supporting jci standards for hospitals, july 2015...supporting jci standards for hospitals, july...

*The solutions listed may not be available in all markets or in all language versions - please contact your local sales representative

Supporting JCI Standards for Hospitals, July 2015BD Medication Management - Dispensing Solutions*

This document highlights selected BD Dispensing solutions with matching feature capabilities to the 5th Edition of the Joint Commission International Standards for Hospitals - update July 2015.It focuses on following chapters: Patient-Centered Standards - International Patient Safety Goals, Access to Care and Continuity of Care, Patient and Family Rights, Assessment of Patients, Care of Patients, Medication Management and Use. Health Care Organization Management Standards - Quality Improvement and Patient Safety, Governance, Leadership and Direction and Management of Information. For intent statements and further information, please consult the 2015 International Hospital Accreditation Standards.

International Patient Safety GoalsIdentify Patients Correctly

Standard IPSG.1 The hospital develops and implements a process to improve accuracy of patient identifications

Element JCI Description BD Dispensing solution BD Dispensing solution capability

1 Patients are identified using two patient identifiers, not including the use of the patient’s room number or location

BD Cato™ • BD Cato offers different patients identifiers such as Hospital Patient Number, DOB, Name, Social Security Number or by means of specific wristband barcode allocation. Those paramenters are being registered in the system

• A specific patient screen in BD Cato will show all necessary information of any given patient registered in BD Cato

Pyxis MedStation™ ES system Pyxis MedStation™ 4000 systemPyxis Anesthesia™ ES system Pyxis Anesthesia™ system Pyxis ProcedureStation™ system Pyxis SupplyStation™ system

• A second patient identifier can be displayed on the screen when removing a medication or supply from the station

• A second patient identifier can be printed on a transaction slip when removing a medication or supply from the station and taken to the patient bedside

• Demographic screen displays patient-specific information supporting verification of patient identity prior to accessing medication

• The Pyxis Supply system provides several patient identifiers including patient name, visit ID and, optionally, medical record number

Pyxis™ Connect system • Every order is linked and indexed by patient name and patient ID from the pharmacy system or patient bar code

Pyxis CIISafe™ system • Patient name and identifier is included on printed paperwork that accompanies patient-specific controlled substance prescription orders

Rowa™ Label Rowa Vmax™ systemRowa™ Refrigerated UnitRowa™ Mosaic Rowa™ Box-Picking Unit Rowa™ Conveyor system

• Medication is labeled with patient name and eventually with birth date and patient ID (depending on PIS)

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International Patient Safety Goals continued

Identify Patients Correctly

Standard IPSG.1 The hospital develops and implements a process to improve accuracy of patient identifications


2 Patients are identified before providing treatments or procedures

BD Cato • BD Cato does not permit the user to provide treatments before having identified the patient. Each treatment will individually be prescribed in the patient screen. In addition to this, BD Cato has imbedded mechanism to prevent treatment or procedures to the wrong patient. Patient information will be present on screen informing the user which patient is being treated

Pyxis ProcedureStation systemPyxis SupplyStation system

• Patient selection can be required prior to allowing end user access to inventory within the Pyxis Supply system

3 Patients are identified before any diagnostic procedures

BD Cato • No treatment that takes places in BD Cato, either based on a diagnosis or label result, can take place without identifying the patient. Patient information will be present on screen informing the user which patient is being treated

Improve Effective Communication

Standard IPSG.2 The hospital develops and implements a process to improve the effectiveness of verbal and/or telephone communication among caregivers

1 The complete verbal order is documented and read back by the receiver and confirmed by the individual giving the order

BD Cato • BD Cato is also a prescribing software. Incoming orders are received electronically, and BD Cato features many security checks in order to guarantee the intention and correctness of the order prescribed. Incoming orders are validated in BD Cato, meaning the user confirms he/she understood and approves the content of the sent order

Rowa Label Rowa Vmax systemRowa Refrigerated UnitRowa Mosaic Rowa Box-Picking Unit Rowa Conveyor system

• Limiting verbal communication of prescription achieved with electronic order transmission (PIS send orders, Rowa dispenses)

2 The complete telephone order is documented and read back by the receiver and confirmed by the individual giving the order

BD Cato • Orders are streamlined through hospital´s network, therefore telephone orders are not matching BD Cato’s electronically standardized workflow. Should an order be taken and inserted telephonically, the user can document that the order has been read back in the system before the next step in the workflow can be followed

3 The complete test result is documented and read back by the receiver and confirmed by the individual giving the result

BD Cato • As test results are streamlined thorough hospital´s network through an specific interface, reading back test results is not necesseray. However, should the test results communicated verbally and inserted manually in BD Cato, the systems features many security checkpoints in order to avoid possible interpretation errors, such as confusing height and weight

3Supporting JCI standards for hospitals, July 2015 - BD Status March 2016 *The solutions listed may not be available in all markets or in all language versions - please contact your local sales representative



Standard IPSG.2.1 The hospital develops and implements a process for reporting critical results of diagnostic tests


1 The hospital has defined critical values for each type of diagnostic test

BD Cato • BD Cato supports the definition of critical values for each type of diagnostic test

2 The hospital has identified by whom and to whom critical results of diagnostic tests are reported

BD Cato • Within BD Cato critical results information will only be available to those users having the rights to access such information. An automatic report of the data is not available

3 The hospital has defined critical values for each type of diagnostic test

BD Cato • BD Cato offers the possibility to create a patient folder for each patient. The patient folder is a blank page saved locally in which all necessary information regarding a patient can be recorded . There are no restrictions to what type of information can be documented. The user may decide which information is being registered in the patient folder

Standard IPSG.2.2 The hospital develops and implements a process for handover communication

1 Standardized critical content is communicated between health care providers during handovers of patient care

BD Cato • As a software all critical and non critical patient content is automatically available for the next ward / recipient

Pyxis Enterprise™ serverPyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia systemPyxis ProcedureStation systemPyxis SupplyStation system

• Profile workflow continuously tracks all activity by patient across shifts

• Availability of Past Removed data for new care provides

• Too close/too soon removal warnings

• Clinical Data Category can be used to standardize the communication of critical content


• The Pyxis Supply system provides a standardized view to all critical data to the end user performing inventory management and inventory related patient care tasks. The data is not end user specific so it is accessible to other users as handovers occur

Pyxis Anesthesia ES system • Anesthesia system “switch user” functionality

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Standard IPSG.2.2 The hospital develops and implements a process for handover communication


2 Standardized forms, tools, and methods support a consistent and complete handover process

BD Cato • Handover process occurs within BD Cato paperless and electronically. The system however supports a paper-based method for handover process shall the new recipient requires so

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia systemPyxis ProcedureStation systemPyxis SupplyStation system

• Profile workflow continuously tracks all activity by patient across shifts

• Availability of Past Removed data for new care provider

• Too close/too soon removal warnings

• Clinical Data Category

• Station transaction reports, discrepancy management reports

• Override reports

Pyxis Anesthesia ES system • Anesthesia system “switch user” functionality



3 Data from handover communications are tracked and used to improve approaches to safe handover communication

BD Cato • Handover communication occurs between users electronically. This the safest approach and in addition to this BD Cato logs the handover medication between locations or users

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia systemPyxis ProcedureStation systemPyxis SupplyStation system

• Station transaction reports, discrepancy management reports

• Override reports



Improve the Safety of High Alert Medicine

Standard IPSG.3 The hospital develops and implements a process to improve the safety of high-alert medications

1 The hospital has a list of all high-alert medications, including look-alike/sound-alike medications, that is developed from hospital-specific data

BD Cato • BD Cato supports the efforts of the hospital to enhance patient safety. BD Cato Master Data, where all relevant drug information is being entered, offer different possibilites in order to ensure proper drug entry, such as automatic check if a medication drug name already exists in the system or the use of tall man lettering



Improve the Safety of High Alert Medications

Standard IPSG.3 The hospital develops and implements a process to improve the safety of high-alert medications


2 The hospital implements strategies to improve the safety of high-alert medications, which may include specific storage, prescribing, preparation, administration, or monitoring processes

BD Cato • All drugs entered in the system have their specifc information such a specific application routes, storage, preparation or adminstration instructions. The electronic processing of the drug information helps to reduce prescription, preparation or adminstration errors, as specific data can be entered for such drugs in the system. All medications can be assigned an unique barcode number, this enables the correct assembly of raw parts

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000 systemCUBIE™

Pyxis Anesthesia ES system Pyxis Anesthesia system

• Variety of secure drawer and pockets types (i.e. CUBIE pockets, MiniDrawers) supports segregation of medications and appropriate access to medications by medication type

• Pyxis systems can be configured to require medication scanning by user on various workflows to warn of wrong medication

• Clinical Data Category and/or system Notes can be used to alert nursing and pharmacy users about high alert medications

• Ability to block loading of select medications from specific care areas (such as blocking adult dose meds from pediatric areas)

• Patient dose-specific labeling capability for configured meds

Rowa™ Dose system • Rowa Dose allows increasing safety of high-alert medications in solid oral forms by printing easily visible information and alerts on the pouches

3 The location, labeling, and storage of high-alert medications, including look-alike/sound-alike medications, is uniform throughout the hospital

BD Cato • BD Cato features a stock management system that guarantees the correct labeling of all medications. The location of the drugs can also be manage thorough BD Cato. This enables the proper assembly of high-alert medications, as they have an unique assigned barcode and lot number system

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000 systemCUBIE Pyxis Anesthesia ES system Pyxis Anesthesia system

• All medication configurations are centrally managed within or across facilities using source of truth data from Pharmacy Information systems (PIS)

• Patient dose-specific labeling is configured by med at the Pyxis Enterprise Server level for all devices

• Tall man lettering

Pyxis CIISafe system • Pyxis CIISafe system has the ability to require the user to scan the medication and warn them if the medication removed is not the medication selected

Rowa Dose system • Using the Rowa Dose system, high-alert medications in solid oral forms can be labeled with all required information (including color, shape, or special markers on the drugs) in a uniform manner throughout the hospital

Rowa Label Rowa Vmax systemRowa Mosaic

• Labels can contain warning/alert text (depending on PIS)

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Improve the Safety of High Alert Medications

