Roche cobas infinity central lab User guide

cobas infinity central lab
Roche
Brand
Roche
Model
cobas infinity central lab
Category
Antivirus security software
Type
User guide
cobas
®
infinity central lab
EU GDPR Compliance Guide
Software version 3.03 and higher
Publication version 2.0
2
Roche Diagnostics
cobas
®
infinity central lab · · Publication version 2.0
Publication information
Publication version Software version Revision date Change description
1.0 >1.2.0 July 2018 First edition
2.0 >3.03 December 2020
• Reference material number, GTIN number and intended
use updated
• Migration from screenshots to illustrations.
• Cover page information updated.
y Revision history of GDPR Compliance Guide
Edition notice
This publication is intended for operators of the cobas
®
infinity central lab.
Every effort has been made to ensure that all the
information contained in this publication is correct at the
time of publishing. However, the manufacturer of this
product may need to update the publication information
as output of product surveillance activities, leading to a
new version of this publication.
Where to find information
The User Assistance contains all information about the
product, including the following:
• Safety
• Routine operation
• Configuration information
The User Guide focuses on routine operation. The
chapters are organized according to the normal
operation workflow.
General attention
To avoid incorrect results, ensure that you are familiar
with the instructions and safety information.
r Pay particular attention to all safety notices.
r Always follow the instructions in this publication.
r Do not use the software in a way that is not described
in this publication.
r Store all publications in a safe and easily retrievable
place.
Training
Do not carry out operation tasks or maintenance actions
unless you have received training from Roche
Diagnostics. Leave tasks that are not described in the
user documentation to trained Roche Service
representatives.
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Roche Diagnostics
cobas
®
infinity central lab · · Publication version 2.0
Screenshots
The screenshots in this publication have been added
exclusively for illustration purposes. Configurable and
variable data, such as tests, results, or path names visible
therein must not be used for laboratory purposes.
Warranty
Any customer modification to the system renders the
warranty or service agreement null and void.
For conditions of warranty, contact your local sales
representative or refer to your warranty contract partner.
Always leave software updates to a Roche Service
representative, or perform such updates with their
assistance.
Copyright
© 2013-2020, F. Hoffmann-La Roche Ltd. All rights
reserved.
License information
cobas
®
infinity central lab software is protected by
contract law, copyright law, and international treaties.
cobas
®
infinity central lab contains a user license
between F. Hoffmann-La Roche Ltd. and a license
holder, and only authorized users may access the
software and use it. Unauthorized use and distribution
may result in civil and criminal penalties.
Open Source and Commercial Software
cobas
®
infinity central lab may include components or
modules of commercial or open-source software. For
further information on the intellectual property and other
warnings, as well as licenses pertaining to the software
programs included in cobas
®
infinity central lab, refer to
the electronic distribution included with this product.
This open source and commercial software and cobas
®
infinity central lab as a whole can constitute a device
regulated in accordance with applicable law. For more
detailed information, refer to the user manual and
labeling.
Please note that the respective authorization is no longer
valid according to the corresponding legislation should
any unauthorized changes be made to cobas
®
infinity
central lab.
Trademarks
The following trademarks are acknowledged:
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Roche Diagnostics
cobas
®
infinity central lab · · Publication version 2.0
COBAS, COBAS INFINITY, and LIFE NEEDS ANSWERS
are trademarks of Roche.
All other trademarks are the property of their respective
owners.
Feedback
Every effort has been made to ensure that this
publication fulfills the intended use. All feedback on any
aspect of this publication is welcome and is considered
during updates. Contact your Roche representative,
should you have any such feedback.
Disclaimer
This publication may contain information and references
to products that may not be available in your country or
sold by Roche Diagnostics. This publication makes no
claims regarding the use or performance of those
products. Selected third-party products are available for
use with cobas
®
infinity central lab.
Contact addresses
Roche Diagnostics GmbH
Sandhofer Strasse 116
D-68305 Mannheim
Germany
Made in Spain
Distributed in the United States by:
Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46256
USA
Date of manufacture
07613336177129
09180443001
Consult instructions for use
Consult the instructions for use for important cautionary
information such as warnings and precautions that
cannot, for a variety of reasons, be presented on the
medical device itself.
