OBX-5-observation
value (results)) and OBX-8-abnormal flag that indicates whether the
organism is sensitive, resistant, or intermediate (see HL7 table 0078-
Abnormal flags under abnormal flag fields).
Or, an OBX can contain a disk diffusion result string (e.g., sensitive)
in the Observation Results field and the disk diffusion interpretation in
OBX-8-abnormal flags (e.g., S).
A susceptibility battery may only contain results corresponding to a single
organism that has been previously reported in a culture battery.
The
following is the preferred, but not required method of organizing data about
antimicrobial susceptibility.
A susceptibility battery may only contain results corresponding to a single
organism that has been previously reported in a culture battery.
A susceptibility battery is always a child order to a culture battery.
OBR-29-parent (parent's filler order number) in the susceptibility OBR
is equal to OBR-3-filler order number in the parent culture OBR and is
used to link the two batteries logically.
The susceptibility battery also contains a linkage back to a particular
organism in the culture battery. OBR-26-parent result of the
susceptibility OBR contains two components--OBX-3-observation identifier
(code only) and OBX-4-observation sub-ID of the OBX in the culture
battery which contains the organism name.
The identity of an organism/isolate is expected to be refined over time. When
an organism identification changes, the parent culture battery can be resent
without resending the child susceptibility battery.
The case may occur where a susceptibility battery is reported on an organism
which has not yet been identified. In this case, it is required that a
placeholder OBX for the organism name be reported in the corresponding culture
battery so that OBR-26-parent result in the susceptibility OBR will
point to a valid organism OBX in the culture battery. Transmission of an
organism OBX (in the culture battery) with the Sub-ID field valued must precede
the susceptibility battery which uses the identical Sub-ID in OBR-26-parent
result.
Discussion and examples:
Order micro results (blood culture)
MSH|^~\&|LAB1||DESTINATION||19910127105114||ORU^R01|LAB1003929|...<cr>
PID|...<cr>
PV1|...<cr>
ORC|NW|...<cr>
OBR|1|A485388^OE|H29847^LAB1|1234^BLOOD CULTURE|||...<cr>
Result for culture
ORC|RE|...<cr>
OBR|1|A485388^OE|H29847^LAB1|1234^BLOOD CULTURE||...<cr>
OBX|1|FT|SDES^SOURCE||BLOOD-RAPID||||||F|...<cr>
OBX|2|FT|EXAM^MICROSCOPIC||GRAM POSITIVE COCCI IN
GROUPS||||||F|...<cr>
OBX|3|FT|600-7^MICROORGANISM IDENTIFIED^LN|1|ISOLATE 1||||||F|...<cr>
Result for susceptibility
ORC|RE|...<cr>
OBR|1|A485388^OE|H29848^LAB1|BT1^SUSCEPTIBILITY
BATTERY||||||123^MANSFIELD^CHARLES| ||||||||||||||||600-7&MICROORGANISM
IDENTIFIED&LN ^1|||A485388&OE^H29847&LAB1|...<cr>
OBX|1|NM|6932-8^PENICILLIN^LN||0.5|||R|||F|...<cr>
OBX|2|NM|347-5^NAFCILLIN^LN||1|||R|||F|...<cr>
OBX|3|ST|193-3^CLINDAMYCIN^LN||<=0.1|||S|||F|...<cr>
Result for Culture ID
ORC|RE|...<cr>
OBR|1|A485388^OE|H29847^LAB1|1234^BLOOD CULTURE||...<cr>
OBX|1|FT|600-7^ MCIROORGANISM IDENTIFIED^LN |1|STAPH
EPI||||||F|...<cr>
New result for culture ID
ORC|RE|...<cr>
OBR|1|A485388^OE|H29847^LAB1|1234^BLOOD CULTURE||...<cr>
OBX|1|FT|600-7^MCIROORGANISM IDENTIFIED^LN|1|STAPH EPI SERO TYPE
3||||||F|...<cr>
Assumptions
1. All OBXs in the parent order must employ the same coding scheme.
2. The Sub-ID of the parent OBXs (result) cannot change.
Suppose
an order has been placed to the EKG system for three EKGs to be performed on
successive days. These results can be reported in various ways.
1. The EKG application needs to communicate to anyone the results of the 1st
EKG:
ORU message:
MSH|...<cr>
PID|...<cr>
OBR|1||89-551^EKG|93000^EKG REPORT|...<cr> // 1ST child OBR.
OBX|1|ST|93000.1^VENTRICULAR RATE (EKG)|...<cr>
OBX|2|ST|93000.2^|...<cr>
...
...
OBX|14|FT|93000.14^EKG COMMENT|...<cr>
OBR|...<cr> // other observation
segments to follow
* Notice that this report is without reference to the original order.
* No ORC is required because the identifying Fillers Order Number (and other
ORC fields) are carried in the OBR segment.
2. The EKG application needs to communicate to anyone the original order
information, the details of the child orders, the fact of the child spin off,
and the results of all three EKGs:
ORU message:
MSH|...<cr>
PID|...<cr>
ORC|PA|A226677^OE|89-450^EKG|...<cr> // original order's
ORC.
OBR|1|||93000^EKG REPORT|...<cr> // original order segment
ORC|CH|A226677^OE|89-451^EKG|...<cr> // 1st child ORC.
OBR|1|||93000^EKG REPORT|...<cr> // 1st EKG child OBR.
OBX|1|ST|...<cr> // 1st EKG report
OBX|2|ST|...<cr>
...
OBX|14|FT|...<cr>
ORC|CH|A226677^OE|89-452^EKG|...<cr> // 2nd child ORC.
OBR|1|||93000^EKG REPORT|...<cr> // 2nd EKG child OBR.
OBX|1|ST|...<cr> // 2nd EKG report
OBX|2|ST|...<cr>
...
OBX|14|FT|...<cr>
ORC|CH|A226677^OE|89-453^EKG|...<cr> // 3rd child ORC.
OBR|1|||93000^EKG REPORT|...<cr> // 3rd EKG child OBR.
OBX|1|ST|...<cr> // 3rd EKG report
OBX|2|ST|...<cr>
...
OBX|14|FT|...<cr>
... // Other parts of message might follow.
In this case, we are transmitting the information about the fact of child spin
off, the original order and the results all at the same time. Thus, this form
of the ORU message reports not only the results of an order, but all of its
associated ordering information including the original OBR for three EKGs that
was replaced by three separate OBR EKG segments.
Reporting
body weight and height with a creatinine clearance.
MSH|...<cr>
PID|...<cr>
ORC|NW|...<cr> // New order.
OBR|1|P42^PC||2164-2^CREATININE RENAL CLEARANCE: QN^LN|...<cr>
OBX|1|NM|3141-9^BODY WEIGHT:^LN||62|kg|...<cr>
OBX|2|NM|3137-7^BODY HEIGHT:^LN||190|cm|...<cr>
ORC|NW|...<cr> // Next order.
Academic
medical institutions, academic research coordinating centers, and
industry-based research organizations often have computer systems that support
registration, compliance and safety monitoring, and outcomes analysis for
clinical trials. Patients on these trials may receive their treatment and
evaluation at one research facility or at many different medical facilities.
Clinical trials systems could message other applications that a patient is
registered on a clinical trial. Several functional examples follow: (1) Some
of the data required to monitor or analyze outcomes on the trial are generated
in other medical computer systems, such as pharmacy, laboratory, or clinical
applications. These applications may tag patients on clinical trials so that
data may be sent back to the clinical trials system. (2) Order entry systems
could also use patient registration information: they could display standard
order sets for the protocol or particular treatment/evaluation phases of a
complex protocol. They could pass the clinical trials status on to service
provider applications to initiate a results report to the clinical trials
system. It could also be passed to billing applications that may use
specialized procedures for research-related costs. (3) Nursing and pharmacy
systems can use information on patients' clinical trials status for care plans
or dispensing authorization (auxiliary to the physician's prescription),
respectively. There could be many other uses of this message since a patient's
involvement on a clinical trial affects all concurrent medical care.
To meet monitoring and analysis requirements, patient registration, treatment,
diagnostic, and study summary data are reported to study sponsors like
pharmaceutical or medical device companies, regulatory agencies, and data
management centers for collaborative studies. Automated procedures must be
used to transfer these voluminous data among the participant computer systems
in a cost-efficient and timely manner. The following additions to HL7 aim to
specify standard messaging transactions to automate such reporting as well as
to enable communication of clinical trials registration data to relevant
medical applications as described above.
The objectives of the clinical trials messages and segments are to identify
that patients are registered on clinical trials, have entered a study-specific
phase of treatment or evaluation, or to indicate the study protocol's data
schedule. Messages include OBR (Section 4.5.1, "OBR - observation request
segment"), OBX (Section 7.4.2, "OBX - observation/result segment"), RXA
(Section 4.8.14, "RXA - pharmacy /treatment administration segment"), and RXR
(Section 4.8.3, "RXR - pharmacy/treatment order segment") segments to report
observations or drug administration that are relevant to the study. In
addition to study-related clinical data, OBX segments may contain the results
of study variables according to master code tables such as the Health Outcomes
Variables (HL7 Implementation Guide). There are also master segments to
describe the clinical trial, its treatment phases, and its scheduled date-time
points for message recipients. These are analogous to the Test/Observation
Master Segments (Chapter 8), with the trials, phases, or scheduled time points
treated as the OMX treats observation identifiers.
A scientifically rigorous study of individual outcomes to some process of healthcare intervention. Clinical trials usually involve medical treatments so this document will use the term treatment, rather than the broader term intervention. A clinical trial design may randomly assign and compare one treatment approach with another, or generate safety and efficacy data on a single treatment approach. The clinical trial has a protocol for the patient's course of treatment and/or evaluation. There is usually a schedule for collection of data to measure compliance, safety, and outcomes.
A
treatment and/or observation interval of a clinical trial. A phase may
represent an interval with a specific treatment regimen assigned randomly or
otherwise, with each regimen of a progression of treatments, or with an
evaluation component only. Generally, for each phase, there is an explicit
patient management, evaluation, and data collection schedule. Each of these
phases may have associated safety, outcome, and quality-control variables. A
simpler study design need not use the phase structures.
The phase structure serves several purposes in the clinical trials messages.
Other computer systems may need to know that the patient has begun a phase with
a particular treatment regimen or diagnostic schedule, such as the pharmacy or
order entry systems. When reporting study data, observations and variables
often describe particular phase instances. For example, each course of
treatment may have its own values for the same set of observations or
variables. Phase instances may also have distinct data schedules that need to
be linked to submitted data.
Several examples follow with each line depicting a phase.
Alternating
treatment plus observation intervals:
__________> _________> _________> _________> ...
Rx A Rx B Rx A Rx B
Random
assignment to two courses each of treatment A or B, all responding patients to
treatment C, continue with observation and a diagnostic regimen after all
treatment phases are completed. Treatment phases include the evaluation
component for that course of treatment:
___________> __________
Rx A Crs 1 Rx A Crs 2
\> __________> __________> _______
/ Rx C Crs 1 Rx C Crs 2
Observe
___________> __________/
Rx B Crs 1 Rx B Crs 2
Random
assignment to placebo or treatment A, both taken daily and evaluated
monthly.
___________> __________> __________> __________> . . .
Month 1 Month 2 Month 3 Month 4
The
treatment, diagnostic, and procedural requirements, as well as data collection
due dates, scheduled on a timeline for most clinical trials. As data are
reported, they may need to reflect the scheduled time point that they satisfy.
Clinical trials quality control requires attention to compliance between the
protocol's schedule and patient data records.
The data schedule will be keyed by time points relative to the study. Some
data may be due prior to and at the conclusion of the study and/or one or more
of its phases. Some are interim within the study or its phases depending on
protocol events such as administration of treatment, arbitrary time intervals
instated to make and record assessments, or some clinical milestone such as
relapse of disease. Often, multiple data parameters are scheduled at the same
time point. Several examples follow:
Treatment 1st - 3rd Years |
||||||||||||||||||
Reg |
Rand |
Months |
||||||||||||||||
3 |
6 |
9 |
12 |
18 |
24 |
30 |
36 |
42 |
48 |
54 |
60 |
66 |
72 |
78 |
84 |
|||
Disease Staging |
X |
|
||||||||||||||||
H & P |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
Assess Adverse Events and Outcome Variables |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
Chest PAL X-ray |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
||
CBC, Diff, Plt |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
||||||
SMA 12 |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|||||
Cholesterol and Triglyceride |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|||||||||
Electrolytes |
X |
|||||||||||||||||
Plasma Retinoic Acid |
X |
X |
||||||||||||||||
Cotinine Level (nonsmokers) |
X |
|
Prior to Each Cycle |
|
Every 3 Cycles |
|
|
Informed Consent |
X |
X |
|||
H & P Neurologic |
X1 |
X |
|||
Vital Signs |
X1 |
X2 |
X |
||
Disease Staging |
X |
X3 |
X |
||
ECG |
X1 |
X4 |
|||
Radiology* |
X |
X5 |
X |
||
Chest X-ray |
X |
X |
X |
||
Bone Marrow Bx. |
X6 |
||||
HCG |
X1 |
||||
Assess Adverse Events |
X |
X |
|||
CBC, Diff, Plt |
X1 |
X7 |
X |
||
UA, PT, PTT |
X1 |
X |
|||
SMA12, Mg, CEA |
X1 |
X |
X |
1.
Within 3 days prior to start of infusion.
2. At 0,10,30, and 60 minutes after start of drug administration and one-half
hour after test drug infusion ends for cycles 1 and 2. For subsequent cycles
at 0 and 10 minutes after start of drug administration, and at the end of
infusion.
3. Record tumor measurements at the end of every cycle if assessable clinically
by physical examination or with simple X-ray.
4. Continuous ECG monitoring during infusion if necessary, due to bradycardia
(<50 beats/min) or other significant cardiac findings.
5. When measurable disease requires complex radiologic studies such as CT or
radionucleide scans.
6. To be done at baseline (if clinically indicated) at the option of the
investigator and also during study if patient has prolonged myelosuppression
(WBC<2000 cells/mm3>14 days).
7. Blood counts will be done twice weekly during cycles 1 and 2, then
weekly.