Standard IPSG.3.1 The hospital develops and implements a process to manage the safe use of concentrated electrolytes


1 The hospital has a process that prevents inadvertent administration of concentrated electrolytes

BD Cato • All medications are managed throughout the electronic workflow in BD Cato. Essentially this means that no inadvertent adminstration of any drugs can happen. By using the concentration alerts in BD Cato, the system will prevent the administration of concentrated electrolytes

• Prescribers and pharmacists can control in the system the course of preparation and administration of concentrated electrolytes

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000 systemCUBIEPyxis Anesthesia ES system Pyxis Anesthesia system

• Ability to block loading of select medications from specific care areas (such as blocking adult dose meds from pediatric areas)


2 Concentrated electrolytes are present only in patient care units identified as clinically necessary

BD Cato • The user can define in the system that concentrated electrolytes may only be present in patient care units. In addition to this, and following BD Cato´s Worfklow, inadvertend administration of concentrated electrolityes may be prevented as the user will not have the possibility to document its administration in the system

Pyxis Enterprise ServerPyxis MedStation ES system Pyxis MedStation 4000 system

• Ability to block loading of select medications from specific care areas

3 Concentrated electrolytes that are stored in patient care units are clearly labeled and stored in a manner that promotes safe use

BD Cato • BD Cato supports the management of concentrated electrolytes by defining clear storage and temperature conditions, specific labels and security controls as concentration lables and unique ward assigments, the later meaning these drugs can only be used in a certain unit, thus preventing administration to the wrong patient

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000 systemCUBIEPyxis Anesthesia ES system Pyxis Anesthesia system

• Same secure drawer and pockets types (i.e. CUBIE pockets, MiniDrawers) supports segregation of medications and appropriate access to medications by medication type


Rowa Label Rowa Vmax systemRowa Mosaic

• Labels can contain warning/alert text (depending on PIS), the labels are applied on the medication during dispensing from Rowa


Access to Care and Continuity of CareContinuity of Care

Standard ACC.3 The hospital designs and carries out processes to provide continuity of patient care services in the hospital and coordination among health care practitioners


1 The leaders of departments and services design and implement processes that support continuity and coordination of care, including at least a) through e) identified in the intent. (Also see GLD.10)

Pyxis™ ES Link Queue & Waste module

• Nurse can check med availability: if a med is not loaded in the nearest Pyxis MedStation, the correct MedStation can be found easily. For the case an unused med needs to be wasted, the nurse can do this from any computer; no need to wait in line at the Pyxis MedStation or waste precious patient-care time


• The Pyxis Supply system is designed to support flexible workflows through various configuration options so that the inventory management system can blend seamlessly under existing processes

Rowa Vmax systemRowa Conveyor system Rowa MosaicRowa Box-Picking Unit

• Storage of CUBIES into the Vmax for Pyxis replenishment

• Streamlining medication management - detailed information available for every single pack stored in Rowa, expiration date, unique tracking number, lot number, etc..

• The Conveyor System is very flexible, medications can be dispensed almost in every area of the pharmacy

• Mosaic and Rowa Box-Picking Unit do automatically take care about wards replenishment

Rowa Dose system • Rowa Dose can be configured to print administration advice (“take with water”), special alerts and indications (e.g. “beta-blocker”) on unit dose, combi dose or multi dose pouches, assisting the nurse at the point of care with directly accessible information given by the physicians and hospital pharmacists

2 The patient’s record(s) is available to those practitioners who are authorized to have access and need it for the care of the patient. (Also see AOP.1.1)

BD Cato • BD Cato provides a User Management so only the care takers responsible of a certain unit will have access to the patient’s record

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia system

• User Privileges define which users have access to which systems


• The Pyxis Supply system controls the level of access to patient information by the end user. With the proper permissions, a user can review and update patient information, view scheduled procedures and review transactional history. Most users have only the ability to select the proper patient for traceability purposes when removing supplies while others that perform no patient related tasks have no access to patient detail

Knowledge Portal • The Knowledge Portal for Pyxis medication technologies provides access to patients data, from medication, transactions, and users providing care for up to 10 years

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Access to Care and Continuity of Care continued

Continuity of Care

Standard ACC.3 The hospital designs and carries out processes to provide continuity of patient care services in the hospital and coordination among health care practitioners


3 The patient’s record(s) is up to date to ensure communication of the latest information


• System interfaces update in near real-time to ensure current data is available


• The Pyxis Supply system can be interfaced with the hospital admission system and any updates performed for the patient can be sent in real-time to the Supply server. Any pertinent details to the limited patient record kept within the system such as patient location or discharge timing will be updated throughout the system

4 Continuity and coordination of care processes are supported by the use of tools, such as care plans, guidelines, or other such tools


• Patient-centric workflows at devices and in Pyxis ES Link Queue & Waste module

5 Continuity and coordination are evident throughout all phases of patient care


• Centralized data managed at Pyxis Enterprise Server support all system components which are used to support phases of care in applicable environments


Standard ACC.3.1 During all phases of inpatient care, there is a qualified individual identified as responsible for the patient’s care

1 The individual(s) responsible for the coordination of the patient’s care is identified in the patient’s record and available through all phases of inpatient care

BD Cato • The individual(s) responsbile for the coordination of the patient´s care can be entered in the system

3 There is a process for transferring the responsibility for coordination of care from individual to individual

BD Cato • BD Cato supports the transfer process by allocating patient / wards to any individual

Pyxis Anesthesia ES system • Anesthesia ES system - switch user capability

4 The process identifies how these individuals assume the transferred responsibility and document their participation or coverage

Pyxis Anesthesia ES system • Anesthesia ES system - switch user capability


Access to Care and Continuity of Care continued

Continuity of Care

Standard ACC.3.2 Information related to the patient’s care is transferred with the patient


1 The patient’s record or a summary of patient care information is transferred with the patient to another service or unit in the hospital

BD Cato • BD Cato supports the transfer of the patient´s record to another service or unit in the hospital, provided this unit has also access to the system

Pyxis Enterprise serverPyxis MedStation ES system Pyxis Anesthesia ES system

• ES system activity is linked to the patient profile


• The transactions associated with a patient are visible on the Pyxis Supply regardless of which location within the facility they were performed

2 The summary contains the reason for admission

BD Cato • Within the patient's record in BD Cato this information can be inserted as a comment

3 The summary contains the significant findings

BD Cato • Within the patient's record in BD Cato this information can be inserted as a comment

4 The summary contains any diagnosis made

BD Cato • This information can be entered in the system


• The patient record within the Pyxis Supply system can optionally store the diagnosis codes for reference

5 The summary contains any procedures performed

BD Cato • Within the patient´s record in BD Cato this information can be insered as a comment


• The patient record within the Pyxis Supply system can optionally store the procedural schedule

6 The summary contains any medications and other treatments

BD Cato • This information is also provided with the patient record


• All med removal data is tracked with the patient profile


7 The summary contains the patient’s condition at transfer

BD Cato • Within the patient´s record in BD Cato this information can be insered as a comment

Standard ACC.4.3.1 Patient education and follow-up instructions are given in a form and language the patient can understand

1 Follow-up instructions are provided in writing and in a form and language the patient can understand

Rowa Vmax systemRowa Label Rowa Refrigerated UnitRowa MosaicRowa Box-Picking Unit Rowa Conveyor system

• Medications for discharging or transferring patients can be labeled with information in two languages

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Patient and Family RightsProtecting Patient Confidentiality

Standard PFR.1.1 The hospital seeks to reduce physical, language, cultural, and other barriers to access and delivery of services


1 The department/service leaders develop and implement a process to limit the impact of barriers on the delivery of services

Rowa Vmax systemRowa Label Rowa Refrigerated UnitRowa MosaicRowa Box-Picking Unit Rowa Conveyor system

• Medications can be labeled with information in two languages thus allowing to overcome hearing and/or language barriers

Standard PFR.1.3 The patient’s rights to privacy and confidentiality of care and information are respected

3 Confidentiality of patient information is maintained according to laws and regulations

BD Cato • BD Cato identifies the user either per login or barcode identification prior to granting access, assuring only authorized clinicians and end users have access to patient information in accordance to their user rights. Different criteria for passwords: duration, lengths, may contain login. Administrators define user levels

Pyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia systemPyxis CIISafe system Pyxis ProcedureStation systemPyxis SupplyStation systemPyxis StockStation™ system

• The BioID fingerprint identification system physically identifies user identity prior to granting access, assuring only authorized clinicians and end users have access to patient information in accordance with their user privileges

• Optional User ID/Password access: With Pyxis ES solutions, ID/password can be managed by IT using Active Directory integration; all IT policies around password requirements and expiration timing also apply within Pyxis ES system. With previou systems, customer determines password expiration timeframe; password length can be up to eight characters

• User access privileges are defined by managers in conjunction with pharmacist, and/or system administrator

Pyxis ProcedureStation systemPyxis SupplyStation systemPyxis StockStation system

• The Pyxis Supply system contains only the data required for the reporting of transactional events which is a minimal subset of the overall patient data. The data can optionally be encrypted within a secure database and access to the data from any point of use location is controlled by the end user account permissions

Pyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia systemPyxis CIISafe system Pyxis ProcedureStation systemPyxis SupplyStation systemPyxis StockStation system

• User access to patient information can be limited on designated equipment and persmissions can be defined down to the area level of each facility

• Login Activities Console or Server report documents successful/unsuccessful login attempts

• Ability to activate temporary users for a limited time period

Pyxis Connect systemPyxis CIISafe system

• Log of failed attempts documents unsuccessful attempts to access system

• User activation history displays who activated or deactivated a user and when


Patient and Family Rights continued

Protecting Patient Confidentiality

Standard PFR2.3 The hospital supports the patient’s right to assessment and management of pain and respectful compassionate care at the end of life


1 The hospital respects and supports the patient’s right to appropriate assessment and management of pain

BD Cato • BD Cato allows the creation of a Pain Category in the system. Therefore, patient pain level can be documented in the system and pop up alerts in relation to prescribed medications


• Clinical Data Category feature prompts patient assessments and enables clinicians to document pain level when administering analgesics

• Last removed data and too close/ too soon warnings

• Inventory management processes and reporting to ensure right medications available in right areas

