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Safety Concerns With Insulin Use
in the Inpatient Setting:
The Pharmacist’s Role
1
Pharmacist’s Role in the Safe Use of
Insulin in the Inpatient Setting
• Minimizing medication errors
• Discouraging the use of sliding scale insulin
• Development of treatment protocols
• Formulary decision-making
• Supporting the education of patients in advance
of discharge
Cohen MR. Am J Health-Syst Pharm. 2010;67(suppl 8):S17-S21.
Kelly JL. Am J Health-Syst Pharm. 2010;67(suppl 8):S9-S16. 2
Hospital Pharmacists: Key Areas
of Understanding
• Treatment goals
• Treatment options
• Treatment protocols
• Potential medication errors and methods to
reduce errors
• Importance of pharmacy’s role on the
multidisciplinary team to ensure safe and
effective management of hyperglycemia in the
hospital setting
Cohen MR. Am J Health-Syst Pharm. 2010;67(suppl8):S17-S21.
Kelly JL. Am J Health-Syst Pharm. 2010;67(suppl 8):S9-S16. 3
Insulin Use in the Hospital
• Preferred tool to manage inpatient hyperglycemia
– Most potent agent with which to lower blood glucose
– Rapidly effective
– Easily titrated
– Relatively no contraindications to use
• Limitations
– Narrow therapeutic range
– High-alert drug for safety issues
– Consistently implicated in reports of preventable patient
harm in hospitals
• Main concern: risk of severe hypoglycemia
4
Moghissi ES, et al. Endocrine Pract. 2009;15:353-369.
USP, US Pharmacopeia; ISMP, Institute for Safe Medication Practices.
1. JCAHO. Int J Qual Health Care. 2001;13:339-340.
2. ASHP; HAP. Use of insulin. http://www.ashp.org/s_ashp/docs/files/Safe_Use_of_Insulin.pdf.
Insulin Therapy: Safety Concerns
• The Joint Commission considers insulin 1
of the 5 highest-risk medicines in the inpatient
setting1
– The consequences of errors with insulin therapy
can be catastrophic
• Insulin is consistently implicated in causing
severe adverse events in hospitals through
reporting systems maintained by USP and
ISMP2
5
Common Types of Medication Errors
Associated With Insulin Therapy
Transcription
errors
Dispensing
errors
Administration
errors
• Insulin omission
– Leads to hyperglycemia
– Poor outcomes including
increased risk of mortality
• Improper dose or quantity of
insulin
– Leads to hyperglycemia or
hypoglycemia
– Hyperglycemia →
ketoacidosis
– Hypoglycemia → range of
symptoms from nausea to
falls to increased risk of
myocardial ischemia
6
Cohen MR. Am J Health-Syst Pharm. 2010;67(suppl 8):S17-S21.
Types of Medication Errors
• Prescription transcription errors
– Illegible orders
– Missing or misplaced zeros and decimal points
– Use of unsafe abbreviations
– Unintended drug ordered based on variety of drug
formulations
Jackson MA. US Pharm. 2003;28:69-79. 7
Types of Medication Errors
• Dispensing errors
– Look alike/sound alike medications
– Incorrect preparation
– Accessibility as floor stock
– Nonstandard compounded IV solutions and infusion
rates
Jackson MA. US Pharm. 2003;28:69-79. 8
Types of Medication Errors
• Administration errors
– Incorrect drug,
dose/infusion rate, or
timing
– Medication given to the
wrong patient
– Incorrect administration
technique, route
– Omission errors or extra
doses given
– Lack of drug monitoring
– Lack of double-checking
Jackson MA. US Pharm. 2003;28:69-79. 9
Lee A, et al. Intensive Crit Care Nurs. 2010;26:161-168.
