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CPOF Systems Requirements for Intensive Care Unit Use

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CPOF System Requirements

for Intensive Care Unit Use

Coalition for Critical Care Excellence


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Draft Version 4.2 — Coalition CPOF Working Group Revised: 6 November 2003

Donald Chalfin Jim Fackler Erkan Hassan David Minning Barry Shapiro David Swedlow Phil Weinfurt


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Preamble and Scope The Society of Critical Care Medicine (SCCM) represents all major categories of healthcare professionals practicing in the Intensive Care Unit (ICU). The SCCM recognizes the unique partnership that exists between ICU professionals and the pharmaceutical and medical device industries. These partnerships developed because ICU professionals depend upon sophisticated diagnostic and therapeutic medical devices, as well as potent pharmaceutical agents, to care for the critically ill patient. To facilitate and foster this clinician-industry partnership, the SCCM formed the Coalition for Critical Care Excellence (CCCE) in 1992. The CCCE is comprised of industry and clinical partners (18 indus try partners and the SCCM) and is dedicated to the support of ICU related projects that can benefit from the blending of clinical and industry expertise. Emphasis has recently been placed on the assumption that a Computerized Provider Order Entry (CPOE) system will reduce medical errors, improve the quality of care, and reduce costs. The CCCE has previously published requirements for ICU CPOE systems and has made the document available on the SCCM web site (www.sccm.org). Although preventable medical errors occur throughout the spectrum of our healthcare delivery system, it is generally accepted that the negative impact of errors is greatest in patients with life threatening conditions. Since the most seriously ill patients are cared for in the ICU, it is reasonable to conclude that a CPOE system in the ICU should result in a reduction of errors and an improvement of outcomes. Further reduction in errors and improvements in patient safety may result from Computerized Provider Order Fulfillment (CPOF) sys tems. This document addresses the basic requirements of such a fulfillment system for the ICU. CPOF implies a system that provides a means of documenting the status, execution, and completion of all patient orders. The CCCE considers it essential to emphasize that ICU care routinely involves complexities that are seldom, if ever, present elsewhere in the hospital. For example, most ICU patients have multiple intravenous access sites for the administration of multiple drugs, some of which require frequent titration in response to physiologic changes. In addition, ICU patients are often on multiple life support systems, each requiring multiple parameter settings. Medications in


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the ICU are typically administered intravenously rather than by enteral or intramuscular routes. ICU patients typically have multiple care providers attending the patient. It is common for a single healthcare provider such as a physician, nurse, or respiratory therapist to be attending to more than one critically ill patient simultaneously with multiple time-critical interactions taking place. This necessitates special attention to the issues of workflow efficiency that are unique to the ICU environment. These differences between ICU and general care patients require that an ICU CPOF system be specifically designed to optimize care and workflow for the complex ICU environment. This document is intended to describe the essential elements required for a CPOF system to be functional in the ICU. For clarity and completeness, we have included elements common to general-purpose order fulfillment systems. The promulgation of this document has included consultation with healthcare informatics professionals, development engineers, and ICU clinicians. We hope it will be of value to those responsible for developing CPOF systems as well as those who must consider the purchase and implementation of CPOF systems. There may be additional requirements for patient privacy and system security covered by other guidelines and/or regulations (e.g., HIPAA). We have limited the scope of this document to “order fulfillment” and “basic decision support” because of the urgent need to make this information available. This document is not intended to address issues of system management such as specific definition of unit protocols, formulary management and update, and system configuration. This document is not intended to address the issues of accounting, charge capture, staffing, recording of vital signs, or other non-order based tasks in the ICU. This document addresses issues relating to electronically charting the fulfillment of orders in the ICU. In this document, ICU CPOF system requirements are listed using regular font style, while section titles, explanatory notes, comments, and examples are shown in italic font style.

System and Data Access

1) The system must allow documentation of order fulfillment from any system communication device (e.g., barcode scanner, handheld, mobile device, fixed workstation, etc.) within the care unit (e.g., bedside, central station, hallway, etc.).