* Radionucleide scan and X-ray of the bones, CT scans of the chest, pelvis, and
brain only when clinically indicated.
Day
1 |
Day
1 |
|
|
|
H & P |
X |
X |
||
Creat, Bili, SGOT |
X |
|||
Urinalysis |
X |
|||
Pain Diagnosis |
X |
|||
Opioid Dose Strand |
X |
X |
X |
X |
Non-opioid Analgesic |
X |
X |
X |
|
Medications for Side Effects |
X |
X |
X |
|
Phone Report: Pain and Side Effects |
X |
|||
Visual Analog Scales |
X |
X |
X |
X |
Pain Evaluation Form |
X |
X |
The event type will be carried in the message header segment.
The
data are entered in a clinical trials or other patient data system and
broadcast to other facility systems such as order entry, pharmacy, accounting,
and nursing systems. They can be transmitted in batch mode or broadcast to
outside-facility computer systems, including diagnostic and patient management
systems. It is assumed that proper routing and security mechanisms are in
place.
Event |
Description |
|---|---|
C01 |
Register a patient on a clinical trial |
C02 |
Cancel a patient registration on clinical trial (for clerical mistakes since an intended registration should not be canceled) |
C03 |
Correct/update registration information |
C04 |
Patient has gone off a clinical trial |
C05 |
Patient enters phase of clinical trial |
C06 |
Cancel patient entering a phase (clerical mistake) |
C07 |
Correct/update phase information |
C08 |
Patient has gone off phase of clinical trial |
CRM^C01-C08^CRM_C01 |
Clinical Study Registration Message |
Chapter |
|---|---|---|
MSH |
Message Header |
2 |
{ |
||
PID |
Patient Identification |
3 |
[PV1] |
Patient Visit |
3 |
CSR |
Clinical Study Registration |
7 |
{[CSP]} |
Clinical Study Phase |
7 |
} |
Data
are entered in the clinical trials system or may reside in laboratory,
pathology, radiology, pharmacy and/or other clinical applications. Most
clinical trials data - clinical observations and study variables - will be
communicated in OBR and OBX segments. The CSR, CSP, and CSS segments will
identify the specific association these OBR and OBX have to the clinical trial.
Data can be broadcast or transmitted in batch mode to study sponsors or the
data management center for collaborative studies.
Event |
Description |
|---|---|
C09 |
Automated time intervals for reporting, like monthly |
C10 |
Patient completes the clinical trial |
C11 |
Patient completes a phase of the clinical trial |
C12 |
Update/correction of patient order/result information |
CSU^C09-C12^CSU_C09 |
Unsolicited Study Data Message |
Chapter |
|---|---|---|
MSH |
Message Header |
2 |
{ |
PID repeat group open |
|
PID |
Patient Identification |
3 |
[PD1] |
Additional Demographics |
3 |
[{NTE}] |
Notes and comments |
2 |
[ |
PV1 optional group open |
|
PV1 |
Patient Visit |
3 |
[PV2] |
Patient Visit - Additional Info |
3 |
] |
PV1 optional group close |
|
CSR |
Clinical Study Registration |
7 |
{ |
CSP repeat group open |
|
[CSP] |
Clinical Study Phase |
7 |
{ |
CSS repeat group open |
|
[CSS] |
Clinical Study Data Schedule |
7 |
{ |
ORC repeat group open |
|
[ORC] |
Common Order |
4 |
OBR |
Observation Battery |
7 |
{OBX} |
Observation Results |
7 |
} |
ORC repeat group close |
|
{ |
ORC repeat group open |
|
[ORC] |
Common Order |
4 |
{ |
RXA repeat group open |
|
RXA |
Pharmacy Administration |
4 |
RXR |
Pharmacy Route |
4 |
} |
RXA repeat group close |
|
} |
ORC repeat group close |
|
} |
CSS repeat group close |
|
} |
CSP repeat group close |
|
} |
PID repeat group close |
The
CSR segment will contain fundamental administrative and regulatory information
required to document a patient's enrollment on a clinical trial. This segment
is all that is required if one needs to message another system that an
enrollment has taken place, i.e., from clinical trials to pharmacy, accounting,
or order entry systems. The CSR segment may also be used to identify that OBR,
OBX, RXA, and RXR segments that follow represent data applicable to the
identified study.
SEQ |
LEN |
DT |
OPT |
RP/# |
TBL# |
ITEM# |
ELEMENT NAME |
|---|---|---|---|---|---|---|---|
1 |
60 |
EI |
R |
01011 |
Sponsor Study ID |
||
2 |
60 |
EI |
O |
01036 |
Alternate Study ID |
||
3 |
250 |
CE |
O |
01037 |
Institution Registering the Patient |
||
4 |
30 |
CX |
R |
01038 |
Sponsor Patient ID |
||
5 |
30 |
CX |
O |
01039 |
Alternate Patient ID - CSR |
||
6 |
26 |
TS |
R |
01040 |
Date/Time Of Patient Study Registration |
||
7 |
250 |
XCN |
O |
Y |
01041 |
Person Performing Study Registration |
|
8 |
250 |
XCN |
R |
Y |
01042 |
Study Authorizing Provider |
|
9 |
26 |
TS |
C |
01043 |
Date/time Patient Study Consent Signed |
||
10 |
250 |
CE |
C |
01044 |
Patient Study Eligibility Status |
||
11 |
26 |
TS |
O |
Y/3 |
01045 |
Study Randomization Date/time |
|
12 |
250 |
CE |
O |
Y/3 |
01046 |
Randomized Study Arm |
|
13 |
250 |
CE |
O |
Y/3 |
01047 |
Stratum for Study Randomization |
|
14 |
250 |
CE |
C |
01048 |
Patient Evaluability Status |
||
15 |
26 |
TS |
C |
01049 |
Date/time Ended Study |
||
16 |
250 |
CE |
C |
01050 |
Reason Ended Study |
Components:
<entity identifier (ST)> ^ <namespace ID (IS)> ^ <universal ID
(ST)> ^ <universal ID type (ID).
Definition: The field contains the universal identifier for the clinical
trial. Since many clinical trials are collaborative and multi-centered, and
since one goal of these standards is to promote automated data exchange among
sites, the primary identifier should come from the sponsor. The coding system
component may reference the sponsor. Example:
T93-0807^NCI (where NCI refers to the National Cancer Institute).
Components:
<entity identifier (ST)> ^ <namespace ID (IS)> ^ <universal ID
(ST)> ^ <universal ID type (ID)>
Definition: This field contains an alternate identifier that may be used as
agreed upon by messaging parties. For example, the sending application may
code its internal study number here.
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field distinguishes the institution where registration
occurred. The legal approval to give patients access to a trial lies with the
Internal Review Board for the institution. Universal healthcare provider
facility codes should be used when they exist. Currently coding systems must
be devised by users.
Components:
<ID (ST)> ^ <check digit (ST)> ^ <code identifying the check
digit scheme employed (ID)> ^ < assigning authority (HD)> ^
<identifier type code (ID)> ^ < assigning facility (HD) ^
<effective date (DT)> ^ <expiration date (DT)>
Subcomponents of assigning authority: <namespace ID (IS)> &
<universal ID (ST)> * <universal ID type (ID)>
Subcomponents of assigning facility: <namespace ID (IS)> &
<universal ID (ST)> * <universal ID type (ID)>
Definition: This field contains the main patient identification for the study.
The sponsor patient ID allows automation of records on patients treated at
various institutions. The sponsor patient ID should be unique for each patient
participating on the study identified in CSR-1-sponsor study ID.
Components:
<ID (ST)> ^ <check digit (ST)> ^ <code identifying the check
digit scheme employed (ID)> ^ < assigning authority (HD)> ^
<identifier type code (ID)> ^ < assigning facility (HD) ^
<effective date (DT)> ^ <expiration date (DT)>
Subcomponents of assigning authority: <namespace ID (IS)> &
<universal ID (ST)> * <universal ID type (ID)>
Subcomponents of assigning facility: <namespace ID (IS)> &
<universal ID (ST)> * <universal ID type (ID)>
Definition: This field may be the sending application's patient
identification. Coding conventions may be used as agreed upon by users.
Definition: This field contains the date of the patient registration is mandatory. The time component is optional. The time stamp for a registration may be useful. For example, patients may be randomized at the pharmacy according to the order in which they were registered.
Components:
In Version 2.3 and later, use instead of the CN data type. <ID number
(ST)> ^ <family name (FN)> ^ <given name (ST)> ^ <second or
further given names or initials thereof (ST)> ^ <suffix (e.g., JR or III)
(ST)> ^ <prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (IS)> ^
<source table (IS)> ^ <assigning authority (HD)> ^ <name type
code (ID)> ^ <identifier check digit (ST)> ^ <code identifying the
check digit scheme employed (ID)> ^ <identifier type code (IS)> ^
<assigning facility (HD)> ^ <name representation code (ID)> ^
<name context (CE)> ^ <name validity range (DR)> ^ < name
assembly order (ID)>
Subcomponents of assigning authority: <namespace ID (IS)> &
<universal ID (ST)> & <universal ID type (ID)>
Subcomponents of assigning facility ID: <namespace ID (IS)> &
<universal ID (ST)> & <universal ID type (ID)>
Definition: This field contains the healthcare facility employee who actually
phoned, submitted a form, or interactively registered the patient on the
clinical trial. This is generally done under authorization from the attending
physician or a principal or collaborating investigator.
Components:
In Version 2.3 and later, use instead of the CN data type. <ID number
(ST)> ^ <family name (FN)> ^ <given name (ST)> ^ <second or
further given names or initials thereof (ST)> ^ <suffix (e.g., JR or III)
(ST)> ^ <prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (IS)> ^
<source table (IS)> ^ <assigning authority (HD)> ^ <name type
code (ID)> ^ <identifier check digit (ST)> ^ <code identifying the
check digit scheme employed (ID)> ^ <identifier type code (IS)> ^
<assigning facility (HD)> ^ <name representation code (ID)> ^
<name context (CE)> ^ <name validity range (DR)> ^ < name
assembly order (ID)>
Subcomponents of assigning authority: <namespace ID (IS)> &
<universal ID (ST)> & <universal ID type (ID)>
Subcomponents of assigning facility ID: <namespace ID (IS)> &
<universal ID (ST)> & <universal ID type (ID)>
Definition: This field contains the healthcare provider, generally the
attending physician, who is accountable that the patient is eligible for the
trial and has signed an informed consent. National standard healthcare
provider codes should be used when they exist. This field is required for the
patient registration trigger event (C01).
Definition: This field contains the consent form signing date is collected to provide a checkpoint that the consent form was obtained. Since many trials involve unapproved drugs and other treatment modalities, the consent form is highly important to document and store. This field is required for the patient registration trigger event (C01). The time component is optional.
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field indicates whether the patient was an appropriate
candidate for the trial. It is important for quality control and data
analysis. The code set will vary among clinical trials. An example answer set
is: Yes, No, By Approval, Not Assessed, Unknown. This field is
required for the patient registration trigger event (C01).
Definition: This field contains the date the patient was randomized. The time component is optional. Up to three randomizations are supported. Sequential randomizations are listed in chronological order.
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field contains codes that must be developed by users. The
blind treatment assignment may be communicated as a dummy text: ^blind
or if a coded treatment assignment must also be communicated:
1^blind^local_code. If more than one randomization occurs, the second and
third repetitions will correspond to the second and third repetitions of
CSR-11-study randomization date/time, if they exist.
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: Many studies have stratified randomization schemas. The strata
codes must be developed for each clinical trial. This field is important for
statistical analysis of the study results. The second and third repetitions
will correspond to the second and third repetitions of CSR-11-study
randomization date/time and CSR-12-randomized study arm, if they
exist.
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field categorizes the inclusion of this patient's data for
various analyses. The patient's data may be evaluable for analysis of adverse
events but not for outcomes. Or it may be evaluable for some outcomes and not
others. The coding systems will vary among trials. This field is required for
the off-study trigger event (C04).
Definition: This field contains the date the patient completes or is otherwise removed from the study. This field is required for the off-study event (C04). The time component is optional.
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This information is important for quality control and data
analysis. The coding systems will vary among trials. An example answer set
is: Adverse Events, Completed Trial, Death, Drug Resistance, Intercurrent
Illness, Lost to Follow up, No Response to Therapy, Noncompliance, Progression
of Disease, Protocol Violation, Refused Further Therapy. This field is
required for the off-study trigger event (C04).
The
CSP segment contains information on a patient's status for a particular phase
of the study. This segment is optional and is useful when a study has
different evaluation intervals within it. (See Section <IP_ADDRESS>, "
Phase
of a clinical trial:Phase of a Clinical Trial." The CSP segment is implemented
on a study-specific basis for messaging purposes. The fact that the patient
has entered a phase of the study that represents a certain treatment approach
may need to be messaged to other systems, like pharmacy, nursing, or order
entry. It is also important to sponsors and data management centers for
tracking patient progress through the study and monitoring the data schedule
defined for each phase. It may subsume OBR and OBX segments that follow it to
indicate that these data describe the phase.
SEQ |
LEN |
DT |
OPT |
RP/# |
TBL# |
ITEM# |
ELEMENT NAME |
|---|---|---|---|---|---|---|---|
1 |
250 |
CE |
R |
01022 |
Study Phase Identifier |
||
2 |
26 |
TS |
R |
01052 |
Date/time Study Phase Began |
||
3 |
26 |
TS |
O |
01053 |
Date/time Study Phase Ended |
||
4 |
250 |
CE |
C |
01054 |
Study Phase Evaluability |
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field identifies the phase of the study that a patient has
entered. The set of codes will generally be developed for each clinical trial,
although there are patterns that trials in particular disease or prevention
categories may follow. The phase structure will be based on data collation and
reporting needs for the study. It is an operational structure and need not be
discussed in the clinical trial protocol documentation or even made known to
patient care or data collection personnel. The coding system will usually be
developed by the sponsor for multicentered clinical trials to standardize the
receipt of automated data. Local codes could be added if an additional local
message is desired. Otherwise, local coding conventions will be used.
Example: 2^Init Rx, Crs 1^NCI T93-0807 Phases
Definition: This field contains the date the patient began this phase interval. The time is optional.
Definition: This field contains the date the patient ended this phase interval.