Assessment of PatientsLaboratory Services

Standard AOP.5.3.1 The laboratory uses a coordinated process to reduce the risks of infection as a result of exposure to biohazardous materials and waste

1 The laboratory has a defined process for reducing the risks of infection


• Automated inventory management electronically alerts pharmacy to replenish medication in stations

Rowa Vmax system with Rowa™ MedPort

• Rowa Medport has a cleanroom lock function

Standard AOP.5.5 All equipment and medical technology used for laboratory testing is regularly inspected, maintained, and calibrated, and appropriate records are maintained for these activities

4 Laboratory equipment and medical technology are inspected and tested when new and according to age, use, and manufacturers’ recommendations thereafter and the inspections are documented

Rowa Vmax systemRowa Smart systemRowa LabelRowa Refrigerated UnitRowa MosaicRowa Box-Picking Unit Rowa Conveyor systemRowa ProLog™

• Rowa products are tested during commissioning and at least once a year

5 Laboratory equipment and medical technology are calibrated and maintained according to manufacturers’ recommendations, and the calibration and maintenance are documented

BD Cato • BD Cato is a medical technological tool and it is and has site acceptance tests which attest the suitability of the system within customers specifications. The perform regularly at customer´s site validation tests (IQ,OQ) not only for the software, but also for all hardware components (barcode, scales, printers). Validation is being documented


• The Pyxis Supply system maintains UL and CE certifications as Medical Equipment

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Assessment of Patients continued

Laboratory Services

Standard AOP.5.5 All equipment and medical technology used for laboratory testing is regularly inspected, maintained, and calibrated, and appropriate records are maintained for these activities


6 The hospital has a system in place for monitoring and acting on laboratory equipment and medical technology hazard notices, recalls, reportable incidents, problems, and failures

BD Cato • BD Cato offers technical support including remote access to trouble shoot incidents related to the system and its hardware components

Rowa Vmax systemRowa MosaicRowa MedPort

• The remote access allows to retrieve error statistics, to modify parameters or calibrate and finally to check and fix failures remotely


• The Pyxis Supply system maintains UL and CE certifications as Medical Equipment

Standard AOP.5.7 Procedures for collecting, identifying, handling, safely transporting, and disposing of specimens are established and implemented

2 Procedures are established and implemented for the collection and identification of specimens. (Also see IPSG.1, ME 3)


• Specimen tracking is not directly relevant to Pyxis Supply. Pyxis Supply does offer an optional Tissue and Implant module product that can assist in maintaining appropriate documentation on chain of custody for human tissue and other implanatible items that will be used for patient care

4 Procedures are established and implemented for the receipt and tracking of specimens


• Specimen tracking is not directly relevant to Pyxis Supply. Pyxis Supply does offer an optional Tissue and Implant module product that can assist in maintaining appropriate documentation on chain of custody for human tissue and other implanatible items that will be used for patient care

Standard AOP.5.8 Established norms and ranges are used to interpret and to report clinical laboratory results.

1 The laboratory has established reference ranges for each test performed

BD Cato • Reference ranges for test performance can be allocated

Care of PatientsCare Delivery for All Patients

Standard COP.2 There is a process to integrate and to coordinate the care provided to each patient

1 Care planning is integrated and coordinated among settings, departments, and services

BD Cato • BD Cato can manage patient´s care planning in terms of the therapy plan by taking into consideration other departments or specific services

Pyxis SupplyCenter™ server • The Pyxis SupplyCenter server provides a global view of all activity performed within the Supply system from all locations. Some activites, such as item discard documentation, can be done universally within the Supply system


Care of Patients continued

Care Delivery for All Patients

Standard COP.2 There is a process to integrate and to coordinate the care provided to each patient


2 Care delivery is integrated and coordinated among settings, departments, and services

BD Cato • BD Cato can manage patient´s care planning in terms of the therapy plan by taking into consideration other departments or specific services

3 The results or conclusions of any patient care team meetings or other collaborative discussions are documented in the patient’s record

BD Cato • All relevant information can be entered in the patients records

Standard COP.2.1 An individualized plan of care is developed and documented for each patient

2 The plan of care is individualized based on the patient’s initial assessment data and identified needs

BD Cato • Therapy Plans in BD Cato can be individualized according to the assessed data and patient´s need

Rowa Dose system • The Rowa Dose system supports fully documented dispensing of solid oral drugs according to individualized medication plans, providing a very flexible scheme to administer medication at the right time with all required information on the pouch (e.g., 11:45, 12:00, 12:15; “take with water”)

3 The plan of care is updated or revised and reviewed by the multidisciplinary team based on the reassessment of the patient by the health care practitioners.

BD Cato • Multidisciplinary reviews and reassesment of patient therapy is supported providing all relevant actors have access to the system

6 The planned care is provided for each patient and documented in the patient’s record by the health professional providing the care. (Also see COP.2.3; ASC.3; ASC.5; and MOI.10.1, ME 4)

BD Cato • BD Cato supports this requirement in reference to the therapy plan prescribed

Standard COP.2.3 Clinical and diagnostic procedures and treatments performed, and the results or outcomes, are documented in the patient’s record

2 The person requesting, and the reason for requesting, the procedure or treatment are documented in the patient’s record


• The Pyxis Supply system can optionally track the Primary care physician detail and related case and procedure scheduling information. Rationale for such association is not relevant to the Supply system

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Care of Patients continued

Care Delivery for All Patients

Standard COP.2.3 Clinical and diagnostic procedures and treatments performed, and the results or outcomes, are documented in the patient’s record


3 The results of procedures and treatments performed are documented in the patient’s record


• Although procedural results are not a tracked component within the Supply system, item usage can be associated to specific patient procedures to provide post-procedure analytical benefits such as case/procedure costing or to drive best practices among surgical staff on procedural pick lists

Medication Management and UseOrganization and Management

Standard MMU.1 Medication use in the hospital is organized to meet patient needs, complies with applicable laws and regulations, and is under the direction and supervision of a licensed pharmacist or other qualified professional

1 A written document identifies how medication use is organized and managed throughout the hospital

BD Cato • BD Cato can support to a certain level written documents. For the management of drugs the system features a four eyes principle which can be in accordance with the hospitals’ regulation

Pyxis Enterprise server Pyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia system

• System can leverage Knowledge Portal reports which provide drug utilization data by drug and clinical area for use in evaluating and properly adjusting drug utilization patterns

Knowledge Portal • The Knowledge Portal for Pyxis medication technologies provides access to activites supporting medication usage, order details, patients, transactions and other key data elements support hospitals policies and procedures

6 Appropriate sources of drug information are readily available to those involved in medication use

BD Cato • BD Cato offers the possibility to link each drug with its drug information file. This file may be saved locally or on the server - drug information is readily available for those involved

Pyxis MedStation 4000 system Pyxis Anesthesia system

• Lexi-Comp drug reference information database available at the station provides immediate access to drug information

Pyxis Enterprise server Pyxis MedStation ES system Pyxis Anesthesia ES system


Rowa Dose system • Rowa Dose can be configured to print administration advice (“take with water”), special alerts and indications (e.g. “beta-blocker”) on unit dose, combi dose or multi dose pouches, assisting the nurse at the point of care with directly accessible information given by the physicians and hospital pharmacists

Rowa Vmax systemRowa LabelRowa Refrigerated UnitRowa MosaicRowa Box-Picking Unit Rowa Conveyor system

• Drug information can be printed on the labels (depending on PIS)


Medication Management and Use continued

Selection and Procurement

Standard MMU.2 Medications for prescribing or ordering are stocked, and there is a process for medications not stocked or normally available to the hospital or for times when the pharmacy is closed


1 There is a list of medications stocked in the hospital or readily available from outside sources

BD Cato • BD Cato has its own stock management system which can be easily linked with the hospital central system or outside sources


• Pyxis ES system formulary, standardized across all facilities, areas and devices as appropriate


• Not directly relevant to Pyxis Supply but Supply does track a list of inventory managed within a facility

Rowa Vmax systemRowa Smart™ systemRowa Mosaic

• The list of medications stored in Rowa is available on Vmax GUI, Mosaic GUI and finally PIS.

Rowa Vmax systemRowa Smart system

• Rowa reports all currently available stock per machine

Rowa Mosaic • Rowa Mosaic reports all currently available stock over all machines and also provides this information to the PIS where it can be consolidated with the data from other systems to create a detailed stock view over the whole pharmacy

Rowa Visavia™ • Provides the ability for the patient to pick his prescribed medication up outside the opening times of the hospital pharmacy

Rowa Vpoint™ • Offers the possibility by using a patient’s card at the terminal to inform the patient about the the prescribed medication

• Using the Vpoint as a Self Check-out Terminal Contactless, the patients are able to inform themselves about the available products in the hospital pharmacy, they can reserve them and pay directly, if appropriate

3 There is a process for obtaining medications during the night or when the pharmacy is closed

Pyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia system

• Override Group Feature can be used to grant specific users (e.g. night managers) access to medications not normally on override ensuring availability of medication

• Double-check of medications removed on override is ensured with the Witness on Remove During Override function

• Clinical Data Category feature can be used to communicate information on hospital policies and guidelines for medication use (e.g. if a pharmacy closes at 2300, when a user attempts to remove amino glycoside antibiotic after 2300, instructions are displayed on the station screen to contact the pharmacist to calculate the first dose). Optional display on override only

• Global Find enables the user to search for specific medications not available in their station and then locates which station have that medication loaded and what quantities are available

• Helps ensure medications are available for therapy

16



Standard MMU.2 Medications for prescribing or ordering are stocked, and there is a process for medications not stocked or normally available to the hospital or for times when the pharmacy is closed


3 There is a process for obtaining medications during the night or when the pharmacy is closed.

Pyxis Connect system • Supports electronic transmission of new medication orders to the pharmacist for prompt review and processing

• Provides “stat order” prioritization helping to reduce order-processing time and supports process improvement efforts to improve legibility of physician orders

Knowledge Portal • Provides aggregate and detail data for analysis and compliance, including the duration of time the meds are not available

• Can be used to identify areas of improvement and document success of process change

