FAQ's for the 2004 ISMP Medication Safety Self Assessment® for Hospitals

General Questions

What are the benefits of completing the assessment and submitting data to ISMP?
The following benefits to healthcare consumers and hospitals can only be achieved if we have the ability to collect and aggregate data on a national level:

• Aggregate results from a large pool of respondents will provide US hospitals with important information about the status of the medication use system that can be compared to a baseline set of results obtained in 2000 and set a new baseline for future years. Such data will be useful in advising hospitals about ongoing medication system improvements.
• The project will be of great value in gaining consumer confidence. There is great concern that US hospitals are "hiding" information from the public. This project can help by allaying these contentions, as the public will be able to see that hospitals are being proactive in identifying safe practices and will be able to track aggregate progress over time. We intend to enhance the tool and do follow up studies in years to come.

The project will be of significant assistance to hospital managers who seek to identify areas of weakness in their organization, related to medication use so that top leadership support can be sought for improvements in these critical areas.

The project will provide ISMP, AHA, HRET, and others with the ability to identify common medication system weaknesses in US hospitals that have persisted since 2000, identify new areas of focus, and offer practical system enhancements, including those that are thought to provide the highest leverage for overall error reduction activities.

ISMP, AHA, HRET, and others will be able to focus additional educational efforts and design useful programs to help hospitals implement high leverage strategies that can positively impact patient safety. Results of the 2000 Self Assessment have lead to the development of the Pathways for Medication Safety® educational tools available at http://www.medpathways.info/medpathways/index.jsp

How many team meetings should we schedule and do we need senior administrative staff on our team?
According to the hospitals that participated in the 2000 Self Assessment, their suggestion is to schedule three team meetings of at least one-hour in length. Some participants completed the assessment in less time and some have needed more than one hour at scheduled meetings, but none met more than three times. It is important to have a senior administrator at these meetings because the assessment contains many items that challenge or inquire about your organization's overall commitment to patient safety. Depending on the size of your organization the attendance of the CEO or COO may not be possible at all meetings, but a senior administrator for hospital operations should be in attendance for all meetings if possible.

What if a specific item doesn't apply to the services provided in my hospital?
A few items list Not Applicable as a choice if the item doesn't apply to services provided in your hospital. For example, if you don't provide any chemotherapy in your hospital, including oral agents, you can answer Not Applicable to item number 44.

We are a three-hospital healthsystem that shares many corporate functions (e.g., one Pharmacy and Therapeutics Committee, Risk Management, Information Technology, shared policies and procedures). Should we complete just one assessment for all three hospitals?
It is important that each hospital in a multihospital system complete the assessment individually and submit their data separately. The items in the assessment ask questions well beyond governance and policies and procedures that are in place. Each hospital will truly benefit if they complete the assessment individually and obtain their own individual set of scores.

We are unable to locate our scores from the 2000 ISMP Medication Safety Self Assessment®. Will my password for the 2004 assessment provide us with our scores from 2000? Is there any other way ISMP can provide me with my 2000 scores?
The passwords you received for the 2000 and 2004 assessments are different and were randomly assigned in the booklets. If you keep your 2004 assessment password you may review your submitted data at a later time. Unfortunately if you did not keep the scores from the 2000 assessment, we are unable to provide you with that information since ISMP can't match any individual hospital with their assessment results.

We are a behavioral health/ambulatory care organization. Is the ISMP assessment valid for our organization?
Many of the items contained in the assessment may not be applicable to your organization but we would encourage you to organize an interdisciplinary team, review those items that are appropriate for your organization and use the results internally. If you have further questions contact selfassess@ismp.org .

Demographics

Must I answer all the questions under demographics?
There are several questions that are marked optional. These do not need to be answered. We would hope that all questions are completed in order for ISMP to better analyze the aggregate data and provide more concise demographic comparisons for hospitals.

Are there guidelines available for the choices in this section?
Hospital administration should be contacted for the correct responses when completing the demographic questions. Answers to questions such as staffed inpatient beds (#1), type of organization (#2), type of service (#3), shared ownership with a healthcare system (#7), and location (#9) should be consistent with the responses your organization submits to state and federal agencies for licensure, medicare participation, and on accreditation surveys and applications.
How do I answer question 11 if my hospital is located outside of the United States?
The drop down box under question 11 contains US Military Foreign and Other as choices. If you answered demographic question number 2 as Military then use US Military Foreign as your response to this question. If you are a non-military hospital outside the United States completing this assessment then answer other. You can also supply your country name in this question but it is optional.

