Institute for Healthcare Improvement: Failure Modes and Effects Analysis Tool Process Data Report

Step	Description



1	Existing issues with medication bar code scanning

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



RN's are not scanning the patient's ID band prior to medication	Busy staff, human error, unfamiliar workflow process	1. Wrong med or wrong dose is given 2. Death 3. Increased pt. illness 4. Increased legal risk	2	8	5	80



RN's are not scanning med and ID band if they are going into isolation rooms	Busy staff, human error, unfamiliar workflow process, lack of education about proper isolation practices	1. Wrong med or wrong dose is given 2. Death 3. Increased pt. illness 4. Increased legal risk	6	8	5	240



RN's are scanning after the insulin is given	Lack of understanding why scanning before administration is important, unfamiliar workflow	1. Wrong med or wrong dose is given 2. Death 3. Increased pt. illness 4. Increased legal risk	2	8	5	80



RN's are not scanning	Busy staff, human error, unfamiliar workflow process	1. Wrong med or wrong dose is given 2. Death 3. Increased pt. illness 4. Increased legal risk	2	8	5	80



Issues with technology of bar code scanning system	Epic downtime, equipment malfunction, damaged bar code	1. Wrong med or wrong dose is given 2. Death 3. Increased pt. illness 4. Increased legal risk	1	1	1	1



Bar code not integrated into delivery device	Medication is not in the delivery device; Device is not patient specific; Not practical due to competing demands	1. Wrong med or wrong dose is given 2. Death 3. Increased pt. illness 4. Increased legal risk	10	1	5	50

Step	Description



2	Drawing Insulin out of vial with contaminated needle

Failure Mode

Causes

Effects

Occ

Det

Sev

RPN

Actions

Poor technique

human error, lack of education, distraction, design issues of syringe and vial (potential multiple uses)

Infection risk to staff and patient, transmission, increased pain, legal risk, systemic infection

243

Large doses to same patient

lack of knowledge/double dipping, Apathy

Infection risk to staff and patient, transmission, increased pain, legal risk, systemic infection

Step	Description



3	Recapping or Post Use Syringe Handling

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Needle Sticks to Staff	Slipping/Human Error, Can't see, Design of caps, distraction, double checking mistake, device failure, administration (went through patient skin)	Infection, Blood Borne pathogen exposure, staff turnover	7	2	5	70



Contaminated	Slipping/Human Error, Can't See, Design of caps, Distraction, Double checking mistake, Patient Moves	Infection, Blood Borne pathogen exposure, staff turnover	7	2	5	70



Damaged device/unable to activate the safety device	Slipping/Human Error, Can't see, Design of caps, Distraction	Infection, Blood Borne pathogen exposure, staff turnover	7	2	5	70

Step	Description



4	Not mixing/rolling cloudy insulin prior to use

Failure Mode

Causes

Effects

Occ

Det

Sev

RPN

Actions

Lack of education on types of insulin that need mixing

Lack of education, busy staff, unfamiliar workflow

1. Inaccurate therapeutic effect
2. Onset, duration, and peaks of insulin are altered

In a hurry

Lack of education, busy staff, unfamiliar workflow

1. Inacurrate therapeutic effect
2. Onset, duration, and peaks are altered

Step	Description



5	Using the wrong insulin

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



RN forgets to scan/override	Lack of education, busy staff, unfamiliar workflow	Blood sugar fluctuations Wrong drug/dose Overtreatment/Undertreatment Cost Increased LOS	3	7	5	105



Short dosed/hyperglycemia or hypoglycemia	Lack of education, busy staff, unfamiliar workflow	Blood sugar fluctuations Wrong drug/dose Overtreatment/Undertreatment Cost Increased LOS	3	7	5	105



Alteration of future doses	Lack of education, busy staff, unfamiliar workflow	Blood sugar fluctuations Wrong drug/dose Overtreatment/Undertreatment Cost Increased LOS	3	7	5	105



Wrong insulin in accudose	Lack of education, busy staff, unfamiliar workflow	Blood sugar fluctuations Wrong drug/dose Overtreatment/Undertreatment Cost Increased LOS	3	7	5	105



Pick up wrong vial from accudose	Human Error	Blood sugar fluctuations Wrong drug/dose Overtreatment/Undertreatment Cost Increased LOS	3	7	5	105



Wrong Product Dispensed	Human Error	Blood sugar fluctuations Wrong drug/dose Overtreatment/Undertreatment Cost Increased LOS	3	7	5	105

Step	Description



6	Staff draws up the incorrect dose (RN or Pharmacy)

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Lack of education (i.e. 500 unit)	Unfamiliar workflow	Incorrect dose Blood sugar fluctuation Overtreatment or undertreatment Hyper/Hypo glycemia Death Increased legal risk/Pt. Harm Increased Cost Increased LOS	1	9	7	63