Rowa Dose system • Medications in solid oral forms can be pre-packaged as individualized unit doses (including patient name) or single doses (without patient name) and stored in a Pyxis system

Rowa Vmax systemRowa Smart systemRowa MosaicRowa Refrigerated UnitRowa Conveyor system

• Afterhours drop points can be installed outside the pharmacy, order requests are managed by the PIS

Rowa Visavia • Provides the ability for the patient to pick his prescribed medication up outside the opening times of the hospital pharmacy

Standard MMU.2.1 There is a method for overseeing the hospital’s medication list and medication use

1 There is a method for overseeing medication use in the hospital

Pyxis Enterprise server Pyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia system Knowledge Portal

• Server/Console and Knowledge Portal reports on medication use and override activity provide information useful in formulary management

• Server/Console and Knowledge Portal reports provide information to track costs

• Knowledge Portal reports provide data to evaluate usage patterns and costs

2 Health care practitioners involved in ordering, dispensing, administering, and patient-monitoring processes are involved in evaluating and maintaining the medication list


• 4000 & ES: Pharmacy maintains system formulary list using PIS as source of truth

• Pyxis ES system formulary can be automatically standardized with PIS interface

Knowledge Portal • The Knowledge Portal can help auditing users, medications, transactions and patients as needed to support hospitals policies and procedures

Rowa Vmax systemRowa Smart systemRowa ProLogRowa Mosaic

• Rowa stores ONLY products authorized by the PIS (bidirectional interface with PIS), thus available on the formulary




Standard MMU.2.1 There is a method for overseeing the hospital’s medication list and medication use


3 Decisions to add or to remove medications from the list are guided by criteria


• Pyxis ES system formulary standardized using PIS as source of truth

• Meds not removed report

Knowledge Portal • The Knowledge Portal helps hospitals determine which medications should be removed or added based on inventory movements



4 When medications are newly added to the list, there is a process or mechanism to monitor how the drug is used and any unanticipated adverse events


• Clinical Data Category are useful to alert nurses of potential adverse events associated with new medications, and can be used as a tool for nurses to document adverse events

5 The list is reviewed at least annually based on safety and efficacy information



Storage

Standard MMU.3 Medications are properly and safely stored

1 Medications are stored under conditions suitable for product stability, including medications stored on individual patient care units

Pyxis™ SMART Remote Manager

• Monitors storage device temperatures and provides a warning at the station and on the server/console in the pharmacy if a storage device temperature goes outside of the user-defined range

Pyxis MedStation ES system Pyxis MedStation 4000 systemCUBIE

• Outdate tracking allows pharmacy to store and monitor medications by expiration date

• Outdate icon can warn users of approaching expiration dates for drugs that have a short product stability period helping to ensure viability

18


Storage



1 continued Medications are stored under conditions suitable for product stability, including medications stored on individual patient care units

Pyxis Anesthesia ES systemPyxis Anesthesia system

• Outdate Tracking and Expired Med icon supports management of medication expiration dates

Pyxis CIISafe system • Pyxis CIISafe system Outdate tracking allows pharmacy to store and monitor medications by expiration date

Rowa Vmax systemRowa Mosaic Rowa Refrigerated Unit


• Refrigerated unit´s temperature monitor informs the user whether the Rowa fridge temperature is irregular

• The Vmax can pe connected to the A/C system, thus allowing the medication to be stored safely and in compliance with local storage temperature specifications

Rowa Smart systemRowa Mosaic


• The Smart can be connected to the A/C system, thus allowing the medication to be stored safely and in compliance with local storage temperature specifications

Rowa Dose system • Solid oral drugs can be dispensed and stored in Rowa Dose pouches for a variable time-period (depending on the characteristics of the used medications); pouch packaging material meets container class A requirements

2 Controlled substances are accurately accounted for according to applicable laws and regulations


• The Pyxis BioID fingerprint identification system helps ensure only approved personnel access the station

• Inter-disciplinary clinical team defines user access privileges through Security Group and Override Group features

• Discrepancy icon on station screen supports resolution of inventory variances

• Supports single-line item access to selected drug via Pyxis CUBIE Drawers, Pyxis MiniDrawers

• Supports single dose access to selected medication via Pyxis Minidrawer in single-dose mode

Knowledge Portal • Reports available through the Knowledge Portal facilitate monitoring controlled substances for diversion

• Reports support analysis of transaction trends

Pyxis CIISafe system • Segregates controlled substances from general medication stock and securely stores in locked cabinets restricting access to authorized users only

• Reports provide detailed audit trail for hospital-wide controlled substance activity and assist with proactive monitoring for diversion




• Secured Drawer Reverification mandates users to re-authenticate (by reentering their passwords or fingerprint) before allowing them to remove items stored in secure drawers after a preset activity time has expired. The activity time is configured through Security Group

• Inter-disciplinary clinical team defines user access privileges through Security Group

• Discrepancy Icon on station screen supports resolution of inventory variances

• Provides effective management of medications and supplies directly in the operating room suite and other special procedure areas (e.g., Endoscopy, Emergency, Trauma Rooms, Cath Lab, etc.) via Pyxis MiniDrawers



Storage



3 Medications and chemicals used to prepare medications are accurately labeled with contents, expiration dates, and warnings

BD Cato • BD Cato guarantees a correct label of all medications which includes but not limited to content, expiration dates, warnings, date, patient etc

Pyxis MedStation ES system • Medication Label module with Pyxis MedStation ES system supports appropriate labeling of patient dose-specific medications prepared on the nursing unit

Rowa Label Rowa Vmax systemRowa Mosaic Rowa Regrigerated UnitRowa Box-Picking Unit Rowa Conveyor system

• Medication stored in Rowa can be labeled with contents, expiration dates and warnings during dispensing and not during input (depending on PIS)

4 All medication storage areas, including medication storage areas on patient care units, are periodically inspected to ensure that medications are stored properly

Rowa Vmax systemRowa Smart systemRowa Mosaic


• The laser shelves scanning functionality allows to check stock for presence and correct positioning

Rowa Dose system • Expiration dates of solid oral drugs in canisters used for pouch packaging can be periodically inspected with a report generator. In addition to that, the system can be configured to make sure that expired medications cannot be dispensed

5 Medications are protected from loss or theft throughout the hospital


• Profile Interface allows nurse access to unit-dose medications per the patient profile

• Pyxis MiniDrawers secure medication dispensing system support unit dose dispensing in single dose or multi-dose format or provides single line item access if needed

• Pyxis CUBIE pockets and carousel drawers support single-line item access

• Secure access drawers prevent inadvertent access or open medication availability present in medication carts or matrix drawers


• Pyxis MiniDrawers secure medication dispensing system support unit dose dispensing in single dose or multi-dose format or provides single line time access if needed

Rowa Vmax system • User access protected with password or BioID allows safe storage

• Rowa access door can be locked

Rowa Smart system • User access protected with password allows safe storage

• Rowa access door can be locked

20


Storage

Standard MMU.3.1 There is a process for storage of medications and nutrition products that require special consideration


1 The hospital establishes and implements a process for how nutrition products requiring special considerations are stored

Pyxis SMART Remote Manager • Ability to properly store, access and track removal of nutritional products that require refrigerated storage

Standard MMU.3.2 Emergency medications are available, monitored, and safe when stored out of the pharmacy

1 Emergency medication are available in the units where they will be needed or readily accessible within the hospital to meet emergency needs

Pyxis MedStation ES system Pyxis MedStation 4000 system

• Override feature can be used to appropriately manage select emergency medications

• Pyxis CUBIE pockets allow for segregation of age-specific medications

• Physical kits can be stored for use in emergency situations; user-defined virtual kits allow for fewer steps during removal of multiple emergency medications

• Can provide back-up inventory in emergency situations

• Always make sure medication needed for emergency situations are available outside of the Pyxis system


• Provides Anesthesiologists with secure access to emergency drugs

• Virtual kits allow fewer steps to specific controlled emergency medications

• Break-away emergency drug kit provides manual access to non-controlled emergency drugs when the provider is not logged into the system and/or during transport

Rowa Dose system • Emergency medications in solid oral forms can be pre-packaged as individualized unit doses (including patient name) or single doses (without patient name) and stored in a Pyxis system

2 The hospital establishes and implements a process for how emergency medications are stored, maintained, and protected from loss or theft

Pyxis MedStation ES systemPyxis MedStation 4000 system

• Override feature can be used to manage select emergency medications

• Pyxis CUBIE pockets allow for segregation of age-specific medications

• Physical kits can be stored for use in emergency situations; user-defined kits allow for fewer steps to access during removal of multiple emergency medications

• Can provide back-up inventory in emergency situations


• Provides Anesthesiologists with secure access to emergency drugs

• Virtual kits allow fewer steps to access to specific controlled emergency medications

• Break-away emergency drug kit provides manual access to non-controlled emergency drugs when the provider is not logged into the system and/or during transport

3 Emergency medications are monitored and replaced in a timely manner after use or when expired or damaged

Pyxis MedStation ES systemPyxis MedStation 4000 system

• Automated inventory management electronically alerts pharmacy to replenish medication in stations



Storage

Standard MMU.3.3 The hospital has a medication recall system


1 There is a medication recall system in place

BD Cato • Any product in BD Cato including medications can be recalled easily and fast within the system. It gives information of the quantity prescribed, the batch number as well as the patient information

Pyxis MedStation ES system Pyxis MedStation 4000 system Pyxis Anesthesia ES system Pyxis Anesthesia system

• Security Group feature can be utilized to immediately stop access to a medication or a recalled medication and enable fewer steps for removal of it from dispensing cabinets

• Outdate Tracking console report and expired med icon displayed at the station support management of medication expiration dates

• Hospital Wide Summary console report identifies which pockets contain specific medications facilitating retrieva.