What are the Pathways for Medication Safety® tools referred to in question 13?
These are a set of comprehensive tools that were designed to address hospital needs identified in the 2000 ISMP Medication Safety Self Assessment®. They consist of Leading a Strategic Planning Effort, Looking Collectively at Risk, and Assessing Bedside Bar-Coding Readiness. The tools can be found and downloaded at http://www.medpathways.info/medpathways/index.jsp. If no one on the team completing the assessment has heard of these tools than your hospital most likely has not utilized them and you should answer NO.

NOTE: An additional question appears in the online data entry section of the demographics. This question (#14) does not appear in the printed booklet or PDF of the assessment. Answering this question is optional. If you are participating in a defined collaborative effort and will be sharing your aggregate data within the group, please answer "YES" and provide your assigned collaborative code in the box provided. If you do not know your code, please contact your collaborative leader before you submit your data online. If you are not sharing aggregate data within a defined collaborative, please leave this question blank or answer "NO".

Questions related to specific self-assessment items
(listed in ascending order of numbered item)

Click here to view additional FAQ's, prepared by a HIMSS work group, on items that are specifically IT related.

5. What does "verifying" allergy information, mean?
If allergy information is entered into the computer system by non-licensed personnel (e.g. admissions staff, unit secretary) a licensed healthcare professional (nurse, pharmacist, or physician) must verify the information from patient records, patient interview, etc. for accuracy and correct spelling. If applicable, a pharmacist must verify that the allergies are correctly entered as the appropriate classification to allow correct computer screening.

13. What does "and available in the pharmacy computer for reference" mean?
A patient's comorbid and/or chronic conditions should be contained in the pharmacy computer system for pharmacists to have easy access to review this information as orders are processed. If the information is available in a separate system that must be accessed, then the answer to this item should not exceed response C.

N4. How do I answer this item if allergy information is transferred from prior admissions but practitioner verification is only needed for certain medications?
Your answer should not exceed a C for this item. The intent of this item is that if your system allows allergy information from a patient's prior admission to automatically populate a new patient profile, the information must first be verified before medication orders are processed. ISMP has received error reports when allergies from prior admissions populate the pharmacy computer system without further verification, and pharmacists dispense medications assuming that current allergies have been entered.

24 and 25. Are there examples that you can provide for answering these items?
Examples of medication orders to perform testing on your computer system can be found at the end of this document. These examples don't represent an exhaustive check of computer systems but can be used to identify categories (e.g., allergy checks, drug-drug interactions, maximum doses) of routine medication testing.

28. Does this mean that anyone can screen medication orders in a computer system?
The intent of this item is that all new patient medication orders are entered and screened against the patient's total medication profile in an electronic system by a pharmacist before the medication is dispensed and administered unless it is an emergent lifesaving situation (e.g., cardiac arrest). In a hospital without 24-hour pharmacy service this process should be performed by a licensed healthcare professional when a pharmacist is not available.

33. What is meant by the "potential for error is investigated?"
The potential for error in this item refers to a review of external publications (e.g., ISMPISMP Medication Safety Alert!®, FDA and manufacturer notices) for information on reported errors. Feedback from hospital committee members on any personal experiences with the medication is also obtained and discussion about errors that may be prone to happen due to characteristics of the medication or drug category is reviewed before adding a drug to the formulary.

37. What is meant by "therapeutically necessary and appropriate?" We are fairly liberal with maintaining patients on the medications they are receiving before they enter the hospital to decrease any chance of adverse effects of switching medications for a short hospital stay. How would we answer this item?
In our experience the policy of maintaining patients on all medications "taken at home" can lead to the rapid demise of the formulary system and add to possible errors due to the lack of proper professional staff education regarding prescribed medications, which are not on the formulary. Hospitals must have a strict policy on the use of non-formulary medications that would include prescribers stating the reason why a non-formulary medication is needed and a process to review the use of all non-formulary medication use. The P&T Committee should review non-formulary medication use and recommend additions and deletions to the formulary according to the medications most commonly prescribed in the outpatient setting as well as safety concerns with these medications. If your hospital has this strict control over non-formulary medication use then answers of C through E may be appropriate for this item.

N12. What does adequately monitor and manage mean in this item?
Adequately monitor and manage refers to the ability of the healthcare organization to provide necessary and current laboratory information, up to date drug alerts, and appropriate monitoring equipment in order for practitioners to adjust medication therapy, prevent adverse drug effects (including errors), from occurring or to help mitigate their adverse effects.

38. We have CPOE and all of our prescribers enter orders directly into the system. Do I answer E for this item?
Self-assessment scores should not exceed level C (i.e., can not score D or E) if prescribers enter orders into a computer system that is not directly interfaced or integrated with the pharmacy computer system, even if the vast majority of physicians or other prescribers enter orders via computerized prescriber order entry.