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field contains the disposition of the patient's data for this
phase interval for quality control and data analysis purposes. The set of
codes will vary across clinical trials. An example answer set: Complete,
Adverse Events Only, Outcome Only, None, Unknown.
The
Clinical Study Data Schedule (CSS) segment is optional depending on whether
messaging of study data needs to be linked to the scheduled data time points
for the study. (See Section <IP_ADDRESS>, "data schedule.") The CSS segment
enables communication of data schedules and adherence that ranges from the
basic to the elaborate. Use of the segment must be planned for each
implementation. Each CSS segment will subsume observation and drug
administration segments that follow, indicating that they satisfy this
scheduled time point.
SEQ |
LEN |
DT |
OPT |
RP/# |
TBL# |
ITEM# |
ELEMENT NAME |
|---|---|---|---|---|---|---|---|
1 |
250 |
CE |
R |
01055 |
Study Scheduled Time Point |
||
2 |
26 |
TS |
O |
01056 |
Study Scheduled Patient Time Point |
||
3 |
250 |
CE |
O |
Y/3 |
01057 |
Study Quality Control Codes |
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field contains the time point for which some instance of data
for the clinical trial was scheduled. The time point may be expressed in any
coded format. Some examples of time point values are: Prestudy,
Pretreatment, 4 times/day, Weekly, Every 3 days, Every course, At Relapse, At
Off Study. Alternatively, frequency values from Section 4.4.2, "Interval
component (CM)," (the Interval component of the TQ Timing/Quantity data type
could be used.) Time point naming conventions and usage must be specified by
implementers.
Definition: This field contains the date/time that the scheduled time point should occur for this patient. The date/time may be used for a reference in reviewing the actual dates on which scheduled items that follow in OBR segments occur for the patient. The time component is optional.
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: In clinical settings, the actual date of a treatment or
procedure may vary considerably from the due date. Various coding
systems may be used to evaluate the adherence to the schedule or acceptability
of the data. Coding systems will vary among trials.
The
CTI segment is an optional segment that contains information to identify the
clinical trial, phase and time point with which an order or result is
associated.
SEQ |
LEN |
DT |
OPT |
RP/# |
TBL# |
ITEM# |
ELEMENT NAME |
|---|---|---|---|---|---|---|---|
1 |
60 |
EI |
R |
01011 |
Sponsor Study ID |
||
2 |
250 |
CE |
C |
01022 |
Study Phase Identifier |
||
3 |
250 |
CE |
O |
01055 |
Study Scheduled Time Point |
Components:
<entity identifier (ST)> ^ <namespace ID (IS)> ^ <universal ID
(ST)> ^ <universal ID type (ID)>
Definition: This field contains the universal identifier for the clinical
trial. The coding system is as described in CSR-1-sponsor study ID.
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field identifies the phase of the study that a patient has
entered. See CSP-1-study phase identifier for details of coding systems.
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field identifies a time point in the clinical trial phase.
CTI-2-study phase identifier must be valued if CTI-3-study scheduled
time point is valued. Should correspond to CSS-1-study scheduled time
point.
The clinical study master segment (CMO) is described in Chapter 8 section 8.11.2.
The clinical study phase master segment (CMI) is described in Chapter 8, section 8.11.3.
The clinical study schedule master segment is described in Chapter 8, section 8.11.4.
MSH|^~\&|PDMS|MDACC|ORDER
ENTRY|MDACC|200006021649||CRM^C01|...<cr>
PID|1||223892||King^Sally^Brown||19530117|...<cr>
CSR|DM94-004^MDACC||MDACC|3||19941013||342^^^^^^^PDMS|
|||||1005^^^^^^^MDACC|19941013|Y^Meets All Requirements^PDMS|...<cr>
MSH|^~\&|PDMS|MDACC|PHARM|MDACC|200006050925||CRM^C05|...<cr>
PID|1||352352||West^Mary^L.||19230213|...<cr>
CSR|ID91-025^MDACC||MDACC|301||19941005||342^^^^^^^PDMS
|||19941201|2^blind^PDMS|
12^Smoker,Stage
II,<60^PDMS|...<cr>
CSP|2^Treatment^PDMS|19941201|...<cr>
MSH|^~\&|PDMS|MDACC|CTMS|NCI|200006050927||CSU^C09|...<cr>
PID|1||235925||J^F^M||19350616|...<cr> [note:anonymous]
CSR|T93-080^NCI|ID93-030^^MDACC|MDACC|14||19941205|...<cr>
CSS|^Prestudy|19941204|C^compliant^NCI<cr>
OBR|1|1234|1234|3^EligibilChecklist^StudyFormsList|||19941205|...<cr>
Note: The clinical trials section probably needs its own definition of OBR.
OBR-2&3 have condition rules indicating that the placer and filler numbers
must be present in either the ORC or the OBR. Since an ORC is not present,
then these fields must be populated in the OBR. My guess is that clinical
trials aren't interested in the placer and filler number.
OBX|1|CE|ELIG1^Elig Crit 1^NCI|Text Elig Crit 1|Y|...<cr>
OBX|2|CE|ELIG2^Elig Crit 2^NCI||Y|...<cr>
OBR|2|1235|1235|4^Prestudy Form^StudyFormsList|||19941205|...<cr>
OBX|1|CE|QOL^Quality of Life^NCI||2\T\3\T\2\T\4\T\2^SPITZER|...<cr>
OBX|2|CE|PRICHEM^Prior Chemo^NCI||Yes|...<cr>
OBX|3|CE|PRIBIOL^Prior Biologics^NCI||No|...<cr>
OBX|4|NM|NUMREM^Number Prior Remissions^NCI||2|...<cr>
OBR|3|932^OE|243789^LAB|88304^SURG PATH REPORT|||19940101|...<cr>
OBX|1|CE|88304&ANT|1|9999^PANCREAS^SNM|...<cr>
OBX|2|CE|88304&IMP|2|9999^ADENOCARCINOMA^SNM|...<cr>
OBR|4|933^OE|243790^LAB|85022^CBC|||199412050800|...<cr>
OBX|1|NM|718-7^HEMOGLOBIN:^LN||13.4|GM/DL|14-18|N||S|F|19860522|...<cr>
[cbc values]
OBX|2|NM|4544-3^HEMATOCRIT:^LN||40.3|%|42-52|L||S|F|19860522|...<cr>
OBX|3|NM|789-8^ERYTHROCYTES:^LN||4.56|10*6/ml|4.7-6.1|L||S|F|19860522|...<cr>
OBX|4|NM|787-22^ERYTHROCYTE MEAN CORPUSCULAR VOLUME:^LN||88|fl
|80-94|N||S|F|19860522|...<cr>
OBX|5|NM|785-6^ERYTHROCYTE MEAN CORPUSCULAR HEMOGLOBIN:^LN||29.5|pg
|27-31|N||N|F|19860522|...<cr>
OBX|6|NM|786-4^ERYTHROCYTE MEAN CORPUSCULAR HEMOGLOBIN
CONCENTRATION:^LN||33|%|33-37|N||N|F|19860522|...<cr>
OBX|7|NM|6690-2^LEUKOCYTES:^LN||10.7|10*3/ml|4.8-10.8|N||N|F|19860522|...<cr>
OBX|8|NM|764-1^NEUTROPHILS BAND FORM/100
LEUKOCYTES:^LN||2|%|||||F|...<cr>
OBX|9|NM|769-0^NEUTROPHILS SEGMENTED/100 LEUKOCYTES:^LN||67|%|||||F
|...<cr>
OBX|10|NM|736-9^LYMPHOCYTES/100 LEUKOCYTES:^LN||29|%|||||F|...<cr>
OBX|11|NM|5905-5^MONOCYTES/100 LEUKOCYTES:^LN||1|%|||||F|...<cr>
OBX|12|NM|713-8^EOSINOPHILS/100 LEUKOCYTES:^LN||2|%|||||F|...<cr>
OBR|5|934^OE|243791^LAB|80004^ELECTROLYTES|||199412050800|...<cr>
OBX|1|NM|2947-0^SODIUM:^LN||150|mmol/l|136-148|H||A|F|19850301
|...<cr>
OBX|2|NM|2823-3^POTASSIUM:^LN||4.5|mmol/l|3.5-5|N||N|F|19850301|...<cr>
[electrolytes values]
OBX|3|NM|2069-3^CHLORIDE:^LN||102|mmol/l|94-105|N||N|F|19850301|...<cr>
OBX|4|NM|2028-9^CARBON DIOXIDE.TOTAL:^LN||27|mmol/l|24-31|N||N|F
|19850301|...<cr>
CSP|^Course 1|19941205|19950120|Y^Toxicity and Response^NCI |...<cr>
CSS|^Course Completion|19950120|...<cr>
OBR|1|935^OE|243791^LAB|2039-6^CARCINOEMBRYONIC
AG:^LN|||19941008|...<cr>
OBX|1|NM|2039-6^CARCINOEMBRYONIC AG:^LN||15.2|IU |...<cr>
OBR|2|1236|1236|10^Course Completion Form^StudyPhaseFormsList|||19950120
|...<cr>
OBX|1|CE|CRSRESP^Course Response^NCI||4^Partial Response|...<cr>
OBX|2|NM|DRUGDISP^Capsules Dispensed^NCI||60|...<cr>
OBX|3|NM|DRUGRETN^Capsules Returned^NCI||5|...<cr>
OBX|4|ID|DXCOMP^Diagnostic Tests Compliance^NCI||Y|...<cr>
OBX|5|CE|PERSTAT^Performance Status^NCI||3^ZUBRODS|...<cr>
OBR|3|1237|1237|9999^Adverse
Events|...<cr> |
[Note: Needs to maintain compatibility with ongoing product experience message efforts.] |
OBX|4|CE|9999&GRADE|1|M^MODERATE|...<cr> |
[Note2: There are other possible OBX suffixes defined by FDA: APEX/ NADIR, ACTION, THERAPY, OUTCOME, RECHALLENGE.] |
Patients
experience symptoms, manifest signs or develop diseases or syndromes while
exposed to medical devices and/or drugs. Evidence suggests that some of these
symptoms, signs, diseases or syndromes may develop as a consequence of the
products used. Examples include the development of clear cell adenocarcinoma
of the vagina in the daughters of mothers treated with diethylstilbestrol
during pregnancy and gastrointestinal bleeding in patients treated with
non-steroidal anti-inflammatory drugs. While it is difficult to prove
causality, strong evidence exists in many cases.
It is important to document such experiences during the development and testing
of products to identify potential adverse effects but also during routine use
of the product to identify serious adverse effects which occur infrequently.
The latter is the realm of pharmacoepidemiology and post-marketing
surveillance.
Adverse events are important for product manufacturers as signal generating
hypotheses concerning drug kinetics or dynamics, often in special populations
of patients. Adverse events are important for regulators in ensuring that
manufacturers protect the public health in assessments of risk and benefits,
including special populations, and that they promptly and thoroughly
investigate individual events and clusters of events. Adverse events are
especially important for practitioners and patients who always deal with a
special population of one individual who may be having an event and a
practitioner seeking information about related events seen with the same or
similar products.
Reporting has usually focused on serious and unexpected events.
Serious, if defined unambiguously, focuses attention on those events of most
importance to the patient and practitioner. Expected events are those which
prior experience has demonstrated to be probabilistically linked to the product
and are generally included in product labeling.
Because of the risks associated with the uses of drugs and medical devices, a
system of surveillance has been established in most developed countries. With
globalization of the marketplace, the need to share this information across
national boundaries has increased. Currently most reporting is performed using
a series of forms, including CIOMS, yellow cards, the FDA's 1639 and MedWatch
forms and the Japanese form, which are sent:
* from identified reporting sources to regulatory bodies
* from identified reporting sources to product manufacturers
* between regulatory bodies
* within product manufacturers
* within regulatory bodies
* from product manufacturers to regulatory bodies
* from regulatory bodies to the WHO Collaborative Drug Surveillance Center
Any chemical compound that may be used on or administered to humans or animals as an aid in the diagnosis, treatment or prevention of disease or other abnormal condition, for the relief of pain or suffering, or to control or improve any physiological condition (Dorland's Illustrated Medical Dictionary 27th edition).
Something contrived for or used in the diagnosis (vascular catheters), treatment (thermotherapy units) or prevention of disease or other abnormal condition, for the relief of pain or suffering or to control or improve any physiologic condition, including instrumentation and implanted devices (prosthetic cardiac valves, pacemakers, hip prostheses).
A drug or medical device.
Drug name that is not protected by a trademark, usually descriptive of its chemical structure; sometimes called a public name. In the US, most generic drug names are assigned by the US Adopted Name Council (USAN). Other generic names in common use are the National Formulary (NF) and the US Pharmacopoeia (USP) names. Figure 7-3 lists other available drug coding systems.
Proprietary names that are registered to protect the name for the sole use of the manufacturer holding the trademark.
*
Pre-marketing: Any untoward medical occurrence in a patient or clinical
investigation subject administered a pharmaceutical product and which does not
necessarily have a causal relationship with this treatment.
* Post-marketing/European Union: Any undesirable experience occurring to a
patient treated with a pharmaceutical product whether or not considered related
to the medicinal product.
* Post-marketing/US: Any adverse event associated with the use of a drug in
humans, whether or not considered drug related, including the following: An
adverse event occurring in the course of the use of a drug product in
professional practice; an adverse event occurring from drug overdose; an
adverse event occurring from drug withdrawal; and any failure of expected
pharmacologic action.
* WHO: Any untoward medical occurrence that may present during treatment with a
pharmaceutical product but which does not necessarily have a causal
relationship with this product.
*
Pre-marketing: All noxious and unintended responses to a medicinal product
related to any dose.
* Post-marketing/WHO: A response to a drug which is noxious and unintended, and
which occurs at doses normally used in man for prophylaxis, diagnosis, or
therapy of disease or for the modification of physiologic function
* Post-marketing/European Union: A reaction which is harmful and unintended and
which occurs at doses normally used in man for the prophylaxis, diagnosis, or
treatment of disease or the modification of physiological function.
* Post-marketing/US: Any undesirable effect reasonably associated with the use
of the drug, that may occur as part of the pharmacological action of the drug
or may be unpredictable.