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2) The system must be secured against unauthorized entry both from within the healthcare facility and from outside the healthcare facility as follows:

The system must provide restricted access to patient data inside the healthcare facility by means of user-specific identification (such as a login name and password).

The system may provide optional restricted off-site access for read-only review of order fulfillment, also by means of user-specific identification.

Note: For off-site access, an additional step to access the system (such as a card with a randomly changing password) is desirable.

If a provider is interrupted and fails to interact with the system within a given time period, the system must time-out (that is, close out the current session) automatically after a specified period.

When a provider for whom a session has timed out accesses the system again, the system shall not resume the timed-out session. Information entered before the time-out must be re-entered:

3) The process to register a new user in the system, set up the corresponding clearance and authorization levels, and terminate a user’s registration in the system must be straightforward and unambiguous.

Comment: For example, the system should be able to configure security-setting templates without the need to define all security privileges each time a user is added. A new user registration or a user registration termination should take effect immediately.

4) The system must allow the facility to assign users different levels of clearance, defining the access and documentation privileges related to different types of data, patient categories, and physical locations.

Example: The facility must explicitly specify which users are authorized to document the fulfillment of which orders.

Data Integration With Ancillary Information Systems

5) The system must be able to retrieve and display orders to be fulfilled from ancillary systems (e.g., pharmacy, laboratory, respiratory care, and radiology systems), if such ancillary systems exist in the facility.

6) Patient data must be immediately available in the system when a new patient enters the ICU.


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7) The system must be compatible with the latest published version of the generally accepted information interface standard (HL7 as of this writing).

8) The system must be HIPAA compliant.

General Order Fulfillment Requirements

Patient Selection

9) The system must have straightforward and unambiguous methods to select the desired patient.

Examples: Acceptable methods of patient selection may include, but are not limited to:

Doctor- or Service-specific lists

Patient search by physical location

Patient search by patient identifying characteristics

Patient search by Soundex or partial alphabetical listing

In-Box

10) There must be a method to communicate with clinicians concerning issues on their patients.

Examples: Items that would be communicated through this method include but are not limited to the following:

New Results that affect an unfulfilled order

Comments or messages resulting from order fulfillment to the clinician originating the order providing new information to the ordering clinician (e.g., patient developed rash following drug administration)

Therapeutic substitution mandated by hospital policy and implemented by the appropriate ancillary department.

Description of ICU Patient Technologies

11) The system shall provide for the documentation of order fulfillment involving an item or device included in the inventory of ICU-related special technologies. Where appropriate, the system shall identify the type of device and its location on or in the patient (e.g., left vs. right chest tube, pacemaker, site of specimen collection for microbiological exam) of the special technology.


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Examples: Special technologies may include but are not limited to the following:

Vascular access lines

Pressures monitors

Infusion pumps uniquely identified

Point-of-care testing equipment

Artificial airway

Feeding tubes

Urinary drainage catheter

Chest tubes and suction pressure, if any.

Surgical drains

Intracranial pressure monitor

Cerebral spinal fluid drains

Organ support systems

Ventilator

Therapeutic beds or patient support systems

Pacemaker/defibrillator

Renal support

Intra-aortic balloon counter-pulsation pump

Extra-Corporeal Membrane Oxygenator

Types of Order Fulfillment and Documentation to be handled by the system

12) The system must allow users to document the fulfillment of the entire array of orders typically handled by a paper system, including, but not limited to, the following:

Medications

Irrigations

Diagnostic laboratory tests

Radiology tests

Intravenous fluids

Admit/discharge/transfer and bed type

Consultations to hospital services (e.g., to Medicine, Neurology, Surgery, etc.) or to a specified care provider


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Enteral and parenteral nutrition

Treatments (such as wound care)

Activity/restraints/out of bed/positioning, mobility/specialty beds - degree of rotation/ degree of head of bed elevation

Respiratory therapy

Physical therapy

Occupational therapy

Vital signs monitoring

General System Processing Requirements

13) The response time of the system must be under one second for all basic operations (such as when the ENTER key is pressed or a new screen is called up). Exceptions can be made when recalling large amounts of data, such as the history of a patient or a complete formulary list.

