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Heparin Administration Failure Mode Effects Analysis (FMEA):
Focus on Neonatal and Pediatric Medication Management Processes (Heparin/Heparin Flush)
Failure Cause / Failure Effect / Likelihood of Occurrence / Likelihood of Detection / Severity / RPN=Risk Priority Number (RPN) / Actions to Reduce Occurrence of Failure /Scoring for Failure Modes: Likelihood of Occurrence: 1-10 10=very likely to occur; Likelihood of Detection: 1-10, 10=very unlikely to detect; Severity: 1-10, 10=most severe effect. RPN = the composite of multiplying the Occurrence, Detection and Severity scores. Use the relative values of the RPN to help prioritize failure modes and serve as baseline prior to process changes; recalculate after process improvements to determine impact on risk reduction. /
I. Selection and Procurement
Standardization
A. Availability/supply of standardized/unit dose medication / Potential patient harm: bleeding, thromboses, death / 1. Standardize dosing . Routinely, use only single-dose vials, syringes and/or premixed solutions. Buy specific doses rather than compounding whenever possible. Special dosing compounded in pharmacy only.
2. Eliminate all but the lowest-dose heparin from nursing stations and dispensing units and confine high-dose heparin to separate or high-hazard areas in the pharmacy.
3. Eliminate the 10,000-unit/ml form of heparin in the hospital, substitute heparin 5000 unit/ml (or even better syringe) as a distinction/differention of “1”’s and “10’s”; additional visual differentiation if syringe only carries one concentration and vial another
4. Select primary and backup vendor for procurement
5. Educate staff/physicians/mid-level practitioners to expected sourcing/stocking and visual cues.
6. Limit procurement of premixed IV heparin to pharmacy only (no dual source in materials management, clinical depts., etc.)
B. Vendors have different “nonstandardized” product packaging and dosing / 1. Treat heparin as look-alike, sound alike medication/high alert medications and take appropriate precautions,
2. Buy supply from Mfg who provide packaging with safety alerts
C.. Failure to differentiate among Heparin, hetastarch (Hespan, B. Braun/McGaw) and hetastarch in lactated electrolyte solution (Hextend, Hospira) / 1. Treat products as look-alike, sound alike /high alert medication, see above.
2. Routine Pharmacist review of all physician orders and medication profiles with heparin and related products for possible discrepancies
II. Storage
Appropriate Storage of Different Types of Heparin
A. Same-shelf stocking of heparin flushes with other heparin solutions / Potential patient harm: bleeding, thromboses death / 1. Other heparin solutions are separated, flush dosage is not - provide separate shelving/ storage area for heparin flush.
2. See IV. Preparing and Dispensing below.
B. Multiple types of heparin available / Confusion among products, lack of visual cues / 1. See I. Selection and Procurement above re: standardization
2. See IV. Preparing and Dispensing below.
3. Limit heparin in Automatic Dispensing Machine/Medication storage area to one concentration per drawer
4. Eliminate all but the lowest-dose heparin from nursing stations and dispensing units and confine high-dose heparin to separate or high-hazard areas in the pharmacy.
5. Large volumes of flush for central & umbilical lines must be available only from pharmacy (Pharmacy will dispense on case by case basis)
6. Limit stock of premixed IV heparin to pharmacy only (no dual source in materials management, clinical depts., etc.)
C. Readily available, unrestricted access of heparin on clinical units: heparin stocked as unit stock instead of patient specific dose. / 1. See IV. Preparing and Dispensing
2. Double-check by additional professional when dose retrieved from “open” stock/storage on unit.
3. Reduce or Eliminate any open unit stock .
D. Heparin flush stocked as unit stock instead of patient specific dose.
(failure to treat heparin flush as high risk medication/medical device) / 1. Eliminate heparin flush stock in neonatal areas
2. All neonatal flushes and IV’s containing heparin must be compounded in pharmacy
3. FDA considers heparin flush a device not a medication, clarify in hospital policy how this is to be handled.
4. Recommend continued inclusion of heparin flush on MAR
E. Heparin bins filled by automatic robots / technicians/ pharmacists/ nurses and placed in wrong bins / 1. Routine oversight audits of accuracy of bin refills
2. Competency based orientation with Pre and Post Tests to evaluate knowledge and sustained compliance
F. Heparin expired- automatic dispensing machines/medication storage areas not checked for outdates / 1. Validate that current audit process captures this.