An exposure which truly does increase or decrease the probability of a certain outcome.
When an event occurs a product may be suspected as causing the event but rarely can it be proven particularly at an early stage of the product's life. Certain information about the relationship between the product and the event can reinforce the belief in a causal relationship between the product and the event while others can decrease the probability that there is a causal relationship.
Many geopolitical entities have established agencies/authority responsible for regulating products used in health care. The agencies are collectively referred to as regulatory agencies.
The organization which is responsible for the manufacture of a product. This will usually be the entity, which holds the marketing authorization for the product.
The organization which holds the authority to market a product. This will often be the organization, which manufactures the product.
An
adverse product reaction which:
* is fatal (results in death)
* is life threatening
* requires hospitalization or prolongation of a hospitalization
* results in persistent or significant disability/incapacity
* results in a congenital anomaly/birth defect.
Medical and scientific judgment should be exercised in deciding whether
expedited reporting is appropriate in other situations, such as important
medical events that may not be immediately life threatening or result in
hospitalization but may jeopardize the patient or may require intervention to
prevent one of the other outcomes listed in the definition above. These should
also be considered serious.
Expected
events are those which prior experience has demonstrated to be
probabilistically linked to the product and are generally included in product
labeling.
Pre-marketing: An adverse reaction, the nature or severity of which is not
consistent with the applicable product information (e.g., Investigator's
Brochure for an unapproved investigational product).
Post-marketing/European Union: This relates to an adverse reaction which is not
mentioned in any EC summary of product characteristics (SPC). In the absence
of any European SPC, an international document prepared by the marketing
authorization holder containing all relevant safety information which the
marketing authorization holder considers should be listed for the medicinal
product in all countries where the medicinal product is marketed (Care Data
Sheet).
Post-marketing/US current: Unexpected means an adverse drug experience that is
not listed in the current labeling for the drug product and includes an event
that may be symptomatically and pathophysiologically related to an event listed
in the labeling but differs from the event because of greater severity or
specificity.
Post-marketing/US (proposed): The applicant's core safety data sheet shall be a
document prepared by the applicant that contains all relevant safety
information, including adverse drug experiences, which the applicant believes
should e listed for the drug in all countries where the drug is marketed. It
may be used by the applicant as the reference document by which an adverse drug
experience is judged to be expected or unexpected for purposes of this
post-marketing periodic report.
Post-marketing/WHO: An adverse reaction, the nature or severity of which is not
consistent with domestic labeling or market authorization, or expected from
characteristics of the drug.
Gabrielli
ER. Standard specification for drug therapy documentation. ASTM Committee
E31.12 July (1993).
Kessler DA. Introducing MEDWatch. JAMA 269: 2765-2768(1993).
Kurata JH, Overhage JM, Gabrielli E, Jones JK. International Data Standards
for Hospital-based Drug Surveillance. M.D. Computing 12(1) 50-57 (1995).
Moore N, Montera d, Coulson R, DeAbajo F, Kreft-Jais C, Biron A, Monteaugudo J.
The single case format: proposal for a structured message for the telematic
transmission of information on individual case reports in pharmacovigilance.
Pharmacoepidemiology and Drug Safety 3: 157-162 (1994)
Thompson WL. A modest proposal for enhancing the safety and effectiveness of
use of human drugs, biologics and devices and animal health products with human
health implications through cost-effective health informatics tools supporting
a global database of safety reports as a joint ICH E2, M1 and M2 initiative.
Private communication. March (1995)
The
message header segment will care one of three event types at MSH-9-message
type.
Event |
Description |
|---|---|
P07 |
PEX - Unsolicited initial individual product experience report |
P08 |
PEX - Unsolicited update individual product experience report |
P09 |
SUR - Summary product experience report |
The
primary application of this message is to transfer information related to an
adverse event occurring while a patient was exposed to a product.
PEX^P07-P08^PEX_P07 |
Product Experience Message |
Chapter |
|---|---|---|
MSH |
Message Header |
2 |
EVN |
Event Type |
3 |
PID |
Patient Identification |
3 |
[PD1] |
Additional Demographics |
3 |
[{NTE}] |
Notes and comments |
2 |
[PV1 |
Patient Visit |
3 |
[PV2]] |
Patient Visit - Additional Info |
3 |
{ |
||
PES |
Product Experience Sender |
7 |
{ |
||
PEO |
Product Experience Observation |
7 |
{ |
||
PCR |
Potential Causal Relationship |
7 |
[ |
||
RXE |
Pharmacy/Treatment Encoded Order |
4 |
[{RXR}] |
Pharmacy/Treatment Route |
4 |
] |
||
[{ |
||
RXA |
Pharmacy/Treatment Administration |
4 |
[RXR] |
Pharmacy/Treatment Route |
4 |
}] |
||
[{PRB}] |
Detail problem segment |
12 |
[{OBX}] |
Observation/Result Segment |
7 |
[{NTE}] |
Notes and comments |
2 |
[ |
||
NK1 |
Associated parties segment |
2 |
[ |
||
RXE |
Pharmacy/Treatment Encoded Order |
4 |
[{RXR}] |
Pharmacy/Treatment Route |
4 |
] |
||
[{ |
||
RXA |
Pharmacy/Treatment Administration |
4 |
[RXR] |
Pharmacy/Treatment Route |
4 |
}] |
||
[{PRB}] |
Detail Problem Segment |
12 |
[{OBX}] |
Observation/Results Segment |
7 |
] |
||
[{ |
||
CSR |
Clinical study registration |
7 |
[{CSP}] |
Clinical study phase segment |
7 |
}] |
||
}}} |
The
PID segment provides the patient identification information including
institutional identification numbers, date of birth and in the case of patients
who die, information about their death. Patients are frequently identified
only by their initials which can be represented in the PID segment, e.g. the
initials JMO would appear as J^M^O in the name field of the PID segment. The
EVN segment identifies the type of transaction that is being sent -- primarily
it specifies who the sender is and implies which information is expected to be
included in the message. A message sent from a healthcare provider, for
example, might contain minimal information, while a message from a
pharmaceutical manufacturer might contain nearly complete information.
The PES or Product Experience Sender segment provides information about the
message sender and its knowledge of the event. The heart of the product
experience message is the product experience observation (PEO) segment and the
PCR segments clustered under it. The PEO segment identifies a clinical event
and the PCR segments identify products which are potentially causally related
to the event. There may be more than one product which is potentially related
to the event so multiple PCR segments can be included. RXE and RXR segments
can be repeated and provide information about the products the patient was
exposed to at the time of the event (typically excluding those used to treat
the event). Details about the administration of the products identified in the
PCR segments should be described with RXE and RXR segments. Repeated PRB
segments provide information about diagnoses which represent comorbid
conditions. The repeated OBX segments are used to send patient observations
such as height, weight, last menstrual period, and laboratory results.
Analytical commentary can be included in the NTE segment. This commentary will
typically be the sender's analysis of the event and the potentially causally
related products. Finally, the CSR and CSP segments can optionally be included
if the event occurred during a formal clinical trial in order to describe the
trial.
When a product experience relates to an exposure which occurred indirectly
(transmammary or transplacentally for example), the individual experiencing the
adverse effect -- the fetus or child -- would be described in the PID segment
and the individual via which they are exposed in the NK1 segment. The first
set of RXE segments would typically indicate the drugs which to which the fetus
or child was exposed. Additional codes for the route are defined in this
Appendix to allow the suspected routes of exposure to be represented. The
second set of RXE/RXR segment - those clustered under the NK1 segment - would
represent the route by which the mother or father was exposed to the drug.
Early spontaneous abortion would normally be treated as an adverse effect on
the mother rather than on the fetus, and the PID would refer to the mother.
The second set of PRB/OBX segments reflects the problems/observations
associated with the individual via which they were exposed.
Each message contains information about a single case including one patient
(PID), at least one sender (PES), one or more events (PEO) and one or more
suspected products (PCR and RXE/RXA) for a minimal message. The structure of
the message allows actual administration information to be sent in the RXA if
known; if administration information is unavailable, or the adverse reaction
cannot be related to a single administration event, the RXE segment can be used
to send prescription level information. Additional information may be included
based on availability and regulatory requirements.
The MSH segment specifies the character set (MSH-18) and the language
(MSH-19) used in the PEX message.
The PEX message is designed to accommodate required reporting of adverse
product events to the responsible regulatory agencies. In the United States,
the paper version of this report is Medwatch.
Sending
summary reports related to products constitutes a P09 event.
SUR^P09^SUR_P09 |
Summary Product Experience Report |
Chapter |
|---|---|---|
MSH |
Message Header |
2 |
{ |
||
FAC |
Facility |
7 |
{ |
||
PSH |
Product Summary Header |
7 |
PDC |
Product Detail Country |
7 |
} |
||
PSH |
Product Summary Header |
7 |
{ |
||
FAC |
Facility |
7 |
PDC |
Product Detail Country |
7 |
NTE |
Notes (for PCR) |
2 |
} |
||
ED |
Encapsulated Data |
2 |
} |
The
Summary Product Experience Report message can be divided into two separate
parts. Part 1 consists of a Facility segment which identifies the reporting
organization, a Product Summary Header segment which provides summary
information about the products and manufacturers, and a Product Detail Country
segment which provides country specific product identification and marketing
information. Part 2 consists of a repeating series of segments. These
segments could be used to represent data about each model of a medical device
(Part 2 of FDA Form 3417, for example). The Product Summary Header segment
provides manufacturer's data, under which repeating sets of Facility segments
(representing multiple manufacturing sites), a Product Detail Country segment
(representing marketing and product identification data) and the Note segment
(for other commentary) may follow. Finally, the Encapsulated Data (ED) segment
can be used to transmit images of documents, including any of the MIME
(Multimedia Internet Mail Extension) support formats such as JPEG, GIF, and
FAX.
Regulatory agencies require a variety of reports that are centered on the
product, not on a single patient. Some of these reports request information
just about the product, and some request information about the product combined
with a summary of the product experience reports on that product. These are
used by regulatory agencies to provide totals against which they can verify
that they have received and processed all of the relevant reports, and to
calculate denominators for computing event rates. If manufacturers begin to
transmit these reports electronically and regulatory agencies in turn
electronically confirm the receipt of such reports, the need for some of these
summary reports will decline.
The SUR message provides a mechanism for sending a variety of different summary
reports. In the United States, the Medical Device Reporting Annual
Certification and the Medical Device Reporting Baseline Report are examples of
such reports. Below, we use these two medical device reports to illustrate how
one would map the contents of this kind of report to the SUR message.
Manufacturers are required to submit a Baseline Report (FDA Form 3417 of
October, 1995 (when a device is first released. The focus of this report is a
single product. The first part requests information about the manufacturer of
the product (Questions 2a through 2g), e.g., the firm's name, street address,
city, country, type of firm (e.g., manufacturer, distributor, both); the
manufacturer's contact (Questions 3a through 3g). e.g., title, street address,
city, state, phone number, and whether the firm is an organization of a foreign
manufacturer. Most of this information can be transmitted as fields within the
FAC (Facility segment - the first segment in the SUR message following the
MSH). Question 1 (which asks the type of baseline report - initial or annual
update) and Question 7 (the date of the report) are reported in the PSH
(Product Summary Header) segment that follows the FAC segment in the SUR
message. The second part of the Baseline Report form also includes information
about the device name (Question 2), generic name (Question 3), device model
number (Question 4), device catalogue number (Question 5), other device
identifier (Question 6), product code (Question 7), and device family (Question
8), related device information (Question 9), the basis for marketing the device
(Question 10), device life (Question 11), the date the device was first
marketed (Question 12), the date the device ceased being marketed (Question
13), whether the device was the subject of a 522 study (Question 14), and the
number of devices manufactured, distributed, and in current use (Question 15).
All of these questions with the exception of #9 are represented in the PDC
segment. Questions 16a and 16b are represented by nested PSH segments.
The Medical Device Reporting Annual Certification form consists of two parts.
Part 12 transmits information describing the firm submitting the report
(Questions 2a through 2h) and the individual who completed the report
(Questions 3a through 3g). These questions are represented in the FAC segment.
Question 1 (period covered by the certification) corresponds to the PSH
segment. Part 2, Question 3, which details one or more individual devices, can
be transmitted in the repeating FAC and PSH segments. Figure 7-19 summarizes
the mapping between questions on these two FDA forms and the SUR message.
Baseline Report |
Annual Certification |
SUR |
|---|---|---|
MSH |
||
Part
1 |
Part
1 |
{ FAC |
Part
1 |
Part
1 |
{PSH |
PDC |
||
} |
||
Part
2 |
Part
2 |
PSH |
Part
2 |
Part
2 |
{ FAC |
Part
2 |
PDC |
|
NTE |
||
} |
||
Part
2 |
ED |
|
} |
SEQ |
LEN |
DT |
OPT |
RP/ # |
TBL # |
ITEM # |
ELEMENT NAME |
|---|---|---|---|---|---|---|---|
1 |
250 |
XON |
O |
Y |
01059 |
Sender Organization Name |
|
2 |
250 |
XCN |
O |
Y |
01060 |
Sender Individual Name |
|
3 |
250 |
XAD |
O |
Y |
01062 |
Sender Address |
|
4 |
250 |
XTN |
O |
Y |
01063 |
Sender Telephone |
|
5 |
75 |
EI |
O |
01064 |
Sender Event Identifier |
||
6 |
2 |
NM |
O |
01065 |
Sender Sequence Number |
||
7 |
600 |
FT |
O |
Y |
01066 |
Sender Event Description |
|
8 |
600 |
FT |
O |
01067 |
Sender Comment |
||
9 |
26 |
TS |
O |
01068 |
Sender Aware Date/Time |
||
10 |
26 |
TS |
R |
01069 |
Event Report Date |
||
11 |
3 |
ID |
O |
Y/2 |
0234 |
01070 |
Event Report Timing/Type |
12 |
1 |
ID |
O |
0235 |
01071 |
Event Report Source |
|
13 |
1 |
ID |
O |
Y |
0236 |
01072 |
Event Reported To |
Components:
<organization name (ST)> ^ <organization name type code (IS)>
^<ID Number (NM)> ^ <check digit (NM)> ^ <code identifying the
check digit scheme employed (ID)> ^ <assigning authority (HD)> ^
<identifier type code (IS)> ^ <assigning facility ID (HD)> ^
<name representation code (ID)>
Subcomponents of assigning authority: <namespace ID (IS)> &
<universal ID (ST)> * <universal ID type (ID)>
Subcomponents of assigning facility: <namespace ID (IS)> &
<universal ID (ST)> * <universal ID type (ID)>
Definition: This field contains the name of the organization sending the
message. Coded lists of manufacturers such as that from the World Health
Organization database might be used in the component of the coded name to
identify the source code type. If sent from an individual, this field may not
be sent.