14) The system must accept and post the order fulfillment (whether a medication order, diagnostic test, or special order) only when all the required parameters for the order have been provided and confirmed. If the user tries to confirm an incomplete order fulfillment, the system must not accept the order fulfillment, but must instead display a warning, indicate which parameters are missing (e.g., by highlighting the incomplete fields), and offer appropriate options that must be explicitly chosen by the fulfiller.

Note: Once an order fulfillment is documented, the system should make available that documentation to appropriate ancillary information systems for summary reporting and audit purposes.

ICU Orders — Special Requirements Note: It is common in the ICU for a patient to be receiving multiple medications by multiple routes as well as by routes not typical on non ICU patients It is also common for a single healthcare provider such as a physician, nurse, or respiratory therapist (or a team of such providers) to be attending to more than one critically ill patient simultaneously with multiple time-critical interactions taking place. This necessitates special attention to the issues of workflow


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efficiency that are unique to the ICU environment. Due to these unique considerations, the ICU CPOF system requires special capabilities for documenting the fulfillment of ICU orders.

15) The order fulfillment process must be accessible by means of a graphical interface with clearly comprehensible menus and windows.

Note: Due to the complexity of ICU orders, and the fact that a single patient may be attended by multiple care givers with multiple time-critical interactions, a heightened awareness and consideration for workflow efficiency in the ICU should be an integral part of the CPOF system. It is left to the provider of the CPOF system to address this problem.

16) The processes and pathways for all order fulfillment activities must be consistent across the system in order to reduce errors in order fulfillment.

17) There must be sufficient information on each screen to uniquely and unambiguously identify the patient.

18) The system must display the provider’s ID on each order fulfillment and store that information with the documentation of the order fulfillment.

19) The system must track all user access, even if no data is entered during a session.

20) The system must accommodate configurable views of order fulfillment and review that are specific to the facility, unit, service, and/or physician.

Examples: Such views include but are not limited to: ordered by date of fulfillment, by category of order, by yet to be fulfilled orders, etc.

21) The system must accommodate the documentation of STAT order fulfillment in the ICU.

Note: Acute physiologic instability is a common condition in the ICU and requires immediate intervention without the burden of documentation that impedes the rapid execution of STAT orders.

The system must allow for the fulfillment of a STAT order to generate the matching order entry if the order does not already exist.

The system must provide for a means of documenting the fulfillment of STAT orders retrospectively, after the STAT has completed or commenced.


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Note: Under ideal conditions, STAT orders should be fulfilled in real time whenever feasible.

Data elements that must be provided in the documentation of a STAT order fulfillment include:

Positive identification of patient and drug, intervention, or procedure (i.e., bar codes or equivalent technology)

Time of execution

Name of intervention (specific drug, paracentesis, intubation, cardiac massage, etc.)

Dose and route (if appropriate, e.g., for drugs)

Name or ID of care provider authorizing the order or intervention.

Name or ID of care provider fulfilling the order.

22) The system must support the documentation of fulfillment of complex therapeutic regimens.

Examples: Examples include but are not limited to:

multiple intravenous medication titrations based on rapidly changing physiologic variables or clinical states,

sliding scales for insulin and other potent medications (DDAVP, etc.),

irregularly timed dosage administrations,

tapering dosage regimens (e.g., tapering steroid doses over several days with changing dosing intervals),

23) The system must provide the ability to document the fulfillment of orders resulting from the use of expanded order sets (protocols) unique to the ICU. The fulfillment of each individual order is documented in the same manner as any other order.

Intravenous Infusions

24) The system must maintain an inventory of available vascular access lines and ports.