• Hospital Wide Summary console report identifies which pockets contain specific medications facilitating retrieval

• Security Group feature can be utilized to immediately stop access to a recalled medication in secure Pyxis MiniDrawers and enable fewer steps for removal of the medication from the dispensing cabinet

Rowa Vmax systemRowa Smart systemRowa Mosaic Rowa Refrigerated Unit


• The PIS can output from Rowa all recalled packs by their batch number (depending on PIS)

Rowa Dose system • Recalled medciation already dispensed in pouches or filled into canisters can be searched for using a report generator. Rowa Dose supports a complete tracking & tracing system

2 The hospital establishes and implements a process for use of medications known to be expired or outdated

BD Cato • BD Cato prevents the use of medications expired or outdated. Those medications are not being automatically selected for patient use. BD Cato will warn the user if this medications are being used inadvertendly in a compounding porcess

Pyxis MedStation ES system Pyxis MedStation 4000 system Pyxis Anesthesia ES system Pyxis Anesthesia system

• Expired/expiring meds notification at device level

• Security Group feature can be utilized to immediately stop access to a medication and enable quick removal of it from dispensing cabinets

• Outdate Tracking console report and expired med icon displayed at the station support management of medication expiration dates

• Meds not removed feature/report to help rebalance med loads

22


Storage

Standard MMU.3.3 The hospital has a medication recall system


2 continued The hospital establishes and implements a process for use of medications known to be expired or outdated

Pyxis CIISafe system • Pyxis CIISafe system Outdate tracking allows pharmacy to store and monitor medications by expiration date

Rowa Smart systemRowa Mosaic


Rowa Vmax systemRowa ProLog Rowa Mosaic


• ProLog’s OCR expiration date recognition system allows pharmacy to load medications automatically into the Vmax with their expiration date

Rowa Dose system • Expiration dates of solid oral drugs in canisters used for pouch packaging can be periodically inspected with a report generator. In addition to that, the system can be configured to make sure that expired medications cannot be dispensed

3 The hospital establishes and implements a process for the destruction of medications known to be expired or outdated

Pyxis CIISafe system • Maintains detailed records of medication quantities stored until removed for destruction

• Pyxis CIISafe system has explicit Expire, Waste, and Recall function to identify and trace recalled item transactions

Ordering and Transcribing

Standard MMU.4 Prescribing, ordering, and transcribing are guided by policies and procedures

1 The hospital establishes and implements a process for the safe prescribing, ordering, and transcribing of medications in the hospital

BD Cato • BD Cato is also a powerful prescribing OE system. If used at ward level, it drastically reduces prescribing errors, as BD Cato controls many parameters in the background such as validity of lab results, cumulative and exceeding doses, drug concentration, material incompatibility. Ordered medications are being sent to the pharmacy in real time thus avoiding paper and enhancing efficiency both at prescribing and pharmacy level

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000 system Pyxis Anesthesia ES system Pyxis Anesthesia System

• Profile interface/workflow uses the pharmacy information system as the source of truth for pharmacist-reviewed medication orders

• Order Profile Override features allows for nurse access to medications needed in urgent/emergent patient situations

• Override reports provides tool for monitoriing override activity

Rowa Mosaic • Mosaic provides a standardized electronic interface for medication ordering in the hospital. Using this interface a fully automated medication handling can be established




Standard MMU.4 Prescribing, ordering, and transcribing are guided by policies and procedures


2 The hospital establishes and implements a process for managing illegible prescriptions and orders, including measures to prevent continued occurrence

BD Cato • BD Cato focuses on patient safety. By changing to a paperless based system illegible prescptions are being managed through electronic prescriprition. Quality checkpoints through the medication validation process help to ensure no prescribing errors are slipped through, thus jeopardizing patients safety

Rowa Mosaic • Mosaic provides a standardized electronic interface for medication ordering in the hospital. Using this interface fully illegible prescriptions are not possible anymore

3 Staff are trained in correct prescribing, ordering, and transcribing processes

BD Cato • BD Cato´s team will train all relevant actors to perform their tasks efficiently and safely

4 Patient records contain a list of current medications taken prior to admission, and this information is made available to the pharmacy and the patient’s health care practitioners

BD Cato • All medication information prior to admission can be inserted in the patients therapy plan thus being available both for the pharmacy and care givers

5 Initial medication orders are compared to the list of medications taken prior to admission, according to the hospital’s established process

BD Cato • The systems supports this requirement. Patients therpay plan may include this information is necessary to comply to hospital processes. The system has the ability to adapt its workflow structure that of the hospital in terms of prescription and medication verification process

Standard MMU.4.1 The hospital defines the elements of a complete order or prescription

4 The hospital develops and implements a process to monitor the completeness and accuracy of medication orders and prescriptions

BD Cato • Completeness and accuracy of medication orders and prescriptions can be check electronically by means of a released questionnaire. The electronic released questionnaire can be configured according to customer needs and only after it has been answered according to hospital process the user may go to the next step of the process. The system can created a hardstop in the workflow chain for the case the internal processes related to completeness and accuracy of medication orders and prescriptions are not fully met

24



Standard MMU.4.2 The hospital identifies those qualified individuals permitted to prescribe or to order medications


1 Only those permitted by the hospital and by relevant licensure, laws, and regulations prescribe or order medications

BD Cato • BD Cato can manage through the user rights who may prescribe or order medications

Rowa Vmax system • User access protected with password or BioID allows medication to be retrieved directly from the Vmax by authorized individuals only

Rowa Smart system • User access protected with password allows medication to be retrieved directly from the Smart by authorized individuals only

Standard MMU.4.3 Medications prescribed and administered are written in the patient’s record

1 Medications prescribed or ordered are recorded for each patient

BD Cato • The patients individual therapy plan records and tracks all the medications as well as what has been done to those medications, such as changing the dose or lab result, changing the diluent, date, application time etc

Rowa Dose system • All solid oral drugs dispensed and packaged with a Rowa Dose system can be tracked to the patient and/or ward receiving the medication

2 Medication administration is recorded for each dose

BD Cato • BD Cato ensures medication administration record for each doses by means of barcoding the medication, patient and care giver. In this manner, and for each dose, a single record in the system is being created

Rowa Dose system • Barcodes on each pouch support bedside verification at the point of care

3 Medication information is kept in the patient’s record or inserted into his or her record at discharge or transfer

BD Cato • All relevant medication information is automatically kept in the patients record after each action has been performed. Shall the patient be discharged all relevant information related to the medication will be found on each patients therapy plan event log

Preparing and Dispensing

Standard MMU.5 Medications are prepared and dispensed in a safe and clean environment

1 Medications are prepared and dispensed in clean and safe areas with appropriate medical technology, equipment, and supplies

BD Cato • All hardware components recommended by BD Cato for compounding or related activites have been tested or/and validated ensuring full functionality and ability for the intended purpose

Rowa Dose system • The Rowa Dose systems is designed and constructed according to GMP requirements and can be opereated in cleanroom environments. The device itself can be thoroughly cleaned

Rowa MedPortRowa Mosaic Rowa Vmax system

• Medications are safely prepared and dispensed in a clean room envinronment with the MedPort (cleanroom lock function)




Standard MMU.5 Medications are prepared and dispensed in a safe and clean environment


2 Medication preparation and dispensing adhere to laws, regulations, and professional standards of practice

BD Cato • BD Cato is a ISO certified software and complies to the GMP and GAMP 5 Guidelines

Rowa Dose system • The Rowa Dose system has been designed according to applicable laws, regulations, and professional standards (e.g., EU Guideline for Good Manufacturing Practice, Title 21 CFR Part 11)

Rowa MedPortRowa Mosaic Rowa Vmax system

• Medications are safely prepared and dispensed in a clean room envinronment with the MedPort (cleanroom lock function)

Standard MMU.5.1 Medication prescriptions or orders are reviewed for appropriateness

1 The hospital defines the patient-specific information required for an effective review process, and the source or availability of this information is available at all times when the pharmacy is open or closed

BD Cato • Patient specific information is always availble in the system. It is readily accessible from any terminal located in or outside the pharmacy


• Profile interface/workflow uses the pharmacy information system as the source of truth for pharmacist-reviewed medication orders

• Order Profile Override features allows for nurse access to medications needed in urgent/emergent patient situations

• Override reports provides tool for monitoriing override activity

2 Apart from exceptions identified in the intent, each prescription or order is reviewed for appropriateness prior to dispensing and administration and includes elements a) through g) in the intent. Thus, each prescription or order is evaluated for appropriateness

BD Cato • Every OE is checked during the verification process only by authorized staff. BD Cato can create throughout the workflow different checkpoints in order to review and guarantee the correctness and intend of the prescription as well as the elements of such


• Profile interface restricts access to only medication orders reviewed and approved by a Pharmacist

• Profile interface helps ensure that the hospital policy is adhered to by allowing for display of appropriate and complete medication order information

• Override report allows review of all meds accessed before being profiled

• Clinical Data Category feature can be used to capture the reason for all medications removed on override

• Reports such as Profile History and Patient Profiles allow for reviewing orders sent across the interface from the HIS/PIS are compliant wiht the policies

• Server/Console reports enable monitoring of compliance to policies

26



Standard MMU.5.1 Medication prescriptions or orders are reviewed for appropriateness


2 continued Apart from exceptions identified in the intent, each prescription or order is reviewed for appropriateness prior to dispensing and administration and includes elements a) through g) in the intent. Thus, each prescription or order is evaluated for appropriateness



• Facilitates pharmacist off-site order review prior to dispensing and administration of medication

Knowledge Portal • Aggregates data and drill down on Override removals by drug, station, and user

• Analysis of individual variance between removal of ordered meds via the Profile interface and through the Override function to measure compliance

5 Review is facilitated by a record (profile) for all patients receiving medications, and this record is available at all times when the pharmacy is open or closed

BD Cato • This review can be created as a questionnaire available for all medications. The outcome of this questionnaire is available to all users who have access to BD Cato even outside pharmacy opening hours

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia systemKnowlegde Portal

• All transactions are electronically captured and can be stored, printed, or archived

• The Knowledge Portal enables monitoring of compliance to profile override policies




Standard MMU.5.2 A system is used to dispense medications in the right dose to the right patient at the right time


1 There is a uniform medication and dispensing system in the hospital

BD Cato • BD Cato is aimed to manage chemotherapy drugs, however drugs for other purposes such as oral medication, co-medications, antibiotics can also be prescribed through BD Cato, thus creating an uniform prescribing method


• Pyxis products provide a secured, consistent, and replicable system to manage, store, and dispense medications

Rowa Dose system • The Rowa Dose systems can be used to establish a uniform, cost-effective and safe medication and dispensing system for solid oral drugs as unit doses, combi doses, multi doses and/or single doses

Rowa Vmax systemRowa Smart systemRowa LabelRowa Refrigerated UnitRowa Mosaic Rowa Box-Picking Unit Rowa Conveyor systemRowa ProLog

• Rowa products provide a secured, consistent, and replicable system to manage, store, and dispense medications

• The Partial Packs Management functionality allows to dispense the precise unit dose quantity, packs with remaining units will have to be re-stocked in Rowa

Rowa Mosaic • Automatic ward box filling that ensures that the right medication is shipped to the right ward at the right time

2 After preparation, medications not immediately administered are labeled with the name of the medication, the dosage/concentration, the date prepared, the expiration date, and the patient’s name.