RN's are unable to see markings on syringe/misreads syringe	Label placement, vision difficulty, human error, distractions	Incorrect dose Blood sugar fluctation Overtreatment or undertreatment Hyper/Hypo glycemia Death Increased legal risk/Pt. Harm Increased Cost Increased LOS	2	1	2	4



No double check/both staff make error	Busy, Human error, Personal Choice, using incorrect process	Incorrect dose Blood sugar fluctation Overtreatment or undertreatment Hyper/Hypo glycemia Death Increased legal risk/Pt. Harm Increased Cost Increased LOS	6	7	5	210



RN could use non-insulin or incorrect syringe	Human Error, Wrong Syringe stocked in Omnicell, Consciously use incorrect syringe	Incorrect dose Blood sugar fluctation Overtreatment or undertreatment Hyper/Hypo glycemia Death Increased legal risk/Pt. Harm Increased Cost Increased LOS	1	8	9	72

Step	Description



7	Patient draws up wrong dose

Failure Mode

Causes

Effects

Occ

Det

Sev

RPN

Actions

Lack of patient education

health literacy, staff too busy, conflicting instructions, too many instructions, pt. doesn't double check with nurse

Incorrect dose
Blood sugar fluctuation
Overtreatment/Undertreatment
Increased cost, legal risk, LOS

Visual Difficulties

Poor vision, lack of education, human error

Incorrect dose
Blood sugar fluctuation
Overtreatment/Undertreatment
Increased cost, LOS, legal risk

Step	Description



8	Patient receives insulin late

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Insulin vial is unavailable (in pockets, pt. room, break room)	Human error, busy, inconvenient to return it to med room, waiting for dispense, unable to find it, pharmacy not notified of insulin not needing refill	Overtreatment/Undertreatment Increased LOS Decreased RN and Pt. Satisfaction	7	1	3	21



Nurses aren't aware of when patients are eating	Unaware when food trays arrive Family/friends bring food to the patient Patient goes to cafeteria or kitchen for snack	Overtreatment/Undertreatment Increased LOS Decreased RN and Pt. Satisfaction	7	3	3	63



Moving/transfering patient	Meds do not travel with patient New med order Staff unaware patient has been transfered	Dose not refelective of current blood sugar Blood sugar fluctuation Decreased Pt/Family satisfaction Overtreatment or under treatment Hyper/Hypo Glycemia Death Increased legal risk/Pt. Harm Decreased RN satisfaction Increased LOS Increased cost/w	2	2	3	12



New admission, and RN is waiting for the insulin	Nursing staff unaware of 2 hour TAT for non-urgent meds No admission orders	Dose not refelective of current blood sugar Blood sugar fluctuation Decreased Pt/Family satisfaction Overtreatment or under treatment Hyper/Hypo Glycemia Death Increased legal risk/Pt. Harm Decreased RN satisfaction Increased LOS Increased cost/w	2	1	3	6

Step	Description



9	Confusion on when to use insulin pen versus syringe

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Patient ability to use the device	Unfamiliar with mode to administer medications Physical limitations	RX delay Wrong dose Decreased Pt/Family satisfaction Overtreatment or under treatment Hyper/Hypo Glycemia Death Increased legal risk/Pt. Harm Decreased RN satisfaction Increased LOS Increased cost/waste	1	1	1	1



Technique experience	Lack of education, Busy staff, Unfamiliar workflow, no established procedures, incorrect order	RX delay Wrong dose Decreased Pt/Family satisfaction Overtreatment or under treatment Hyper/Hypo Glycemia Death Increased legal risk/Pt. Harm Decreased RN satisfaction Increased LOS Increased cost/waste	1	1	1	1



Size and/or Frequency of dose	Half unit increments not available with pen, Doses larger than 80 units can't be given with pen	RX delay Wrong dose Decreased Pt/Family satisfaction Overtreatment or under treatment Hyper/Hypo Glycemia Death Increased legal risk/Pt. Harm Decreased RN satisfaction Increased LOS Increased cost/waste	1	1	1	1

Step	Description



10	Pharmacy labeling issues

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Inpatient versus outpatient label issues (lack of standardizied process)	Human Error, Lack of staff awareness	Decreased staff satisfaction Increased pharmacy turn around time overdose/underdose Patient harm	1	8	1	8



Label placement: Unable to see expiration date	human error	Decreased satisfaction Increased pharmacy turn around time overdose/underdose Patient harm	2	2	1	4



Labeled wrong product	Human error	Decreased satisfaction Increased pharmacy turn around time overdose/underdose Patient harm	2	2	8	32



Label is not usable for scanning	Label placement error Printer head failure Equipment unable to read bar code	Decreased satisfaction Increased pharmacy turn around time overdose/underdose Patient harm	1	8	2	16

