medication delivery/ administration failure mode, effects, analysis (fmea) september 2002

Medication Delivery/Administration

Failure Mode, Effects, Analysis (FMEA)

September 2002

Medication Delivery/AdministrationProject - FMEA

A.Team Members

B. Presentation

C. Process Flow Chart

D. Bibliography

Medication Delivery/Administration Team Members

Kristin Gibbons, RN – 14th

Traenette Williams, RN – 14th

Christie Wafford, RN – 12th

Laura Gardner, RPh Mary Beverley – Pharmacy Technician Kim Williamson, RN – CTD

Facilitators Karen Finkel, QOM – Team Lead Carol Miller, QOM Carrie Smith, QOM Cathey Stewart, QOM

Medication Delivery/Administration – What we heard…..

•CSC Assessment (Oct ’01) found:•Inconsistent checking of “5 rights”•Inconsistent checking of MAR with batch delivery•Delays in delivery of meds•Inconsistent practice of 12 hour chart checks

•PCA’s don’t take off orders and avoid the job•Nurses admit they don’t do the batch delivery checks•Nurses don’t always get paged when new meds come up•Nurses don’t trust pharmacy blue bin for new orders•Labels not always placed on yellow copy of order sheet•Pharmacy feels the medication system is safe due to multiple checks•Medication drawers are not consistently locked, locks broken

Agenda

I. Overview

-FMEA methodology

II. Medication delivery/administration 12th. and 14th. Floors

-Strengths and Opportunities

-Benchmark Facilities Comparison

III. Wrap Up

-Modeling TCH to Benchmark/s

FMEA Process

Literature review Identify benchmark facility/s Data analysis High level process review Convene team members Shadow personnel Interviews Use Triage questions to identify failures Conduct hazard analysis

Literature Review & Benchmarks

Literature search ( 27 references) Reviewed sites (16 sites) - Dallas, Cincinnati, Seattle, Wisconsin, Virginia,

Denver, Dayton, Minneapolis, Miami, Cook/Fort Worth, Houston Northwest Medical Center, Houston; Driscoll, Corpus Christi; Wesley Medical Center, Kansas City; UTMB, Galveston; Conroe Regional Medical Center, Conroe; St. Lukes Episcopal Hospital, Houston

Benchmark facility – Univ. of Wisconsin @ Madison (471beds) Primary nursing model Uses McKesson bar coding system – 1 ½ years Does not have an EMR Demonstrated cost savings Demonstrated improvement in patient safety

Literature Review

Recent study (ARCH Intern Med/Vol. 162, Sept 9, 2002)- 19% of the doses were in error- Nearly 1 in every 5 doses in error- 7% of errors rated potentially harmful (40/day in typical 300 bed facility)

Public pressure and awareness to improve system Bar coding – FDA mandate pending

The problem of defective medication administration systems, although varied, is widespread.

Data Review

CSC Data (Oct. 01) TCH Data Wisconsin Data Industry Experience/RN Time – McKesson TCH Observational Study

CSC Data TCH July 00 – June 01

Approx 150 medication errors related to “5 rights” (though difficult to determine the exact cause in all cases)

Approx 95 medication errors related to delays in delivery

Data organization and utility of data unclear which leads to limited ability to identify/problem solve issues and reduce errors

TCH Data –Medication AdministrationCurrent Error Rates

Q3 FY01 – Q2 FY02 Error Rate calculated for:– Wrong time, dose and technique– Omissions– Unauthorized– Other

CSC stated accurate data analysis is problematic due to:– Up to 50% of medication errors

are not reported– Near misses are not reported

True error rate unknown

TCH Data –Reserves and Paid Claims

Money in reserves or paid in claims for Medication Administration Errors for FY 99 – FY 02 (current) was analyzed.