BD Cato • BD Cato labels with the name of the medication, the dosage/concentration, the date prepared, the expiration date, and the patient’s name

• Medication that have not be administered may be elegible to be reused for another patient if drug concentration and stability are still good for the new order. Once this returned medication has been assigned to a new patient, the system will generate a new label with the patients new information

Pyxis MedStation ES system Pyxis Anesthesia ES system

• Medication Label module with Pyxis ES system supports appropriate labeling of patinet dose-specific medications prepared on the nursing unit

Rowa Dose system • All pouches produced with the Rowa Dose system are labeled with the name of the medication, the dosage, the date prepared, the expiration date, the patient’s name and other required information according to the specific needs of the hospital

Rowa Vmax systemRowa LabelRowa Mosaic

• Medication stored in Rowa can be labeled with its name, its dosage/concentration, its dispensing date, its expiration date and patient´s name during dispensing and not during input (depending on PIS)

28



Standard MMU.5.2 A system is used to dispense medications in the right dose to the right patient at the right time


3 Medications are dispensed in the most ready-to-administer form

Pyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia systemCUBIE

• Pyxis MiniDrawers secure medication dispensing system support unit dose dispensing in single dose format if needed

• Pyxis CUBIE pockets and carousel drawers support single-line item access which provide safge access if multiple strengths of the same line-item are needed

• Combination order feature supports multi-item dispensing (e.g. ready-to-use IV admixtures)

• Equivalency order feature helps ensure availability of ordered dose

Rowa Dose system • Rowa Dose allows dispensing of medications as unit doses, combi doses, and multi doses with the patient’s name as well as single doses with required medication information, but without the patient’s name

4 The system supports accurate and timely dispensing


• Supports ISMP guidelines on safe use of automated dispensing cabinets

• All transactions are electronically captured and can be stored, printed, or archived

• Outdate tracking console report and expired med icon displayed at the station support management of medication expiration dates

• User privileges and Security Group features limit access to appropriately trained and licensed individuals.

• The Pyxis BioID fingerprint identification system physically verifies user identity limiting access to appropriately trained and licensed clinicians

• Electronic interface with pharmacy’s patient medication profile helps reduce time to first dose.

• Helps ensure availability of medications in care areas, supporting timely administration

• Too Early or Too Late warnings (Profile only) and Too Close warnings help ensure medications are being accessed with appropriate institutionally defined time frames

• Patient Summary feature can be used to identify medications due for several patients or an individual patient for designated times

• My Worksheet feature can be used to identify medications due for several patients or an individual patient for designated times

• Med Locator feature icon (on My Worksheet) indicates location of medications in stations within the same Pyxis products defined area if they are not available at the station

Pyxis CIISafe system Accurate dispensing:

• Assists in meeting regulatory requirements related to controlled substance record keeping.

• The Pyxis BioID fingerprint identification system physically verifies user identity limiting access to appropriately trained and licensed clinicians

Pyxis Anesthesia ES system Pyxis Anesthesia System

Accurate dispensing:

• Assists in meeting regulatory requirements related to controlled substance record keeping

Knowledge Portal Timely dispensing:

• Reports available through Knowledge Portal suppport system optimization with data on stock-outs and usage patterns

Rowa Dose system • The Rowa Dose system supports a accurate and timely dispensing of solid oral medications by providing a very flexible scheme to print detailed information about administration time on each pouch (e.g., 11:45, 13:30)

Rowa Vmax systemRowa Smart systemRowa Mosaic Rowa Conveyor system

• Rowa dispenses as soon as it receives an order from the PIS

• Rowa can manage the correct unit dose quantity with the Partial Pack Management functionality (packs with remaining units, if necessary, can be re-inputted in Rowa)



Administration

Standard MMU.6 The hospital identifies those qualified individuals permitted to administer medications


2 Only those permitted by the hospital and by relevant licensure, laws, and regulations administer medications

BD Cato • No other individuals than those defined for medication administration and document may do so in BD Cato


• Provides layers of security locks (software and hardware) to control access to medication

• The Pyxis BioID fingerprint identification systems helps ensure only approved personnel access the station

• Access requires User ID and fingerprint or password

• User Privileges or Security Groups features limit access to appropriately trained and licensed indivduals

• Pyxis MiniDrawers secure medication dispensing pockets support unit dose dispensing in single dose format to selected drug

• Pyxis CUBIE pockets and carousel drawers support single-line item access to selected drugs

• All transactions (including controlled substances) are electronically tracked and documented

• Discrepancy icon on the station screen supports resolution of inventory variances

• Non-profile station supports automated dispensing in areas where a licensed independent practitioner(LIP) controls ordering, dispensing, and administering (e.g. Endoscopy, Emergency Department)

Rowa Vmax system • User access protected with password or BioID allows medication to be ordered and loaded from/into the Vmax by authorized individuals only

• Vmax access door can be locked

Rowa Smart system • User access protected with password allows medication to be ordered and loaded from/into the Smart by authorized individuals only

• Smart access door can be locked

3 There is a process to place limits, when appropriate, on the medication administration of individuals






• Pyxis MiniDrawers secure medication dispensing pockets support unit dose dispensing in single dose format to selected drug

• Pyxis CUBIE pockets and carousel drawers support single-line item access to selected drugs




30


Administration

Standard MMU.6.1 Medication administration includes a process to verify the medication is correct based on the medication prescription or order


1 Medications are verified with the prescription or order

BD Cato • Medications in BD Cato can be verified both against a prescription (per fax) or per order (made with BD Cato)

Pyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia SystemCUBIE

• Profile interface restricts access to only medication orders reviewed and approved by a Pharmacist.

• Profile interface helps ensure that the hospital policy is adhered to by allowing for display of appropriate and complete medication order information.






Rowa Dose system • Rowa Dose is a validated system dispensing and packaging solid oral drugs according to the order received from the hospital information system

Rowa™ Photon • The Rowa Photon inspection systems is an optional add-on verifying the correct content of each pouch by comparing the observed content with expected values (defined by the original order)

Rowa Vmax systemRowa Smart systemRowa Mosaic

• Rowa dispenses the correct medication after the PIS sends an output request, the delivered medication can be checked for correctness in pharmacy against the CPOE order on the screen or the PIS pick list

2 The dosage amount of the medication is verified with the prescription or order

BD Cato • Dosage amounts in BD Cato can be verified both against a prescription (per fax) or per order (made with BD Cato)

Pyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia SystemCUBIE








Knowledge Portal • Aggregates data and drill down on Override removals by drug, station, and user

• Analysis of individual variance between removal of ordered meds via the Profile interface and through the Override function to measure compliance

Rowa Dose system • Rowa Dose is a validated system dispensing and packaging solid oral drugs according to the order received from the hospital information system

Rowa Photon • The Rowa Photon inspection systems is an optional add-on verifying the correct content of each pouch by comparing the observed content with expected values (defined by the original order)



Administration

Standard MMU.6.1 Medication administration includes a process to verify the medication is correct based on the medication prescription or order


3 The route of administration is verified with the precription or order

BD Cato • Route of administration is always linked to the drug, in most of the cases there will be a defined medication entry level. For medications with different application routes, the application route can be verified both against a prescription per fax) or per order (made with BD Cato)

Pyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia systemCUBIE





4 Medications are administered on a timely basis


• Electronic interface with pharmacy’s patient medication profile helps reduce time to first dose.

• Helps ensure availability of medications in care areas supporting timely administration

• Too Early or Too Late warnings (Profile only) and Too Close warnings help ensure medications are being accessed with appropriate institutionally defined time frames

• Patient Summary feature can be used to identify medications due for several patients or an individual patient for designated times.

• My Worksheet feature can be used to identify medications due for several patients or an individual patient for designated times

• Global Find feature indicates location of medications in stations within the same Pyxis products defined area if they are not available at the station

Rowa Dose system • Rowa Dose pouches contain all information needed for adminstration of medication on a timely basis

5 Medications are administered as prescribed and noted in the patient's record

BD Cato • After administration, nursing can record the administration (entering the real administration time, problems) in BD Cato which is traceable in the patient’s therapy plan


• Medication remove data is maintained on the system transaction database by patient until discharge

• Charting Interface records dose given on the hospitals Nurse Charting system or eDrug Chart (online MAR)

Standard MMU.6.2 Policies and procedures govern medications brought into the hospital for patient self-administration or as samples

1 The hospital establishes and implements a process to govern patient self-administration of medications

Rowa Dose system • Rowa Dose pouches contain all information needed for patient self-administration of solid oral medications (e.g., including administration time, intake advice)

32


Monitoring

Standard MMU.7 Medication effects on patients are monitored


1 Medication effects on patients are monitored


• Clinical Data Category feature supports collection of patient clinical information such as potential adverse drug reactions

2 Medication adverse effects on patients are monitored and documented



• Reports for removals of reversal agents can provide a suggestions for chart review to identify potential adverse drug events

Standard MMU.7.1 The hospital establishes and implements a process for reporting and acting on medication errors and near misses

2

The hospital establishes and implements a process for reporting and acting on medication errors and near misses



Quality Improvement and Patient SafetyMeasure Selection and Data Collection

Standard QPS.2 Quality and patient safety program staff support the measure selection process throughout the hospital and provide coordination and integration of measurement activities throughout the hospital

1 The quality and patient safety program supports the selection of measures throughout the hospital at the hospitalwide level and at the hospital department or service level

Knowledge Portal • Provides analytics, trending and health system views to support policies and procedures - to help drive compliance and improvements

