ISMP Canada

Institute for Safe Medication Practices Canada

Medication Safety Self-Assessment Pilot: Focus on "Never Events"

Demographics

1. Province
2. Which category best describes the size of the community served by your facility?
Small population centre (1,000 - 29,999)
Medium population centre (30,000 - 99,999)
Large population centre (100,000 and over)
3. Which category best describes your facility?
Hospital
Ambulatory care centre
Long-term care home
Other _________________________________
4. Please indicate your facility type:
Hospital
4a. Type of hospital
Teaching (university affiliation/medical students)
Community
Specialty
5. Hospital Size
Less than 50 beds
50-99 beds
100-299 beds
300-499 beds
More than 500 beds
Long-term care
4b. Type of long-term care
general
complex care/rehabilitation
other specialty
Long-term care: complex care/rehabilitation
Long-term care: other specialty
Ambulatory care centre
4c. Type of ambulatory care centre
general medical
emergency/urgent care
dialysis
oncology
surgical
other
6. Average number of outpatient visits per month
Less than 500
500-2499
2500-4999
More than 5000
7. Pharmacy services
Inpatient pharmacy
Medications received from an affiliated hospital or healthcare system
Medications received from an outsourced provider not affiliated with the organization
Other _________________________________
8. Is your facility part of a larger healthcare organization with common governance?
No
Yes
8a. How many sites are there in your organization?
2-5
6-10
11-30
More than 30
9. Has your facility previously completed a Medication Safety Self-Assessment (MSSA)?
No
Yes
9a. If yes, which of the MSSAs have you completed? (Check all that apply.)
MSSA for Hospitals, Canadian Version I, II or III
MSSA for Long-term Care, Version I or II
Anticoagulant Safety
Epidural Label Safety Checklist
HYDROmorphone Safety Self-Assessment
ISMP International Medication Safety Self-Assessment for Oncology
Operating Room Medication Safety Checklist

I: Never Events

  1. A There has been no activity to implement this item
  2. B This item has been formally discussed and considered but not implemented
  3. C This item has been partially implemented for some areas, patients, medications and/ or staff in the facility
  4. D This item is fully implemented for some areas, patients, medications and/or staff in the facility
  5. E This item is fully implemented throughout the facility
  6. N/A Not applicable is available as an option for selected items

Core characteristic 1:

  Strategies have been implemented to address known never events.
Reference: 		ABCDEN/A
1.1
Medication orders are screened against validated allergies available on patient records (paper and electronic) and throughout the drug distribution system (CPOE, Pharmacy computers, ADC screens, etc.).

**Never event: patient harm or death associated with administration of a medication to which the patient was known to be allergic.**
1.2
Medications intended for topical use (e.g., concentrated epinephrine, chlorhexidine) are never placed in a parenteral syringe and open containers are not used to hold medications intended for injection (e.g., local anesthetic with diluted epinephrine combination products.).

**Never event: inadvertent injection of medications intended for topical use**
1.3
Vincristine (and other vinca alkaloids as applicable) is always dispensed in a minibag and labelled with a prominent warning label that reads "For intravenous use only – fatal if given by other routes", in accordance with World Health Organization recommendations (i.e., syringes are never used).

**Never event: wrong route administration of chemotherapy agents**
1.4
Confirmation is required (e.g., by sequential sign off) that the administration of any prescribed intrathecal medications has been completed before dispensing any medication that is known to be fatal if inadvertently given by this route (e.g., vinca alkaloid or bortezomib).

**Never event: wrong route administration of chemotherapy agents**
1.5
Vials of concentrated forms of electrolytes (e.g., potassium chloride, potassium phosphate, sodium chloride) are not available as unit stock in any care areas.

**Never event: intravenous administration of a concentrated electrolyte solution.**
1.6
High dose/high concentration formats of opioids, are not available as unit stock in care areas.

Specific products not to be stocked:
  • Fentanyl ampoules or vials with total dose greater than 100 mcg per container;
  • HYDROmorphone ampoules or vials with total dose greater than 2 mg; and
  • Morphine ampoules or vials with total dose greater than 15 mg in adult care areas and 2 mg in pediatric care areas.