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cobas
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infinity central lab · · Publication version 2.0
Table of contents
Intended use ............................................................................ 7
Use environment and intended users ............................ 8
Symbols and abbreviations ................................................ 9
Safety classifications............................................................. 11
System safety information .................................................. 11
EU General Data Protection Regulation........................ 17
Recommendations regarding environment,
accesses, and processes..................................................... 21
Database backup................................................................... 25
About database backup in the software............ 25
Data retention and data removal ..................................... 26
About data retention and data removal in the
software.......................................................................... 26
Configuring automatic data removal................... 27
Deleting orders manually......................................... 28
Pseudonymization.................................................................. 30
About pseudonymization in the software.......... 30
Defining the patient ID1........................................... 31
Defining sample IDs .................................................. 32
Disabling patient demographics ........................... 34
Data minimization.................................................................. 36
About data minimization in the software........... 36
Editing patient demographics ................................ 37
User authentication and authorization .......................... 38
About user authorization and authentication
in the software ............................................................. 38
Creating profiles.......................................................... 39
Creating users.............................................................. 41
Logging on to the software..................................... 42
Encryption at rest and in transit ....................................... 44
cobas
®
infinity central lab and data subject rights
45
Deleting patient records........................................... 45
Deleting software users............................................ 46
Correction of data subject information............... 47
Editing data subject information
manually.............................................................. 47
Configuring the software to allow
patient data modification through HCA.. 48
Exporting order data.................................................. 49
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cobas
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infinity central lab · · Publication version 2.0
Exporting user information...................................... 50
Configuring report information.............................. 50
About the disclosure of personal data........................... 52
About data details.................................................................. 54
Patient data ................................................................... 54
HCP data ........................................................................ 55
Product user data ....................................................... 55
Product service staff .................................................. 56
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Roche Diagnostics
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®
infinity central lab · · Publication version 2.0
Intended use
Intended use of the EU GDPR Compliance
Guide
This compliance guide explains the EU GDPR provisions
to help your laboratory or medical organization as data
controller or processor comply with its requirements
while using the cobas
®
infinity central lab. It is intended
for those individuals in your organization, whose daily
responsibility is data protection.
Intended use of the cobas
®
infinity central lab
cobas
®
infinity central lab software is intended to be
used for:
• the configuration and connectivity management of
instruments and software systems
• the management of data regarding
– Samples
– Technical validation including automatic release
– Quality control (both qualitative and quantitative)
– Test results and their entry (offline workplaces)
• the management and storing of information, such as
– Samples Archiving Storage information
– Rule engine for technical validation
– Notifications from any part of the system
– Reagent and Calibrator management
– Turn Around Time management
– Production statistics
In addition to the above intended use, the cobas
®
infinity central lab software is intended for:
• the management of data regarding
– Order Data
– Patient Data for Clinical Labs (not relevant to
cobas® infinity central lab if intended for Blood/
Plasma Donor Screening Labs)
– Medical Validation support for Clinical Labs (not
relevant to cobas® infinity central lab if intended
for Blood/Plasma Donor Screening Labs)
– Result Consolidation and Reporting
– Billing support
• the management and storing of information, such as
– General statistics (Data Warehouse)
• Microbiology workflows and data for (Microbiology
module):
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®
infinity central lab · · Publication version 2.0
– Human samples
cobas
®
infinity central lab is intended for Clinical
Laboratories.
cobas
®
infinity central lab is intended for Blood/Plasma
Donor Screening Laboratories (Excluding U.S.).
Use environment and intended users
cobas
®
infinity central lab is intended for Clinical
Laboratories.
cobas
®
infinity central lab is intended for Blood/Plasma
Donor Screening Laboratories (Excluding U.S.).
You can find different user profiles using the cobas
®
infinity central lab software.
Lab Technician
Lab technicians utilize the solution to perform technical
validation on patient and QC results, manually edit orders
(add or remove tests, edit patient-demographic data),
enter patient and QC results that have been obtained
from offline workplaces, print-out patient and QC reports,
archive samples, retrieve samples from the archive, etc.