Step	Description



11	Inconsistent practice of handling insulin vials in isolation rooms

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Multi dose meds are not cleaned before being returned to the med room	Busy, Lack of Knowledge, Messiness	Regulation risk Increased cost Infected patients/staff Infection transmission to other patients	10	10	8	800



Multi dose vials are left in the patient room	Busy, Human Error, Perception it is safer, for scanning	Regulation risk increased cost infected patient/staff infection transmission to other patients	7	2	3	42



Multi dose vials can't be adequately cleaned	Lack of education-perception that they can be cleaned; Lack of clear policy	Regulation Risk, Incraesed cost, infected patients/staff, infection transmission	10	10	8	800

Step	Description



12	Needle stick risk for staff

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Pinching the patient skin for adminstration	Patient movement, Poor vision, Distraction	Infection, blood borne pathogen exposure, increased costs, litigation, OSHA fines, staff turnover	3	1	9	27



Pre administration (pt risk)	Drawing up insulin and you miss the bull eyes; pulling cap off, recapping and needle goes through skin	Infection, blood borne pathogen exposure, increased costs, litigation, OSHA fines, staff turnover	1	10	9	90



Post Administration (staff risk)	Recapping, Distraction, Flipping needle, Lack of education, Movement of patient, Full or dysfunctional sharp container	Infection, blood borne pathogen exposure, increased costs, litigation, OSHA fines, staff turnover	5	1	9	45



Recapping (drawing up, transporting to patient)	Drawing up insulin in med room before taking to patient, dysfunctional syringe	Infection, blood borne pathogen exposure, increased costs, litigation, OSHA fines, staff turnover	1	1	1	1



Not engaging safety feature	Malfunction, Lack of knowledge, habit	Infection, blood borne pathogen exposure, increased costs, litigation, OSHA fines, staff turnover	1	10	9	90



Improper Disposal (Trash or Left in bed or cart)	Human Error, Patient Error, Accident	Infection, blood borne pathogen exposure, increased costs, litigation, OSHA fines, staff turnover	2	1	3	6

Step	Description



13	Lack of process to reduce insulin waste

Failure Mode

Causes

Effects

Occ

Det

Sev

RPN

Actions

Insulin is removed from McKesson in med room

Isolation Patients, Not patient specific, forgot to return it, scanning patient at the bedside, looking for staff to do double check

increased patient cost, increased staff time, increased pharmacy cost/times

Cannot locate

Pharmacy delivers in multiple locations (fridge, inbox, tube system); in rooms; in staff pockets, carts, patient rooms; leave the unit (transfer)

inceased patient cost, increased staff time, increased pharmacy cost/times

Step	Description



14	No standardized process for insulin education for patients

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Lack of resources/staff to educate patients	Budget restraints High Census	Readmission, Decreased patient satisfaction, Patient Harm	5	9	9	405



AVS information is confusing and/or contradictory	Epic Lack of resources to correct issues Lack of knowledge with epic and med rec	Readmission Increased harm risk for patients Decreased satisfaction	10	2	9	180



Lack of weekend, night, holiday availability to educate the patients	Low census/combined units Budget constraints	Readmission Increased harm risk for patients Decreased satisfaction	5	9	9	405



Wrong information/med/mode is given (med rec failure)	Lack of knowledge about med rec Lack of knowledge with Epic MD writes wrong order Enter wrong information on patient Pharmacy gives wrong med Discharge papers switched with another person	Readmission Increased harm risk for patients Decreased satisfaction	5	5	9	225

Step	Description



15	Too many steps/logestics in insulin administration

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



McKesson does not have patient specific insulin	too time consuming for pharmacy/nursing, Insulin is not cheap	Nurse dissatisfaction, Delay in Treatment	10	1	1	10



Med bar scanning process with patients	Only having one vial in mcKesson and vial is left in room etc.	Nurse Dissatisfaction, Delay in Treatment	5	1	5	25



McKesson might not have right kind of insulin	Not enough room in machine, put wrong type in bin, cost savings, delivered wrong kind of insulin	Delay in Treatment, Nurse Dissatisfaction	1	1	5	5



Double check process	Locating staff, only one vial of insulin or vials leave the room, short staffed	Nurse Dissatisfaction, Delay in Treatment	10	10	4	400

Step	Description



16	One vial for multiple patients/multiple users

Failure Mode

Causes

Effects

Occ

Det

Sev

RPN

Actions

Multidose vials/wardstock-UIHC policy

Cost Savings, Able to provide timely insulin, Less waste

Contamination, lack of availability, increased cost due to replacing vials that are not stored properly or missing

Calculated Totals



Total Risk Priority Number for the process	5977

Occ:

Likelihood of Occurrence (1-10)

Det:

Likelihood of Detection (1-10)

NOTE:	1	= Very likely it WILL be detected
	10	= Very likely it WILL NOT be detected

Sev:

Severity (1-10)

RPN:

Risk Priority Number (Occ × Det × Sev)