**Never event: Overdose of hydromorphone (and other opioids) by administration of higher doses than intended due to complex calculations required with high dose/high concentration formats of these medications.**

 FAQ

1.7
Paralyzing agents (neuromuscular blocking agents) are only available in critical care areas and are segregated from other stock medications.

**Never event: Neuromuscular blockade without sedation, airway control and ventilation capability.**

II: General Strategies for Safety

  1. A There has been no activity to implement this item
  2. B This item has been formally discussed and considered but not implemented
  3. C This item has been partially implemented for some areas, patients, medications and/ or staff in the facility
  4. D This item is fully implemented for some areas, patients, medications and/or staff in the facility
  5. E This item is fully implemented throughout the facility
  6. N/A Not applicable is available as an option for selected items

Core characteristic 2:

  Recognized high-leverage strategies for safety are implemented throughout the facility. 		ABCDEN/A
2.1
Patients and family caregivers are actively involved in shared decision-making about medication treatment and are encouraged to ask questions about the medications they are receiving.
2.2
Patients prescribed high-alert medications are provided with information about common types of errors known to be problematic with these drugs, and how to prevent and detect these errors at home (e.g., methotrexate inadvertently prescribed daily for arthritis, wrong dose errors due to frequently changing warfarin orders, mix-ups between rapid-acting and basal insulins).
2.3
Computerized prescriber order entry (CPOE) systems are used to transmit orders for medications throughout in the facility.
2.4
Standardized protocols/order sets have been developed for high-alert medications (e.g., chemotherapy, anticoagulants, opioids, insulin, concentrated electrolytes), and are used whenever these medications are prescribed, dispensed, and administered.
2.5
Concentrations of infusions of high-alert medications are standardized to limit the number of choices available, and the majority of infusions are standardized to a single concentration only.
2.6
Standard infusion concentrations are selected based on commercially available premixed solutions of high-alert medications.
2.7
Standard protocols and order sets express high-alert medication infusion doses in a manner (e.g., mg, mmol, mEq, mg/kg, mcg/kg/min) and sequence that matches the entries on medication administration records (paper/electronic), pharmacy labels and medication administration and preparation devices (e.g., infusion pumps, automated compounders).
2.8
A list of prohibited dangerous abbreviations, symbols and dose designations has been established for all communication of drug information and orders, including in handwritten or preprinted orders, medication administration records, medication labels, and in electronic systems. (Examples include avoidance of "u" for "units" and abbreviated medication names, and use of leading zeros but not trailing zeros.)
2.9
Prescribers include the mg/kg dose for pediatric patients (under 40 kg) along with the patient-specific dose when prescribing medications that have published pediatric mg/kg dosing guidelines.
2.10
All practitioners involved in the medication use process can easily and electronically access laboratory values while working in their respective clinical locations.
2.11
A pharmacist verifies the prescriber's calculated dose (based on mg/kg dosing guidelines) for pediatric medication orders and confirms the appropriateness of the dose before the medication is prepared and dispensed.
2.12
Machine-readable coding (e.g., bar coding) is used in the pharmacy to verify medication selection prior to dispensing.
2.13
Machine-readable coding (e.g., bar coding) is used to verify products being loaded when filling automated dispensing cabinets (ADCs).
2.14
Commercially prepared, premixed IV solutions of high-alert medications are used whenever they are available from the manufacturer.
2.15
Infusions of high-alert medications, when not available commercially, are prepared in the pharmacy (i.e., not prepared by nurses in care areas).
2.16
TALLman lettering, when used for high-alert medications, follows the conventions recommended by ISMP Canada.
2.17
Electronic medication administration records (eMARs) are immediately accessible and used for reference during medication administration (i.e., at the bedside or medication administration location).