Wisconsin DataMedication Safety Initiative

Preparation/dispensing– Barcodes

Administration- Barcodes

Wisconsin Data –Medication AdministrationInitial 450 Observations (2/01)

Overall error rate less than most literature:– 9.1% total error rate– 5.1% error rate without timing errors

29% patients not observed during administration (left at bedside)

84% did not check armbands 8% of doses not charted accurately

Wisconsin Data –Medication AdministrationPre & Post AcuScan Rx

0.00%1.00%2.00%3.00%4.00%5.00%6.00%7.00%8.00%9.00%

10.00%

Total

Wro

ng T

ime

Wro

ng D

ose

Omiss

ion

Wro

ng T

echn

ique

Unaut

horiz

ed

Feb-01

Feb-02

Most likely to cause harm

McKesson ‘Industry Experience’ – Proportion of RN Time per 12h Shift

0% 5% 10% 15% 20% 25% 30%

Pe

rce

nt

RN

Ho

urs

/ 1

2h

Sh

ift

Medication Planning MAR Comparison

Batch delivery Old order reconciliation

New order reconcilation Documentation of administration

Other Time

TCH Data RN Medication Administration Observation Sept 2002

Study group - 12th and 14th floors Average # scheduled doses per patient/per day = 12 to 17

doses Variables collected:

– Order processing– MAR check am– MAR check pm– Batch delivery– Administration – 5 Rights

RN’s acutely aware that data collection was occurring (practice was affected)

TCH Observation Study12th & 14th FloorOrders Processing

PCA job description allocates 20 % of time to performing clerical functions (e.g. taking orders off chart)

Order sets taken off in a 24 hour period

RN94%

PCA6%

RN

PCA

N=220

TCH Observation Study12th & 14th FloorEstimated RN Hours for Processing Batch Delivery

Total estimated RN time range = 1.24 – 3.30 hours

0

0.5

1

1.5

2

2.5

3

3.5

Batch Delivery

RN

Ho

urs

in

24 H

ou

rs

TCH Observation Study12th & 14th FloorEstimated RN Hours for MAR checks 0700 & 1900

Total estimated RN time range = 2.3 - 9.3 hours

0

1

2

3

4

5

6

MAR am MAR pm

RN

Ho

urs

fo

r 2

Un

its

in 2

4 H

ou

rs

TCH Observation Study12th & 14th FloorEstimated RN Hours for Verification of 5 Rights

0

5

10

15

20

25

30

35

40

Verification of 5 Rights

RN

Ho

urs

in

24

Ho

urs

Total estimated RN time range = 19.32 – 37.78 hours

TCH Observation Study12th & 14th FloorIdentification of Patient – Armband Check by RN

44%

56%

Checked

Not Checked

N=25

Process Review

0800New Order

0900Med

Delivery 0915Medication

Administration1130, 1700, 2300“Batch” Delivery

1900MAR

Check 0500 New MAR

delivery 0700MAR

Check

HourlyMAR Checks

FMEA – Hazard Score Matrix

Frequent 16 12 8 4

Occasional 12 9 6 3

Uncommon 8 6 4 2

Remote 4 3 2 1

Severity of Effect

Catastrophic

Major

Moderate

Minor

Pro

bab

ilit

y

Medication Delivery &Administration

The 12th and 14th Floors are very busy and the physical environment is quiet and well organized. The medication delivery & administration process, however, is very complex.

Areas of Strength

Nursing & Pharmacy staff work hard and always worry about safe care

Bedside medication storage system Chart at bedside Bedside computer terminals Unit dose system Omnicell system for narcotics

Major Areas of Opportunity

The current system is extremely complex. Policies and procedures throughout this system are problematic due to:

difficult to access; procedure sections are very weak; lack of nursing/pharmacy integration; incomplete; and inaccurate.

Inconsistent training content and methods are used by preceptors. MAR’s are not being checked per policy. RN’s are not checking patient armbands. Nurses have assumed clerical duties assigned to the PCA’s. Nurses perform pharmacy delivery duties. Medications are not secured at the beside storage drawer and at Team

Comm A & B.