Access level depends on specific user rights.
Lab Physician/Director
Lab Physicians/Directors utilize the solution to check
technically validated results, search for samples or test
results on patient results, and add comments to the
results or order.
Access level depends on specific user rights.
Lab IT Administrator
Lab IT Administrators maintain users and authorization,
and maintain tests and senders.
Access level will depend on specific user rights.
GP/Hospital doctor/Hospital nurse/
Community nurse
These users are not employees of the laboratory; thus
their access is restricted to the Lab Link module only.
They enter orders manually within the Lab Link module,
release print-outs of barcode labels for the tubes for
positive patient/sample identification, release print-outs
of reports for the patient for blood drawing, and view and
print the patient result report of their patients.
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®
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Phlebotomist
These users are employees of the laboratory, but their
access is restricted to the Lab Link module only.
Phlebotomists confirm in the software that the samples
have been taken according to the order.
IT Manager
• Network and security configurations
• WLAN device configuration security type EAP
• EAP Settings management (EAP settings and EAP
settings assignment)
Roche Service representative (global and
local)
Roche Service representatives configure the system and
master data (test, test groups, senders, instruments,
reports, interfaces, etc.) according to specific
requirements of the customers with regards to
connected hosts, instruments, and sample workflow.
Access level depends on specific user rights.
Symbols and abbreviations
Product names
Except where the context clearly indicated otherwise, the
following product names and descriptors are used.
Product name Descriptor
cobas
®
infinity central lab
software
cobas
®
infinity general lab
module
cobas
®
infinity emergency lab
module
cobas
®
infinity lab flow
module
cobas
®
infinity lab link
module
cobas
®
infinity microbiology
module
cobas
®
infinity total quality
management
module
y Product names
Symbols used in the publication
Symbol Explanation
o
List item
u
Related topics containing further information
q
Tip. Extra information on correct use or useful
hints.
r
Start of a task
I
Extra information within a task
y Symbols used in the publication
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Roche Diagnostics
cobas
®
infinity central lab · · Publication version 2.0
Symbol Explanation
f
Result of an action within a task.
j
Prerequisites of a task.
u
Topic. Used in cross-references to topics.
p
Task. Used in cross-references to tasks.
y
Table. Used in table titles and cross-references
to tables.
y Symbols used in the publication
Abbreviations
The following abbreviations are used.
Abbreviation Definition
ACL Access control list
ANSI American National Standards
Institute
API Application programming interface
CIR Case Investigation and Resolution
DBI Database Independence
EU European Union
GCS Global Customer Support
GDPR General Data Protection Regulation
HCA Host Connectivity Agent
HCP Healthcare Professional
HIS Hospital Information System
ID Identifier
IT Information Technology
JDBC Java Database Connectivity
LAN Local Area Network
LDAP Lightweight Directory Access
Protocol
LIS Laboratory Information System
ODBC Open Database Connectivity
OS Operating System
PC Personal Computer
RCSC Regional Customer Support Center
REST Representational State Transfer
RnD Research and Development
SOP Standard Operating Procedure
SSL Secure Sockets Layer
TLS Transport Layer Security
VPN Virtual Private Network
y Abbreviations
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Roche Diagnostics
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®
infinity central lab · · Publication version 2.0
Safety classifications
The safety precautions and important user notes are
classified according to the ANSIZ535.6 standard.
Familiarize yourself with the following meanings and
icons.
These symbols and signal words are used for specific
hazards:
WARNING!
Warning...
r ...indicates a hazardous situation which, if not
avoided, could result in death or serious injury.
CAUTION!
Caution...
r ...indicates a hazardous situation which, if not
avoided, could result in minor or moderate injury.
NOTICE!
Notice...
r ...indicates a hazardous situation that, if not avoided,
may result in damage to the system.
Important information that is not safety relevant is
displayed as the following icon:
i
Tip...
...indicates additional information on correct use
or useful tips.