Select A or B if paper medication records are used (handwritten or computer-generated).
Please answer one of the following: 
2.18a
Selected high-alert medications (as defined by the facility) are independently double-checked by another practitioner before administration, and the check is documented in the health record.
OR 
2.18b
Machine-readable coding (e.g., bar coding) is used prior to medication administration to identify both the patient and the medication/dose.
2.19
Infusion pumps with activated dose error-reduction software (DERS), are used to administer infusions of high-alert medications via the intravenous and epidural routes.
2.20
Practitioners who prescribe, dispense, and administer high-alert medications receive ongoing information about associated risks, errors that have occurred in the facility or have been reported by external organizations, and strategies to minimize these risks and errors.
2.21
One or more convened committees that include patient(s) and representatives from disciplines involved in the medication management process have been assigned responsibility for monitoring and evaluating the safety of the medication use system in the facility.
2.22
The facility has identified a list of high-alert medications in use in the facility and established strategies to ensure the safe use of these medications.
2.23
Internal reports of identified risks (including near misses), errors, and adverse reactions associated with high-alert medications are regularly reviewed and actions taken to address identified vulnerabilities.
2.24
There is a standardized process to track the use of reversal agents and antidotes (e.g., flumazenil, naloxone, glucagon), and unexpected patterns of use are investigated to identify adverse drug events (preventable and non-preventable).
2.25
Standardized processes are in place to review data and reports available through medication system technology (e.g., barcode scanning technology rates, activation of smart infusion pump dose error-reduction software (DERS), automated dispensing cabinet [ADC] overrides), investigates identified problems, learns their causes, and recommends/facilitates action for improvement.

III: Communication of Medication Orders and Other Drug Information

  1. A There has been no activity to implement this item
  2. B This item has been formally discussed and considered but not implemented
  3. C This item has been partially implemented for some areas, patients, medications and/ or staff in the facility
  4. D This item is fully implemented for some areas, patients, medications and/or staff in the facility
  5. E This item is fully implemented throughout the facility
  6. N/A Not applicable is available as an option for selected items

Core characteristic 3:

  Strategies have been implemented to address risks associated with prescribing, dispensing, administering and monitoring of anticoagulants (blood thinners).

Scope: Unless otherwise stated, these items apply to warfarin, direct oral anticoagulants (e.g., dabigatran, apixaban, rivaroxaban), unfractionated heparin, and low molecular weight heparins (e.g., dalteparin, enoxaparin). 		ABCDEN/A
3.1
A standard, reliable process is in place to screen patients for recent anticoagulant use before invasive procedures, and, if therapy must be discontinued, protocols or guidelines define when anticoagulants should be stopped and restarted, and when alternative agents to bridge the patient should be considered.

 FAQ

3.2
Infusions of unfractionated heparin for therapeutic indications are standardized to a single concentration.
3.3
Protocols and order sets direct the reversal of anticoagulation.
3.4
High-dose unfractionated heparin products (greater than or equal to 10,000 total units per container) are not stocked in care areas.
3.5
When patients taking an anticoagulant are discharged from an inpatient or ambulatory care facility, or admitted to a long-term care home, a practitioner verifies that the patient has a scheduled appointment for clinician reassessment of anticoagulation and laboratory testing if required.

IV: Oral Anti-Cancer Drugs (Chemotherapy)

  1. A There has been no activity to implement this item
  2. B This item has been formally discussed and considered but not implemented
  3. C This item has been partially implemented for some areas, patients, medications and/ or staff in the facility
  4. D This item is fully implemented for some areas, patients, medications and/or staff in the facility
  5. E This item is fully implemented throughout the facility
  6. N/A Not applicable is available as an option for selected items

Core characteristic 4:

  Strategies have been implemented to address risks associated with prescribing, dispensing, administering and monitoring of oral anti-cancer drugs.

Scope: Unless otherwise stated, these items apply to oral medications used to treat cancer, including hormonal agents. The health risks associated with exposure to individual OACDs are typically assessed based on their potential for carcinogenicity, teratogenicity, genotoxicity, reproductive toxicity or organ toxicity.