2 The quality and patient safety program provides coordination and integration of measurement activities throughout the hospital


3 The quality and patient safety program provides for the integration of event reporting systems, safety culture measures, and others to facilitate integrated solutions and improvements



Quality Improvement and Patient Safety continued

Analysis and Validation of Measurement Data

Standard QPS.4 The quality and patient safety program includes the aggregation and analysis of data to support patient care, hospital management, and the quality management program and participation in external databases


1 The quality and patient safety program has a process to aggregate data.

Knowledge Portal • Aggregates data and drill down for drugs, supplies, station, and user

• Analysis of individual variance between key performance indicators and current status

Pyxis SupplyCenter™ server • The Pyxis SupplyCenter server acts as a central repository for transactional data and provides a global view of all activity performed within the Supply system from all locations. The data can be exported for further analysis

• Aggregates data and drill down for drugs, supplies, station, and user

2 Aggregate data and information support patient care, hospital management, professional practice review, and the overall quality and patient safety program



Pyxis SupplyCenter server • The Pyxis SupplyCenter server acts as a central repository for transactional data and provides a global view of all activity performed within the Supply system from all locations. The data can be exported for further analysis



Standard QPS.4.1 Individuals with appropriate experience, knowledge, and skills systematically aggregate and analyze data in the hospital

1 Data are aggregated, analyzed, and transformed into useful information to identify opportunities for improvement





2 Individuals with appropriate clinical or managerial experience, knowledge, and skills participate in the process

Knowledge Portal • The Knowledge Portal can provide user access across the health system or division to easy aggregage, trend and benchmark data to improve medication and inventory usage patterns, and compliance



34

Quality Improvement and Patient Safety continued


Standard QPS.4 The quality and patient safety program includes the aggregation and analysis of data to support patient care, hospital management, and the quality management program and participation in external databases


6 Data analysis supports comparisons internally over time, including comparisons with databases of like organizations, with best practices, and with objective scientific professional sources

Knowledge Portal • Reporting enables comparison between different hospitals within a hospital network



Standard QPS.6 The hospital uses an internal process to validate data

1 Data validation is used by the quality program as a component of the improvement process selected by leadership

Knowledge Portal • Analysis of individual variance between key performance indicators and current status can be compared between systems

• Trending analysis of key performance indicators available for comparison over designated time periods provides internal validity of data

Pyxis™ Supply Virtual Manager • The Pyxis Supply system is rigorously tested to ensure that the data generated within the system is accurate and has full completeness

2 Data are validated when any of the conditions noted in a) through f) in the intent are met

Knowledge Portal • Analysis of individual variance between key performance indicators and current status can be compared between systems

• Trending analysis of key performance indicators available for comparison over designated time periods provides internal validity of data

Pyxis™ Supply Virtual Manager • The Pyxis Supply system is rigorously tested to ensure that the data generated within the system is accurate and has full completeness

3 An established methodology for data validation is used

Knowledge Portal • Reporting enables comparison between different hospitals within a hospital network

Pyxis Supply Virtual Manager • The Pyxis Supply system is rigorously tested to ensure that the data generated within the system is accurate and has full completeness.

Gaining and Sustaining Improvement

Standard QPS.10 Improvement in quality and safety is achieved and sustained

2 Data are available to demonstrate that improvements are effective and sustained


4 Successful improvements are documented



Governance, Leadership and DirectionHospital Leadership for Quality and Patient Safety

Standard GLD.4 Hospital leadership plans, develops, and implements a quality improvement and patient safety program


2 Hospital leadership selects and implements a hospitalwide process to measure, assess data, plan change, and sustain improvements in quality and patient safety, and provides for staff education on this quality improvement process


4 Hospital leadership implements a structure and process for the overall monitoring and coordination of the quality improvement and patient safety program


Hospital Leadership for Quality and Patient Safety

Standard GLD.5 Hospital leadership prioritizes which hospitalwide processes will be measured, which hospitalwide improvement and patient safety activities will be implemented, and how success of these hospitalwide efforts will be measured

1 Hospital leadership uses available data to set collective priorities for hospitalwide measurement and improvement activities and consider potential system improvements


36

Facility Management and SafetyMedical Technology

Standard FMS.8 The hospital establishes and implements a program for inspecting, testing, and maintaining medical technology and documenting the results


4 The medical technology program includes preventive maintenance

BD CatoCUBIEPyxis Anesthesia ES system Pyxis Anesthesia systemPyxis Connect systemPyxis CIISafe systemPyxis MedStation ES system Pyxis MedStation 4000 systemPyxis ProcedureStation systemPyxis SMART Remote ManagerPyxis StockStation systemPyxis SupplyStation system Rowa Dose systemRowa PhotonRowa Vmax systemRowa Smart systemRowa LabelRowa Refrigerated UnitRowa Box-Picking Unit Rowa Conveyor systemRowa ProLog

• Preventive maintenance is performed at least once a year

5 Staff providing these services are qualified and trained for the services being provided

BD CatoCUBIEPyxis Anesthesia ES system Pyxis Anesthesia systemPyxis Connect systemPyxis CIISafe systemPyxis MedStation ES system Pyxis MedStation 4000 systemPyxis ProcedureStation systemPyxis SMART Remote ManagerPyxis StockStation systemPyxis SupplyStation system Rowa Dose systemRowa PhotonRowa Vmax systemRowa Smart systemRowa LabelRowa Refrigerated UnitRowa Box-Picking Unit Rowa Conveyor systemRowa ProLog

• Service and maintenance activities are performed by trained personnel only


Management of Information Information Management

Standard MOI.1 The hospital plans and designs information management processes to meet internal and external information needs


1 The information needs of those who provide clinical services are considered in the planning process

Pyxis Enterprise serverPyxis™ Med ConsolePyxis™ Supply ConsoleKnowledge Portal

• Operational reports available to individual with access rights

• Aggregates data and drill down for drugs, supplies, station, and user to any individual with access rights

• Analysis of individual variance between key performance indicators and current status available to any individual with access rights (KP)

Pyxis Supply Virtual Manager • The Pyxis Supply system is designed to capture all data relevant to the inventory management process as it applies to patient care

2 The information needs of those who manage the hospital are considered in the planning process

Pyxis Enterprise serverPyxis Med ConsolePyxis Supply ConsoleKnowledge Portal

• Operational reports available to individual with access rights

• Aggregates data and drill down for drugs, supplies, station, and user to any individual with access rights

• Analysis of individual variance between key performance indicators and current status available to any individual with access rights (KP)

Pyxis Enterprise serverKnowledge Portal

• The Pyxis Supply system is designed to capture all data relevant to the inventory management process as it applies to patient care

4 The planning is based on the hospital’s size and complexity

Pyxis Supply Virtual Manager • Key performance indicators are determined by hospital leadership to meet the needs of the organization

Standard MOI.2 Information privacy, confidentiality, and security - including data integrity - are maintained

1 The hospital has a written process that protects the confidentiality, security, and integrity of data and information

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia systemPyxis CIISafe systemCUBIE








38

Management of Information continued

Information Management

Standard MOI.2 Information privacy, confidentiality, and security - including data integrity -are maintained


1 continued The hospital has a written process that protects the confidentiality, security, and integrity of data and information


• Provides layers of security locks (software and hardware) to control access to supplies and implants



• All transactions are electronically tracked and documented

• System access can be limited by door based on user rights

• The Pyxis Supply system optionally provides database encryption to protect data from both virtual and physical attack. Furthermore, physical access to the system and its data are protected through user management permissions and various options for end user authentication

Rowa Dose system • Access requires User ID and password

• All transactions are electronically tracked and documented

• User rights can be configured and thoroughly maintained in the Rowa Dose system

2 The process is based on and consistent with laws and regulations

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia systemPyxis CIISafe system

• Provides layers of security to control access to data that may support laws and regulations

• User Privileges limit access to appropriately trained and licensed indivduals that may support lasws and regulations


• Provides layers of security to control access to data

• User Privileges limit access to appropriately trained and licensed indivduals

• The level of security is configurable based on the strength desired or as required by law

3 The process identifies the level of confidentiality maintained for different categories of data and information







• The user permissions that are defined within the Supply system allow for varying levels of data access to be assigned to end users of the system




Standard MOI.2 Information privacy, confidentiality, and security - including data integrity -are maintained


4 Those persons who need or have a job position permitting access to each category of data and information are identified




5 Compliance with policy is monitored

Pyxis Med ConsoleKnowledge Portal

• Reports enable compliance monitoring of policies

Standard MOI.3 The hospital determines the retention time of records, data, and information

1 The organization has a policy on the retaining patient’s clinical records and other data and information

Pyxis Enterprise ServerPyxis Supply ConsoleKnowledge Portal

• Appropriate data management and archiving systems in place with all Pyxis systems



• Transaction data can be archieved to hospital server

• The Pyxis Supply system provides configurability of data retention based on each data type. Patient records may be purged upon patient discharge while transactional data may be retained for a longer period

2 The retention process provides expected confidentiality and security







• Data maintained within the Pyxis Supply system can be optionally encrypted in the database and access to the data is controlled by end user permissions and user authentication requirements

40



Standard MOI.4 The hospital uses standardized diagnosis codes, procedure codes, symbols, abbreviations, and definitions


1 Standardized diagnosis codes are used and use monitored

BD Cato • ICD 9 and ICD 10 Codes are supported by default. BD Cato offers the possibility to create your own diagnosis codes. Monitoring of diagnoses code is currently not supported


• Pyxis ProcedureStation software permits the association of products associated with standardized diagnosis codes. These codes can be customized by the facility.

• The Pyxis Supply system can optionally store diagnosis codes within the patient record as a reference for end users

2 Standardized procedure codes are used and use monitored

BD Cato • ICD 9 and ICD 10 Codes are supported by default. BD Cato offers the possibility to create you own diagnosis codes. Monitoring of diagnoses code is currently not supported


• Pyxis ProcedureStation software permits the association of products associated with standardized diagnosis codes

• The Pyxis Supply system can optionally store procedure codes for association to inventory usage at the point of use within the ProcedureStation software functionality

3 Standardized definitions are used

BD Cato • Standardized definitions are incorporated whenever possible per hospital policy


• Standardized definitions are incorporated whenever possible per hospital policy

• With Pyxis ES system, centralized management of medication formulary using pharmacy information system as source of truth supports standardized data management

Pyxis Anesthesia system • Standardized definitions are incorporated whenever possible per hospital policy

4 Standardized symbols are used, and those not to be used are identified and monitored

BD Cato • Standardized definitions are incorporated whenever possible per hospital policy


• Standardized symbols are used in software for medication and supply processes.