Potential for Insulin Dosing Errors Using
Infusion Protocols
Potential Errors
• Multiple optional starting points
• Lengthy instructions
• Complex mathematical
calculations
• Potential errors from frequent
insulin dosage adjustments
– Misinterpretation of how to use the
protocol
– Ordered for or administered to
incorrect patient
– Failure to recognize a new order
– Miscalculations
– Transcription errors
– Frequent alert alarms, leading to
desensitization and delays in testing
Solution Strategies
• Increase use of user-friendly
protocols
• Increase staff education on
insulin infusion protocols
• Use computerized provider
order entry systems and tools
• Establish multidisciplinary task
force to oversee glycemic
control in institution
10
Insulin Storage Practices Recommended
to Reduce Risk for Insulin Error
• Remove unusual concentrations (eg, Humulin® R U-500) from
patient care areas
• Store insulin and heparin separately on nursing units and in the
pharmacy
• Store insulin syringes apart from tuberculin syringes and remove
tuberculin syringes from nursing units, if possible
• Label insulin vial with patient’s name and vial expiration per
institutional guidelines
• Conduct unit inspections to ensure proper labeling and disposal per
institutional guidelines
• Do not dispense insulin in original carton, or discard carton upon
dispensing or delivery to nursing unit
• Provide ongoing education and oversight to assure insulin pens are
not shared between patients and that cartridges are not used to
prepare insulin doses with a conventional insulin syringe
Cohen MR. Am J Health-Syst Pharm. 2010;67(suppl 8):S17-S21. 11
Medical Abbreviations to Avoid
12
Cohen MR. Am J Health-Syst Pharm. 2010;67(suppl 8):S17-S21.
U-500 Insulin
• When daily insulin requirements exceed 200
units/day
– Volume of U-100 injected insulin may be problematic
– Use of U-500 insulin (5 times more concentrated than
U-100 insulin) may be appropriate
• Possible patients
– Obstetrics patients
– Patients receiving high-dose glucocorticoid therapy
– Patients with type 2 diabetes, obesity, or severe
insulin resistance
13
Kelly JL. Am J Health-Syst Pharm. 2010;67(suppl 8):S9-S16.
Addressing Safety Concerns About U-500 in a
Hospital Setting: One Hospital’s Approach
• Home dose verification by a pharmacist or a CDE is required
• U-500 is not stocked or stored in automatic dispensing
machines on the nursing unit
• When ordered, a 2-pharmacist order-entry process is followed
– Total dose in units is entered
– Computer converts to volume
• Pharmacist checklist and dispensing kit are stored with
product
• Pharmacist hand delivers insulin to charge nurse and bedside
nurse
– Safety time out is taken to review drug, orders, and medication
administration record
• Patient and staff education are provided
Samaan KH, et al. Am J Health Syst Pharm. 2011;68:63-68. 14
Current Recommendations for
Hospitalized Patients
• All critically ill patients in intensive care unit settings
– BG level 140-180 mg/dL
– Premeal: <140 mg/dL
– Intravenous insulin preferred
• Noncritically ill patients
– Random: <180 mg/dL
– Scheduled SC insulin preferred
– Sliding-scale insulin discouraged
• Hypoglycemia
– Reassess the regimen if BG level is <100 mg/dL
– Modify the regimen if BG level is <70 mg/dL
BG, blood glucose.
Moghissi ES, et al. Endocrine Pract. 2009;15:353-369.
Umpierrez GE, et al. J Clin Endocrinol Metab. 2012;97:16-38. 15
Treatment Considerations for
Management of Inpatient Hyperglycemia
16
• Non-insulin antihyperglycemic agents have a limited role in acute-care settings
• Practitioners should consider discontinuing them in favor of insulin during acute
illness
Moghissi ES, et al. Endocrine Pract. 2009;15:353-369.
Selection of an Insulin Infusion Protocol
• Ideal
– Based not only on current level of glucose but also on
rate of change of glucose, insulin sensitivity of patient
– Easy to implement
– Clear and specific directions for titration, blood
glucose monitoring, and treatment of hypoglycemia
17
Safe Use of IV Insulin Therapy
• Insulin infusion concentrations and protocols
should be standardized within a hospital
• Staff should receive training on insulin infusion
protocol, and competency should be assessed
regularly
• Accurate bedside blood glucose monitoring
done hourly (and if stable, every 2 hours)
• Potassium should be monitored and given if
necessary
Clement S, et al. Diabetes Care. 2004;27:553-591. 18
Essential Part of Any Insulin Use:
A Hypoglycemia Protocol
• Clear definition of hypoglycemia
– BG <70 mg/dL
• Nursing order to treat without delay
– Stop insulin infusion (if applicable)
– Oral glucose (if patient is able to take oral)
– IV dextrose or glucagon (if patient is unable to take oral)
– Repeat BG monitoring 15 min after treatment for
hypoglycemia and repeat treatment if BG not up to target
– Directions for when and how to restart insulin
• Document the incident
• Look for the cause of hypoglycemia and determine if
other treatment changes are needed
BG, blood glucose.