Components:
In Version 2.3 and later, use instead of the CN data type. <ID number
(ST)> ^ <family name (FN)> ^ <given name (ST)> ^ <second or
further given names or initials thereof (ST)> ^ <suffix (e.g., JR or III)
(ST)> ^ <prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (IS)> ^
<source table (IS)> ^ <assigning authority (HD)> ^ <name type
code (ID)> ^ <identifier check digit (ST)> ^ <code identifying the
check digit scheme employed (ID)> ^ <identifier type code (IS)> ^
<assigning facility (HD)> ^ <name representation code (ID)> ^
<name context (CE)> ^ <name validity range (DR)> ^ < name
assembly order (ID)>
Subcomponents of assigning authority: <namespace ID (IS)> &
<universal ID (ST)> & <universal ID type (ID)>
Subcomponents of assigning facility ID: <namespace ID (IS)> &
<universal ID (ST)> & <universal ID type (ID)>
Definition: This field contains the name of the contact individual. If sent by
an organization, the individuals in the organization who serve as primary
contact points correspondence regarding this event.
Components:
In Version 2.3 and later, replaces the AD data type. <street address
(SAD)> ^ <other designation (ST)> ^ <city (ST)> ^ <state or
province (ST)> ^ <zip or postal code (ST)> ^ <country (ID)> ^
< address type (ID)> ^ <other geographic designation (ST)>
^ <county/parish code (IS)> ^ <census tract (IS)> ^
<address representation code (ID)> ^ <address validity range
(DR)>
Definition: This field contains the postal address of the message sender to
which correspondence regarding the experience being reported should be directed.
Components:
[NNN] [(999)]999-9999 [X99999] [B99999] [C any text] ^ <telecommunication
use code (ID)> ^ <telecommunication equipment type (ID)> ^ <email
address (ST)> ^ <country code (NM)> ^ <area/city code (NM)> ^
phone number (NM)> ^ <extension (NM)> ^ <any text (ST)>
Definition: This field contains the telephone number of the message sender to
which telephone communications regarding the experience being reported should
be directed. An electronic mail address can be specified in this field.
Components:
<entity identifier (ST)> ^ <namespace ID (IS)> ^ <universal ID
(ST)> ^ <universal ID type (ID)>
Definition: The first component of this field contains the product
manufacturer's unique alphanumeric identifier for this specific event. This
identifier will be used on all subsequent communications regarding this event.
For events reported to the FDA, the identifier is: the FDA assigned
manufacturer or distributor number; a hyphen; the 4-digit year; a hyphen; and a
consecutive 5-digit sequence number for each report filled by the sender that
year. For example, the event identifier for the third event reported in 1996
by a manufacturer whose FDA-assigned registration number is 1234567 would be
1234567-1993-3. Organizations without a FDA-assigned registration number
should use 0000000 until assigned a number. Reports from other facilities
should use the 10-digit HCFA number left padded with zeros in place of the
FDA-assigned registration number. The second through fourth components are
defined in exactly the same way as the three components of the hierarchic
designator (HD) data type (Section 2.8.18, "HD - hierarchic designator").
Definition: This field contains sequentially assigned integer values which distinguish messages which share the same sender event identification element. 0 for initial report, 1 for second, and so on.
Definition: This field contains the summary narrative text description of the event that occurred written by the sender, which may include a description of the nature of the event, how the product was involved, any environmental conditions that may have influenced the event, and patient follow-up or required treatment. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative. By representing clinical information in OBX segments rather than in the narrative, these data become much more useful and flexible.
Definition: This field contains the text commentary regarding the report being made, such as disclaimers, which is not necessarily part of the report.
Definition: This field identifies the date the sender became aware of the event.
Definition: This field contains the date the message was originally sent to the regulatory agency.
Definition:
This field contains the timing type of report as required by regulatory
agency. Refer to HL7 Table 0234 - Report timing for valid
values.
Value |
Description |
|---|---|
CO |
Correction |
AD |
Additional information |
RQ |
Requested information |
DE |
Device evaluation |
PD |
Periodic |
3D |
3 day report |
7D |
7 day report |
10D |
10 day report |
15D |
15 day report |
30D |
30 day report |
Definition:
This field identifies the source from which the sender learned about the
event. Multiple sources may be reported by repeating the element.
If the source of the report is a clinical trial, the CSR and CSP segments can
be included to define the study. Refer to HL7 Table 0235 - Report
source for valid values.
Value |
Description |
|---|---|
C |
Clinical trial |
L |
Literature |
H |
Health professional |
R |
Regulatory agency |
D |
Database/registry/poison control center |
N |
Non-healthcare professional |
P |
Patient |
M |
Manufacturer/marketing authority holder |
E |
Distributor |
O |
Other |
Definition:
This field indicates all the entities to whom the entity submitting the report
has reported the event. Repeat the element if the report was submitted to more
than one entity. Refer to HL7 Table 0236 - Event reported to for
valid values.
Value |
Description |
|---|---|
M |
Manufacturer |
L |
Local facility/user facility |
R |
Regulatory agency |
D |
Distributor |
Details
related to a particular clinical experience or event are embodied in the PEO
segment. This segment can be used to characterize an event which might be
attributed to a product to which the patient was exposed. Products with a
possible causal relationship to the observed experience are described in the
following PCR (possible causal relationship) segments. The message format was
designed to be robust and includes many optional elements which may not be
required for a particular regulatory purpose but allow a complete
representation of the drug experience if needed.
A PEX message can contain multiple PEO segments if the patient experienced more
than one event but must contain at least one PEO segment.
SEQ |
LEN |
DT |
OPT |
RP/ # |
TBL # |
ITEM # |
ELEMENT NAME |
|---|---|---|---|---|---|---|---|
1 |
250 |
CE |
O |
Y |
01073 |
Event Identifiers Used |
|
2 |
250 |
CE |
O |
Y |
01074 |
Event Symptom/Diagnosis Code |
|
3 |
26 |
TS |
R |
01075 |
Event Onset Date/Time |
||
4 |
26 |
TS |
O |
01076 |
Event Exacerbation Date/Time |
||
5 |
26 |
TS |
O |
01077 |
Event Improved Date/Time |
||
6 |
26 |
TS |
O |
01078 |
Event Ended Data/Time |
||
7 |
250 |
XAD |
O |
Y |
01079 |
Event Location Occurred Address |
|
8 |
1 |
ID |
O |
Y |
0237 |
01080 |
Event Qualification |
9 |
1 |
ID |
O |
0238 |
01081 |
Event Serious |
|
10 |
1 |
ID |
O |
0239 |
01082 |
Event Expected |
|
11 |
1 |
ID |
O |
Y |
0240 |
01083 |
Event Outcome |
12 |
1 |
ID |
O |
0241 |
01084 |
Patient Outcome |
|
13 |
600 |
FT |
O |
Y |
01085 |
Event Description From Others |
|
14 |
600 |
FT |
O |
Y |
01086 |
Event From Original Reporter |
|
15 |
600 |
FT |
O |
Y |
01087 |
Event Description From Patient |
|
16 |
600 |
FT |
O |
Y |
01088 |
Event Description From Practitioner |
|
17 |
600 |
FT |
O |
Y |
01089 |
Event Description From Autopsy |
|
18 |
250 |
CE |
O |
Y |
01090 |
Cause Of Death |
|
19 |
250 |
XPN |
O |
Y |
01091 |
Primary Observer Name |
|
20 |
250 |
XAD |
O |
Y |
01092 |
Primary Observer Address |
|
21 |
250 |
XTN |
O |
Y |
01093 |
Primary Observer Telephone |
|
22 |
1 |
ID |
O |
0242 |
01094 |
Primary Observer's Qualification |
|
23 |
1 |
ID |
O |
0242 |
01095 |
Confirmation Provided By |
|
24 |
26 |
TS |
O |
01096 |
Primary Observer Aware Date/Time |
||
25 |
1 |
ID |
O |
0243 |
01097 |
Primary Observer's identity May Be Divulged |
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field may be used to transmit the event identifier used by
other entities for this event. The entry would typically contain a unique
alphanumeric identifier assigned by an entity with the text component null or
repeating the unique alphanumeric identifier followed by the organization's
identifier. An event identifier might be GB1234^GB1234^PharmaGiant for example.
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field is the coded diagnosis or problem description which best
describes the event. A text representation of the coded item should routinely
be included. MEDDRA and WHO-ART are examples of appropriate coding schemes, as
are the patient and device codes included in the FDA Center for Devices and
Radiologic Health's coding manual for Form 3500A.
Definition: This field contains a report or best estimate of the date/time of onset of the event. The date/time can be recorded to any level of precision it is known (hour, day, month, year).
Definition: This field identifies the best estimate of the date/time the event was exacerbated.
Definition: This field identifies the best estimate of the date/time the event improved.
Definition: This field identifies the best estimate of the date/time the event resolved.
Components:
In Version 2.3 and later, replaces the AD data type. <street address
(SAD)> ^ <other designation (ST)> ^ <city (ST)> ^ <state or
province (ST)> ^ <zip or postal code (ST)> ^ <country (ID)> ^
< address type (ID)> ^ <other geographic designation (ST)>
^ <county/parish code (IS)> ^ <census tract (IS)> ^
<address representation code (ID)> ^ <address validity range
(DR)>
Definition: This field identifies the location at which the event started.
Often this will specify only the country in which the event started.
Definition:
This field is contains a classification of the type of product experience this
event is considered to represent. Refer to HL7 Table 0237 - Event
qualification for valid values.
Value |
Description |
|---|---|
I |
Interaction |
O |
Overdose |
A |
Abuse |
M |
Misuse |
D |
Dependency |
L |
Lack of expect therapeutic effect |
W |
Drug withdrawal |
B |
Unexpected beneficial effect |
Unexpected beneficial effects would not often be reported but are required by certain countries.
Definition:
This field indicates whether the event was judged as serious. If the event
did not meet the criteria for seriousness but the sender judges the event
significant on other grounds, the event can be identified as significant
[but not serious]. Refer to HL7 Table 0238 - Event
seriousness for valid values.
Value |
Description |
|---|---|
Y |
Yes |
S |
Significant |
N |
No |
Definition:
This field indicates whether the observed event was expected or unexpected as
judged. Refer to HL7 Table 0239 - Event expected for valid
values.
Value |
Description |
|---|---|
Y |
Yes |
N |
No |
U |
Unknown |
Definition:
This field identifies the consequence of the event on the patient. If
the consequence of the event is not understood or not available, the patient
outcome element may be used although neither is required. May be repeated if
more than one is appropriate. Refer to HL7 Table 0240 - Event
consequence for valid values.
Value |
Description |
|---|---|
D |
Death |
L |
Life threatening |
H |
Caused hospitalized |
P |
Prolonged hospitalization |
C |
Congenital anomaly/birth defect |
I |
Incapacity which is significant, persistent or permanent |
J |
Disability which is significant, persistent or permanent |
R |
Required intervention to prevent permanent impairment/damage |
O |
Other |
When
an event specific outcome is not available, the patient outcome element may be
used to represent the patient's overall outcome if that information is known.
Refer to HL7 Table 0241 - Patient outcome for valid values.
Value |
Description |
|---|---|
D |
Died |
R |
Recovering |
N |
Not recovering/unchanged |
W |
Worsening |
S |
Sequelae |
F |
Fully recovered |
U |
Unknown |
Definition: This field contains a summary narrative text description of the event that occurred written by the sender. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative. By representing clinical information in OBX segments rather than in the narrative, these data become much more useful and flexible.
Definition: This field contains a summary narrative text description of the event provided by the original reporter. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative.
Definition: This field contains a summary narrative text description of the event obtained directly from the patient. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative, which will allow the data to be more readily represented and manipulated.
Definition: This field contains a summary narrative text description of the event provided by the practitioner most familiar with the event. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative.
Definition: This field contains a summary narrative text description of the autopsy results. Note that laboratory results can be encoded as OBX segments rather then including them in the narrative.
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field identifies the coded cause of death. May be repeated
as necessary to list multiple contributing causes. A text description can be
included by including text but no code or coding system. For example, if the
cause of death is to be determined at autopsy but results are not yet
available, the cause of death element could be ^Pending autopsy^. The
date/time of death can be sent in the PID and the autopsy results sent in the
event description from autopsy element of the PEO segment.
Components:
In Version 2.3, replaces the PN data type. <family name (FN)> ^
<given name (ST)> ^ <second and further given names or initials
thereof (ST)> ^ <suffix (e.g., JR or III) (ST)> ^ <prefix (e.g.,
DR) (ST)> ^ <degree (e.g., MD) (IS)> ^ <name type code (ID)
> ^ <name representation code (ID)> ^ <name context (CE)> ^
<name validity range (DR)> ^ <name assembly order (ID)>
Definition: This field identifies the name of the person who initially
described the event.
Components:
In Version 2.3 and later, replaces the AD data type. <street address
(SAD)> ^ <other designation (ST)> ^ <city (ST)> ^ <state or
province (ST)> ^ <zip or postal code (ST)> ^ <country (ID)> ^
< address type (ID)> ^ <other geographic designation (ST)>
^ <county/parish code (IS)> ^ <census tract (IS)> ^
<address representation code (ID)> ^ <address validity range
(DR)>
Definition: This field identifies the address of the person who initially
described the event.
Components:
[NNN] [(999)]999-9999 [X99999] [B99999] [C any text] ^ <telecommunication
use code (ID)> ^ <telecommunication equipment type (ID)> ^ <email
address (ST)> ^ <country code (NM)> ^ <area/city code (NM)> ^
phone number (NM)> ^ <extension (NM)> ^ <any text (ST)>
Definition: This field identifies the telephone number of the person who
initially described the event.