For a more detailed assessment of oncology-related medication safety strategies, refer to the 2012 ISMP Medication Safety Self-Assessment for Oncology; available from: https://mssa.ismp-canada.org/oncology. 		ABCDEN/A
4.1
Verbal/telephone orders are never accepted for oral anticancer drugs, except to hold or discontinue treatment.
4.2
Orders for oral anti-cancer drugs to be taken or given on specific days are written explicitly including the specific dates medications are to be given (e.g., written as "Day 1, 2, 3," not "Days 1-3", noting the dates or indicating the start date and noting it as "Day1").
4.3
For intermittent treatment with oral anti-cancer drugs, the quantity prescribed and dispensed (e.g., number of tablets/capsules) for ambulatory patients/long-term care residents is the exact quantity required for a single cycle of treatment.

For example, capecitabine is available in 500 mg tablets. If one cycle of treatment is ordered for capecitabine 1,250 mg/m2 [BSA = 1.6 m2] twice a day for 2 weeks, then the order would note 2,000 mg twice a day for 2 weeks with 112 tablets prescribed to be dispensed.
4.4
All oral anti-cancer drugs are provided in a ready-to-use form that requires no further preparation or manipulation by the practitioner who will be administering it (i.e., provided in the exact dose required).
4.5
Oral anti-cancer drugs are handled in accordance with applicable guidelines and best practices, including use of personal protective equipment in pharmacy as well as in care areas.

V: Concentrated Electrolytes

  1. A There has been no activity to implement this item
  2. B This item has been formally discussed and considered but not implemented
  3. C This item has been partially implemented for some areas, patients, medications and/ or staff in the facility
  4. D This item is fully implemented for some areas, patients, medications and/or staff in the facility
  5. E This item is fully implemented throughout the facility
  6. N/A Not applicable is available as an option for selected items

Core characteristic 5:

  Strategies have been implemented to address risks associated with prescribing, dispensing, administering and monitoring of concentrated electrolytes by infusion.

Scope: Unless otherwise stated, these items apply to the following injectable concentrated electrolytes: calcium chloride and calcium gluconate, magnesium sulfate, potassium acetate, potassium chloride, potassium phosphate, hypertonic sodium chloride for injection (greater than 0.9% concentration), and sodium phosphate. 		ABCDEN/A
5.1
Practitioners use mmol as the standard, facility-defined dosing unit of measure to prescribe, label, dispense, administer, and document doses of potassium for all adult and pediatric patients (i.e., mEq is not used).
5.2
Small volume single or intermittent IV infusions of potassium chloride, potassium phosphate, sodium phosphate, or sodium chloride in concentrations greater than 0.9%, are never referred to as "bolus" doses in computer order entry systems, order sets, protocols, pharmacy labels or medication administration records (paper or electronic), automated dispensing cabinet (ADC) screens, or infusion pump screens.

 FAQ

5.3
In the pharmacy, containers of concentrated electrolytes are stored separately from other medications.
5.4
Sodium phosphate injection is used in place of potassium phosphate to treat hypophosphatemia because it is a safer alternative.
5.5
To prevent mix-ups with 5% dextrose solutions, IV containers of 5% sodium chloride are not procured, ordered, or stocked in the facility.
5.6
Containers of 3% sodium chloride are restricted to the pharmacy and approved critical care or emergency/urgent care units, stocked in limited quantities, labelled with appropriate warnings (e.g., CONCENTRATED sodium chloride, administer via central line only), and segregated from other medications.
5.7
Magnesium sulfate is provided in a ready-to-use, standard concentration (e.g., 20 g/500 mL) for bolus doses and maintenance infusions in obstetrical patients.
5.8
Loading doses of magnesium sulfate are administered from a maintenance infusion bag, using only infusion pumps with dose error-reduction software and a "loading dose" (sometimes called a "bolus dose") feature that automatically starts/ resumes the maintenance infusion at the prescribed rate of infusion once the loading dose has infused. Loading doses are never administered via a basic infusion mode.

