PYXIS USER REVIEW

LEAH LADLEY

DIRECTOR OF INTERNAL AUDIT

ST. JUDE CHILDREN’S RESEARCH

HOSPITAL

AHIA 33rd Annual Conference – September 21-24, 2014 – Austin, Texas

www.ahia.org

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Background:

St. Jude Children’s Research Hospital

Treatment center for children with cancer and other

catastrophic illnesses

Research facility (bench science and clinical

research)

66 inpatient beds; no Emergency Room

www.stjude.org

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Background:

Internal Audit Department

Director, Admin. Assistant, 4 Sr. Internal Auditors

IT Audits are outsourced

CPA or CIA required, 5 years recent experience

required, etc.

Background is financial and audit; not nurse/clinical

auditors

St. Jude also has a Compliance Department

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Background:

MedStations: located in patient care areas

Outpatient Rx: located in pharmacy – used to fill

take-home Rx and mailouts

CII safe: located in Central Pharmacy

CII Bulk Safe: located in Central Pharmacy

PIRC – Pharmacy Inventory Resource Center

(storeroom area)

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Background:

St. Jude Access Audit included the following:

Physical security

Network access

Systems access to three (high-risk) applications:

Lawson (employee data and financial reporting)

Milli (electronic medical record)

Pyxis MedStations (delivery of controlled substances)

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Objectives:

Understand how access is granted and restricted in

the Pyxis MedStation system

Become aware of system functions and how they

interact

Begin to understand some of the system reports that

can assist with monitoring

Review systems recommendations

Risk Assessment thoughts….

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Access

Pyxis MedStation 4000 System

Console User Guide

239 pages

“This guide provides information on how to set up, use,

and maintain the Pyxis MedStation 4000 system

console.”

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Access

Note: Pyxis translates patient data from the

hospital’s host information system (SJ: Cerner’s

Millennium) into a usable format for the Pyxis

MedStation system. It serves as a connection

between the console and the hospital’s billing (SJ:

IDX and Sapphire) and clinical (patient-profile)

pharmacy systems (SJ: Pharmnet).

(not included in our scope)

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Access

The Pyxis MedStation system allows a pharmacy to store and track a range of medications and floor-stock items:

Controlled medications

Floor stock

Pro re natas (PRNs)

First Doses

Some IV solutions and sets

Rescue medications (using the Override function)

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Access

System Components:

Console

Usually located in the pharmacy

Communicates data to and updates activity information in all the stations

Maintains copies of all patient, user, formulary, and activity information used to generate pharmacy reports.

Station

Located throughout the facility

Provide secure and reliable storage for medications of all types

Stations communicate with the console, receiving information and continuously reporting all medication transactions.

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Access

Console Privileges include:

Inventory – assign meds to station pockets, replace

meds, or assign more meds to pocket, or make pockets

unavailable

Reports – access inventory reports, activity reports,

system activity reports, view the print queue, add to or

edit the list of batch reports

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Access

Console Privileges (continued):

System setup – define system components such as

devices, formulary, users, patients, and areas

Utilities – globally edit your formulary, devices, and

users, and archive data

(others not related to meds: change password, help,

communication status, logoff*)

*note – the system allows admin role to define a period

of inactivity to be followed by an auto-logoff

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Access

Station Privileges include:

Station Login/Witness Ability – limited station access

with no access to the drawers (witness/change

password/print your activity transactions)

Station Report Access – run reports limited to your own

activities and discrepancies at the station

Activate/Create Temporary User – lets you activate the

password of a temporary user (think float nurse) on a

station to which access is not assigned for up to 99 hour

access (general setting)

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Access

Station Privileges include (continued):

Credit Patients – credit a patient when wasting a

complete dose (med package is damaged or

contaminated)

Admit/Edit/Discharge Patients

Create Permanent Users – differs from the

Activate/Create Temporary User in that permanent

users do not have a time limit. Permanent users are

allowed to assign any station or medication privilege

that they themselves have to users they create.

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Access

Station Privileges include (continued):

Station Administrator – initial setup and ongoing

troubleshooting of the station (and system)

No Witness Required – user can waste, return, or

inventory meds without a witness even though the

selected medication’s security group requires a

witness

Add temporary patients – allows user to add a

temporary patient at the station

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Access

Station Privileges include (continued):

Independent Inventory Count – allows inventory of

medications without a witness (used to recover a

malfunctioning drawer only when user has access to that

medication’s security group)

Independent Discrepancy Documentation – no

witness required to clear discrepancy; only requires

that user has access to that medication’s security

group

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Access

Adding a formulary item: (Generic name, brand name, ID, strength, etc.)

Security Group – determines if you can access this

medication; your security group must match the

medication’s security group

Verify count – select ON if you want to require the

user to count the pocket each time the pocket is

accessed. You can also select With Blind Count ON,

which asks how many meds are in the pocket or

At/Below Min to require a count when the inventory

level reached the minimum specified

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Access

Formulary Options Tab:

Witness required to:

Remove Override

Remove – requires a witness to enter an ID and password during the Remove process for designated medications

Override – requires a witness to enter an ID and password when a user tires to remove this medication for a patient when no order exists (emergent conditions)

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Access

Enabling Undocumented Waste: allows a facility to

track any and all remove transactions in which a

user removes a quantity greater than the ordered

dose

From the Formulary Options Tab:

Undocumented Waste

* Reportable as Undocumented Waste

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Access

Pharmacy Informatics Team – provides and restricts access to MedStations

System access occurs when a user is added to the system and assigned to a Template

Examples of Templates:

Admin

Anesthesia Tech or Staff

Staff Nurse or LPN or Nursing Supervisor

Pharmacy Tech or Pharmacist

Templates do not contain area information: area information is assigned to individual users

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Access

Each Template (group) can be assigned select Console Privileges

Examples:

Basic Pharmacy (A) (inventory, assign meds to pockets, add formulary items)

User Entry (B)

Pharmacy Supervisor (C) (global formulary edits)

System Administrator (D) (devices, stations, communications, area information, assign users to stations, etc.)