G. Heparin not available-product broken or not stocked / 2. Current redundant processes of stocking capture this component
III. Prescribing/Ordering
A. Unnecessary use of anticoagulants
(knowledge deficit, outdated policy/ procedure) / Potential patient harm: bleeding, thromboses death / 1. Use saline not heparin flushes for peripheral lines
2. Consider use of NS IV bags instead of heparin flush for arterial lines
3. Mix umbilical line flush in pharmacy only
B. Incomplete/incorrect original medication order / 1. Ensure accurate, timely & complete order at time of receipt: name of drug, route, dose and frequency
2. Legible authentication - date, time, signature
IV. Preparation and Dispensing
Accurate/Appropriate Dosing of Heparin
A. Failure to treat heparin as a high risk medication / Potential patient harm: bleeding, thromboses death / 1. Evaluate culture of safety within organization and Pharmacy & Therapeutics Committee
B. Failure to treat heparin flush as high risk medication/ medical device* / *FDA guidelines stipulate that the heparin flush is categorized as a device, however consider placing on MAR anyway!
Neonatal./ pediatric considerations: Adequacy of established procedures and conditions of work:
1. Limit preparation to pharmacy staff only
2. Develop specific work specifications for admixture of neonatal/ pediatric medications:
3. Add two independent checks
4. Consider physically separate neonatal/pediatric medication preparation from other activities ..
5. Address environmental human factors: appropriate light, limit noise and distractions.
6. Specify preparation of only one medication at a time for neonates/pediatrics, keeping workstation clear of any other medications.
7. Keep original source container at workstation for independent verification upon final preparation.
8. Two independent double checks prior to final preparation Avoid confirmation bias – educate staff and physicians on confirmation bias.
IV. Preparation and Dispensing
Dose Discrepancy at Point of Admixture in Pharmacy
C. Adequacy of staffing –
pharmacy / Dosing Errors / 1. Ensure adequate FTE’s available/on-call on 24 hr. basis
2. Ensure appropriate backup and surge plans in place to address staffing requirements
3. Provide appropriate guidance and oversight of HR/competency functions.
· Failure to confirm/track qualifications
· Failure to confirm/track performance
· Adequacy of promotion and termination policies
D. Wrong concentration used-Pharmacy filled wrong
Flush: 10 units/ ml; 100 units/ ml
Vial:
1000 units/ml; 10,000 units /ml
5000 units/ml
5000 unit/0.5ml
Note: An order incorrectly filled and labeled may not be captured via bar coding / Potential patient harm: bleeding, thromboses death / 1. See Staffing C. above
2. Pharmacy dual practitioner check of medication at key preparation and dispensing risk points: (list here)
· At selection of medication
· At labeling of medication container
· Preparation
· Dispensing of medication to point of use
3. Keep original source container at workstation for verification prior/during/post labeling medication.
4. Validation of dual checking must be evident via unique practitioner ID on label.
5. Check med before distributing to unit
6. Consider complexity of process: evaluate control of pharmacy diluting practices: i.e. adult dosing diluted 10 fold prior to compounding. Consider pediatric concentrations whenever possible/practical.
E. Weight based dosing- miscalculation by pharmacy, math error; guidelines not available not in medication preparation area / 1. Current neonatal competency included for all pharmacist/ technicians (annually)
2. Guidelines available, posted in medication preparation area (pharmacy and patient care units)
F. Weight based dosing- miscalculation by nursing, and/ or LIP (Math Error, computer entry error) / 1. Current physician/ nursing competency includes calculation of weight based dosing
G. Weight based dosing - wrong weight recorded by LIP/staff (“guestimation”, etc.) / 1. Staff and contract staff education
2. Initial education and ongoing as defined by the organization
3. Random audits: direct observation, Medical record review and interview of LIP and staff
H. Weight based dosing – weight not communicated to pharmacy by nursing unit / 1. Current process via pharmacy includes double-check of weights prior to preparation, unit is contacted if weight not present and repeats back
IV. Preparation and Dispensing
Heparin Not Available
I. Human Factors:
· Short Staffed
· Overtime-Fatigue
· Multitasking
· Interruptions/distractions
· Lack of concentration
· Knowledge deficit new hire, agency or contract staff;
· Resources: short stock
· Pharmacy does not send or not sent timely
· Sent through tube system to wrong unit, removed from end point and
· Left on wrong unit does not reach destination (lost in transit)
· Interruptions when delivering to unit
· Stored in wrong cassette/ drawer / Omitted dose or inappropriate “borrowed” dose / 1. Ensure design of processes include consideration of:
a. Work space with limited interruptions, noise
b. Appropriate lighting
2. Education on hire and ongoing thereafter; as defined by health care institution
3. Proctoring of new hires (staff agency ,contract individuals and LIPs)
4. Direct random observation of the medication preparation process
5. Any new vendor or supply educate in advance and monitor effectiveness of education
6. Establish par levels for ordering to avoid short stock issues. If forced to compound due to manufacturer shortage, always use a pre-calculated and verified compounding worksheet (e.g. “recipe card”) to prevent math and compounding errors.