System safety information
Roche Diagnostics has established a series of
recommendations with the aim of allowing the user to
work with the software under safe conditions and
guaranteeing the correct operation and proper
performance of the communication network in which this
product has been installed.
i
Read the following recommendations carefully for
the correct operation of the software.
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Roche Diagnostics
cobas
®
infinity central lab · · Publication version 2.0
Security overview
WARNING!
Antivirus and firewall software
Under normal circumstances, the system is connected to
other networks or to the Internet. Make sure that the
following points are carefully adhered to:
r Make sure that antivirus software is installed.
r Use the most recent version of the antivirus software
and keep it up to date.
r Use a firewall to block unauthorized access. Confirm
that cobas
®
infinity central lab is compatible with
the antivirus and firewall software in use.
r Block the unnecessary inbound and outbound ports
in the firewall. For further information, contact your
Roche Service representative.
r Restrict the “Allow”-firewall-rules to a specific port,
application (e.g. executable, or dll), and/or remote
system (IP).
r Always delete the HealthShare and database paths
from the configuration of the real-time protection
agent of the antivirus software. Doing this prevents
critical files in the operating system from becoming
blocked.
r Remove all console administration applications from
Apache Tomcat, leaving only the report server
application.
r Block access to the HealthShare documentation and
management portals. For further information, contact
your Roche Service representative.
r Enable monitoring solutions to proactively identify
unusual system or network activity (for example,
unusual processes, high resource consumption,
unusual network traffic, unrecognized ports).
r Configure HTTPS.
WARNING!
Database encryption
Unauthorized parties could access confidential data and
configuration items. HealthShare provides a mechanism
to manage database encryption keys securely.
r Encrypt the database with the Caché proprietary
option (managed key encryption). For further
information about database encryption and its correct
use, contact your Roche Service representative.
r Configure the operating system security appropriately.
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Roche Diagnostics
cobas
®
infinity central lab · · Publication version 2.0
i
Keep all security parameters (profiles, access
restrictions, etc.) enabled (they are enabled by
default) as disabling security parameters may
lead to potentially major risks. For example,
unqualified personnel may change instruments or
system configurations or unauthorized users may
access confidential information.
i
To ensure that the software is properly
configured, contact your Roche Service
representative, as unauthorized users could gain
access to the system, which could lead to a
potential harm to patient safety.
Data safety precautions
WARNING!
Loss of data integrity or unavailability of the system
due to malicious software or unauthorized system
access
To avoid infection of malicious software or the
unauthorized misuse of the system, the following
recommendations are important:
r Make sure that other computers and services on the
network are properly secured and protected against
malicious software and unauthorized access.
r Activate Caché backup and recovery features.
r Laboratory IT is responsible for the security of their
local area network, especially in protecting it against
malicious software and attacks. This protection might
include measures, such as a firewall, to separate the
device from uncontrolled networks as well as
measures that ensure that the connected network is
free of malicious code.
r Restrict physical access to the system and all
attached IT infrastructure (computer, cables, network
equipment, ports, wiring, etc.).
r Make sure that system backups and archive files are
protected from any unauthorized access and disaster.
This includes remote storage location, disaster
recovery sites, secure transfer of backup files.
r Use TLS or SSL-encrypted communication channels
between authenticated nodes. For further information,
contact your Roche Service representative.
r Write access to application files and folders on any
computer should be restricted only to authorized
personnel.
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Roche Diagnostics
cobas
®
infinity central lab · · Publication version 2.0
WARNING!
Risk of privacy violations
A secure infrastructure for the software network and
security policies must be defined to address potential
problems or system failures.
r Access is controlled by a login. Every access to the
software is registered and logged, including the
unsuccessful ones.
r Change all default configuration settings of the
operating system, the services, and the database to
ensure better protection.
r Lock down system commands and utilities with
restricted ACLs.
r Deploy up-to-date versions of off-the-shelf software
with product releases.
r Remove all console administration applications from
Apache Tomcat, leaving only the report server
application.
r Enable monitoring solutions to proactively identify
unusual system and network activity, such as unusual
processes, high resource consumption, unusual
network traffic, or unexpected ports.
r Pay special attention when configuring the number of
logon attempts, the password expiry period, and
session management.