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Access

Each User is further assigned locations

Examples:

ICU

MEDROOM

ANES

BMT

2NORTH

2SOUTH

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Access

Additionally, Station Privileges and Station Med

Privileges are granted or restricted

Station Privileges include:

Station Report Access (report of any station activity)

Activate/Create Temp user (think float nurse)

Credit Patient – (when wasting a complete dosage):

note – pts are automatically credited when meds are

returned in the Return feature (original pocket or return

bin)

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Access

No witness required: waste, return, or inventory

meds without a witness even though the med’s

security group requires a witness

Exceptions:

User with Independent Inventory Count privilege can

inventory without a witness

Witness Required to Empty Return Bin option enabled

requires witness for all returns

Independent Discrepancy Documentation privilege can clear

discrepancies without a witness

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System Reports

The console retains up to 31 days of transaction data for all stations, including:

Medication removals and returns

Wasted medications

Refill activities

Discrepancy-resolution information

Inventory verification

Also – pocket accesses and orders

Data can be sorted and printed in a variety of reports and kept as a permanent record of medication usage.

Each station can generate summary reports of all transactions for that station for the most recent 32 hours.

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System Reports

Four categories of reports:

1. Inventory – for specific stations, all stations, or by

zone, area, item name, item ID, and door and bin

2. Activity – all user interactions with the system for

specific stations (accesses, charges, credits, loading

and unloading, discrepancies, refills)

3. System Activity – user modification, system access

4. System – snapshot of the system when you run the

report: Example - formulary items and options

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System Reports

Inventory:

Loaded meds w/o orders –would be good candidates

for removal if more space is needed (why loaded?)

Meds Ordered and Below min – identifies meds that

require refilling

Meds without removal – seldom or never used

Outdated inventory

Refill pick and delivery – 2 reports – one for picking

meds (listed by total quantity) and one for delivery

(how much goes where)

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System Reports

Activity:

All discrepancies – lists open and closed discrepancies

Remove warnings – lists all warnings (too early, too

late, and too close) that were overridden and the

response entered to support the override

Return bin activity – transactions for the return bin

Returns and wastes – lists all and links the transactions

with previous remove (if remove was used)

Undocumented waste – lists all undocumented wastes

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System Reports

Activity (continued):

All Station Events – To comply with federal and state regulations, run this report for

all narcotic transactions and retain the report

To support the investigation of unresolved discrepancies

To complete an audit

System Activity:

Console and station activity log (chronological order)

Login Activities (includes attempts)

User modification information – all changes in user security during a specified date range (includes current user changes, addition of temp or perm users)

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System Reports

System:

Formulary – lists all formulary items in the system and

their configuration options at the time the report is run

Override Groups – lists the override group for each

medication at a station; also lists users and their

override groups

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Systems Recommendations

Defined (enforced) procedure for new user setup

(including templates, areas, rights)

Assign access to controlled substances only to

authorized personnel and with correct settings

Restrict the ability to create temporary users and

monitor this activity

Limit station access to areas appropriately

User review by area (regularly) and prompt

removal upon employee separation/transfer

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Systems Recommendations

Consider the need to shred system reports for

policy compliance and HIPAA concerns

Consider requiring password changes on a periodic

basis and upon password confidentiality

compromise

Remain with system representative at a station if it

is necessary for rep to access drawers, inventory

controlled substances, and review station activity

reports

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Systems Recommendations

Controlled Substances (CS):

Use individual pocket access for all CS

Store refrigerated CS in a locked refrigerator

Load all CS into stations, even special patient-specific orders

Inventory CS in each station on a periodic basis (weekly)

Activate the Verify Count option for all formulary CS

Archive Pyxis MedStation system data and maintain a hard copy of console and station reports as required to comply with state and federal requirements

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Systems Recommendations

MedStation Users:

Techs pick and prepare meds for load or refill under

the supervision of a registered pharmacist; pharmacist

checks the meds before they are placed in the station

For certain meds, with RxCheck enabled, the system

prompts for another user to check the pocket after load

Nurses are expected to report any suspected load or

refill error to pharmacy immediately

Pharmacists maintain an ongoing quality monitoring

program (next slide)

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Systems Recommendations

Quality Monitoring Process for Pharmacist:

Following technician load/refill, periodically print

Loading and Unloading and Med Refill reports

Compare the Med Refill report activities with the Refill

Pick and Delivery report used by technician

Monitor load and refill accuracy for meds requiring

RxCheck. Check other pockets randomly to verify

correct med/correct count. (Document checks/results)

Pay extra attention to load, refill, and RxCheck

activities of newly trained personnel

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Risk Assessment

Users with incorrect access

Medication Security Classes

Inconsistent system settings (require witness, etc.)

Activities of system Admins – is anyone watching?

Temporary users?

Much more can be verified – what is your audit

project (hours) budget?

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Save the Date

August 30 - September 2, 2015

34th Annual Conference

Portland, Oregon