0800 New Order Hazard Scores of >8

Data Source

I=interview, O=observation, PR= policy review, OR= other reports

Lack of policy/procedure for flagging new ordersMDs add orders in sections already completed by the nurseJob relationship conflict between RN’s & PCA’sMultiple staff take off ordersOrders not consistently taken off by PCA and communicated to RN per policyInconsistent training methods used by preceptorsMultiple methods used for sending orders to pharmacy

I,O,PR

I

I

I,O,PR

I,O

I

I, O

0800

New Order

0900 Medication DeliveryHazard Scores of >8

Lack of policy/procedure for handling medication delivered to unitMultiple staff involved in notification & disbursement of medications

I, PR,O

I, PR,O


Data Source

0900

Med

Delivery

0915 Medication AdministrationHazard Scores of >8

No reminder system to alert nurse of pending medicationsInconsistent verification of new medication ordersOrders entered incorrectly by pharmacyBDM system “glitch” has potential to generate wrong time on sticker Drug envelope label and enclosed drug is discrepantInpatient first dose time difficult to determine due to illegible EC documentation & use of 2 separate forms

I,O,PR

I

I,OR

I

I

I,O

Data Source


0915

Med

Administration

0915 Medication AdministrationHazard Scores of >8

Inconsistent checking of ID band due to familiarity with patientSome patients do not have ID bandNurses frequently paged/interrupted during administration of medicationsDocumentation of dose administered can only be done after administrationLimited training of 5 rights - focus of training is on infrequently done procedures and high risk processes

I,OR,O

I,O

I,O

I,O

I,OR

Data Source


0915

Med

Administration

1130, 1700, 2300“Batch” Delivery Hazard Scores of >8

Lack of nursing policy/procedure for batch delivery checking Lack of nursing policy/procedure for management of discontinued medicationsBatch delivery not included in the nursing orientation pathwayNurses do not check the summary sheet and MAR with the medications received

I,O,PR

I,O,PR

I,OR

I,O,PR


1130,1700,2300

Batch Delivery

1130, 1700, 2300“Batch” Delivery Hazard Scores of >8

Medications are left unsecured in the bedside storage drawer (left unlocked, lock broken, no key)Medications are unsecured in blue bins on Team Comm A & BNo reconciliation of discontinued medications sent back to pharmacy

I, O

I, O

I


1130,1700,2300

Batch Delivery

1900 MAR Check Hazard Scores of >8

1900

Mar Check

Inconsistent content and methods are used by preceptors in training.Policies and procedures (nursing & pharmacy) for conducting the 12 hour chart check are unclear and have conflicting statements.Nurses use individual judgment in conducting the 12 hour chart check. (timing, completeness, method)12 hour chart checks are not consistently done.Staff do not trust that the off going nurse has done an adequate job of checking the MAR.

I, OR

I, PR

I, O

I, O, OR

I


0500 New MAR Delivery Hazard Scores of >8

0500

New MAR

Delivery


Lack of nursing/pharmacy procedure to define this step of the process.Nurses have assumed the PCA responsibility for gathering the MAR, hole punching, and placement of new MAR in notebook.

I, PR

I,O,PR

0700 MAR Check Hazard Scores of >8

Inconsistent content and methods are used by preceptors in training.Policies and procedures (nursing & pharmacy) for conducting the 12 hour chart check are unclear and have conflicting statements.Nurses use individual judgment in conducting the 12 hour chart check. (timing, completeness, method)12 hour chart checks are not consistently done.Staff do not trust that the off going nurse has done an adequate job of checking the MAR.

I

I, PR

I, O

I, O, OR

I


0700

MAR Check

Hourly MAR Checks Hazard Scores of >8

Hourly

MAR Checks

Nurses do not check the MAR’s hourly due to the multiple locations of the MAR forms.

I,O,PR


TCH compared to Benchmark

TCH1. RN primarily, PCA rarely

No specific benchmark1. Unit clerk Cincinnati:1. CPOE

0800 New Order

0900Med

Delivery

1. RN paged to pickup med from desk.

Cincinnati1. Unit clerk delivers med to the

RN.


TCH1. Reliance on human

factors for checking of the “5” rights.

2. Manual documentation of administration.

Wisconsin1. Bar code sweep of

medication, patient armband & RN badge.

2. No documentation time.3. Flag for reminder of meds

pending.4. Warning if drug or patient

not correct.