7. Monitor the time from preparation to distribution; conduct nursing pharmacy surveys for opportunities for improvement
8. Monitor incident reports for patterns /trends and opportunity for improvement
9. Establish a “no interruption” while preparing medications, or while in the red zone (AKA no interruption zone)
V. Administration
Safe and Efficient Administration of Heparin
A. Failure to treat heparin and/or heparin flush as high risk medication./medical device / Potential patient harm: bleeding, thromboses death / 1. At point of receipt from pharmacy, dual checking of medication by two practitioners (specify level) must occur prior to administration (includes patient name, name of medication, dose, route, frequency)
B. Failure to perform 5 R’s of medication administration at bedside
· Right medication
· Right patient
· Right dose
· Right route
· Right time / 1. Staff competency via computerized LEARN system annually.
2. Staff competency on hire and annual basis must include tow peer to peer observation of 5 R’s. Unit managers randomly observe nursing staff administer medications during year
3. Post 5 R’s at automatic dispensing machines and medication preparation areas/Med Cart as continual reminder
4. Investigate banner as periodic screensaver for selected computers, i.e. Scrolling marquee.
C. Wrong dose administered by clinician , pharmacy sent wrong dose; nurse mixed wrong dose / 1. 5 R’s included in educational competency, includes initial (on hire), annual observational component of medication administration for staff.
2. Admixture controlled via pharmacy/controlled environment with double checks
D. Lack of space at Automatic Dispensing Machine/Medication storage area for safe administration process Inadequate design and maintenance of facilities / 1. Address adequacy of established conditions at work
2. Include costs of space re-design in current and future spaces on clinical units.
E, Adequacy of staffing – nursing / 1. Ensure adequate FTE’s available on 24 hr. basis
2. Ensure appropriate backup and surge plans in place to address staffing requirements
3. Provide appropriate guidance and oversight of HR/competency functions.
· Failure to confirm/track qualifications
· Failure to confirm/track performance
· Adequacy of promotion and termination policies
VI. Effective Monitoring
A. Failure to treat heparin as high risk medication / Potential patient harm: bleeding, thromboses death / 1. Address adequacy of established procedures
B, Failure to treat heparin flush as high risk medication/ medical device / 1. Address adequacy of established procedures
C. Adequacy of staffing – nursing and other providers / 1. Ensure adequate FTE’s available on 24 hr. basis
2. Ensure appropriate backup and surge plans in place to address staffing requirements
3. Provide appropriate guidance and oversight of HR/competency functions.
· Failure to confirm/track qualifications
· Failure to confirm/track performance
· Adequacy of promotion and termination policies
D. Patient monitoring by agency vs. “regular” staff / 1. Provide appropriate guidance and oversight of HR/competency functions.
· Failure to confirm/track qualifications
· Failure to confirm/track performance
· Adequacy of promotion and termination policies
E. Human factors:
· Fatigue
· Distractions/ Multitasking
· Competing Priorities
· Work Environment – noise, lighting, etc.
· Competency
· Appropriate supervision / 1. Designing for safety and control of human factors including:
· Provide adequate break time
· ID of at-risk behavior
· Follow-up on corrective actions
· Report unsafe conditions
2. See C. Adequacy of Staffing above.
3. Enforce rules and regulations of the medical staff. If not then ensure practice follows policy through direct
observation, concurrent medical record audits, etc.
Format derived from http://www.fmeainfocentre.com/examples/FMEA-anticoag-worksheet-empty_scoring.pdf