Definition:
This field contains the qualification of the primary observer which may assist
in assessing the validity of the observations. Refer to HL7 Table
0242 - Primary observer's qualification for valid values.
Value |
Description |
|---|---|
P |
Physician (osteopath, homeopath) |
R |
Pharmacist |
M |
Mid-level professional (nurse, nurse practitioner, physician's assistant) |
H |
Other health professional |
C |
Health care consumer/patient |
L |
Lawyer/attorney |
O |
Other non-health professional |
Definition: This field contains the qualification of the health professional who confirmed the observation if the primary observer was not a health professional. Refer to HL7 Table 0242 - Primary observer's qualification for valid values.
Definition: This field identifies the date/time the primary observer became aware of event.
Definition:
Indicates whether or not the primary observer, if known to the sender, grants
permission to disclose his or her identity to the product manufacturer for the
purpose of further investigating the event. If the element is absent, the
assumption should be made that permission is not granted. Refer to
HL7 Table 0243 - Identity may be divulged for valid values.
Value |
Description |
|---|---|
Y |
Yes |
N |
No |
NA |
Not applicable |
The
PCR segment is used to communicate a potential or suspected relationship
between a product (drug or device) or test and an event with detrimental effect
on a patient. This segment identifies a potential causal relationship between
the product identified in this segment and the event identified in the PEO
segment.
More than one PCR segment can be included in the message if more than one
product is possibly causally related to the event.
SEQ |
LEN |
DT |
OPT |
RP/ # |
TBL # |
ITEM # |
ELEMENT NAME |
|---|---|---|---|---|---|---|---|
1 |
250 |
CE |
R |
01098 |
Implicated Product |
||
2 |
1 |
IS |
O |
0249 |
01099 |
Generic Product |
|
3 |
250 |
CE |
O |
01100 |
Product Class |
||
4 |
8 |
CQ |
O |
01101 |
Total Duration Of Therapy |
||
5 |
26 |
TS |
O |
01102 |
Product Manufacture Date |
||
6 |
26 |
TS |
O |
01103 |
Product Expiration Date |
||
7 |
26 |
TS |
O |
01104 |
Product Implantation Date |
||
8 |
26 |
TS |
O |
01105 |
Product Explantation Date |
||
9 |
8 |
IS |
O |
0244 |
01106 |
Single Use Device |
|
10 |
250 |
CE |
O |
01107 |
Indication For Product Use |
||
11 |
8 |
IS |
O |
0245 |
01108 |
Product Problem |
|
12 |
30 |
ST |
O |
Y/3 |
01109 |
Product Serial/Lot Number |
|
13 |
1 |
IS |
O |
0246 |
01110 |
Product Available For Inspection |
|
14 |
250 |
CE |
O |
01111 |
Product Evaluation Performed |
||
15 |
250 |
CE |
O |
0247 |
01112 |
Product Evaluation Status |
|
16 |
250 |
CE |
O |
01113 |
Product Evaluation Results |
||
17 |
8 |
ID |
O |
0248 |
01114 |
Evaluated Product Source |
|
18 |
26 |
TS |
O |
01115 |
Date Product Returned To Manufacturer |
||
19 |
1 |
ID |
O |
0242 |
01116 |
Device Operator Qualifications |
|
20 |
1 |
ID |
O |
0250 |
01117 |
Relatedness Assessment |
|
21 |
2 |
ID |
O |
Y/6 |
0251 |
01118 |
Action Taken In Response To The Event |
22 |
2 |
ID |
O |
Y/6 |
0252 |
01119 |
Event Causality Observations |
23 |
1 |
ID |
O |
Y/3 |
0253 |
01120 |
Indirect Exposure Mechanism |
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field contains the coded identity of the product (drug,
device, etc.) which is possibly causally related to the event. Includes the
product identity number such as NDC, model or catalogue numbers. If a coded
value is not available for the product a text description can be included as
the second component of the CE data. See Chapter 2 for a listing of some
recognized coding systems for drugs and devices.
Definition:
This field indicates whether the product used was a generic or a branded
product. Refer to User-defined Table 0249 - Generic product for
suggested values.
Value |
Description |
|---|---|
No suggested values defined |
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field contains the coded classification of the implicated
product. For drugs, this would usually be the drug class - calcium channel
blocking agents for nifedipine for example. For other products it would be the
generic type of device, e.g., urinary catheter, cardiac pacemaker. If a coded
value is not available for the class, a text description can be included.
Components:
<quantity (NM)> ^ <units (CE)>
Subcomponents of units: <identifier (ST)> & <test (ST)>
& <name of coding system (IS)> & <alternate identifier
(ST)> & <alternate text (ST)> & <name of alternate coding
system (IS)>
Definition: This field represents the total duration of therapy with product
listed. The treatment at the current dose and schedule are indicted in the
quantity timing attribute of the RXE segment but the patient may have been
treated for some time previously at a different dose or on a different
schedule. The quantity in the second component of the CQ should be a time
quantity.
Definition: This field indicates the date the product was manufactured.
Definition: This field contains the expiration date indicated on the product packaging.
Definition: If an implantable medical device, this field identifies the date device was implanted.
Definition: If an implantable medical device and it was removed, the field identifies the date it was removed.
Definition:
This field indicates whether the product was designed for a single use. Refer
to User-defined Table 0244 - Single use device for suggested
values.
Value |
Description |
|---|---|
No suggested values defined |
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field contains coded representation of the problem or
diagnosis for which the product was used. See Chapter 2 for some coding
systems which might be chosen to transmit diagnoses or problems.
Definition:
A product problem would exist if a product malfunction could lead to death or
serious injury. Refer to User-defined Table 0245 - Product
problem for suggested values.
Value |
Description |
|---|---|
No suggested values defined |
Definition: This field is an alphanumeric descriptor which identifies the specific item or lot of drug. This descriptor would normally be obtained from the package labeling or item itself.
Definition:
This field indicates that the product is available for analysis.
User-defined Table 0246 -Product available for inspection is
used as the HL7 identifier for the user-defined table of values for this
field. If the product was returned to the manufacturer, this would be
indicated by including the date it was returned in the date product returned to
manufacturer element.
Value |
Description |
|---|---|
No suggested values defined |
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field indicates the type of product evaluation performed.
The evaluation codes listed in SubPart B of the Coding Manual for FDA Form
3500A, "Type of Evaluation Performed" may be used. If no codes are available,
text may be sent in the second component of the field.
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field identifies the status of product evaluation. Subpart A
Item H.3 of the Coding Manual for FDA Form 3500A may also be used. If no codes
are available, text may be sent in the second component of the field. Refer to
HL7 Table 0247 - Status of evaluation for valid values.
Value |
Description |
|---|---|
Y |
Evaluation completed |
P |
Evaluation in progress |
K |
Problem already known, no evaluation necessary |
X |
Product not made by company |
A |
Evaluation anticipated, but not yet begun |
D |
Product discarded -- unable to follow up |
C |
Product received in condition which made analysis impossible |
I |
Product remains implanted -- unable to follow up |
U |
Product unavailable for follow up investigation |
Q |
Product under quarantine -- unable to follow up |
R |
Product under recall/corrective action |
O |
Other |
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field contains the results of the product evaluation.
Definition:
This field contains the source of the product evaluated. Refer to HL7
Table 0248 - Product source for valid values.
Value |
Description |
|---|---|
A |
Actual product involved in incident was evaluated |
L |
A product from the same lot as the actual product involved was evaluated |
R |
A product from a reserve sample was evaluated |
N |
A product from a controlled/non-related inventory was evaluated |
Definition: If the product was returned to the manufacturer, this field contains the date it was returned may be reported.
Definition: This field identifies the qualification of the person operating the device when the event occurred. Refer to HL7 Table 0242 - Primary observer's qualification for valid values.
Definition:
This field represents the assessment of relatedness of the product to the
event. Refer to HL7 Table 0250 - Relatedness assessment for valid
values.
Value |
Description |
|---|---|
H |
Highly probable |
M |
Moderately probable |
S |
Somewhat probable |
I |
Improbable |
N |
Not related |
Definition:
This field indicates the action taken as a result of the event. Segment may
repeat if multiple categories of evidence are relevant. Refer to
HL7 Table 0251 - Action taken in response to the event for
valid values.
Value |
Description |
|---|---|
WP |
Product withdrawn permanently |
WT |
Product withdrawn temporarily |
DR |
Product dose or frequency of use reduced |
DI |
Product dose or frequency of use increased |
OT |
Other |
N |
None |
Definition:
This field contains observations made about the event which may bear on
causality. Refer to HL7 Table 0252 - Causality observations for
valid values. Segment may repeat if multiple categories of evidence are
relevant.
Value |
Description |
|---|---|
AW |
Abatement of event after product withdrawn |
BE |
Event recurred after product reintroduced |
LI |
Literature reports association of product with event |
IN |
Event occurred after product introduced |
EX |
Alternative explanations for the event available |
PL |
Effect observed when patient receives placebo |
TC |
Toxic levels of product documented in blood or body fluids |
DR |
Dose response observed |
SE |
Similar events in past for this patient |
OE |
Occurrence of event was confirmed by objective evidence |
OT |
Other |
Definition:
The patient identified in the PID segment, who experienced the event, might
have been exposed to the potential causal product via an intermediary, e.g., a
child might be exposed to a product through the placenta or in breast milk, or
a transfusion recipient might be exposed via a blood product. If this is the
case, the mechanism of product transmission is identified in this field, using
the valid values in HL7 Table 0253 - Indirect exposure mechanism.
If this field is populated, the identity of the person through whom the product
was transmitted is contained in NK1 and RXE segments which follow.
Value |
Description |
|---|---|
B |
Breast milk |
P |
Transplacental |
F |
Father |
X |
Blood product |
O |
Other |
SEQ |
LEN |
DT |
OPT |
RP/ # |
TBL # |
ITEM # |
ELEMENT NAME |
|---|---|---|---|---|---|---|---|
1 |
60 |
ST |
R |
01233 |
Report Type |
||
2 |
60 |
ST |
O |
01297 |
Report Form Identifier |
||
3 |
26 |
TS |
R |
01235 |
Report Date |
||
4 |
26 |
TS |
O |
01236 |
Report Interval Start Date |
||
5 |
26 |
TS |
O |
01237 |
Report Interval End Date |
||
6 |
12 |
CQ |
O |
01238 |
Quantity Manufactured |
||
7 |
12 |
CQ |
O |
01239 |
Quantity Distributed |
||
8 |
1 |
ID |
O |
0329 |
01240 |
Quantity Distributed Method |
|
9 |
600 |
FT |
O |
01241 |
Quantity Distributed Comment |
||
10 |
12 |
CQ |
O |
01242 |
Quantity in Use |
||
11 |
1 |
ID |
O |
0329 |
01243 |
Quantity in Use Method |
|
12 |
600 |
FT |
O |
01244 |
Quantity in Use Comment |
||
13 |
2 |
NM |
O |
Y/8 |
01245 |
Number of Product Experience Reports Filed by Facility |
|
14 |
2 |
NM |
O |
Y/8 |
01246 |
Number of Product Experience Reports Filed by Distributor |
Definition: This field contains the name, title, or other description of the report. Typically, the field will include the agency name (e.g., FDA), agency component if applicable (e.g., CDRH) and the report type (e.g., Medical Device Reporting Baseline Report).
Definition: This field contains the form descriptor which describes the report. Typically, the field will include the agency name (e.g., FDA), agency component if applicable (e.g., CDRH) and the form number (e.g., 3417).
Definition: This field contains the date as assigned by the sender.
Definition: This field contains the date that marks the beginning of the time interval covered by the current report.
Definition: This field contains the date which marks the inclusive end of the time interval covered by the current report.
Components:
<quantity (NM)> ^ <units (CE)>
Subcomponents of units: <identifier (ST)> & <test (ST)>
& <name of coding system (IS)> & <alternate identifier
(ST)> & <alternate text (ST)> & <name of alternate coding
system (IS)>
Definition: This field is used to send the number of units of the product
manufactured during the reporting interval. The second component can be used
to specify the units for the quantity.
Components:
<quantity (NM)> ^ <units (CE)>
Subcomponents of units: <identifier (ST)> & <test (ST)>
& <name of coding system (IS)> & <alternate identifier
(ST)> & <alternate text (ST)> & <name of alternate coding
system (IS)>
Definition: This field is used to send the number of units of the product
which was distributed during the reporting interval. The second component can
be used to specify the units for the quantity.
Definition:
This field is used for measuring the quantity distributed. An explanation of
the method used for estimation can be included in PSH-9-quantity distributed
comment. Refer to HL7 Table 0329 - Quantity method for
valid values.
Value |
Description |
|---|---|
A |
Actual count |
E |
Estimated (see comment) |
Definition: This field is used for any explanatory text needed but in particular should provide a description of the estimation method used. If referring to the description used in a previous report, the comment should include the product identifier and data of that report.
Components:
<quantity (NM)> ^ <units (CE)>
Subcomponents of units: <identifier (ST)> & <test (ST)>
& <name of coding system (IS)> & <alternate identifier
(ST)> & <alternate text (ST)> & <name of alternate coding
system (IS)>
Definition: This field is used to send the number of units of the product
which were in use during the reporting interval. The second component can be
used to specify the units for the quantity.
Definition: This field contains the method used for measuring the quantity in use. An explanation of the method used for estimation can be included in PSH-12-quantity in use comment. Refer to HL7 Table 0329 - Quantity method for valid values.
Definition: This field can be used for any explanatory text needed but in particular should provide a description of the estimation method used. If referring to the description used in a previous report, the comment should include the product identifier and data of the report.
Definition: The field contains the number of product experience reports filed by facility.
Definition: This field contains the number of product experience reports filed by distributor.