VI: Epidural and Spinal (Neuraxial) Anesthesia

  1. A There has been no activity to implement this item
  2. B This item has been formally discussed and considered but not implemented
  3. C This item has been partially implemented for some areas, patients, medications and/ or staff in the facility
  4. D This item is fully implemented for some areas, patients, medications and/or staff in the facility
  5. E This item is fully implemented throughout the facility
  6. N/A Not applicable is available as an option for selected items

Core characteristic 6:

  Strategies have been implemented to address risks associated with prescribing, dispensing, administering and monitoring of epidural and spinal (neuraxial) anesthesia.

Scope: Unless otherwise stated, these items apply to single drug and combinations of all opioids and local anesthetics administered to adults, neonates, and pediatric patients. This includes continuous infusions of epidural analgesia/anesthesia with opioids or local anesthetics (including epidural PCA), single injections of epidural or intrathecal opioids or local anesthetics, and combination intrathecal injection and epidural continuous infusion.

Examples of medications administered via these routes include opioids (e.g., morphine, HYDROmorphone, fentanyl, and SUFentanil) and local anesthetics (e.g., bupivacaine, ropivacaine, lidocaine). 		ABCDEN/A
6.1
Patients receive verbal and written information about the signs and symptoms of an epidural abscess or post-dural puncture headache and what to do if it occurs, since patients may be discharged before the onset of symptoms.
6.2
The facility has established standard mixtures, concentrations, and safe maximum doses for epidural and spinal opioids and local anesthetics that reflect the needs of the population(s) served.
6.3
Order sets include instructions on when to discontinue and restart anticoagulants and antiplatelet medications when inserting or removing epidural and spinal catheters (to prevent spinal hematoma).
6.4
For epidural products containing both a local anesthetic and an opioid, the anesthetic agent is listed first on the label followed by the opioid (e.g., bupivacaine 0.1% and fentanyl 2 mcg/mL).
6.5
All bags and syringes of epidural/spinal opioids and local anesthetics, and their overwraps, if applicable, are labelled with a prominent auxiliary warning (e.g., on a brightly coloured label) indicating "Epidural Use Only".
6.6
Epidural medications are administered using dedicated infusion pumps, specifically configured for the epidural route, that are clearly differentiated from all other medication administration devices and are placed on separate poles from those used for other medications.
6.7
The administration set used for epidural infusion pumps does not contain any access ports (Y-connectors), can be distinguished from all other administration sets and medical tubing (e.g., a yellow stripe running the length of the tubing), and is not used for anything other than epidural infusions.
6.8
Medications for epidural and spinal administration are obtained from the unit supply by the person who will be administering the medication and brought to the patient's bedside immediately before use.
6.9
Epidural infusion lines and central venous access lines are secured on opposite sides of the patient’s back or chest.

VII: Insulin, Subcutaneous and Intravenous

  1. A There has been no activity to implement this item
  2. B This item has been formally discussed and considered but not implemented
  3. C This item has been partially implemented for some areas, patients, medications and/ or staff in the facility
  4. D This item is fully implemented for some areas, patients, medications and/or staff in the facility
  5. E This item is fully implemented throughout the facility
  6. N/A Not applicable is available as an option for selected items

Core characteristic 7:

  Strategies have been implemented to address risks associated with prescribing, dispensing, administering and monitoring of insulin.