Moghissi ES, et al. Endocrine Pract. 2009;15:353-369.
Umpierrez GE, et al. J Clin Endocrinol Metab. 2012;97:16-38. 19
Moghissi ES, et al. Endocrine Pract. 2009;15:353-369.
Standardize Insulin Therapy
to Reduce Errors
• Single insulin infusion concentration
• Single insulin infusion protocol
• Guidelines for transitions: IV to SC
• Guidelines for special situations
– Steroid therapy
– Enteral nutrition
– Parenteral nutrition
– Patient transportation and other handoffs
– Pre-procedure (NPO)
– Hypoglycemia: BG <70 mg/dL
20
Grissinger M. P&T. 2003;28:628.
ASHP; HAP. Use of insulin. http://www.ashp.org/s_ashp/docs/files/Safe_Use_of_Insulin.pdf.
ISMP. High-alert medications. http://www.ismp.org/Tools/highalertmedications.pdf.
Standardize Operations of Pharmacist
and Pharmacy Staff
• Prepare all insulin infusions
within the pharmacy
• Double-check all insulin
preparations against original
order
• Use a standard insulin
concentration to prepare
infusion bags
• Verify diagnosis and indication
for insulin
• Store insulin in high-alert bins,
away from other drugs
• Alert staff about insulin-
containing IV solutions by
brightly labeling bag
• Prohibit acceptance of orders
containing trailing zeros and
“U” in place of “units”
• Use preprinted insulin order
sets
21
ASHP; HAP. Use of insulin. http://www.ashp.org/s_ashp/docs/files/Safe_Use_of_Insulin.pdf.
PPSA. PA-PSRS Patient Safety Advisory. 2005;2:30-31.
Hellman R. Endocr Pract. 2004;10(suppl 2):100-108.
Educate Nursing and Support Staff
• Staff should demonstrate appropriate insulin
administration techniques
• Familiarize staff with insulin order sets and
protocols
• Educate staff on insulin products and formulary
status
• Provide training on blood glucose monitoring
• Enforce backup checks by peers
22
Hellman R. Endocr Pract. 2004;10(suppl 2):100-108.
ASHP; HAP. Use of insulin. http://www.ashp.org/s_ashp/docs/files/Safe_Use_of_Insulin.pdf.
Implement Hospital-Wide Initiatives
• Use standardized insulin infusion protocols
• Transition to computerized physician order entry (CPOE)
system or standardized medication orders
• Switch to electronic medical records
• Institute a medication error reporting system
– Participate in multidisciplinary review process of all insulin-
related events
– Lead implementation of practice changes or protocol revisions to
minimize insulin-related events
• Reevaluate hospital formulary
– Include insulin delivery devices that have safety features,
perform reliably, and are easy to administer
– Request that the pharmacy and therapeutics (P&T) committee
limits types of insulin on formulary and eliminates duplicate types
23
Adopt Diabetes Certification Standards
• Specific staff education requirements
• Blood glucose monitoring protocols
• Treatment plans for hyperglycemia and
hypoglycemia
• Data reporting of incidences of hypoglycemia
• Patient education on diabetes management
• Identified program champion or team
Joint Commission. Advanced certification in inpatient diabetes.
http://www.jointcommission.org/certification/inpatient_diabetes.aspx. 24
Joint Commission. Advanced certification in inpatient diabetes.
http://www.jointcommission.org/certification/inpatient_diabetes.aspx.
Adopt Joint Commission Diabetes
Certification Standards
• Certificate of merit awarded to hospitals that
exemplify superior inpatient diabetes
management
• Includes adoption of specific American Diabetes
Association (ADA) protocols and initiatives to
continually improve patient care and outcomes
25
Points to Consider
• What practices do you currently utilize in your
hospital to promote a safe patient environment?
• Since insulin is a high-alert medication, what
actions can your hospital take to address safety
concerns surrounding its use?