SEQ |
LEN |
DT |
OPT |
RP/ # |
TBL # |
ITEM # |
ELEMENT NAME |
|---|---|---|---|---|---|---|---|
1 |
250 |
XON |
R |
Y |
01247 |
Manufacturer/Distributor |
|
2 |
250 |
CE |
R |
01248 |
Country |
||
3 |
60 |
ST |
R |
01249 |
Brand Name |
||
4 |
60 |
ST |
O |
01250 |
Device Family Name |
||
5 |
250 |
CE |
O |
01251 |
Generic Name |
||
6 |
60 |
ST |
O |
Y |
01252 |
Model Identifier |
|
7 |
60 |
ST |
O |
01253 |
Catalogue Identifier |
||
8 |
60 |
ST |
O |
Y |
01254 |
Other Identifier |
|
9 |
250 |
CE |
O |
01255 |
Product Code |
||
10 |
4 |
ID |
O |
0330 |
01256 |
Marketing Basis |
|
11 |
60 |
ST |
O |
01257 |
Marketing Approval ID |
||
12 |
12 |
CQ |
O |
01258 |
Labeled Shelf Life |
||
13 |
12 |
CQ |
O |
01259 |
Expected Shelf Life |
||
14 |
26 |
TS |
O |
01260 |
Date First Marketed |
||
15 |
26 |
TS |
O |
01261 |
Date Last Marketed |
Components:
<organization name (ST)> ^ <organization name type code (IS)>
^<ID Number (NM)> ^ <check digit (NM)> ^ <code identifying the
check digit scheme employed (ID)> ^ <assigning authority (HD)> ^
<identifier type code (IS)> ^ <assigning facility ID (HD)> ^
<name representation code (ID)>
Subcomponents of assigning authority: <namespace ID (IS)> &
<universal ID (ST)> * <universal ID type (ID)>
Subcomponents of assigning facility: <namespace ID (IS)> &
<universal ID (ST)> * <universal ID type (ID)>
Definition: This field contains the identity of the manufacturer/distributor.
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field contains the country to which this product detail is
relevant. ISO 3166 provides a list of country codes that may be used.
Definition: This field contains the name under which the product is marketed by this manufacturer.
Definition: This field contains the name used by the manufacturer to describe the family of products to which this product belongs.
Components<identifier
(ST)> ^ <text (ST)> ^ <name of coding system (IS)> ^
<alternate identifier (ST)> ^ <alternate text (ST)> ^ <name of
alternate coding system (IS)>
Definition: This field contains the name generically used to identify the
product.
Definition: This field contains the manufacturer's model identifier for the product.
Definition: This field contains the manufacturer's catalogue identifier for the product.
Definition: This field contains any other identifier used to for the product.
Components:
<identifier (ST)> ^ <text (ST)> ^ <name of coding system
(IS)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^
<name of alternate coding system (IS)>
Definition: This field contains the product code from an external coding
system such as that used by the CDRH at the FDA.
Definition:
This field contains the basis for marketing approval. Refer to HL7
Table 0330 - Marketing basis for valid values.
Value |
Description |
|---|---|
510K |
510 (K) |
510E |
510 (K) exempt |
PMA |
Premarketing authorization |
PRE |
Preamendment |
TXN |
Transitional |
522S |
Post marketing study (522) |
Definition: This field contains the designation or description of the marketing basis.
Components:
<quantity (NM)> ^ <units (CE)>
Subcomponents of units: <identifier (ST)> & <text (ST)>
& <name of coding system (IS)> & <alternate identifier
(ST)> & <alternate text (ST)> & <name of alternate coding
system (IS)>
Definition: This field contains the shelf life of the product as labeled.
This will usually be in months or years. If there is no shelf life indicated
in the product labeling, this field will be empty.
Components:
<quantity (NM)> ^ <units (CE)>
Subcomponents of units: <identifier (ST)> & <text (ST)>
& <name of coding system (IS)> & <alternate identifier
(ST)> & <alternate text (ST)> & <name of alternate coding
system (IS)>
Definition: This field contains the shelf life of the product expected by the
manufacturer. This will usually be in months or years.
Definition: This field contains the date the product was first marketed in the country.
Definition: This field contains the date the product was last marketed in the country. This field will be omitted if the product is still being marketed.
SEQ |
LEN |
DT |
OPT |
RP/ # |
TBL # |
ITEM # |
ELEMENT NAME |
|---|---|---|---|---|---|---|---|
1 |
20 |
EI |
R |
01262 |
Facility ID-FAC |
||
2 |
1 |
ID |
O |
0331 |
01263 |
Facility Type |
|
3 |
250 |
XAD |
R |
Y |
01264 |
Facility Address |
|
4 |
250 |
XTN |
R |
01265 |
Facility Telecommunication |
||
5 |
250 |
XCN |
O |
Y |
01266 |
Contact Person |
|
6 |
60 |
ST |
O |
Y |
01267 |
Contact Title |
|
7 |
250 |
XAD |
O |
Y |
01166 |
Contact Address |
|
8 |
250 |
XTN |
O |
Y |
01269 |
Contact Telecommunication |
|
9 |
250 |
XCN |
R |
Y |
01270 |
Signature Authority |
|
10 |
60 |
ST |
O |
01271 |
Signature Authority Title |
||
11 |
250 |
XAD |
O |
Y |
01272 |
Signature Authority Address |
|
12 |
250 |
XTN |
O |
01273 |
Signature Authority Telecommunication |
Components:
<entity identifier (ST)> ^ <namespace ID (IS)> ^ <universal ID
(ST)> ^ <universal ID type (ID)>
Definition: This field contains the facility identifier.
Definition:
This field contains the type of facility. Refer to HL7 Table 0331 -
Facility type for valid values.
Value |
Description |
|---|---|
U |
User |
M |
Manufacturer |
D |
Distributor |
A |
Agent for a foreign manufacturer |
Components:
In Version 2.3 and later, replaces the AD data type. <street address
(SAD)> ^ <other designation (ST)> ^ <city (ST)> ^ <state or
province (ST)> ^ <zip or postal code (ST)> ^ <country (ID)> ^
< address type (ID)> ^ <other geographic designation (ST)>
^ <county/parish code (IS)> ^ <census tract (IS)> ^
<address representation code (ID)> ^ <address validity range
(DR)>
Definition: This field contains the facility's address.
Components:
[NNN] [(999)]999-9999 [X99999] [B99999] [C any text] ^ <telecommunication
use code (ID)> ^ <telecommunication equipment type (ID)> ^ <email
address (ST)> ^ <country code (NM)> ^ <area/city code (NM)> ^
phone number (NM)> ^ <extension (NM)> ^ <any text (ST)>
Definition: This field contains the facility's telecommunication information.
Components:
In Version 2.3 and later, use instead of the CN data type. <ID number
(ST)> ^ <family name (FN)> ^ <given name (ST)> ^ <second or
further given names or initials thereof (ST)> ^ <suffix (e.g., JR or III)
(ST)> ^ <prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (IS)> ^
<source table (IS)> ^ <assigning authority (HD)> ^ <name type
code (ID)> ^ <identifier check digit (ST)> ^ <code identifying the
check digit scheme employed (ID)> ^ <identifier type code (IS)> ^
<assigning facility (HD)> ^ <name representation code (ID)> ^
<name context (CE)> ^ <name validity range (DR)> ^ <name
assembly order (ID)>
Subcomponents of assigning authority: <namespace ID (IS)> &
<universal ID (ST)> & <universal ID type (ID)>
Subcomponents of assigning facility ID: <namespace ID (IS)> &
<universal ID (ST)> & <universal ID type (ID)>
Definition: This field contains the primary contact person's name.
Definition: This field contains the primary contact person's title.
Components:
In Version 2.3 and later, replaces the AD data type. <street address
(SAD)> ^ <other designation (ST)> ^ <city (ST)> ^ <state or
province (ST)> ^ <zip or postal code (ST)> ^ <country (ID)> ^
< address type (ID)> ^ <other geographic designation (ST)>
^ <county/parish code (IS)> ^ <census tract (IS)> ^
<address representation code (ID)> ^ <address validity range
(DR)>
Definition: This field contains the primary contact person's address.
Components:
[NNN] [(999)]999-9999 [X99999] [B99999] [C any text] ^ <telecommunication
use code (ID)> ^ <telecommunication equipment type (ID)> ^ <email
address (ST)> ^ <country code (NM)> ^ <area/city code (NM)> ^
phone number (NM)> ^ <extension (NM)> ^ <any text (ST)>
Definition: This field contains the primary contact person's telecommunication
information.
Components:
In Version 2.3 and later, use instead of the CN data type. <ID number
(ST)> ^ <family name (FN)> ^ <given name (ST)> ^ <second or
further given names or initials thereof (ST)> ^ <suffix (e.g., JR or III)
(ST)> ^ <prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (IS)> ^
<source table (IS)> ^ <assigning authority (HD)> ^ <name type
code (ID)> ^ <identifier check digit (ST)> ^ <code identifying the
check digit scheme employed (ID)> ^ <identifier type code (IS)> ^
<assigning facility (HD)> ^ <name representation code (ID)> ^
<name context (CE)> ^ <name validity range (DR)> ^ < name
assembly order (ID)>
Subcomponents of assigning authority: <namespace ID (IS)> &
<universal ID (ST)> & <universal ID type (ID)>
Subcomponents of assigning facility ID: <namespace ID (IS)> &
<universal ID (ST)> & <universal ID type (ID)>
Definition: This field contains the name of the individual with signature
authority or who is responsible for the report.
Definition: This field contains the title of the individual with signature authority or who is responsible for this report.
Components:
In Version 2.3 and later, replaces the AD data type. <street address
(SAD)> ^ <other designation (ST)> ^ <city (ST)> ^ <state or
province (ST)> ^ <zip or postal code (ST)> ^ <country (ID)> ^
< address type (ID)> ^ <other geographic designation (ST)>
^ <county/parish code (IS)> ^ <census tract (IS)> ^
<address representation code (ID)> ^ <address validity range
(DR)>
Definition: This field contains the address of the individual with signature
authority or who is responsible for this report.
Components:
[NNN] [(999)]999-9999 [X99999] [B99999] [C any text] ^ <telecommunication
use code (ID)> ^ <telecommunication equipment type (ID)> ^ <email
address (ST)> ^ <country code (NM)> ^ <area/city code (NM)> ^
phone number (NM)> ^ <extension (NM)> ^ <any text (ST)>
Definition: This field contains the telecommunication information of the
individual with signature authority of who is responsible for this report.
MSH|^-&|SAP||RAP||200006051512||PEX^P07|...<cr>
EVN|...<cr>
PID|1||""|A^A^A||19230616|F|||||||||||||||||Y|...<cr>
Note: This section probably needs to have its own definition of the PID.
PID-3 is a required field in chapter 3, but in the context of this section
probably shouldn't be required. I also removed PID-23, Birthplace (19950710).
A date is not a birthplace.
PES|Eli Lilly and Company||Lilly Corporate Center^^Indianapolis^IN^46285||
GB95070448A|0|||19950704|19950710|10D|...<cr>
PEO||^Awaiting results of autopsy|19950704||||^^^^^GB||S|N|D~H~O||Patient
admitted via casualty with increased shortness of breath and left sided chest
pain on 04 JUL 95 for assessment.~11-JUL-95 Patient admitted 09-JUL-95 at 11:30
PM with an 18 hour history of diarrhoea followed by collapse. On admission,
patient was exhausted and dehydrated. She had a rash on both breasts and
abdomen. Patient found to have deteriorating renal function. Patient commenced
IV fluid, however patient was found dead on 10-JUL-95 morning. Query vomited
and aspirated. Post mortem requested. Events possibly related to study
drug.|...<cr>
PCR|xxxxx^Wonder Drug 1^ATC|N|^antineoplastic|||||||^NON SMALL CELL LUNG
CANCER|...<cr>
RXE|1^^^19950629^19950710|xxxxx^Wonder Drug
1^ATC|1||TAB|||||||||||||||||M1|3||||NON SMALL CELL LUNG
CANCER|...<cr>
RXR|PO|...<cr>
Note: The message structure for the PEX does not allow repeating RXE/RXR
groups within a PCR group. This is probably a mistake in the message
definition table for the PEX messages.
PRB|AD|19950704|705^DYSPNEA^MEDR|...<cr>
PRB|AD|19950710|20143^DEATH^MEDR|...<cr>
PRB|AD|19950704|18330^CHEST PAIN^MEDR|...<cr>
PRB|AD|19950709|21197^DIARRHEA^MEDR|...<cr>
PRB|AD|19950709|6432^SYNCOPE^MEDR|...<cr>
PRB|AD|19950709|4966^DEHYDRATION^MEDR|...<cr>
PRB|AD|19950709|20544^KIDNEY FUNCTION ABNORMAL^MEDR|...<cr>
OBX|1|NM|804-5^lEUKOCYTES^LN||2300|10*3/ml|||||F|19940704|...<cr>
OBX|2|NM|770-8^NEUTROPHILS/100
LEUKOCYTES^LN||1.9|%|||||F|19950704|...<cr>
OBX|3|NM|6299-2^UREA NITROGEN^LN||22.3|mg%|||||F|19950709|...<cr>
OBX|4|NM|2160-0^CREATININE^LN||247|mmole|||||F|19950709|...<cr>
NTE|||Additional details must be obtained from the affiliate in order to assess
causality. A three day alert phone call was made to the FDA on
12-JUL-95|...<cr>
HL7
support for waveform data is intended to provide access to waveform data in a
variety of situations. Needs include remote access to waveform data, research,
and input to clinical decision making, as well as obtaining snippets of
waveform data to complete waveform data sets. In some cases, predominantly in
research oriented environments, a physician may want to manually interpret,
scale the raw data, and/or apply alternative algorithms to the raw data values.
In these environments, the review of waveform data includes the processing of
the raw data. The HL7 waveform data capabilities allow for these applications,
including data collection information such as skew between channels, in-band
with the waveform.
Waveform observations, like other results, can be transmitted in solicited mode
(in response to a query) or in unsolicited mode - see Section 7.15.1, "W01 -
waveform result, unsolicited transmission of requested information," for
discussion. In either mode of transmission the timing information, channel
definition, annotations, and digital time series data in the waveform recording
are treated as individual "observations" within a result "battery." For a
given "battery," each of the result fragments is transmitted in a separate OBX
segment, where the Observation ID suffix for the OBX is used to identify the
result fragment. To reduce ambiguity, an explicit framework for defining the
structure of waveform result messages is provided. The elements of that
framework include the following:
* Waveform specific data types which enable transmission of channel definition
and waveform data
* Waveform specific Observation ID suffixes (OBX-3-observation identifier)
which uniquely identify the category of waveform result in a given OBX
segment
* Fixed rules for combining OBX segments of each category in the waveform
response messages
* Explicit definition of which OBX fields may be populated for each category of
waveform result
* Unique trigger events which identify result messages which contain batteries
of waveform result OBX segments
Three waveform specific data types have been defined to enable transmission of waveform results.