Scope: Unless otherwise stated, these items apply to all concentrations of insulin prescribed, prepared, dispensed, and/or administered by the subcutaneous, IM (rare), and IV routes of administration, using a vial and syringe, pen, IV infusion or continuous subcutaneous insulin infusion device (insulin pump). 		ABCDEN/A
7.1
Patients who will be taking a concentrated insulin receive verbal and written instructions explaining how to administer the specific insulin dose(s) and the importance of using the correct measuring device.
7.2
The names for insulin products in computer order entry systems match order sets, protocols, medication administration records (paper and electronic), automated dispensing cabinet screens, infusion pump screens, pharmacy labels, and any other format used to communicate medication information in the facility.
7.3
Combination insulins are expressed using the full brand name and dose expression on the same line (e.g., NovoLOG Mix 70/30, not just NovoLOG Mix) in computer order entry systems, order sets, protocols, medication administration records (paper and electronic), automated dispensing cabinet (ADC) screens, infusion pump screens, pharmacy labels, and any other format used to communicate medication information in the facility.
7.4
Standard order sets that promote best practice (e.g., use of scheduled basal and bolus insulin doses, and appropriate correction doses) are used for all patients/residents receiving subcutaneous insulin.
7.5
Concentrated insulin products (e.g. U-200, U-300, U-500) are clearly identified in computer order entry systems, order sets, protocols, guidelines, medication administration records (paper and electronic), automated dispensing cabinet (ADC) screens, infusion pump screens, drug storage bins, pharmacy labels, and any other format used to communicate medication information in the facility.
7.6
Insulin pens are dispensed from the pharmacy for individual patients/residents OR stocked in a profiled ADC.
7.7
Concentrated insulins (U-200, U-300, U-500), not given via a pen, are administered with syringes specific to their strengths (i.e., U-100 insulin syringes and tuberculin syringes are not used).
7.8
During initial orientation and annually thereafter, all nurses and other health professionals who may administer insulin are educated about the proper use of insulin pens for a single patient and the dangers of sharing pens among multiple patients/residents, even if changing the needle.
7.9
Concentrations for continuous IV infusions of insulin are standardized for the patient groups served by the facility (i.e., neonates, pediatric patients and adults) and ideally there is one concentration used for each group (e.g., 1 unit/mL for adults).

VIII: Lipid-Based Medications vs. Conventional Formulations

  1. A There has been no activity to implement this item
  2. B This item has been formally discussed and considered but not implemented
  3. C This item has been partially implemented for some areas, patients, medications and/ or staff in the facility
  4. D This item is fully implemented for some areas, patients, medications and/or staff in the facility
  5. E This item is fully implemented throughout the facility
  6. N/A Not applicable is available as an option for selected items

Core characteristic 8:

  Strategies have been implemented to address risks associated with prescribing, dispensing, administering and monitoring of lipid-based medications.

Scope: Unless otherwise stated, these items apply only to drugs available in both lipid-based and conventional formulations, including amphotericin B, bupivacaine, cytarabine, DOXOrubicin, irinotecan, and vinCRIStine. 		ABCDEN/A
8.1
Only one formulation is available on formulary or used in the facility for medications in this category to reduce the risk of dosing errors with these products.
8.2
Practitioners who may prescribe, dispense, or administer lipid-based medications or their conventional formulations have been educated about the differences between products and the risk of patient harm if these products are confused with each other.

IX: Methotrexate for Non-Oncologic Use

  1. A There has been no activity to implement this item
  2. B This item has been formally discussed and considered but not implemented
  3. C This item has been partially implemented for some areas, patients, medications and/ or staff in the facility
  4. D This item is fully implemented for some areas, patients, medications and/or staff in the facility
  5. E This item is fully implemented throughout the facility
  6. N/A Not applicable is available as an option for selected items

Core characteristic 9:

  Strategies have been implemented to address risks associated with prescribing, dispensing, administering and monitoring of methotrexate for non-oncologic indications.

Scope: Unless otherwise stated, these items apply to methotrexate administered by any route (i.e., oral, IM, subcutaneous, or IV) and used ONLY to treat non-oncologic conditions, such as rheumatoid arthritis, psoriasis, certain connective tissue or muscle inflammatory diseases, Crohn’s disease, and multiple sclerosis. Methotrexate used for an oncologic indication is excluded. 		ABCDEN/A
9.1
Patients who are discharged on methotrexate receive clear verbal and written instructions that specify the weekly dosing schedule, emphasize the danger of taking extra doses, and warn patients to avoid taking extra doses for symptom control.
9.2
Computer order entry systems have been programmed to default to a weekly rather than daily dosage regimen for subcutaneous, IM, and oral methotrexate.
9.3
Prescriptions for non-oncologic use of methotrexate provided to patients upon discharge only include the number of tablets or other dosage forms needed for weekly dosing, not to exceed a 4-week supply.