26
Summary
• Insulin is the most appropriate agent for the
majority of hospitalized patients
• Insulin is a high-alert medication
• For effective and safe use of insulin, institutions
need to consider
– Standardized pharmacy and practice operations
– Education of nursing and support staff
– Implementation of hospital-wide initiatives
– Effective communication and collaboration among
caregivers
27

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Strategies-S5-Safety-Concerns-and-Pharmacist-Role-011614.pptx

  • 1. Safety Concerns With Insulin Use in the Inpatient Setting: The Pharmacist’s Role 1
  • 2. Pharmacist’s Role in the Safe Use of Insulin in the Inpatient Setting • Minimizing medication errors • Discouraging the use of sliding scale insulin • Development of treatment protocols • Formulary decision-making • Supporting the education of patients in advance of discharge Cohen MR. Am J Health-Syst Pharm. 2010;67(suppl 8):S17-S21. Kelly JL. Am J Health-Syst Pharm. 2010;67(suppl 8):S9-S16. 2
  • 3. Hospital Pharmacists: Key Areas of Understanding • Treatment goals • Treatment options • Treatment protocols • Potential medication errors and methods to reduce errors • Importance of pharmacy’s role on the multidisciplinary team to ensure safe and effective management of hyperglycemia in the hospital setting Cohen MR. Am J Health-Syst Pharm. 2010;67(suppl8):S17-S21. Kelly JL. Am J Health-Syst Pharm. 2010;67(suppl 8):S9-S16. 3
  • 4. Insulin Use in the Hospital • Preferred tool to manage inpatient hyperglycemia – Most potent agent with which to lower blood glucose – Rapidly effective – Easily titrated – Relatively no contraindications to use • Limitations – Narrow therapeutic range – High-alert drug for safety issues – Consistently implicated in reports of preventable patient harm in hospitals • Main concern: risk of severe hypoglycemia 4 Moghissi ES, et al. Endocrine Pract. 2009;15:353-369.
  • 5. USP, US Pharmacopeia; ISMP, Institute for Safe Medication Practices. 1. JCAHO. Int J Qual Health Care. 2001;13:339-340. 2. ASHP; HAP. Use of insulin. http://www.ashp.org/s_ashp/docs/files/Safe_Use_of_Insulin.pdf. Insulin Therapy: Safety Concerns • The Joint Commission considers insulin 1 of the 5 highest-risk medicines in the inpatient setting1 – The consequences of errors with insulin therapy can be catastrophic • Insulin is consistently implicated in causing severe adverse events in hospitals through reporting systems maintained by USP and ISMP2 5
  • 6. Common Types of Medication Errors Associated With Insulin Therapy Transcription errors Dispensing errors Administration errors • Insulin omission – Leads to hyperglycemia – Poor outcomes including increased risk of mortality • Improper dose or quantity of insulin – Leads to hyperglycemia or hypoglycemia – Hyperglycemia → ketoacidosis – Hypoglycemia → range of symptoms from nausea to falls to increased risk of myocardial ischemia 6 Cohen MR. Am J Health-Syst Pharm. 2010;67(suppl 8):S17-S21.
  • 7. Types of Medication Errors • Prescription transcription errors – Illegible orders – Missing or misplaced zeros and decimal points – Use of unsafe abbreviations – Unintended drug ordered based on variety of drug formulations Jackson MA. US Pharm. 2003;28:69-79. 7
  • 8. Types of Medication Errors • Dispensing errors – Look alike/sound alike medications – Incorrect preparation – Accessibility as floor stock – Nonstandard compounded IV solutions and infusion rates Jackson MA. US Pharm. 2003;28:69-79. 8
  • 9. Types of Medication Errors • Administration errors – Incorrect drug, dose/infusion rate, or timing – Medication given to the wrong patient – Incorrect administration technique, route – Omission errors or extra doses given – Lack of drug monitoring – Lack of double-checking Jackson MA. US Pharm. 2003;28:69-79. 9
  • 10. Lee A, et al. Intensive Crit Care Nurs. 2010;26:161-168. Potential for Insulin Dosing Errors Using Infusion Protocols Potential Errors • Multiple optional starting points • Lengthy instructions • Complex mathematical calculations • Potential errors from frequent insulin dosage adjustments – Misinterpretation of how to use the protocol – Ordered for or administered to incorrect patient – Failure to recognize a new order – Miscalculations – Transcription errors – Frequent alert alarms, leading to desensitization and delays in testing Solution Strategies • Increase use of user-friendly protocols • Increase staff education on insulin infusion protocols • Use computerized provider order entry systems and tools • Establish multidisciplinary task force to oversee glycemic control in institution 10
  • 11. Insulin Storage Practices Recommended to Reduce Risk for Insulin Error • Remove unusual concentrations (eg, Humulin® R U-500) from patient care areas • Store insulin and heparin separately on nursing units and in the pharmacy • Store insulin syringes apart from tuberculin syringes and remove tuberculin syringes from nursing units, if possible • Label insulin vial with patient’s name and vial expiration per institutional guidelines • Conduct unit inspections to ensure proper labeling and disposal per institutional guidelines • Do not dispense insulin in original carton, or discard carton upon dispensing or delivery to nursing unit • Provide ongoing education and oversight to assure insulin pens are not shared between patients and that cartridges are not used to prepare insulin doses with a conventional insulin syringe Cohen MR. Am J Health-Syst Pharm. 2010;67(suppl 8):S17-S21. 11
  • 12. Medical Abbreviations to Avoid 12 Cohen MR. Am J Health-Syst Pharm. 2010;67(suppl 8):S17-S21.