• With Pyxis ES system, centralized management of medication formulary using pharmacy information system as source of truth supports standardized data and symbol management

Pyxis MedStation 4000 systemPyxis Anesthesia systemPyxis CIISafe system

• Standardized symbols are used in software for medication and supply processes

5 Standardized abbreviations are used, and those not to be used are identified and monitored

BD Cato • Standardized abbreviations are incorporated whenever possible per hospital policy


• Standardized abbreviations are incorporated whenever possible per hospital policy




Standard MOI.5 The data and information needs of those in and outside the hospital are met on a timely basis in a format that meets user expectations and with the desired frequency


1 Data and information dissemination meets user needs

BD Cato • BD Cato is able to adapt its internal workflow structure to adopt user data and information dissemination needs

Pyxis Enterprise serverPyxis Med ConsoleKnowledge Portal


• Analysis of individual variance between key performance indicators and current status available to any individual with access rights

• Operational reports for users with access rights

2 Users receive data and information on a timely basis

BD Cato • All data and information dissemintated in BD Cato occurs in real time. In some cases information is already available as of the prescribing time


• Analysis of individual variance between key performance indicators and current status available to any individual with access rights

• Frequency of reporting and comparisons are determined by clinical and adminstrative leaders within the organization

• Operational reports available on demand for users with access rights

• The Pyxis Supply system provides data relevant to the inventory management process in real-time

3 Users receive data and information in a format that aids its intended use

BD Cato • Information format may be electronically inside BD Cato itself or in electornic (PDF, Excel Flies) or printed from


• Aggregates data and drill down for drugs, supplies, stations, and user can be formatted in multiple ways and exported for further analysis

• Operational reports available for users with acess rights

• The Pyxis Supply system provides the necessary data in a clear and understandable format throughout each functionality of the system

4 Staff have access to the data and information needed to carry out their job responsibilities

BD Cato • At all times, staff will be able to access information according to user level and performing tasks within the system




• User Privileges determine access to information

• Operational reports avialable on demand for users with access rights

• The Pyxis Supply system provides all necessary data to enable the inventory management and inventory related patient care processes

42



Standard MOI.7 Records and information are protected from loss, destruction, tampering, and unauthorized access or use


1 Records or information are protected from loss

BD Cato • All transactions are electronically captured and are being stored in the server. They can also be archived electronically or in printed form

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000 system Pyxis Anesthesia ES system Pyxis Anesthesia systemPyxis ProcedureStation systemPyxis SupplyStation systemPyxis StockStation systemPyxis CIISafe systemKnowledge Portal

• All transactions are electronically captured and can be stored, printed, and/or archived


• The Pyxis Supply system provides multiple level of data protection. Measures such as database encryption and stringent end user authentication requirements keep data secure from external threats while processes such as data back-up, export and archiving can ensure access in case of equipment failure or other unexpected event

Rowa Vmax system • All data is backed up

Rowa Mosaic • All data is backed up

2 Records and information are protected from damage or destruction

BD Cato • All transactions are electronically captured and are being stored in the desigend server. They can also be archived electronically or in printed form

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000 system Pyxis Anesthesia ES system Pyxis Anesthesia systemPyxis ProcedureStation systemPyxis SupplyStation systemPyxis StockStation systemPyxis CIISafe systemKnowledge Portal

• All transactions are electronically captured and can be stored, printed, and/or archived


• The Pyxis Supply system provides multiple level of data protection. Measures such as data back-up to network locations, physical export and archiving can ensure access in case of equipment failure or other unexpected event




Standard MOI.7 Records and information are protected from loss, destruction, tampering, and unauthorized access or use


3 Records and information are protected from tampering and unauthorized access or use

BD Cato • The user access level defines which users may have access to this information. The system offers different subdivisions of user levels, such as viewer, modifying or delete

• Protection from tampering of sensible data is ensured

• Records and information are hardcoded and cannot be modified or deleted

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia systemPyxis ProcedureStation systemPyxis SupplyStation systemPyxis StockStation systemPyxis CIISafe systemPyxis Med ConsolePyxis Supply ConsoleKnowledge Portal

• The Pyxis BioID fingerprint identification system physically identifies user identity prior to granting access assuring only authorized clinicians and end users have access to patient information in accordance with their user privileges

• Optional User ID/Password access. Customer determines password expiration timeframe. Password length can be up to eight characters

• User access privileges are defined by managers in conjunction with pharmacist, and/or system administrator

• The Pyxis Supply system provides multiple level of data protection. Measures such as database encryption and stringent end user authentication requirements keep data secure from external threats

Patient Clinical Record

Standard MOI.10 The hospital initiates and maintains a standardized clinical record for every patient assessed or treated anddetermines the record’s content, format, and location of entries

1 A clinical record is initiated for every patient assessed or treated by the hospital

BD Cato • BD Cato automatically creates a patient record when therapy plan beginns. Patient record is retrievable at any stage, providing the users has the corresponding rights

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000 systemPyxis Anesthesia ES system Pyxis Anesthesia systemPyxis ProcedureStation

• Transactional data is maintained on the Server/Console database by patient until discharge

• The Pyxis Supply system can be interfaced with the hospital admission system so that all patients are represented within the system’s patient census and are therefore availabel for clinical access and documentation of inventory use

44



Standard MOI.10 The hospital initiates and maintains a standardized clinical record for every patient assessed or treated and determines the record’s content, format, and location of entries


2 Patient clinical records are maintained through the use of an identifier unique to the patient or some other effective method

BD Cato • BD Cato automatically creates a patient record when therapy plan beginns. Patient record is retrievable at any stage, providing the users has the corresponding rights

Pyxis Enterprise serverPyxis MedStation ES system Pyxis MedStation 4000Pyxis Anesthesia ES system Pyxis Anesthesia systemPyxis ProcedureStation systemPyxis SupplyStation system




• The Pyxis Supply system tracks patients based on their unique visit ID. Optionally, the patient’s unique Medical Record number can be tracked to provide a second patient identifier

Pyxis Connect system • Every order is linked and indexed by patient name and patient ID from the pharmacy system or patient bar code

Pyxis CIISafe system • Patient name and identifier is included on printed paperwork that accompanies patient-specific controlled substance prescription orders

Standard MOI.10.1 The clinical record contains sufficient information to identify the patient, to support the diagnosis, to justify the treatment, and to document the course and results of treatment

1 Patient clinical records contain adequate information to identify the patient

BD Cato • All clinical records or patient related information is always clearly identifiable to prevent confusion. Patient name, SS numer or patient number are used as identifiers






• Although the patient record stored within the Pyxis Supply system are a small subset of the total patient data, the patient identfiers managed including patient name, visit ID and medical record are adequate to properly identify the patient

2 Patient clinical records contain adequate information to support the diagnosis


• Although the Pyxis Supply system can optionally receive and store the patient’s diagnosis codes and procedural schedule detail, the system itself only captures details relevant to inventory usage for the patient and not a total reference for supporting a diagnosis

3

Patient clinical records contain adequate information to justify the care and treatment

BD Cato • Patient clinical record in BD Cato shows the diagnosis assigned to the patient as well as the chosen therapy treatment


• The Pyxis Supply system only captures data relevant to inventory usage for a specific patient but the data may be used to help justify the care and treatment provided




Standard MOI.10.1 The clinical record contains sufficient information to identify the patient, to support the diagnosis, to justify the treatment, and to document the course and results of treatment


4 Patient clinical records contain adequate information to document the course and results of treatment

BD Cato • BD Cato therapy plan includes the medication course according to the chosen treatment as well as all records to any given medication. The results of the treatment can also be documented within the patients therapy plan


• The Pyxis Supply system only captures data relevant to inventory usage for a specific patient but the data may be used to help document the course of treatment provided.

Standard MOI.11 The hospital identifies those authorized to make entries in the patient clinical record

1 Those authorized to make entries in the patient clinical record are identified in hospital policy

BD Cato • Only authorized physicians, pharmacists and end users have access to patient information in accordance with their user rights

• Administrator can determine password characteristics such as expiration timeframe, length ,numeric and non numeric digits login as password. Password length can be up to eight characters

• User access privileges are defined by system administrator




• User access privileges are defined by managers, pharmacist, or system administrator

• Access to the Pyxis Supply system is controlled through end user authentication with various options ranging from user name and password to badge swipe and Biometric fingerprint scanning. Only users that can be properly authenticated and that have the appropriate user permissions can make entries in the patient record

2 There is a process to ensure that only authorized individuals make entries in patient clinical records


• Administrator can determine password characteristics such as expiration timeframe, length, numeric and non numeric digits login as password. Password length can be up to eight characters







46


Patient clinical record

Standard MOI.11 The hospital identifies those authorized to make entries in the patient clinical record


4 Those authorized to have access to the patient clinical record are identified in hospital policy









5 There is a process to ensure that only authorized individuals have access to the patient clinical record











Patient clinical record

Standard MOI.11.1 Every patient clinical record entry identifies its author and when the entry was made in the record


1 The author can be identified for each patient clinical record entry

BD Cato • All transactions, in this case patient related transaction such as the author of each patient clinical record, are being recorded in the system and patient therapy plan event log


• Stations provide user identification with each transaction

• The Pyxis Supply system tracks the specific end user that performed an inventory activity against a patient record

2 The date of each clinical patient record entry can be identified





3 The time of each patient clinical entry can be identified





Legend: Clinical Data Category (CDC): system software tool that allows healthcare facilities to customize data collection and/or provide information to the end user in order to help reduce the possibility of medication errors

Profile: Removal of a medication for a patient against a pharmacist-verified order that has been communicated to the Pyxis system via an interface.

Override/non-profile: Removal of a medication for a patient against an order that has not been verified by pharmacy, generally due to emergent need for the medication

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