X: Paralyzing Agents (Neuromuscular Blocking Agents)

  1. A There has been no activity to implement this item
  2. B This item has been formally discussed and considered but not implemented
  3. C This item has been partially implemented for some areas, patients, medications and/ or staff in the facility
  4. D This item is fully implemented for some areas, patients, medications and/or staff in the facility
  5. E This item is fully implemented throughout the facility
  6. N/A Not applicable is available as an option for selected items

Core characteristic 10:

  Strategies have been implemented to address risks associated with prescribing, dispensing, administering and monitoring of paralyzing agents (neuromuscular blocking agents).

Scope: Unless otherwise stated, these items apply to all paralyzing agents used in any inpatient and outpatient locations associated with the facility. 		ABCDEN/A
10.1
A standard protocol or order set is used when paralyzing agents are prescribed for ventilated patients outside of the operating room (OR) and post-anesthesia care unit (PACU).
10.2
Paralyzing agents are only available in rapid sequence intubation kits, surgical suites, post-anesthesia care unit/anesthesia stock, the emergency department, and critical care units, where patients can be ventilated and monitored by practitioners with demonstrated competencies.
10.3
Storage bins and ADC pockets or drawers containing paralyzing agents include an auxiliary label to clearly communicate that respiratory paralysis will occur and ventilation is required when administering these agents (e.g., WARNING: PARALYZING AGENT—CAUSES RESPIRATORY ARREST; WARNING: CAUSES RESPIRATORY PARALYSIS—PATIENT MUST BE VENTILATED).

XI: Procedural Sedation

  1. A There has been no activity to implement this item
  2. B This item has been formally discussed and considered but not implemented
  3. C This item has been partially implemented for some areas, patients, medications and/ or staff in the facility
  4. D This item is fully implemented for some areas, patients, medications and/or staff in the facility
  5. E This item is fully implemented throughout the facility
  6. N/A Not applicable is available as an option for selected items

Core characteristic 11:

  Scope for Moderate Sedation: Unless otherwise stated, these items apply to all moderate sedation agents (e.g., ketamine, propofol, midazolam, dexmedetomidine, etomidate, fentanyl used alone or in combination with another agent(s) [e.g., midazolam, propofol, nitrous oxide in oxygen]) and administered to adults, neonates, and pediatric patients undergoing a procedure in any setting.

Scope for Minimal Sedation: Unless otherwise stated, these items apply to all minimal sedation agents (e.g., midazolam, diazepam, ketamine, nitrous oxide) administered to patients undergoing a procedure in any setting.

Exclusions: Sedation of patients undergoing mechanical ventilation in a critical care environment, or sedation used to provide analgesia to patients postoperatively or to patients/residents with chronic painful conditions or receiving hospice/end-of-life care. 		ABCDEN/A
11.1
The facility has conducted a thorough assessment to identify all locations where moderate sedation of patients occurs to standardize their care, monitor these practice sites, and provide oversight to promote safety.
11.2
The medications, routes, and dosage ranges used for moderate sedation have been selected based on known drug properties that impact their onset, duration, synergistic effects, and adverse effects; and they have been reviewed by, at minimum, an anesthesiologist and a pharmacist (ideally the Pharmacy And Therapeutics Committee or similar medical staff committee) to ensure they are supported by current literature, expert opinion, or national guidelines.
11.3
Only a credentialled professional trained in the use of drugs causing deep sedation, and who is not simultaneously involved in a procedure, is permitted to administer medications that could lead to deep sedation of non-ventilated patients (e.g., propofol, ketamine, etomidate), even if moderate sedation is intended. (PALS or ACLS certification alone is not sufficient.)
11.4
In nonhospital facilities, a protocol for the immediate activation of emergency medical services (EMS) for life-threatening complications has been established, with clear understanding that this does not replace the practitioner’s responsibility to provide initial rescue.
11.5
Only a 1 mg/mL strength of midazolam injection is provided to procedural areas to prevent dosing confusion and to facilitate slow titration of the medication.
11.6
Pharmacy dispenses all prescribed doses of oral liquid medications for minimal sedation for pediatric patients in ready-to-use, unit-dose containers that contain the exact prescribed amount.
11.7
Oral sedatives are only administered to children in preparation for a procedure (e.g., MRI) by trained healthcare professionals, or family caregivers under supervision, after the child has arrived at the facility to ensure proper monitoring of neurological and respiratory status.
11.8
For pediatric patients, at least one practitioner skilled in obtaining vascular access in children is available during the procedure and the recovery period.
11.9
Protocols exist that permit emergency administration of appropriate reversal agents and include a minimum requirement for monitoring for re-sedation.