  • 13. U-500 Insulin • When daily insulin requirements exceed 200 units/day – Volume of U-100 injected insulin may be problematic – Use of U-500 insulin (5 times more concentrated than U-100 insulin) may be appropriate • Possible patients – Obstetrics patients – Patients receiving high-dose glucocorticoid therapy – Patients with type 2 diabetes, obesity, or severe insulin resistance 13 Kelly JL. Am J Health-Syst Pharm. 2010;67(suppl 8):S9-S16.
  • 14. Addressing Safety Concerns About U-500 in a Hospital Setting: One Hospital’s Approach • Home dose verification by a pharmacist or a CDE is required • U-500 is not stocked or stored in automatic dispensing machines on the nursing unit • When ordered, a 2-pharmacist order-entry process is followed – Total dose in units is entered – Computer converts to volume • Pharmacist checklist and dispensing kit are stored with product • Pharmacist hand delivers insulin to charge nurse and bedside nurse – Safety time out is taken to review drug, orders, and medication administration record • Patient and staff education are provided Samaan KH, et al. Am J Health Syst Pharm. 2011;68:63-68. 14
  • 15. Current Recommendations for Hospitalized Patients • All critically ill patients in intensive care unit settings – BG level 140-180 mg/dL – Premeal: <140 mg/dL – Intravenous insulin preferred • Noncritically ill patients – Random: <180 mg/dL – Scheduled SC insulin preferred – Sliding-scale insulin discouraged • Hypoglycemia – Reassess the regimen if BG level is <100 mg/dL – Modify the regimen if BG level is <70 mg/dL BG, blood glucose. Moghissi ES, et al. Endocrine Pract. 2009;15:353-369. Umpierrez GE, et al. J Clin Endocrinol Metab. 2012;97:16-38. 15
  • 16. Treatment Considerations for Management of Inpatient Hyperglycemia 16 • Non-insulin antihyperglycemic agents have a limited role in acute-care settings • Practitioners should consider discontinuing them in favor of insulin during acute illness Moghissi ES, et al. Endocrine Pract. 2009;15:353-369.
