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

Step	Description



1	Pens will not address existing issues with med 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	2	8	5	80



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

Step	Description



2	Using the insulin pen on multiple patients

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Insulin pen is not labeled with patient name(Assumes pharmacy is delivering the medication)	Label becomes detached, labeled in wrong place on medication	1. Increased infection risk 2. Need for blood borne pathogen testing 3. Wrong dose/medication 4. Death 5. Increased legal risk 6. Increased pt. illness	1	1	7	7



RN did not scan the insulin pen	Lack of education, busy staff/lack of time, unfamiliar with process	1. Increased infection risk 2. Need for blood borne pathogen testing 3. Wrong dose/medication 4. Death 5. Increased legal risk 6. Increased pt. illness	3	8	7	168



Human error	Lack of education, busy staff/lack of time, unfamiliar with process	1. Increased infection risk 2. Need for blood borne pathogen testing 3. Wrong dose/medication 4. Death 5. Increased legal risk 6. Increased pt. illness	3	8	7	168



RN intentionally resuses insulin pen	Lack of education, cost saving efforts, busy staff/time saving	1. Increased infection risk 2. Need for blood borne pathogen testing 3. Wrong dose/medication 4. Death 5. Increased legal risk 6. Increased pt. illness	1	8	7	56



Pt. gets wrong dose or wrong insulin (results in blood exposure)	Lack of education, human error, bust staff/time constraints	1. Increased infection risk 2. Need for blood borne pathogen testing 3. Wrong dose/medication 4. Death 5. Increased legal risk 6. Increased pt. illness	1	8	7	56

Step	Description



3	Drawing insulin out of the pen with a needle

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



To give IV push insulin	Lack of education, human error	1. Pen will be inaccurate after syringe use 2. Increased infection risk 3. Wrong dose/medication 4. Death 5. Increased legal risk 6. Increased pt. illness 7. Introduction of air into the pen	1	8	6	48



Lack of training/awareness	Lack of education, human error	1. Pen will be inaccurate after syringe use 2. Increased infection risk 3. Wrong dose/medication 4. Death 5. Increased legal risk 6. Increased pt. illness 7. Introduction of air into the pen	1	8	6	48



Borrowing insulin	Lack of education, human error	1. Pen will be inaccurate after syringe use 2. Increased infection risk 3. Wrong dose/medication 4. Death 5. Increased legal risk 6. Increased pt. illness 7. Introduction of air into the pen	3	8	7	168



Faulty pen device	Equipment failure, lack of education on proper pen use	1. Pen will be inaccurate after syringe use 2. Increased infection risk 3. Wrong dose/medication 4. Death 5. Increased legal risk 6. Increased pt. illness 7. Introduction of air into the pen	1	8	6	48

Step	Description



4	Not holding the insulin pen for 10 seconds after the injection

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Pt. preference	Patient discomfort, lack of education on proper administration technique	1. Short dosed/hyperglycemia 2. Alteration in future doses	1	1	5	5



Lack of training/awareness and not in procedure manuals or nursing education	Lack of education on proper administration technique	1. Short dosed/hyperglycemia 2. Alteration in future doses	3	1	5	15



RN's are in a hurry	Short staffing, high acuity patients, lack of education on proper adminstration techniques	1. Short dosed/hyperglycemia 2. Alteration in future doses	3	1	5	15



Inconsistent literature on hold time	Lack of education on proper administration technique	1. Short dosed/hyperglycemia 2. Alteration in future doses	1	1	5	5

Step	Description



5	Insulin pen needle is not primed before use

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Lack of education	Education not provided in same format to all shifts, staff misses training, not enough drug reps or materials	1. Short dosed/hyperglycemia 2. Alteration in future doses	2	8	5	80



Human error	Education not provided in same format to all shifts, staff misses training, not enough drug reps or materials, human error, busy staff	1. Short dosed/hyperglycemia 2. Alteration in future doses	2	8	5	80



In a hurry	Education not provided in same format to all shifts, staff misses training, not enough drug reps or materials	1. Short dosed/hyperglycemia 2. Alteration in future doses	2	8	5	80



Equipment failure	Education not provided in same format to all shifts, staff misses training, not enough drug reps or materials	1. Short dosed/hyperglycemia 2. Alteration in future doses	1	1	3	3

Step	Description



6	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



7	Using the wrong insulin pen type (wrong med)

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	2	8	5	80



Short dosed/hyperglycemia or hypoglycemia	Lack of education, busy staff, unfamiliar workflow	Blood sugar fluctuations Wrong drug/dose Overtreatment/Undertreatment Cost Increased LOS	1	8	5	40



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

Step	Description



8	Using too much pressure with the insulin pen on the patient's skin

Failure Mode

Causes

Effects

Occ

Det

Sev

RPN

Actions

Lack of education for the RN or Patient

Lack of education, busy staff, unfamiliar workflow

Discomfort
Incorrect dosing
Patient refusal of medicine
Bruising
Decreased Pt. satisfaction

Technique/Experience

Lack of education, busy staff, unfamiliar workflow

Discomfort
Incorrect dosing
Patient refusal of medicine
Brusiing
Decreased Pt. satisfaction

Step	Description



9	RN dials the incorrect dose

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Lack of education	Lack of education, busy staff, unfamiliar workflow	Incorrect dose Blood sugar fluctuation Overtreatment or undertreatment Hyper/Hypo glycemia Death Increased legal risk/Pt. Harm Increased Cost Increased LOS	1	8	5	40



RN's are unable to see the numbers on the insulin pen dial	Label placement, vision difficulty, busy staff	Incorrect dose Blood sugar fluctation Overtreatment or undertreatment Hyper/Hypo glycemia Death Increased legal risk/Pt. Harm Increased Cost Increased LOS	1	8	5	40