WARNING!
Unauthorized parties may be able to obtain
confidential patient data
Disclosing confidential data is a severe breach of
regulations and laws.
r Encrypt the database to prevent unauthorized access.
r Do not take any patient identification data outside of
the laboratory.
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Roche Diagnostics
cobas
®
infinity central lab · · Publication version 2.0
WARNING!
Insufficient audit trail
Lack of auditing and logging of changes made to the
configuration information may make it impossible to
identify when changes were made and who made them.
Suspicious activity on the system may go undetected.
r Do not use shared user accounts and instruct
customers not to do it.
r Collect and back up the audit and log files from the
operating system, Apache web server, Apache
Tomcat, and HealthShare.
r Only dedicated application user accounts should have
access to configuration stores, logfiles, and sensitive
data in the file system ACLs and the database.
WARNING!
Caché database backups
If the data in the system are corrupted or manipulated,
test results might be delayed or lost.
r Store the backups securely; that is, save them on
independent disks, separate from the main server, on
a different server, and so on.
r Perform regular backup restores on a test
environment.
WARNING!
Hardware and software requirements for cobas
®
infinity central lab
Not following the hardware and software requirements
may lead to issues in the system.
r To ensure that you follow the hardware and software
requirements, contact your Roche Service
representative.
WARNING!
Backup restores
When restoring a backup, configuration data or test data
may be corrupted. This prevents the software from
operating correctly.
r After restoring a backup, contact your Roche Service
representative to check the source and the integrity
of the data.
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Roche Diagnostics
cobas
®
infinity central lab · · Publication version 2.0
User and password management
WARNING!
Passwords and security
r Ensure that the passwords and, therefore, the
integrity, accessibility, and confidentiality of the data
managed are handled with the appropriate safety
measures. Use the passwords appropriately.
r Do not disclose the password to customers or third
parties, and ensure that customers cannot see the
information in this documentation. For this reason,
never hand out copies of the documentation or leave
it in a place where it may be accessed by people who
are not authorized Roche personnel. Otherwise the
software could display invalid results or information
about patient health or the operation of cobas
®
infinity central lab could be made public.
i
When managing access to the information,
consider the following recommendations:
• Ensure that access to sensitive or confidential
information is always limited to authorized
personnel.
• When managing access by users to the
application, apply the minimum permissions
required for their function.
• Ensure that the cobas
®
infinity central lab
and HealthShare passwords and, therefore,
the integrity, accessibility, and confidentiality
of data involved are handled with the
appropriate safety measures.
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Roche Diagnostics
cobas
®
infinity central lab · · Publication version 2.0
WARNING!
Passwords and security
When managing passwords, consider the following
recommendations:
r Ensure that the cobas
®
infinity central lab and
HealthShare passwords and, therefore, the integrity,
accessibility, and confidentiality of data involved are
handled with the appropriate safety measures.
r Change the passwords every so often, at least every
six months.
r Avoid password re-use.
r The cobas
®
infinity central lab password can be
configured to be as restrictive as possible through the
following general parameters:
• Minimum number of uppercase letters in
password
• Minimum number of digits or symbols in
password
• Minimum password length
WARNING!
Passwords and security
To avoid that the application displays invalid results or
information about patient health or the operation of the
cobas
®
infinity central lab is made public:
r Use the password properly: do not disclose it to
clients or third parties and ensure that clients cannot
see the information described in this service manual.
r Never hand out copies of this documentation or leave
it where people who are not authorized Roche
personnel may access it.
EU General Data Protection Regulation
What is the EU GDPR?
This regulation lays down the rules for protecting EU
citizens and residents with regard to the processing of
personal data and rules relating to the free movement of
personal data. In addition, it protects fundamental rights
and freedoms of natural persons and, in particular, their
right to the protection of personal data.
Who is affected by the EU GDPR?
This regulation applies to the controlling and processing
of personal data carried out by organizations operating
within the EU. It also applies to organizations outside the
EU that offer goods and services to individuals in the EU.