  • 17. Selection of an Insulin Infusion Protocol • Ideal – Based not only on current level of glucose but also on rate of change of glucose, insulin sensitivity of patient – Easy to implement – Clear and specific directions for titration, blood glucose monitoring, and treatment of hypoglycemia 17
  • 18. Safe Use of IV Insulin Therapy • Insulin infusion concentrations and protocols should be standardized within a hospital • Staff should receive training on insulin infusion protocol, and competency should be assessed regularly • Accurate bedside blood glucose monitoring done hourly (and if stable, every 2 hours) • Potassium should be monitored and given if necessary Clement S, et al. Diabetes Care. 2004;27:553-591. 18
  • 19. Essential Part of Any Insulin Use: A Hypoglycemia Protocol • Clear definition of hypoglycemia – BG <70 mg/dL • Nursing order to treat without delay – Stop insulin infusion (if applicable) – Oral glucose (if patient is able to take oral) – IV dextrose or glucagon (if patient is unable to take oral) – Repeat BG monitoring 15 min after treatment for hypoglycemia and repeat treatment if BG not up to target – Directions for when and how to restart insulin • Document the incident • Look for the cause of hypoglycemia and determine if other treatment changes are needed BG, blood glucose. Moghissi ES, et al. Endocrine Pract. 2009;15:353-369. Umpierrez GE, et al. J Clin Endocrinol Metab. 2012;97:16-38. 19
  • 20. Moghissi ES, et al. Endocrine Pract. 2009;15:353-369. Standardize Insulin Therapy to Reduce Errors • Single insulin infusion concentration • Single insulin infusion protocol • Guidelines for transitions: IV to SC • Guidelines for special situations – Steroid therapy – Enteral nutrition – Parenteral nutrition – Patient transportation and other handoffs – Pre-procedure (NPO) – Hypoglycemia: BG <70 mg/dL 20
  • 21. Grissinger M. P&T. 2003;28:628. ASHP; HAP. Use of insulin. http://www.ashp.org/s_ashp/docs/files/Safe_Use_of_Insulin.pdf. ISMP. High-alert medications. http://www.ismp.org/Tools/highalertmedications.pdf. Standardize Operations of Pharmacist and Pharmacy Staff • Prepare all insulin infusions within the pharmacy • Double-check all insulin preparations against original order • Use a standard insulin concentration to prepare infusion bags • Verify diagnosis and indication for insulin • Store insulin in high-alert bins, away from other drugs • Alert staff about insulin- containing IV solutions by brightly labeling bag • Prohibit acceptance of orders containing trailing zeros and “U” in place of “units” • Use preprinted insulin order sets 21
  • 22. ASHP; HAP. Use of insulin. http://www.ashp.org/s_ashp/docs/files/Safe_Use_of_Insulin.pdf. PPSA. PA-PSRS Patient Safety Advisory. 2005;2:30-31. Hellman R. Endocr Pract. 2004;10(suppl 2):100-108. Educate Nursing and Support Staff • Staff should demonstrate appropriate insulin administration techniques • Familiarize staff with insulin order sets and protocols • Educate staff on insulin products and formulary status • Provide training on blood glucose monitoring • Enforce backup checks by peers 22
  • 23. Hellman R. Endocr Pract. 2004;10(suppl 2):100-108. ASHP; HAP. Use of insulin. http://www.ashp.org/s_ashp/docs/files/Safe_Use_of_Insulin.pdf. Implement Hospital-Wide Initiatives • Use standardized insulin infusion protocols • Transition to computerized physician order entry (CPOE) system or standardized medication orders • Switch to electronic medical records • Institute a medication error reporting system – Participate in multidisciplinary review process of all insulin- related events – Lead implementation of practice changes or protocol revisions to minimize insulin-related events • Reevaluate hospital formulary – Include insulin delivery devices that have safety features, perform reliably, and are easy to administer – Request that the pharmacy and therapeutics (P&T) committee limits types of insulin on formulary and eliminates duplicate types 23
  • 24. Adopt Diabetes Certification Standards • Specific staff education requirements • Blood glucose monitoring protocols • Treatment plans for hyperglycemia and hypoglycemia • Data reporting of incidences of hypoglycemia • Patient education on diabetes management • Identified program champion or team Joint Commission. Advanced certification in inpatient diabetes. http://www.jointcommission.org/certification/inpatient_diabetes.aspx. 24
  • 25. Joint Commission. Advanced certification in inpatient diabetes. http://www.jointcommission.org/certification/inpatient_diabetes.aspx. Adopt Joint Commission Diabetes Certification Standards • Certificate of merit awarded to hospitals that exemplify superior inpatient diabetes management • Includes adoption of specific American Diabetes Association (ADA) protocols and initiatives to continually improve patient care and outcomes 25
  • 26. Points to Consider • What practices do you currently utilize in your hospital to promote a safe patient environment? • Since insulin is a high-alert medication, what actions can your hospital take to address safety concerns surrounding its use? 26
  • 27. Summary • Insulin is the most appropriate agent for the majority of hospitalized patients • Insulin is a high-alert medication • For effective and safe use of insulin, institutions need to consider – Standardized pharmacy and practice operations – Education of nursing and support staff – Implementation of hospital-wide initiatives – Effective communication and collaboration among caregivers 27