Each vascular access port of any existing invasive line, along with its insertion date shall be listed in a log.

According to current active orders, the system shall track the specific fluids, blood products, colloids, and medications (if any) that supply each line. “Piggyback” line supplies are listed with each access port.


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If medications or other additives are present in a line supply, the concentrations of that medication or additive are listed.

25) Given the current state of the patient’s IV infusion line inventory, the system must:

Allow for manual (at a minimum ) or automatic (ideally) entry of the current infusion rate from each supply and the start and stop times of all infusions;

Provide total fluids that the patient received over specified time interval (e.g., hours, shifts, days);

Provide total amount of electrolytes that the patient received over specified time interval;

Provide total amount of medications that the patient received over specified time interval; and

Provide total calories, protein, fat, carbohydrates, nutrients, etc., that the patient received over specified time interval.

26) The system must provide documentation of order fulfillment of titration of intravenous medication to physiologic end points.

Given the history of actual medication administration rates, the system must be able to display the total amount of each medication that was administered over a specified time interval.

For each such medication, the fulfilling provider must be able to document the physiologic variable(s) and target value(s) used as change trigger(s) for changing the dosage rate for that medication.

27) The system must provide for the documentation of order fulfillment for orders covering airway pressure support systems (ventilators, CPAP, etc.) and supplemental oxygen orders.

The system must provide the ability for providers to document all necessary settings for airway pressure support systems and supplemental oxygen supply.

For each airway pressure support setting, the provider must be able to document the physiologic variable(s) and target value(s) intended as target(s) for varying the setting.

Patient Safeguards (Basic Decision Support)


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Basic Safety Alerts and Safeguards

28) The system must provide safety alerts against the fulfillment of orders when patient conditions change between the time the order was written and fulfilled.

Example: An order may have been written to administer supplemental K+ when the serum K concentration was low. A subsequent K+ value may have demonstrated a high K+ level, which might obviate the need for K+ administration.

The system shall also automatically alert when the condition for a PRN order is fulfilled. (For example, a low potassium should trigger a reminder to give KCl.)

29) The system must display a list of orders to be fulfilled within the next time interval (specified by the facility or nursing unit).

If order fulfillments are or have been delayed, they shall be included in all future such displays until they are fulfilled. (Optionally, the system may provide an exception report of delayed order fulfillments due on the nursing unit on demand or when a “sufficient number or severity” of delayed fulfillments have accumulated.)

At the time of this display, the system must run all known safety checks on the orders so displayed against appropriate data known or missing about the particular patient.

If one or more of the orders so checked causes or has caused a safety alert, the system shall display, in an unambiguous manner, the fact there is or was a safety alert against a particular order and the reason for the alert, and shall require the provider to either delay the fulfillment of the order, to acknowledge, or to override the alert (providing the provider has the authority to override the alert).

Examples of safety checks to be performed include, but are not limited to:

Known allergies and cross-allergies;

Drug interactions, including drug-drug, drug-disease, and drug-food interactions

Common test interactions, including drug-test and disease-test interactions

Individual and cumulative dose limits

Duplicate drug orders

Examples: Same drug ordered twice, same class of drug intended to provide the same therapy, or duplicate therapy from combination products.


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The system must check the correspondence between the dosage form and the route (to avoid errors such as prescribing an oral medication for IV administration) but must allow drug administration by a nonstandard route when appropriate.

The system must display alerts for dose adjustments, adverse effects, and specific contraindications for certain categories of patients, (e.g., pediatric patients, pregnant women, elderly patients, diabetic patients, and patients with impaired liver or renal function.)

30) In addition to the safety checks described above, the system must continually check for the occurrence of combinations of orders and patient data that generate safety alerts defined against appropriate patient data for the occurrence of safety alerts. When the system finds a safety alert, even if the prior alert check failed to indicate a problem, the system shall announce the existence of a safety alert for the order in question.

31) The system must provide a method for customizing different levels for alerts.

32) The system must provide a method for overriding different levels of alerts.