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Roche Diagnostics
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®
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This regulation does not apply to certain activities, such
as processing for national security purposes or
processing carried out by individuals purely for personal
and household activities.
What information does the EU GDPR apply
to?
This regulation applies to two categories of information:
• Personal data: Any information relating to an
identifiable person who can be directly or indirectly
identifies in particular by reference to an identifier.
• Sensitive personal data: Special categories of
personal data, such as genetic and biometric data,
which can be used to uniquely identify someone if
processed.
What are the lawful bases for collecting and
processing personal data?
One of the following lawful bases has to apply whenever
you collect and process personal data:
• Consent: The data subject has to give clear consent
for the data controller to process their personal data
for a specific purpose.
• Contract: The processing has to be necessary for a
contract the data controller has with the data subject,
or because the data subject have asked the data
controller to take specific steps before entering into a
contract.
• Legal obligation: The processing is necessary for the
data controller to comply with the law (not including
contractual obligations).
• Vital interests: The processing is necessary to protect
someone’s life.
• Public task: The processing is necessary for the data
controller to perform a task in the public interest or
for the official functions of the data controller, and the
task or function has a clear basis in law.
• Legitimate interests: The processing is necessary for
the legitimate interests of the data controller or the
legitimate interests of a third party unless there is a
good reason to protect the individual’s personal data,
which overrides those legitimate interests.
Who are data controllers, processors and
subjects in the EU GDPR?
Data controllers are the principal party who decides why,
how and what personal data needs to be collected and
processed. Data controllers are expected to ensure that
contracts with data processors comply with the EU
GDPR.
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®
infinity central lab · · Publication version 2.0
Data processors are entities that handle personal data on
behalf of data controllers. Specific legal obligations are
placed on data processors. For example, you are required
to maintain records of personal data and processing
activities.
Data subjects are all individuals whose personal data is
collected, managed and processed by data controllers
and data processors.
What are the main topics of the EU GDPR?
This regulation addresses the following fundamental
rights and freedoms of data subjects:
• Right to be informed: EU citizens and residents have
the right to be informed about how personal
information is collected and processed, and what is
the purpose of collecting and processing this
information.
• Right of access: EU citizens and residents have the
right to access their data from the data collector or
data processor.
• Right to rectification: EU citizens and residents have
the right to ask the data controller or processor to
correct information they believe is inaccurate.
• Right to erasure: EU citizens and residents have the
right to have their personal information deleted by the
data controller or processor.
• Right to restriction of processing: EU citizens and
residents have the right to request that the data
controller or data processor to stop processing their
data.
• Right to object: EU citizens and residents have the
right to object to the data controller or data processor
to use their data.
• Right to data portability: EU citizens and residents
have the right to enable the machine and human-
readable export of their personal information from the
data controller or data processor.
• Rights regarding automated decision-making: The
data controller and data processor is responsible for
demonstrating compliance with this regulation if the
use automated individual decision-making and
profiling tools.
In addition, this regulation includes provisions that
promote accountability and governance of personal data.
In order to be EU GDPR compliant, organizations have to
demonstrate the following measures:
• Implement appropriate technical and organizational
measures that ensure and demonstrate that you
comply, such as internal audits of processing
activities and staff training.
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Roche Diagnostics
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®
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• Maintain relevant documentation on processing
activities.
• Appoint a data protection office, where appropriate.
• Implement measures that meet the principles of data
protection by design and by default, such as data
minimization, and pseudonymization.
• Use data protection impact assessments, where
appropriate.
Lastly, organizations have to follow the address the
following data protection principles:
• Security principle: Organizations have to ensure that
they process personal data securely by means of
appropriate technical and organizational measures.
• International data transfers: The EU GDPR imposes
restrictions on the transfer of personal data outside
the EU, to third countries or other international
organizations.
• Personal data breaches: Organizations have a duty to
report certain types of personal data breaches to the
relevant supervisory authority within 72 hours of
becoming aware of the breach, where feasible.
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Roche cobas infinity central lab User guide

cobas infinity central lab
Roche
Brand
Roche
Model
cobas infinity central lab
Category
Antivirus security software
Type
User guide
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