RN misreads the dial	Lack of education, busy staff, unfamiliar workflow		1	8	5	40	Incorrect dose Blood sugar fluctation Overtreatment or undertreatment Hyper/Hypo glycemia Death Increased legal risk/Pt. Harm Increased Cost Increased LOS



RN Fails to double check the dose with another RN	Lack of education, busy staff, unfamiliar workflow, personal choice	Incorrect dose Blood sugar fluctation Overtreatment or undertreatment Hyper/Hypo glycemia Death Increased legal risk/Pt. Harm Increased Cost Increased LOS	4	8	5	160



Defective insulin pen	Equipment failure, improper usuage	Incorrect dose Blood sugar fluctation Overtreatment or undertreatment Hyper/Hypo glycemia Death Increased legal risk/Pt. Harm Increased Cost Increased LOS	1	1	6	6

Step	Description



10	Patient dials incorrect dose

Failure Mode

Causes

Effects

Occ

Det

Sev

RPN

Actions

Lack of patient education

health literacy, staff too busy, conflicting instructions, too many instructions

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

Patient is unable to see or misreads the dial on the insulin pen

Poor vision, lack of education, human error

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

Step	Description



11	Patient receives insulin late

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Pharmacy does not know when insulin pens need to be refilled	Dose variation and lack of trigger to pharmacy that the med is low/out	Overtreatment/Undertreatment Increased LOS Decreased RN and Pt. Satisfaction	8	6	3	144



Nurses inadvertently keep insulin pens in pockets, changing room etc.	Lack of standard storage in/near rooms. Forgetfulness	Overtreatment/Undertreatment Increased LOS Decreased RN and Pt. Satisfaction	5	7	3	105



Lack of standardized storage place for insulin pens in med room/patient's rooms	No place currently in floor plans No current process	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	5	1	3	15



New admission, and RN is waiting for the insulin pen to arrive	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	1	2

Step	Description



12	Lack of visual reference that the correct amount of insulin is given

Failure Mode

Causes

Effects

Occ

Det

Sev

RPN

Actions

Defective pen and/or product design issue

Air entered into device
Design process failure

Overtreatment/Undertreatment
Decreased RN and Pt. Satisfaction

Step	Description



13	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



Volume/Frequency of dose	Lack of awareness	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 satsifaction, Overtreatment or under Treatment, Hyper/Hypoglycemia, Death, Increased Legal Risk/Pt Harm, Decreased RN Satsifaction, Increased LOS, Increased Cost/Waste	1	1	1	1

Step	Description



14	Patient may request one method of insulin adminstration versus the other (i.e. pen or syringe)

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Insulin availability by product type	Manufacturing limitations/issues UIHC Formulary restrictions	Decreased patient satisfaction Increased pharmacy turn around time under dose/over dose	1	1	1	1



Lack of education on how to use syringes	Unfamiliar with mode/process	Decreased satisfaction Increased pharmacy turn around time overdose/underdose	1	1	1	1



Frequency of dose determines mode of adminsitration	Unfamiliar with mode/process	Decreased satisfaction Increased pharmacy turn around time overdose/underdose	1	1	1	1



Amount of dose	Unfamiliar with mode/process	Decreased satisfaction Increased pharmacy turn around time overdose/underdose	1	1	1	1



Order confusion	Unfamiliar mode/process	Decreased satisfaction Increased pharmacy turn around time overdose/underdose	1	1	1	1

Step	Description



15	Pharmacy labeling issues

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Inpatient versus outpatient label issues	Regulatory requirements Lack of staff awareness	Decreased 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



16	Inconsistent practice of handling insulin pens in isolation rooms

Failure Mode

Causes

Effects

Occ

Det

Sev

RPN

Actions

Pens are not cleaned before being returned to the med room

Staff busy
Lack of knowledge
Messiness

Regulation risk
Increased cost
Infected patients/staff
Infection transmission to other patients

800

Pens are left in the patient room

Staff busy
lack of efficiency

Regulation risk
increased cost
infected patient/staff
infection transmission to other patients

Step	Description



17	Needle stick risk for staff

Failure Mode

Causes

Effects

Occ

Det

Sev

RPN

Actions

Pinching the patient skin for adminstration pen technique

Lack of knowledge
Equipment

Body and blood exposure

Device failure

Equipment

Body and blood exposure

Step	Description



18	Lack of process to reduce insulin waste

Failure Mode

Causes

Effects

Occ

Det

Sev

RPN

Actions

Patient receiving pens for only a one time dose

Short LOS
Order set errors

Increased patient cost
increased staff time

Misplaced pen, so a new order is placed, but eventually the orginal pen is found

Lack of awareness
Short LOS

Increased patient cost
increased staff time

Step	Description



19	No standardized process for insulin pen education for patients

Failure Mode	Causes	Effects	Occ	Det	Sev	RPN	Actions



Lack of resources/staff to educate patients	Cost restraints Priority	Increased patient cost Increased harm risk for patients Decreased satisfaction	5	9	9	405



AVS information is confusing and/or contradictory	Epic Lack of resources	Increased patient cost Increased harm risk for patients Decreased satisfaction	10	2	9	180



Lack of weekend, night, holiday availability to educate the patients	Epic Lack of resources	Increased patient cost Increased harm risk for patients Decreased satisfaction	5	9	9	405



Incorrect information is given to the patient.	Epic Lack of resources	Increased patient cost Increased harm risk for patients Decreased satisfaction	2	5	9	90

Calculated Totals



Total Risk Priority Number for the process	4486

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)