The system must allow overriding of low-level alerts with a simple action (such as clicking on an icon).

In contrast, overriding a high-level alert must require entry of a reason and either an electronic signature by the provider or an electronic countersignature by another authorized user.

The reason for the override, along with the ID of the author of the override, must be stored in the system with the order and sent along with the order to the relevant ancillary information system.

General Order Fulfillment Safety Checking Requirements

33) The system must display information on how to reach the provider currently responsible for the order about to be fulfilled (e.g., page number, home telephone number) when an order has generated a safety alert.

Note: It is desirable if the system can support an automated, hierarchical notification protocol (for example, a provider whose order needs to be clarified is first automatically called and then paged; then the notification is directed to another designated


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backup clinician if the primary care provider does not respond in a specified amount of time).

Medication Order Fulfillment Requirements

34) The system must list medications whose orders are due for fulfillment in a clear and explicit way, to reduce the likelihood of errors.

Medications should be always listed by generic name. If a medication was dispensed by brand name, the brand name should be included along with the generic name. If the medication was dispensed generically, a comment should be included in the medication listing indicating the brand equivalent for information and clarity purposes. Medications with similar names must be readily distinguishable (for example, using different fonts, colors, type sizes, symbols, etc.).

35) If an order is actually fulfilled at a time other than originally specified by the order (by a facility specified interval), the system must allow the fulfiller to specify the handling of subsequently timed fulfillments and provide the ability to notify the order originator (see Requirement 10) or designee of the deviation and timing change.

Order Fulfillment for routine medication orders

36) The system must positively link medication and patient in a clear and unambiguous manner.

The system must require a positive identification of the medication about to be administered to a patient before its administration.

Examples of acceptable means of positively identifying individual medications and/or multi-dose vials of medications may include:

Bar coding Electronically readable smart tags

Examples of unacceptable means of identifying medications include:

Relying on printed labels Relying on physical inventory location Relying on shape, color or other physical attributes of product or medication container

The patient to whom the medication is about to be administered must also be positively identified before the medication is administered.


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Examples of means of positively identifying patients may include:

Bar coding patient ID bracelets Electronically read smart tags (wired or wireless) attached to patients Biometric identification (fingerprints, retinal scans, DNA

scans, etc.)

Examples of unacceptable means of identifying patients include:

Verbal interrogation of patient, family, or other individuals Reading a preprinted patient ID bracelet

The system must positively link the ordered and identified medication to the identified patient before the order is fulfilled.

37) Required parameters for a bolus or single dose medication order to be fulfilled must include:

Time for administration

Evidence of positive identification of the medication

Evidence of positive identification of the patient to whom the medication is about to be administered

Dose administered

Dosage form (e.g., intravenous solution, suppositories, capsules, tablets)

Administration route

Clinical indications for an “as necessary” order (i.e., a PRN order)

Comments when appropriate

38) Required parameters for a continuous fluid or blood product intravenous infusions.

Start time for administration

Evidence of positive identification of the infusion and its contents to be administered

Evidence of positive identification of the patient to whom the infusion is about to be administered

Infusion rate of administration (volume of infusion per unit time)

End time of administration


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Infusions will require the use of two separate fulfillment entries, one for starting the infusion and another for stopping it. A third type of fulfillment may also be needed if the administration rate is changed between the start and stop points.

39) Required parameters for a continuous medication-containing intravenous infusions (e.g., vasoactive drugs, neuromuscular blocking agents, psychotropic drugs, anticoagulants, etc.)

Start time for administration

Evidence of positive identification of the medication containing infusion (with drug concentration) to be administered

Evidence of positive identification of the patient to whom the infusion is about to be administered

Infusion rate of administration

The system must display the calculated medication dosage from the medication concentration and administration rate.

End time of administration


Medication infusions will require the use of two separate fulfillment entries, one for starting the infusion and another for stopping it. A third type of fulfillment may also be needed if the administration rate is changed between the start and stop points.

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