49 and 50. Explain what is meant by "uncommon uses and atypical doses".
Medications that are prescribed for indications or at doses that are not supported in the drug approved labeling or in the recent literature would be considered uncommon uses or for atypical doses. A medication being prescribed for a non-FDA indication or recommended dose that is supported in peer-reviewed literature would not be considered an uncommon use.

71. Can you give an example of parameters for "dosing windows"?
One example of parameters for dosing windows would be administering the first dose of an antibiotic, which was ordered at 8 AM and scheduled for every 8 hours, at 8 AM and then scheduling the next dose for 2 PM if the hospital's standardized schedule for every 8 hours is 6 AM, 2 PM, and 10 PM. If the order in this example was written at 12 noon then the first dose could be administered shortly after the order was received and the next dose would be scheduled to be given at 10 PM.

94. What if the manufacturer does not have an expiration date and I repackage the chemical?
If the expiration date is not available from the manufacturer and pharmacy has repackaged the product then an expiration date, according to an established internal policy, should be listed on the container.

110. Does this item infer that all practitioners (nurses, pharmacists, etc.) including agency staff must be educated about medication delivery devices as well as automated equipment used in the pharmacy?
The intent of this item is that practitioners who are required to use the specific equipment are properly educated on its use and competency testing is performed. For example, nurses are competent with the use of monitoring equipment used on their unit, pharmacists are competent with automated compounding equipment used in the pharmacy, and both pharmacists and nurses are competent with the use of automated dispensing cabinets.

125. Explain the term "minimized" in this item.
The overuse of rotating agency personnel has often been associated with errors. This is usually due to the lack of time for a complete orientation, which includes competency testing, to the entire hospital. We recommend that the use of agency personnel, unless in special circumstances (e.g., worker strike, severe recruiting difficulties), be kept to less than 5 % of the total employee pool for each discipline.

147. What is meant by the term "critical drugs" in this item? Is this the same as "high-alert" drugs?
Critical drugs could include drugs on ISMP's high-alert drug list (see definitions) but they may also include any medication that is important in the treatment of the patient's medical condition. For example, continuing antibiotic therapy for a prescribed number of days post discharge could be critical for preventing a re- infection that would require another hospitalization.

159. What is meant by error rate in this item?
Many organizations attempt to use the number of voluntary reported errors as a numerator to calculate a medication error rate using a denominator (such as total doses dispensed) to compare the "rate" of errors in their organization and for unit specific rates of comparison. These calculations should not be used for internal or external comparison. Some organizations may use a determination of error frequency based on the number of errors detected using valid scientific methodologies (numerator), divided by a volume indicator such as the total number of medication doses that should have been administered, total patient admissions, or number of associated procedures (denominator). Even if these methods are employed they should not be used to compare practitioners or units within the hospital.

164 & 165. What is meant by the Board of Trustees commitment to patient safety and the hospital's strategic plans?
These items relate to the atmosphere (culture) that exists within your organization. Everyone, including the Board of Trustees, must believe and exhibit that patient safety and a non-punitive system based approach to medication error prevention is important. Organizations with open error reporting policies, which are non-punitive and that use results of error analysis to institute system changes that may involve capital investment are in our experience ahead of the curve in safe medication use practices. Answers to these items must be honestly agreed upon between the senior administrator(s) on your assessment team as well as all other members.

174 We have an interdisciplinary team that shares error experiences but we do not routinely convene in person. Could we answer E to this item?
In our experience organizations that have set a routine time to meet to share and analyze external and internal errors are more successful than those organizations that seldom meet or only meet when a sentinel event occurs. If you do not have routine face-to-face meetings your answer should be a C or D.

N35. Explain the examples given for "an effective means of measuring medication safety?
These are methods often used by hospitals as a more accurate measurement to track risk reduction strategies. They may include:
Observational methods of error detection- A determination of error frequency based on the number of errors detected during direct observation of performance. This measurement is used to obtain a numerator, which is then divided by a volume indicator such as the total number of medication doses that should have been administered, total patient admissions, or number of associated procedures, which becomes the denominator.
Tracking risk priority numbers from FMEA- A process of assigning a risk assessment number to a specific FMEA for a process, incorporating change strategies into the process, and re-performing the FMEA to determine if the risk assessment number has changed; and
Triggers- A list of laboratory values, medications, procedures, and other measures (e.g., INRs or PTTs above a critical value, one time dose of an antidote, emergency returns to OR) that may indicate an error has occurred. These may be tracked electronically during order entry or manually via electronic printouts and chart review.