XII: Opioids

  1. A There has been no activity to implement this item
  2. B This item has been formally discussed and considered but not implemented
  3. C This item has been partially implemented for some areas, patients, medications and/ or staff in the facility
  4. D This item is fully implemented for some areas, patients, medications and/or staff in the facility
  5. E This item is fully implemented throughout the facility
  6. N/A Not applicable is available as an option for selected items

Core characteristic 12:

  Strategies have been implemented to address risks associated with prescribing, dispensing, administering and monitoring of opioids.

Scope: Unless otherwise stated, these items apply to opioids (including in combination with other analgesics) used for any indication except moderate sedation, that are administered by the following routes: oral, IV, IM, subcutaneous, transdermal, sublingual, buccal/transmucosal, and intranasal.

For opioids used in moderate sedation, see Section XI; for opioids used for epidural or spinal anesthesia (neuraxial administration), see Section VI. 		ABCDEN/A
12.1
Patients discharged on opioids are provided with verbal and written information about pain management and safe use of opioid medications.
12.2
Patients, family members, and visitors are educated about the dangers of any individual other than the patient activating the PCA button to deliver a medication dose (i.e., PCA by proxy); and a warning label, “FOR PATIENT/RESIDENT USE ONLY,” appears on the cord or activation button for PCA.
12.3
Protocols and order sets include dosing guidelines that differentiate the management of opioid-naïve, opioid-tolerant, and high-risk patients (with criteria for determining opioid tolerance) and specify conditions that require dose adjustments.
12.4
Standardized concentrations have been established for continuous IV opioid infusions for the populations served by the facility (i.e., for neonates, pediatric patients and adults).
12.5
Immediate-release and extended-release oral formulations of the same opioid are stored separately in the pharmacy and in care areas.
12.6
A process (e.g., alert requesting confirmation during order entry) is in place to verify that the patient is opioid-tolerant before dispensing (or releasing from an automated dispensing cabinet [ADC]) extended-release and long-acting opioids that are indicated only for such patients (e.g., fentanyl patches).
12.7
Morphine and HYDROmorphone are not stored right next to each other in the pharmacy or in care areas.
12.8
Morphine and HYDROmorphone are stocked in different strengths in the lowest possible strength or concentration in care areas (e.g., HYDROmorphone 2 mg/mL; morphine 10 mg/mL).
12.9
IV push doses of opioids are never prepared by drawing up the contents into a commercially labelled, prefilled flush syringe of 0.9% sodium chloride.
12.10
The date, time, and anatomical location of an opioid transdermal patch applied to a patient is documented on the patient's/resident's MAR/eMAR.
12.11
Practitioners remove any previously applied transdermal opioid patches prior to the application of a new patch and document the patch removal on the patient's/resident's MAR/eMAR.
12.12
A policy on the proper disposal of opioid patches exists and is followed (e.g., narcotic disposal system containers, containers that deactivate residual drug) and these items are not disposed with regular garbage.
12.13
The organization/facility uses a validated, standardized sedation scale (e.g., Pasero Opioid-Induced Sedation Scale ([POSS], Richmond Agitation Sedation Scale) to guide the assessment and early detection of unintended advancing sedation during opioid therapy.
12.14
Protocols for the use of naloxone include a requirement to monitor for signs of re-sedation and respiratory depression for at least 90 minutes after administration of the reversal agent.
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