<value1>
^ <value2> ^ <value3> ^ <value4> ^ ...
Definition: This data type is used to represent a series (array) of numeric
values, each one having a data type of NM. A field of this type may contain a
one-dimensional array (vector or row) of numbers. Also, by allowing the field
to repeat, a two-dimensional array (table) of numbers may be transmitted using
this format, with each row of the table represented as one repetition of the
field. Arrays which have one or more values not present may be transmitted
using this data type. "Not present" values are represented as two adjacent
component delimiters. If the absent values occur at the end of a row, the
trailing component delimiters may be omitted. If an entire row of a table has
no values, no component delimiters are necessary (in this case, there will be
two adjacent repetition delimiters). The maximum number of values in one
repetition of an NA format field is determined by the maximum field length.
Examples:
|125^34^-22^-234^569^442^-212^6| vector of 8 numbers
|1.2^-3.5^5.2~2.0^3.1^-6.2~3.5^7.8^-1.3| 3 x 3 array of numbers
|^2^3^4~5^^^8~9^10~~17^18^19^20| 5 x 4 array of numbers with
the values in positions
1,1), (2,2), (2,3), (3,3),
(3,4), (4,1), (4,2), (4,3),
and (4,4) not present
<sample
1 from channel 1>^<sample 1 from channel 2>^<sample 1 from channel
3> ...~
<sample 2 from channel 1>^<sample 2 from channel 2>^<sample
2 from channel 3> ...~
...
Definition: This data type is used to represent channel-multiplexed waveform
data, (e.g., the digitized values from an analog-to-digital converter or other
digital data source). Each value is of type NM, and represents a time sample
from a channel. This segment may contain data from one or more channels. The
waveform data is in channel-multiplexed format (that is, the values for all
channels for the first time sample are transmitted, then the values for the
next time sample, and so on until the requisite number of time samples have
been transmitted). Time samples are separated by repeat delimiters (~), and
channels within a sample are separated by component delimiters (^). The time
between samples (the sampling interval) is the reciprocal of the digitization
frequency as specified using the CD data type.
Examples:
|0^0^0~1^1^1~2^2^2~3^3^3~4^4^4~5^5^5| 3 channels (identical), 5 time-samples
|0~1~2~3~4~5~6~7~8~9~10| 1 channel, 11 time-samples
Components:
<channel identifier (CM)> ^ <waveform source (CM)> ^ <channel
sensitivity/units (CM)> ^ <channel calibration parameters (CM)> ^
<channel sampling frequency (NM)> ^ <minimum/maximum data values
(CM)>
Subcomponents of channel identifier: <channel number (NM)> &
<channel name (ST)>
Subcomponents of waveform source: <Source name 1 (ST)> &
<Source name 2 (ST)>
Subcomponents of channel sensitivity/units: <channel sensitivity
(NM)> & < unit of measure identifier (ST)> & < unit of
Measure Description (ST)> & < unit of Measure Coding System (IS)>
& <alternate unit of measure identifier (ST)> & <alternate
unit of Measure Description (ST)> & <alternate unit of Measure Coding
System (IS)>
Subcomponents of channel calibration parameters: < channel calibration
sensitivity correction factor (NM)> & < channel calibration baseline
(NM)> & < channel calibration time skew (NM)>
Subcomponents of minimum/maximum data values: < minimum data value
(NM)> & <maximum data value (NM)>
Definition: This data type is used for labeling of digital waveform data. It
defines a recording channel which is associated with one of the values in each
time sample of waveform data. Each channel has a number (which generally
defines its position in a multichannel display) and an optional name or label
(also used in displays). One or two named waveform sources may also be
associated with a channel (providing for the use of differential amplifiers
with two inputs). The other components of the channel definition data type are
optional. The individual components are defined as follows:
Subcomponents:
<channel number (NM)> & <channel name (ST)>
Definition: Two subcomponents separated by subcomponent delimiters (&)
which identify the channel, consisting of a channel number (required, maximum 4
characters, data type NM)and a channel name (optional, maximum 17 characters,
data type ST).
The channel number identifies the recording channel associated with a specified value in a time sample of data. It generally defines its position in a multichannel display.
Definition: The channel name is a text string used as a label in waveform data displays. If this name is not present, the channel label displayed is <source1>-<source2>, where <source1> and <source2> are the names of the two waveform sources connected to this channel, or, if only one waveform sources <source1> is specified, the channel label displayed when the channel name is not given is <source1>.
Subcomponents:
<Source name 1 (ST)> & <Source name 2 (ST)>
Definition: Identifies the source of the waveform connected to the channel.
Two names (each maximum of 8 characters, data type ST) separated by a
subcomponent delimiter (&) may be specified if it is necessary to
individually identify the two inputs for a waveform. Only one name need be
specified if the channel is connected to a single input. For example, in EKG
recordings typically only one name is used (such as I or II); in
electroencephalography, two names are typically used, one for each input of the
differential amplifier (such as F3 and C3). (NOTE: Although the SIG voted
to make waveform source a coded entry, this is not syntactically possible. We
do not have a sub-sub-component delimiter available to separate the sub-fields
of the proposed coded entry. Therefore, waveform source remains a string data
type.).
Definition: Identifies the first input for the waveform source.
Definition: Identifies the second input for the waveform source.
Subcomponents:
<channel sensitivity (NM)> & < unit of measure identifier
(ST)> & < unit of Measure Description (ST)> & < unit of
Measure Coding System (IS)> & <alternate unit of measure identifier
(ST)> & <alternate unit of Measure Description (ST)> &
<alternate unit of Measure Coding System (IS)>
Definition: This CM data type defines the channel sensitivity (gain) and the
units in which it is measured. This component consists of up to seven
subcomponents, separated from each other by subcomponent delimiters (&).
The first subcomponent specifies the sensitivity, while the remaining six
subcomponents are used to specify the units of the sensitivity, using a format
similar to the components of the coded entry (CE) data type. The subcomponents
of the channel sensitivity and units are as follows:
Defines the nominal value (maximum 20 characters, data type NM) that corresponds to one unit in the waveform data, that is, the effective resolution of the least significant bit of the ADC, and the polarity of the channel. The sensitivity incorporates both the amplifier gain and the actual ADC resolution. It does not, however, relate to the vertical scaling of a waveform display (it is, for example, a measure of voltage, not voltage per unit distance). For channels recording potential differences between two electrodes using a differential amplifier, a positive sensitivity indicates that a number in the waveform data which is greater than the channel baseline represents a potential at the first electrode which is more positive than that at the second electrode. A negative sensitivity indicates that a number in the waveform data which is greater than the channel baseline corresponds to a potential at the first electrode which is more negative than that at the second electrode.
Definition: A units designation (for example, uv, mv, v, pal, or mm(hg). Codes from the ISO+ extension of the standard SI single case unit abbreviations are presented as Figure 7-6, 7-7, and 7-8 in Section NNNN, the ANSI+ U.S. customary unit abbreviations, a superset of the ANSI standard which appears in Figure 7-9.
Definition: The full text name of the unit of measure identifier (for example, microvolt, millivolt, volt, pascal or millimeters of mercury) from a designated system of units.
Definition: The designated system of units. Refer to User-defined table 0396 - Coding System for suggested values.
Definition: An alternate units designation (for example, uv, mv, v, pal, or mm(hg) . Codes from the ISO+ extension of the standard SI single case unit abbreviations are presented as Figure 7-6, 7-7, and 7-8 in Section <IP_ADDRESS>.2, the ANSI+ U.S. customary unit abbreviations, a superset of the ANSI standard which appears in Figure 7-9.
Definition: The full text name of the alternate unit of measure identifier (for example, microvolt, millivolt, volt, pascal or millimeters of mercury) from a designated system of units.
Definition: The alternate designated system of units. Refer to User-defined table 0396 - Coding System for suggested values.
Subcomponents:
< channel calibration sensitivity correction factor (NM)> & <
channel calibration baseline (NM)> & < channel calibration time skew
(NM)>
Definition: This component consists of three optional subcomponents (each a
maximum of 20 characters, data type NM), separated from each other by
subcomponent delimiters (&), which define corrections to channel
sensitivity, baseline, and channel time skew which may be derived from a
calibration procedure. The three subcomponents are as follows:
Definition: Defines a correction factor for channel sensitivity which may be derived from the last calibration procedure performed. The actual channel sensitivity is the nominal channel sensitivity given in the previous component multiplied by the unitless correction factor.
Definition: Defines the actual channel baseline (the data value which corresponds to a nominal input signal of zero). The actual baseline may differ from the ideal because of a dc offset in the amplifier connected to the ADC. The actual baseline values for all channels (which need not be integers) may be determined at the time of calibration as the average digitized values obtained when a zero input signal is connected to each channel.
Definition: Defines the time difference between the nominal sampling (digitization) time (which would be the same for all channels) and the actual sampling time of the channel, in seconds (or fractions thereof). This value will differ from zero when all channels in the montage are not sampled simultaneously, as occurs in systems which sample successive channels at regular time intervals. This value may be determined from a calibration procedure in which an identical time-varying signal is applied to all channels and interchannel time differences are estimated, or more commonly it may be taken from the manufacturer's specifications for the digitizing system used. For example, for a system which samples successive channels at regular time intervals t, the time skew of channel number n would be (n-1)t. The actual time of sampling (digitization) of sample number m of channel number n in such a system would be R + (m-1)/f + (n-1)t, where R is the reference time at the start of the epoch and f is the channel sampling frequency (t < 1/f).
Definition: Defines the sampling frequency in hertz of the channel, that is, the reciprocal of the time in seconds between successive samples (maximum 20 characters, data type NM). Note that this is the frequency of transmitted data, which may or may not be the actual frequency at which the data was acquired by an analog-to-digital converter or other digital data source (i.e. the data transmitted may be subsampled, or interpolated, from the originally acquired data.)
Subcomponents:
< minimum data value (NM)> & <maximum data value (NM)>
Definition: Defines the minimum and maximum data values which can occur in this
channel in the digital waveform data, that is, the range of the ADC (each
maximum of 20 characters, data type NM), and also specifies whether or not
nonintegral data values may occur in this channel in the waveform data. If the
minimum and maximum values are both integers (or not present), only integral
data values may be used in this channel. If either the minimum or the maximum
value contains a decimal point, then nonintegral as well as integral data
values may be used in this channel. The minimum and maximum data values are
separated by a component delimiter (&).
Definition:
Defines the minimum data value that can occur in this channel in the digital
waveform data, and also specifies whether or not nonintegral data values may
occur in this channel in the waveform data.
For an n-bit signed ADC, the nominal baseline B = 0, and the
minimum (L) and maximum (H) values may be calculated as
follows:
L = -2n-1
H = 2n-1 - 1
For an unsigned n-bit ADC, the minimum value L = 0, and the
nominal baseline value (B) and maximum value (H) may be
calculated from the formulas,
B = 2n-1
H = 2n - 1
The actual signal amplitude A (for differentially amplified potential
measurements, the potential at electrode number one minus that at electrode
number two) may be calculated from the value D (range L to
H) in the waveform data using the actual baseline value B and the
nominal sensitivity S and actual sensitivity correction factor C
by the formula,
A = SC(D-B)
Definition:
Defines the maximum data value that can occur in this channel in the digital
waveform data, and also specifies whether or not nonintegral data values may
occur in this channel in the waveform data.
For an n-bit signed ADC, the nominal baseline B = 0, and the
minimum (L) and maximum (H) values may be calculated as
follows:
L = -2n-1
H = 2n-1 - 1
For an unsigned n-bit ADC, the minimum value L = 0, and the
nominal baseline value (B) and maximum value (H) may be
calculated from the formulas,
B = 2n-1
H = 2n - 1
The actual signal amplitude A (for differentially amplified potential
measurements, the potential at electrode number one minus that at electrode
number two) may be calculated from the value D (range L to
H) in the waveform data using the actual baseline value B and the
nominal sensitivity S and actual sensitivity correction factor C
by the formula,
A = SC(D-B)
Each
waveform channel in a recording contains timing, channel definition and digital
time series data. The category of waveform result transmitted in a given OBX
segment is determined by the Observation ID Suffix contained in
OBX-3-observation identifier. Four suffixes are provided for the different
categories of waveform result:
Observation |
Suffix |
Data Type |
Timing Information |
TIM |
TS |
Channel Definition |
CHN |
CD |
Waveform Data |
WAV |
NA or MA |
Waveform Annotation |
ANO |
CE |
The Observation Sub-ID is used to associate the TIM, CHN, and subsequent WAV, and ANO category result segments for a given channel or channels in a waveform response message.
Definition: The TIM category OBX result segment establishes the date and time of the first data point in a given Observation Sub-ID grouping of waveform channels. If there is a gap in the time sequence of waveform data, this should be indicated by the transmission of a new TIM category result segment prior to subsequent WAV category result segments with the same Observation Sub-ID. The data type is TS.
Definition:
The CHN category OBX result segment defines recording channels for digitally
sampled time-series waveforms. Subsequent WAV category result segments carry
the actual waveform samples. Each CHN category result segment defines one or
more channels; the OBX-5-Observation Value field may repeat to define
additional channels. Each instance or repetition is formatted as a CD data
type.
Each channel has a number (which generally defines its position in a
multichannel display) and an optional name or label (also used in displays).
One or two named waveform sources may also be associated with a channel
(providing for the use of differential amplifiers with two inputs). A channel
also has an associated sensitivity, calibration parameters (sensitivity
correction factor, baseline, and time skew), sampling frequency, and minimum
and maximum values. The sampling frequency refers to the number of samples per
unit time for the data reported in the subsequent WAV category result
segments.
When multiple channels are defined within a single CHN category result segment,
if the channel sensitivity/units (third component), sensitivity correction
factor (first subcomponent of component 4), baseline (second subcomponent),