178(1). Explain what is meant as "published in drug reference texts" in this item?
The term published refers to a mg/kg dose that is either included in a drug's monograph, published in standard reference texts, or available in peer reviewed journal articles.

181(1) and 181 (2). Can a nurse, rather than a pharmacist, perform the independent double check on chemotherapy and pediatric/neonatal IV admixtures before dispensing the products?
Only if the nurse verifies the actual drugs added to the solutions (i.e. observes the vials and volume/dose of medications which were added). Such an occurrence may happen in satellite pharmacies, which are within oncology/pediatric units when only one pharmacist is available or in the central pharmacy if there is only one pharmacist and no support staff available. Verification would require the nurse to physically view the containers of medications, either by going to the pharmacy or the pharmacist would bring the containers to the patient unit.

189. Where can I get a copy of the USP General Tests and Assays Chapter 797?
The reference, which is included in the United States Pharmacoepia 27th revision or the National Formulary, 22nd edition, can be obtained from your pharmacy, medical library, or directly from the United States Pharmacopeia (www.usp.org). You can also find a 797 Discussion guide on the American Society of Health-System Pharmacists web site (www.ashp.org).

Sample Medication Orders for Computer Testing

(The following are examples only. If you do not have the medications in the sample test orders on your formulary then use other medication examples that may fit the category listed.)

Allergies and cross allergies

Timentin 3.1 grams IV every 4 hours (penicillin allergy)
Bactrim DS one tablet orally twice a day (sulfonamide allergy)
Brinzolamide (Azopt) instill one drop in affected eye three times a day (Sulfa allergy)
Gastrografin (iodine allergy)

Herbal-Drug Interactions

St. John's wort; with Parnate 30 mg daily
Chamomile; with warfarin 5 mg daily

Contraindications/dose limits based on patient diagnosis

Aggrenox one capsule orally twice a day: patient with asthma
Zocor 20 mg once daily; pregnant patient
Depakote 750 mg orally three times a day; patient with hepatic disease
Neurontin 400 mg orally three times a day; patient on dialysis

Contraindications/dose limits based on laboratory studies

Levaquin 500 mg IV every 24 hours; CrCl less than 50 mL/ min
Gentamicin 80 mg IV every eight hours; serum creatinine 3.2 mg/ dL
Gentamicin 60 mg IV every eight hours; trough greater than 3 mcg/ mL
Digoxin 0.25 mg orally once daily; serum potassium less than 3 mEq/ L

Contraindications/dose limits based on patient age/weight

Zyrtec 10 mg once daily; four-year-old patient
Halcion 0.5 mg orally every night; seventy three year old patient
MS Contin 30 mg orally every 12 hours; in a 10 year old patient weighing 40 kg
Morphine 8 mg IV once; in an 18 month old weighing 9 kg
Cisplatin 204 mg IV once; in a 12 year old patient

Single and cumulative dose limits

Atenolol 100 mg one tablet orally three times a day (max recommended dose 200mg/day)
Carbamazepine (Tegretol) 1200mg three times a day (max recommended dose 1600 mg/day)

Dose limits for each component of combination products

Hydrocodone/Acetaminophen 5/500 (Vicodin) 2 tablets every 4 hours (max recommended is 8 tablets per day)

Dose limits for combination and single products

Percocet (7.5 mg/ 500 mg) one tablet every six hours; plus Tylenol 650 mg every 4 hours prn (max. recommended acetaminophen is 4 grams daily)

Therapeutic duplication with the same therapy (same drug)

Enalapril 10 mg daily; Vasotec 5 mg daily
Lopressor 50 mg one tablet twice a day; Toprol XL 50 mg one tablet twice a day
Adalat 10 mg three times a day; Procardia XL 30 mg daily

Therapeutic duplication within a drug class

Pravachol 10 mg daily; Lipitor 10 mg daily
Hytrin 1 mg orally at bedtime; Cardura 1 mg daily

Therapeutic duplication with components of combination products

Enalapril 5 mg daily; Vaseretic one tablet daily
Hydrochlorothiazide 50 mg daily; Maxzide one capsule daily

Contraindicated route of administration

Imitrex 50 mg IV
Lantus insulin 20 units IV

Ability to build customized alerts (including look-alike/sound-alike medications)

Serzone (antidepressant); alerts to verify name and/or warning of mix ups with Seroquel (antipsychotic)
Norvasc (blood pressure/angina); alerts to verify name and/or warning of mix ups with Navane (antipsychotic)

Ability to build corollary orders into the system

Digoxin 0.25 mg once daily; alert that patient doesn't have a potassium level and/or serum creatinine ordered