0915Med

Administration

1130, 1700,2300Batch Delivery

Cincinnati

1. Batch delivery 1-2x day.

2. Delivery to bedside by pharmacy.

1. Batch delivery 3x day.

2. Delivery to med room.

3. RN picks up batch from med room


1900MAR Check

Wisconsin1. No MAR check.

TCH1. RN conducts MAR check.

0500New MARDelivery

1. Pharmacy tubes to floor.2. Receptionist places on

counter.3. RN gathers, punches,

and places in notebooks.

1. No MAR delivery.


0700MAR Check

Wisconsin1. No MAR check.

TCH1. RN conducts MAR check

HourlyMAR Checks

1. RN does hourly check at each workstation.

1. Bar code system alerts when medications are due.

Modeling TCH to Benchmark

0800 New Order0900 Med Delivery(Unit clerk)

Develop a unit secretary role responsible for the clerical tasks being assumed by the RN

– Takes off physician orders– Delivers pharmacy orders to the pharmacist– Conducts hourly rounds for orders– Obtains medications delivered to the unit and delivers to the RN– Delivers discontinued medications to a secured pharmacy bin

Determine the method for flagging orders and implement house-wide

Standardize training methods and materials used by preceptors

0800

New Order

0900

Med

Delivery

0915 Medication Administration(Wisconsin)

Purchase and implement bar coding system Develop 1 FTE job - Bar Code Coordinator Develop timeline for rolling out the product with vendor Develop policies and procedures for medication administration Develop a comprehensive training program for pharmacy, nursing and

medical staff Develop and implement a quality assurance program with defined reporting

and feedback mechanisms to staff &

Revise EC forms to provide capture of all medications administered and communicated to the pharmacy

Design and implement a house-wide nursing education program on the risk of medication administration and related safety issues

0915

Med

Administration

Batch Deliveries(Cincinnati)

1130, 1700,2300

Batch Delivery

Design a secured location for holding discontinued medications Decrease the number of batch deliveries to 1-2 times per day Develop and implement a system in which the batch medications are

delivered to the bedside locked drawer by the pharmacy technician Develop and implement a quality control program to assure all

bedside storage drawers are locked and in good repair

& Investigate methods to assure discontinued medications are returned

to pharmacy and are not lost or stolen

MAR Checks(Wisconsin)

Purchase and implement bar coding system Eliminate 1900 MAR check Eliminate 0500 New MAR delivery Eliminate 0700 MAR check

1900

MAR Check

0500

New MAR

Delivery

0700

MAR Check

Hourly MAR Checks(Wisconsin)

Bar code system provides task list of medications due for the nurse

Hourly

MAR Checks

TCH Observational Study12th & 14th FloorEstimated Annual RN Time Savings/$$

Range from $25,000 to $95,000

$0

$10,000

$20,000

$30,000

$40,000

$50,000

$60,000

MAR am MAR pm Batch Delivery

An

nu

al

Esti

mate

d D

oll

ars

in

RN

Tim

e

Savin

gs

TCH Observational StudyHouse-wide Estimated Annual RN Time Savings/$$

Range from $140,000 to $560,000

$0

$50,000

$100,000

$150,000

$200,000

$250,000

$300,000

$350,000

MAR am MAR pm Batch Delivery

An

nu

al

Esti

mate

d D

oll

ars

in

RN

Tim

e

Savin

gs

Summary

Patient safety and performance improvement: •Implement bar coding system

•Simplify the medication process

Financial perspective:•Limited, if any, savings in hard dollars

•Cost avoidance dollars

($4,000/per single prevention, $100,000/per serious injury)

Summary

Lucian L. Leape, MD, the godfather of patient safety stated…………. 38% of medication errors occur during administration. No human safety net exists for nurses when administering medications. Only 2 percent of errors that reach the point of care are intercepted.

“Systems Analysis of Adverse Drug Events”, JAMA. 1995; 274:35-43

Thank you

QUESTIONS?

medication delivery/ administration failure mode, effects, analysis (fmea) september 2002

Documents

qom slide

medication errors

medication system

data review csc data

bibliography slide

csc data tch

utility of data

delivery data organization